## Protocol Section
### Identification Module
**NCT ID:** NCT01164579

**Brief Title:** Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

**Official Title:** An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

#### Organization Study ID Info
**ID:** A3921068
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
#### Secondary ID Infos
**ID:** 2010-020890-18
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2013-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-04-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-04-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-04-22

**Type:** ESTIMATED

**Results First Submit Date:** 2014-11-05

**Results First Submit QC Date:** 2015-04-21

#### Start Date
**Date:** 2010-10

**Status Verified Date:** 2015-04

#### Study First Post Date
**Date:** 2010-07-16
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-15
**Study First Submit QC Date:** 2010-07-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

### Conditions Module

**Conditions:**

- Rheumatoid Arthritis

**Keywords:**

- Early Rheumatoid Arthritis

- Joint Structure

- Magnetic Resonance Imaging

- Janus Kinase (JAK) Inhibitor

- Tasocitinib

- Tofacitinib

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 109

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Tasocitinib plus Methotrexate

**Label:** Tofacitinib (CP 690,550) 10 mg BID plus MTX

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Tofacitinib plus placebo methotrexate

**Label:** Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: Placebo tofacitinib plus Methotrexate

**Label:** Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tofacitinib (CP 690,550) 10 mg BID plus MTX

**Description:** Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months

**Name:** Tasocitinib plus Methotrexate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX

**Description:** Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.

**Name:** Tofacitinib plus placebo methotrexate

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk

**Description:** Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib

**Name:** Placebo tofacitinib plus Methotrexate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.

**Measure:** Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis

**Time Frame:** Month 3

**Description:** Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.

**Measure:** Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema

**Time Frame:** Month 6

#### Secondary Outcomes

**Description:** Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.

**Measure:** Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis

**Time Frame:** Months 1, 6, and 12

**Description:** Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€"3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€"33% of bone edematous; 2: 34â€"66% of bone edematous; 3: 67â€"100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.

**Measure:** Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP

**Time Frame:** Months 1, 3, and 12

**Description:** Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.

**Measure:** Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions

**Time Frame:** Months 1, 3, 6, and 12

**Description:** Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) plus (+) erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

**Measure:** Modified Total Sharp Score (mTSS) at Months 6 and 12

**Time Frame:** Months 6 and 12

**Description:** Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) + erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

**Measure:** Change From Baseline to Months 6 and 12 in mTSS

**Time Frame:** Months 6 and 12

**Description:** JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

**Measure:** Joint Space Narrowing (JSN) Scores at Months 6 and 12

**Time Frame:** Months 6 and 12

**Description:** JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

**Measure:** Change From Baseline to Months 6 and 12 in JSN Scores

**Time Frame:** Months 6 and 12

**Description:** Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

**Measure:** Erosion Scores at Months 6 and 12

**Time Frame:** Months 6 and 12

**Description:** Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

**Measure:** Change From Baseline to Months 6 and 12 in Erosion Score

**Time Frame:** Months 6 and 12

**Description:** ACR20 response: greater than or equal to (â‰¥)20% improvement in tender joint count; â‰¥20% improvement in swollen joint count; and â‰¥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

**Measure:** Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** ACR50 response: â‰¥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.

**Measure:** Percentage of Participants With an ACR 50% Improvement (ACR50) Response

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** ACR70 response: â‰¥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.

**Measure:** Percentage of Participants With an ACR 70% Improvement (ACR70) Response

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (â‰¤)3.2 implied low disease activity and greater than (\>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (\<)2.6 = remission.

**Measure:** Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])

**Time Frame:** Baseline and Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.

**Measure:** Change From Baseline in DAS28-3 (CRP)

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour \[mm/hour\]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity. DAS28-4 (ESR) â‰¤3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.

**Measure:** Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])

**Time Frame:** Baseline and Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour \[mm/hour\]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.

**Measure:** Change From Baseline in DAS28-4 (ESR)

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).

**Measure:** Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) â‰¤3.2 implied low disease activity.

**Measure:** Percentage of Participants With DAS28-3 (CRP) Score â‰¤3.2

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) \<2.6 implied remission.

**Measure:** Percentage of Participants With DAS28-3 (CRP) Score <2.6

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).

**Measure:** Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) â‰¤3.2 implied low disease activity.

**Measure:** Percentage of Participants With DAS28-4 (ESR) â‰¤3.2

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

**Description:** DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) \<2.6 implied remission.

**Measure:** Percentage of Participants With DAS28-4 (ESR) <2.6

**Time Frame:** Months 1, 2, 3, 6, 9, and 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients with moderate to severe early rheumatoid arthritis (\< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.

Exclusion Criteria:

* Pregnant or lactating patients;
* Patients with renal or hepatic impairment or other severe or progressing disease;
* Patients with contraindication to magnetic resonance imaging with gadolinium contrast.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gilbert

**Country:** United States

**Facility:** ArthroCare, Arthritis Care & Research, PC

**State:** Arizona

**Zip:** 85234

**Location 2:**

**City:** Huntington Beach

**Country:** United States

**Facility:** Talbert Medical Group

**State:** California

**Zip:** 92646

**Location 3:**

**City:** Upland

**Country:** United States

**Facility:** Inland Rheumatology Clinical Trials, Inc.

**State:** California

**Zip:** 91786

**Location 4:**

**City:** Ormond Beach

**Country:** United States

**Facility:** Millennium Research

**State:** Florida

**Zip:** 32174

**Location 5:**

**City:** Pinellas Park

**Country:** United States

**Facility:** DMI Research, Inc.

**State:** Florida

**Zip:** 33782

**Location 6:**

**City:** St. Petersburg

**Country:** United States

**Facility:** St. Petersburg Arthritis Center

**State:** Florida

**Zip:** 33710

**Location 7:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Oklahoma Medical Research Foundation

**State:** Oklahoma

**Zip:** 73104 5005

**Location 8:**

**City:** Allen

**Country:** United States

**Facility:** Office of John P. Lavery, MD, PA

**State:** Texas

**Zip:** 75013

**Location 9:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** OMI - Organización Médica de Investigación

**Zip:** C1015ABO

**Location 10:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Saint Dennis Medical Group S.A.

**Zip:** C1034ACO

**Location 11:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Consultorios Reumatologicos Pampa

**Zip:** C1428DZF

**Location 12:**

**City:** Valdivia

**Country:** Chile

**Facility:** Hospital Base Valdivia

**State:** Region XIV

**Zip:** 5090145

**Location 13:**

**City:** Osorno

**Country:** Chile

**Facility:** Consulta Privada Dr. Juan Ignacio Vargas

**State:** X Region

**Zip:** 5311089

**Location 14:**

**City:** Split

**Country:** Croatia

**Facility:** University Hospital Centre Split,Department for Internal Medicine, Division of Clinical Rheumatology

**Zip:** 21000

**Location 15:**

**City:** Zagreb

**Country:** Croatia

**Facility:** General Hospital Sveti Duh

**Zip:** 10000

**Location 16:**

**City:** Hostivice

**Country:** Czech Republic

**Facility:** ARTMEDI UPD s r.o.

**Zip:** 253 01

**Location 17:**

**City:** Praha 11 - Chodov

**Country:** Czech Republic

**Facility:** DC Mediscan

**Zip:** 148 00

**Location 18:**

**City:** Praha 1

**Country:** Czech Republic

**Facility:** Nemocnice na Frantisku s poliklinikou

**Zip:** 110 00

**Location 19:**

**City:** Praha 1

**Country:** Czech Republic

**Facility:** Nemocnice na Frantisku

**Zip:** 110 00

**Location 20:**

**City:** Praha 2

**Country:** Czech Republic

**Facility:** Revmatologicky ustav

**Zip:** 128 50

**Location 21:**

**City:** Uherske Hradiste

**Country:** Czech Republic

**Facility:** Uherskohradistska nemocnice, a.s.

**Zip:** 686 68

**Location 22:**

**City:** Zlin

**Country:** Czech Republic

**Facility:** Nemocnice Atlas, a.s.

**Zip:** 760 01

**Location 23:**

**City:** Zlin

**Country:** Czech Republic

**Facility:** PV-Medical s.r.o.

**Zip:** 760 01

**Location 24:**

**City:** Balatonfured

**Country:** Hungary

**Facility:** Drug Research Center Kft.

**Zip:** 8230

**Location 25:**

**City:** Budapest

**Country:** Hungary

**Facility:** Orszagos Reumatologiai es Fizioterapias Intezet

**Zip:** 1023

**Location 26:**

**City:** Budapest

**Country:** Hungary

**Facility:** Synexus Magyarorszag Kft.

**Zip:** 1036

**Location 27:**

**City:** Debrecen

**Country:** Hungary

**Facility:** Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Reumatologiai Tanszek

**Zip:** 4032

**Location 28:**

**City:** Gyor

**Country:** Hungary

**Facility:** Petz Aladar Megyei Oktato Korhaz/Reumatologiai es Mozgasszervi Rehabilitacios Centrum

**Zip:** 9027

**Location 29:**

**City:** Mexico

**Country:** Mexico

**Facility:** Centro de Investigacion y Tratamiento Reumatologico S.C.

**State:** D. F.

**Zip:** 11850

**Location 30:**

**City:** Mexico

**Country:** Mexico

**Facility:** Hospital Angeles Mocel

**State:** D.f.

**Zip:** 11850

**Location 31:**

**City:** Mexico

**Country:** Mexico

**Facility:** Centro de Investigacion y Tratamiento Reumatologico SC

**State:** Distrito Federal

**Zip:** 11850

**Location 32:**

**City:** Chapultepec

**Country:** Mexico

**Facility:** Hospital Angeles Mocel

**Zip:** 11850

**Location 33:**

**City:** Chihuahua

**Country:** Mexico

**Facility:** Investigacion y Biomedicina de Chihuahua S.C

**Zip:** 31000

**Location 34:**

**City:** Mexico D.F.

**Country:** Mexico

**Facility:** Hospital Angeles Mocel

**Zip:** 11850

**Location 35:**

**City:** San Luis Potosi

**Country:** Mexico

**Facility:** Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

**Zip:** 78200

**Location 36:**

**City:** Bialystok

**Country:** Poland

**Facility:** Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych J.

**Zip:** 15-879

**Location 37:**

**City:** Poznan

**Country:** Poland

**Facility:** Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

**Zip:** 61-397

**Location 38:**

**City:** Torun

**Country:** Poland

**Facility:** Nzoz "Nasz Lekarz"

**Zip:** 87-100

**Location 39:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** Mindful Medical Research

**Zip:** 00918

**Location 40:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** San Juan Arthritis & Research Center

**Zip:** 00918

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

**PMID:** 34870800

**Citation:** Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

**PMID:** 33127856

**Citation:** van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.

**PMID:** 33057725

**Citation:** Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

**PMID:** 32816215

**Citation:** Conaghan PG, Ostergaard M, Troum O, Bowes MA, Guillard G, Wilkinson B, Xie Z, Andrews J, Stein A, Chapman D, Koenig A. Very early MRI responses to therapy as a predictor of later radiographic progression in early rheumatoid arthritis. Arthritis Res Ther. 2019 Oct 21;21(1):214. doi: 10.1186/s13075-019-2000-1.

**PMID:** 31639034

**Citation:** Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

**PMID:** 28143815

**Citation:** Conaghan PG, Ostergaard M, Bowes MA, Wu C, Fuerst T, van der Heijde D, Irazoque-Palazuelos F, Soto-Raices O, Hrycaj P, Xie Z, Zhang R, Wyman BT, Bradley JD, Soma K, Wilkinson B. Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques. Ann Rheum Dis. 2016 Jun;75(6):1024-33. doi: 10.1136/annrheumdis-2015-208267. Epub 2016 Jan 25.

**PMID:** 27002108

**Citation:** Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

**PMID:** 25047021

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921068&StudyName=Effects%20of%20Tofacitinib%20%28CP-690%2C550%29%20on%20Magnetic%20Resonance%20Imaging%20%28MRI%29-%20Assessed%20Joint%20Structure%20In%20Early%20Rheumatoid%20Arthritis%20%28R

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

### Intervention Browse Module - Ancestors

- ID: D000000020

- Term: Abortifacient Agents, Nonsteroidal

- ID: D000000019

- Term: Abortifacient Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000075242

- Term: Janus Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M11703

- Name: Methotrexate

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M258018

- Name: Tofacitinib

- Relevance: HIGH

- As Found: Voice

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1474

- Name: Janus Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008727

- Term: Methotrexate

- ID: C000479163

- Term: Tofacitinib

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

#### Event Groups

**Group ID:** EG000

**Title:** Tofacitinib (CP-690,550) Plus MTX

**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

**ID:** EG000

**Other Num Affected:** 24

**Other Num at Risk:** 36

**Serious Number Affected:** 2

**Serious Number At Risk:** 36

**Title:** Tofacitinib (CP-690,550) Plus MTX

**Group ID:** EG001

**Title:** Tofacitinib (CP-690,550)

**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

**ID:** EG001

**Other Num Affected:** 31

**Other Num at Risk:** 36

**Serious Number Affected:** 1

**Serious Number At Risk:** 36

**Title:** Tofacitinib (CP-690,550)

**Group ID:** EG002

**Title:** Methotrexate

**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

**ID:** EG002

**Other Num Affected:** 29

**Other Num at Risk:** 37

**Serious Number Affected:** 2

**Serious Number At Risk:** 37

**Title:** Methotrexate

**Frequency Threshold:** 2

#### Other Events

**Term:** Anaemia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Leukopenia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Lymph node pain

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Lymphadenopathy

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Lymphopenia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Macrocytosis

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Neutropenia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Neutrophilia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Normochromic normocytic anaemia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Thrombocytosis

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Angina pectoris

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Myocardial ischaemia

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Palpitations

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Ear pruritus

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Vertigo

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypothyroidism

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Eye disorder

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Lacrimation increased

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Scleritis

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Visual acuity reduced

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Xerophthalmia

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Abdominal distension

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Abdominal pain

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Abdominal pain lower

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Abdominal pain upper

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Abdominal tenderness

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Aphthous stomatitis

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Constipation

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Diarrhoea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Dry mouth

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Dyspepsia

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Food poisoning

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Gastric disorder

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Gastritis

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Gastrooesophageal reflux disease

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hyperchlorhydria

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Irritable bowel syndrome

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Nausea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Stomatitis

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Chest pain

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Local swelling

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Malaise

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Non-cardiac chest pain

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Pyrexia

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Cholelithiasis

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hepatic steatosis

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypertransaminasaemia

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Acute tonsillitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Anal abscess

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Bronchitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Folliculitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Fungal skin infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Furuncle

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Gastroenteritis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Influenza

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Nasopharyngitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Oral fungal infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Oral herpes

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Pharyngitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Pharyngotonsillitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Pneumonia

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Respiratory tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Rhinitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Sinusitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Tonsillitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Tooth abscess

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Tooth infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Upper respiratory tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Urinary tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Viral upper respiratory tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Vulvovaginitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

**Term:** Toxicity to various agents

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA v16.1

**Term:** Alanine aminotransferase increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Aspartate aminotransferase increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Blood bicarbonate decreased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Blood cholesterol increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Blood creatine phosphokinase increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Blood glucose increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Gamma-glutamyltransferase increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Haemoglobin decreased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Hepatic enzyme increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Liver function test abnormal

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Red blood cell count decreased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Transaminases increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Weight increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypercholesterolaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypertriglyceridaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypoglycaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Increased appetite

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Type 2 diabetes mellitus

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Arthralgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Back pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Joint swelling

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Musculoskeletal stiffness

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Myalgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Pain in extremity

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Rheumatoid arthritis

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Rheumatoid nodule

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Tendonitis

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Dizziness

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypoaesthesia

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Sciatica

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Tension headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Depression

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Insomnia

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Dysuria

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Urinary incontinence

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Breast tenderness

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Menorrhagia

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Sexual dysfunction

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Uterine fibrosis

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Vaginal discharge

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Cough

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Epistaxis

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Nasal congestion

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Oropharyngeal pain

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Pharyngeal inflammation

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Rhinitis allergic

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Upper respiratory tract inflammation

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Acne

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Alopecia

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Diffuse alopecia

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Ecchymosis

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Ingrowing nail

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Night sweats

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Pruritus

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Rash

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Rosacea

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v16.1

**Term:** Hypertension

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA v16.1

#### Serious Events

**Term:** Angina pectoris

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA v16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 36

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 36

**Group ID:** EG002

**Num At Risk:** 37

**Term:** Hematochezia

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 36

**Group ID:** EG001

**Num At Risk:** 36

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Cholelithiasis

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA v16.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 36

**Group ID:** EG001

**Num At Risk:** 36

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Anal abscess

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 36

**Group ID:** EG001

**Num At Risk:** 36

**Group ID:** EG002

**Num At Risk:** 37

**Term:** Foot deformity

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v16.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 36

**Group ID:** EG001

**Num At Risk:** 36

**Group ID:** EG002

**Num At Risk:** 37

**Time Frame:** Adverse events were collected up to 28 calendar days after the last administration of investigational product.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 36

**Group ID:** BG001

**Value:** 36

**Group ID:** BG002

**Value:** 37

**Group ID:** BG003

**Value:** 109

**Units:** Participants

### Group

**ID:** BG000

**Title:** Tofacitinib (CP-690,550) Plus MTX

**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

### Group

**ID:** BG001

**Title:** Tofacitinib (CP-690,550)

**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

### Group

**ID:** BG002

**Title:** Methotrexate

**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.3

**Value:** 47.8

#### Measurement

**Group ID:** BG001

**Spread:** 12.8

**Value:** 50.8

#### Measurement

**Group ID:** BG002

**Spread:** 11.6

**Value:** 47.8

#### Measurement

**Group ID:** BG003

**Spread:** 12.2

**Value:** 48.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 29

#### Measurement

**Group ID:** BG003

**Value:** 90

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 19

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** Full Analysis Set (FAS): all participants who were randomized to study medication and received at least 1 dose of randomized study medication.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** ClinicalTrials.gov_Inquiries@pfizer.com
**Organization:** Pfizer, Inc.
**Phone:** 1-800-718-1021
**Title:** Pfizer ClinicalTrials.gov Call Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -1.58
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.31
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.57
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2696
**P-Value Comment:** 2-sided p-value; alpha equals (=) 0.10
**Parameter Type:** Difference in least squares (LS) Mean
**Parameter Value:** -0.63
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.46
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.41
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.57
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3561
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Mean
**Parameter Value:** -0.52
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -2.52
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.58
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.59
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0089
**P-Value Comment:** 2-sided p-value; alpha= 0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.55
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.72
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.59
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0038
**P-Value Comment:** 2-sided p-value; alpha= 0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.74
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -1.19
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.69
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.57
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.6576
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.25
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.09
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.74
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.55
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.7565
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.17
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.89
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.01
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.58
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1038
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.94
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.98
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.04
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.59
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0868
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.01
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.58
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.62
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0103
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.60
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.63
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4350
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.49
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -1.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.56
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.58
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4890
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.40
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.85
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.02
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.57
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8817
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** 0.08
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.21
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.27
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.59
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0351
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.24
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.28
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.37
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.58
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0231
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.32
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -3.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -1.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.62
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0008
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -2.10
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -3.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -1.25
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.63
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0003
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -2.29
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.96
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.19
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2689
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.39
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.58
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.57
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.9935
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** 0
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.15
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.01
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1086
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.57
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.49
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8092
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.08
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.29
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0463
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.71
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.25
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0624
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.67
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.90
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.69
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.37
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.29
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.87
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.65
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.37
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0008
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.26
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -1.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.71
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.72
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5019
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.48
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.28
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.14
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.73
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1462
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.07
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.74
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.72
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.74
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4900
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.51
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.76
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.27
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.75
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0459
**P-Value Comment:** 
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.51
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -1.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.71
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.72
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5019
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.48
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.28
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.14
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.73
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1462
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.07
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.74
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.72
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.74
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4900
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.51
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.76
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.27
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.75
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0459
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.51
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -0.89
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.50
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8959
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.07
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.25
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.43
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.50
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4193
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.41
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.56
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.51
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5764
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.29
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.69
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.02
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.52
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1101
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.83
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** -0.89
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.50
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8959
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.07
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.25
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.43
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.50
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4193
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.41
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.56
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.51
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5764
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.29
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.69
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.02
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.52
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1101
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.83
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** -1.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.16
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2351
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.42
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.27
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.36
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0631
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.67
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.83
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.38
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.36
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5369
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.23
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.37
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0620
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.69
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** -1.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.16
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.35
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2351
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.42
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.27
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.36
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0631
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.67
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.83
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.38
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.36
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5369
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.23
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.37
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0620
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.69
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** -5.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.62
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.24
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2430
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 13.12
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 8.91
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 45.90
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.24
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0147
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 27.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 9.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.54
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.25
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0127
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.03
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 1.73
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 39.41
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.45
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0724
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 20.57
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 10.63
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.35
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.85
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0086
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.49
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -6.54
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.47
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.55
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2808
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 12.46
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 9.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.16
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0115
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.18
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -3.94
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 34.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.56
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1921
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 15.09
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 9.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.16
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0115
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.18
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.05
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 36.79
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.50
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1203
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 17.86
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** 7.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 32.62
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.58
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0078
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 20.15
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 7.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 32.62
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.58
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0078
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 20.15
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 12.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.56
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.37
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0044
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 29.49
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.79
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 33.43
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.92
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0845
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 17.11
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 6.14
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 42.35
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.00
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0275
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 24.24
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 7.71
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 43.63
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.91
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0186
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 25.67
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 17.82
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 53.22
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.75
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0009
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 35.52
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 7.95
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 43.24
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.72
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0169
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 25.60
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 8.91
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 45.90
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.24
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0147
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 27.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -3.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 33.11
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.18
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1882
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.71
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 8.91
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 45.90
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.24
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0147
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 27.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -3.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 33.11
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.18
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1882
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.71
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** 0.78
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 16.35
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 4.73
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0700
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 8.57
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 7.48
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.81
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3102
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 2.85
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 11.73
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 40.30
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.68
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0027
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 26.02
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 3.88
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 29.75
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.86
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0324
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 16.81
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 29.67
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.97
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0969
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.90
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.09
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.84
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.04
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0606
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 16.96
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -4.60
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 29.93
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.49
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2276
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 12.66
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -7.90
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 25.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.23
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3827
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 8.93
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -4.18
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 29.20
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.15
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2177
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 12.50
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.29
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.15
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1558
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -14.89
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 17.36
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.80
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8997
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1.23
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -5.34
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 28.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.36
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2587
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 11.71
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** -0.56
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.13
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Baseline
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.22
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.19
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.43
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Baseline
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.12
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.38
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.50
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.94
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.01
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.22
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.62
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.73
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.70
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.21
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.20
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.18
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.69
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.29
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.81
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.94
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.12
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.41
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.75
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.61
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.18
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.73
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.63
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.18
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.61
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.21
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.13
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.73
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.69
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.10
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.29
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.90
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** -1.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.45
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.26
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0010
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.88
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.24
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.26
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0102
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.67
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.52
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.64
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.27
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.08
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.08
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.20
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.27
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0175
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.64
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.23
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.27
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0125
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.68
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.84
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.05
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.27
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1457
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.39
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.48
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.57
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.28
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0003
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.02
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.49
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.58
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.28
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.03
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.63
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.69
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.28
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.16
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.14
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.20
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.28
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0196
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.67
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.50
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.52
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.30
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0007
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.01
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.35
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.30
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0049
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.84
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 17
#### Analysis
**CI Lower Limit:** -0.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.15
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Baseline
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.19
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.24
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.36
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Baseline
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.06
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.42
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.91
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.01
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.14
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.58
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.82
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.73
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.28
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.25
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.13
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.69
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.55
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.38
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.96
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.12
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.51
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.72
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.43
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.91
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.57
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.24
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.84
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.39
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.11
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.30
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.13
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.59
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.84
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.39
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.11
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.66
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** False
### Outcome Measure 18
#### Analysis
**CI Lower Limit:** -1.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.35
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.29
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0046
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.84
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.11
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.15
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.29
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0303
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.63
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.69
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.68
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.30
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0001
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.18
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.17
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.18
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.30
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0255
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.67
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.39
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.39
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.30
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0035
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.89
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.05
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.05
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.30
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0683
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.55
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.78
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.31
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.29
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.59
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.56
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.31
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0006
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.08
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.62
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.32
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0004
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.15
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.05
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.32
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0706
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.58
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.58
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.33
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0008
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -1.13
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.21
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.33
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0466
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Difference in LS Means
**Parameter Value:** -0.66
**Statistical Comment:** 
**Statistical Method:** mixed model repeated measures analysis
**Tested Non-Inferiority:** False
### Outcome Measure 19
#### Analysis
**CI Lower Limit:** 14.34
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 50.68
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.04
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0032
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 32.51
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 9.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.16
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0115
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.18
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 18.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 50.02
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.48
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 34.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 6.55
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 41.03
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.48
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0231
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 23.79
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 18.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 50.02
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.48
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 34.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 3.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 38.61
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.69
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0493
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 21.02
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 17.92
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 50.43
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.88
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 34.18
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 6.07
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 41.37
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.73
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0270
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 23.72
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 15.80
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 51.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.73
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0018
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 33.46
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 5.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 41.96
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.22
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0363
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 23.49
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 19.16
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 53.64
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.48
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 36.40
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 8.04
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 44.50
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.08
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0177
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 26.27
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 20
#### Analysis
**CI Lower Limit:** 6.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 38.42
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.66
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0197
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 22.52
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -7.09
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 19.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.16
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4379
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.33
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 10.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.34
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.92
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0093
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.37
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.75
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.73
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.48
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1669
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.48
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 10.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.34
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.92
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0093
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.37
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 37.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.64
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0596
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 20.04
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 16.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 52.96
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.07
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0017
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 34.73
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 10.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.69
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.04
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0097
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.52
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 16.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 53.26
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.11
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0016
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 34.97
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 10.28
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 46.91
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.13
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0102
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 28.60
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 16.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 52.96
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.07
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0017
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 34.73
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 4.74
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 41.19
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.07
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0381
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 22.97
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 21
#### Analysis
**CI Lower Limit:** 0.15
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 25.40
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.67
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0959
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 12.77
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -8.58
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 9.19
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 5.40
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.9544
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.30
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 11.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 42.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.34
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0036
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 27.18
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -4.04
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 21.16
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.66
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2640
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 8.55
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.72
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 34.95
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.79
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0544
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 18.83
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -5.96
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 23.38
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.92
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3290
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 8.70
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 13.59
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 48.09
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.48
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0032
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 30.84
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.79
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 33.43
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.92
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0845
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 17.11
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 13.44
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 48.72
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.72
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0037
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 31.08
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.91
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 37.02
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.36
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0540
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 19.96
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 16.70
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 50.39
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.24
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0010
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 33.54
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 3.92
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 35.71
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.66
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0401
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 19.81
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 22
#### Analysis
**CI Lower Limit:** 19.83
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 55.99
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.99
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 37.91
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 14.87
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 51.38
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.09
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0028
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 33.12
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 9.21
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 42.45
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.10
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0105
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 25.83
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -8.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 28.30
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.13
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3700
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 9.98
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 24.11
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 55.53
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.54
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 39.82
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -0.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 36.59
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.24
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1076
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 18.09
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 17.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 50.75
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.21
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0008
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 33.94
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 8.74
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 44.10
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.74
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0139
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 26.42
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 19.16
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 53.64
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.48
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 36.40
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 8.04
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 44.50
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.08
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0177
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 26.27
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 15.80
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 51.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.73
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0018
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 33.46
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 5.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 41.96
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 11.22
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0363
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 23.49
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 23
#### Analysis
**CI Lower Limit:** 5.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 30.10
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.42
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0160
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 17.88
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -3.06
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 14.80
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 5.43
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2798
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 5.86
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 11.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 42.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.34
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0036
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 27.18
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -6.23
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 17.79
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.30
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4287
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 5.78
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.72
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 34.95
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.79
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0544
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 18.83
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 1.39
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 32.69
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.51
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0732
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 17.04
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 4.79
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 39.72
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.61
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0360
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 22.25
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -7.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 25.07
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.85
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3688
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 8.85
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 7.63
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 42.76
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.67
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0182
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 25.19
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -2.29
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.15
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1558
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.41
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 16.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 51.05
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.49
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0012
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 33.78
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.74
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 30.42
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.78
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1426
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 14.33
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
### Outcome Measure 24
#### Analysis
**CI Lower Limit:** -0.75
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 12.52
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 4.03
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1449
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 5.88
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -1.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 7.48
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.81
**Estimate Comment:** 
**Group Description:** Month 1
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3102
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 2.85
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 3.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 26.55
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 7.06
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0342
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.94
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -4.80
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 10.51
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 4.65
**Estimate Comment:** 
**Group Description:** Month 2
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5400
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 2.85
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -5.10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 25.13
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.19
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2759
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 10.01
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -21.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** -0.45
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 6.25
**Estimate Comment:** 
**Group Description:** Month 3
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0859
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -10.73
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.06
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 31.73
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.62
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0985
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 15.89
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -12.86
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 13.61
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.05
**Estimate Comment:** 
**Group Description:** Month 6
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.9628
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.37
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 35.84
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.19
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0612
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 19.07
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -16.08
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 11.43
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.36
**Estimate Comment:** 
**Group Description:** Month 9
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.7807
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.32
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 2.72
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 34.95
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.79
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0544
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 18.83
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -8.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 20.18
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 8.66
**Estimate Comment:** 
**Group Description:** Month 12
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4937
**P-Value Comment:** 2-sided p-value; alpha=0.10
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 5.93
**Statistical Comment:** 
**Statistical Method:** Normal approximation to the binomial
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** -0.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.40
- **Upper Limit:** 
- **Value:** -0.69
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.40
- **Upper Limit:** 
- **Value:** -0.17
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** -1.26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -1.45
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** 0.29
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -0.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.40
- **Upper Limit:** 
- **Value:** -0.34
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.38
- **Upper Limit:** 
- **Value:** -0.17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.40
- **Upper Limit:** 
- **Value:** -1.22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** -1.29
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -0.28
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** -2.26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.43
- **Upper Limit:** 
- **Value:** -1.16
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.46
- **Upper Limit:** 
- **Value:** -0.66
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.43
- **Upper Limit:** 
- **Value:** -0.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** 0.19
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.39
- **Upper Limit:** 
- **Value:** 0.11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -0.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** -0.86
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** 0.47
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** -1.52
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.43
- **Upper Limit:** 
- **Value:** -1.70
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.46
- **Upper Limit:** 
- **Value:** 0.59
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.27
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.24
- **Upper Limit:** 
- **Value:** 0.27
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.24
- **Upper Limit:** 
- **Value:** 0.36
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.02
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.65
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.08
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.26
- **Upper Limit:** 
- **Value:** 1.18
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.50
- **Upper Limit:** 
- **Value:** 11.28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.51
- **Upper Limit:** 
- **Value:** 10.70
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 11.77
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.51
- **Upper Limit:** 
- **Value:** 11.70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 10.69
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.54
- **Upper Limit:** 
- **Value:** 12.21
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.50
- **Upper Limit:** 
- **Value:** 0.44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.51
- **Upper Limit:** 
- **Value:** -0.14
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 0.93
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.51
- **Upper Limit:** 
- **Value:** 0.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** -0.15
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.54
- **Upper Limit:** 
- **Value:** 1.36
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.34
- **Upper Limit:** 
- **Value:** 5.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.35
- **Upper Limit:** 
- **Value:** 5.11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.36
- **Upper Limit:** 
- **Value:** 5.52
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.35
- **Upper Limit:** 
- **Value:** 5.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.36
- **Upper Limit:** 
- **Value:** 5.05
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.37
- **Upper Limit:** 
- **Value:** 5.88
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.34
- **Upper Limit:** 
- **Value:** 0.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.35
- **Upper Limit:** 
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.36
- **Upper Limit:** 
- **Value:** 0.35
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.35
- **Upper Limit:** 
- **Value:** 0.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.36
- **Upper Limit:** 
- **Value:** -0.12
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.37
- **Upper Limit:** 
- **Value:** 0.71
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.24
- **Upper Limit:** 
- **Value:** 5.84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 5.59
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 6.26
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 6.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.26
- **Upper Limit:** 
- **Value:** 5.64
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.27
- **Upper Limit:** 
- **Value:** 6.33
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.24
- **Upper Limit:** 
- **Value:** 0.16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.58
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** 0.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.26
- **Upper Limit:** 
- **Value:** -0.05
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.27
- **Upper Limit:** 
- **Value:** 0.65
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.14
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68.57
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.54
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.65
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.67
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.95
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.24
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.24
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.86
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.22
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.57
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.00
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.32
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.22
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.62
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.73
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.57
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.86
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.22
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.41
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.81
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30.56
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.62
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.92
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.62
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.96
- **Upper Limit:** 
- **Value:** 5.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.78
- **Upper Limit:** 
- **Value:** 5.48
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.80
- **Upper Limit:** 
- **Value:** 5.36
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.15
- **Upper Limit:** 
- **Value:** 3.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.91
- **Upper Limit:** 
- **Value:** 4.03
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.07
- **Upper Limit:** 
- **Value:** 4.65
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.17
- **Upper Limit:** 
- **Value:** 2.99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.15
- **Upper Limit:** 
- **Value:** 3.52
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.31
- **Upper Limit:** 
- **Value:** 4.21
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.02
- **Upper Limit:** 
- **Value:** 3.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.09
- **Upper Limit:** 
- **Value:** 3.46
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.43
- **Upper Limit:** 
- **Value:** 3.87
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.15
- **Upper Limit:** 
- **Value:** 2.74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.95
- **Upper Limit:** 
- **Value:** 2.75
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.49
- **Upper Limit:** 
- **Value:** 3.92
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.98
- **Upper Limit:** 
- **Value:** 2.37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.90
- **Upper Limit:** 
- **Value:** 2.85
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.63
- **Upper Limit:** 
- **Value:** 3.58
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.02
- **Upper Limit:** 
- **Value:** 2.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.05
- **Upper Limit:** 
- **Value:** 2.68
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.40
- **Upper Limit:** 
- **Value:** 3.58
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -1.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.18
- **Upper Limit:** 
- **Value:** -1.40
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.18
- **Upper Limit:** 
- **Value:** -0.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -2.32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -1.88
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -1.24
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -2.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -1.96
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -1.57
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -2.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -2.55
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.19
- **Upper Limit:** 
- **Value:** -1.52
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -2.92
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -2.43
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -1.76
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -2.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -2.61
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -1.77
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.94
- **Upper Limit:** 
- **Value:** 6.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.75
- **Upper Limit:** 
- **Value:** 6.50
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.78
- **Upper Limit:** 
- **Value:** 6.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.37
- **Upper Limit:** 
- **Value:** 4.60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.12
- **Upper Limit:** 
- **Value:** 4.93
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.09
- **Upper Limit:** 
- **Value:** 5.51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.34
- **Upper Limit:** 
- **Value:** 3.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.40
- **Upper Limit:** 
- **Value:** 4.36
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.26
- **Upper Limit:** 
- **Value:** 5.05
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.16
- **Upper Limit:** 
- **Value:** 3.66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.31
- **Upper Limit:** 
- **Value:** 4.12
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.63
- **Upper Limit:** 
- **Value:** 4.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.45
- **Upper Limit:** 
- **Value:** 3.32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.20
- **Upper Limit:** 
- **Value:** 3.51
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.76
- **Upper Limit:** 
- **Value:** 4.75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.27
- **Upper Limit:** 
- **Value:** 3.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.10
- **Upper Limit:** 
- **Value:** 3.58
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.91
- **Upper Limit:** 
- **Value:** 4.17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.22
- **Upper Limit:** 
- **Value:** 3.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.36
- **Upper Limit:** 
- **Value:** 3.47
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.76
- **Upper Limit:** 
- **Value:** 4.13
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -1.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -1.57
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -0.94
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -2.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -2.08
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -1.41
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -2.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -2.35
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -1.80
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -3.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -2.81
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -1.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -3.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -2.72
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.23
- **Upper Limit:** 
- **Value:** -2.14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -3.31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** -2.84
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.24
- **Upper Limit:** 
- **Value:** -2.18
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.43
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.24
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80.56
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.76
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77.78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.76
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88.24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77.78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.05
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.95
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.22
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.95
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.14
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.81
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.62
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 41.67
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.62
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.56
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.03
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.00
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.03
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.71
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.41
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.67
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.22
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.22
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38.89
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.92
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.51
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62.86
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.46
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.35
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77.78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.35
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.22
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.95
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.95
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.57
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.89
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30.56
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 41.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.92
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.92
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30.56
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.22
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.86
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.56
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.78
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.89
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.89
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.22
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.44
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.51
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set: all randomized participants who received at least 1 dose of the randomized investigational drug and for whom a variable is nonmissing at both baseline and the specified timepoint.
**Reporting Status:** POSTED
**Time Frame:** Month 3
**Title:** Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 2
**Description:** Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set
**Reporting Status:** POSTED
**Time Frame:** Month 6
**Title:** Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 3
**Description:** Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set
**Reporting Status:** POSTED
**Time Frame:** Months 1, 6, and 12
**Title:** Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 4
**Description:** Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€"3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€"33% of bone edematous; 2: 34â€"66% of bone edematous; 3: 67â€"100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 3, and 12
**Title:** Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 5
**Description:** Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set
**Reporting Status:** POSTED
**Time Frame:** Months 1, 3, 6, and 12
**Title:** Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 6
**Description:** Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) plus (+) erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 6 and 12
**Title:** Modified Total Sharp Score (mTSS) at Months 6 and 12
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 7
**Description:** Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) + erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 6 and 12
**Title:** Change From Baseline to Months 6 and 12 in mTSS
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 8
**Description:** JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 6 and 12
**Title:** Joint Space Narrowing (JSN) Scores at Months 6 and 12
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 9
**Description:** JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 6 and 12
**Title:** Change From Baseline to Months 6 and 12 in JSN Scores
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 10
**Description:** Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 6 and 12
**Title:** Erosion Scores at Months 6 and 12
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 11
**Description:** Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 6 and 12
**Title:** Change From Baseline to Months 6 and 12 in Erosion Score
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 12
**Description:** ACR20 response: greater than or equal to (â‰¥)20% improvement in tender joint count; â‰¥20% improvement in swollen joint count; and â‰¥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
**Parameter Type:** NUMBER
**Population Description:** FAS Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders. n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 13
**Description:** ACR50 response: â‰¥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assess for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With an ACR 50% Improvement (ACR50) Response
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 14
**Description:** ACR70 response: â‰¥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With an ACR 70% Improvement (ACR70) Response
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 15
**Description:** DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (â‰¤)3.2 implied low disease activity and greater than (\>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (\<)2.6 = remission.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** FAS; n=number of participants assess for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Months 1, 2, 3, 6, 9, and 12
**Title:** Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 16
**Description:** DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** FAS; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Change From Baseline in DAS28-3 (CRP)
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 17
**Description:** DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour \[mm/hour\]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity. DAS28-4 (ESR) â‰¤3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** FAS; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Months 1, 2, 3, 6, 9, and 12
**Title:** Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 18
**Description:** DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour \[mm/hour\]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** FAS; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Change From Baseline in DAS28-4 (ESR)
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 19
**Description:** DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 20
**Description:** DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) â‰¤3.2 implied low disease activity.
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With DAS28-3 (CRP) Score â‰¤3.2
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 21
**Description:** DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) \<2.6 implied remission.
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With DAS28-3 (CRP) Score <2.6
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 22
**Description:** DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 23
**Description:** DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) â‰¤3.2 implied low disease activity.
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With DAS28-4 (ESR) â‰¤3.2
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
#### Outcome Measure 24
**Description:** DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) \<2.6 implied remission.
**Parameter Type:** NUMBER
**Population Description:** FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
**Reporting Status:** POSTED
**Time Frame:** Months 1, 2, 3, 6, 9, and 12
**Title:** Percentage of Participants With DAS28-4 (ESR) <2.6
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG000
**Title:** Tofacitinib (CP-690,550) Plus MTX
##### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG001
**Title:** Tofacitinib (CP-690,550)
##### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** OG002
**Title:** Methotrexate
### Participant Flow Module
#### Group
**Description:** Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** FG000
**Title:** Tofacitinib (CP-690,550) Plus Methotrexate (MTX)
#### Group
**Description:** Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** FG001
**Title:** Tofacitinib (CP-690,550)
#### Group
**Description:** Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
**ID:** FG002
**Title:** Methotrexate
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 5
##### Withdraw
**Type:** Reason not specified
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 36
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 36
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 37
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 21
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 16
**Has Results:** True