## Protocol Section
### Identification Module
**NCT ID:** NCT00528879

**Brief Title:** A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

**Official Title:** A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

#### Organization Study ID Info
**ID:** MB102-014 LT
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**Domain:** Other Study ID Numbers:
**ID:** MB102-014
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2010-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-10-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-05-02

**Type:** ESTIMATED

**Results First Submit Date:** 2014-02-06

**Results First Submit QC Date:** 2014-04-01

#### Start Date
**Date:** 2007-09

**Status Verified Date:** 2015-09

#### Study First Post Date
**Date:** 2007-09-12
**Type:** ESTIMATED
**Study First Submit Date:** 2007-09-11
**Study First Submit QC Date:** 2007-09-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

### Conditions Module

**Conditions:**

- Type 2 Diabetes

**Keywords:**

- Diabetes Mellitus, Type 2

- Diabetes Mellitus

- Endocrine System Diseases

- Glucose Metabolism Disorders

- Metabolic Diseases

- Metformin

- Hypoglycemic Agents

- Pharmacologic Actions

- Physiological Effects of Drugs

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 915

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**Intervention Names:**

- Drug: Placebo

- Drug: Metformin

**Label:** Placebo + Metformin

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**Intervention Names:**

- Drug: Dapagliflozin

- Drug: Metformin

**Label:** Dapagliflozin, 2.5 mg + Metformin

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**Intervention Names:**

- Drug: Dapagliflozin

- Drug: Metformin

**Label:** Dapagliflozin, 5 mg + Metformin

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**Intervention Names:**

- Drug: Dapagliflozin

- Drug: Placebo

- Drug: Metformin

**Label:** Dapagliflozin, 10 mg + Metformin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dapagliflozin, 10 mg + Metformin

- Dapagliflozin, 2.5 mg + Metformin

- Dapagliflozin, 5 mg + Metformin

**Description:** Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks

**Name:** Dapagliflozin

**Other Names:**

- BMS-512148

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Dapagliflozin, 10 mg + Metformin

- Placebo + Metformin

**Description:** Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Dapagliflozin, 10 mg + Metformin

- Dapagliflozin, 2.5 mg + Metformin

- Dapagliflozin, 5 mg + Metformin

- Placebo + Metformin

**Description:** Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

**Name:** Metformin

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.

**Measure:** Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation

**Time Frame:** From Baseline to end of Long-term Period (Week 102)

**Description:** BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.

**Measure:** Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality

**Time Frame:** Day 1 to Week 102

**Description:** 12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.

**Measure:** Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])

**Time Frame:** Baseline to Week 102

**Description:** Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

**Measure:** Mean Changes From Baseline in Seated Systolic Blood Pressure

**Time Frame:** From Baseline to Week 102

**Description:** Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

**Measure:** Mean Changes From Baseline in Seated Diastolic Blood Pressure

**Time Frame:** From Baseline to Week 102

**Description:** Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of \>20 mm Hg in systolic blood pressure or \>10 mm Hg in diastolic blood pressure.

**Measure:** Number of Participants With Orthostatic Hypotension

**Time Frame:** From Baseline to Week 102

#### Primary Outcomes

**Description:** HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

**Measure:** Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

#### Secondary Outcomes

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

**Measure:** Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.

**Measure:** Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

**Measure:** Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c \> 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

**Measure:** Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.

**Measure:** Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

**Measure:** Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

**Measure:** Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 1

**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

**Measure:** Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])

**Time Frame:** From Baseline to Week 24

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria

* Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
* Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
* C-peptide ≥1.0 ng/mL
* Body mass index ≤45.0 kg/m\^2
* Serum creatinine level \<1.50 mg/dL for men or \<1.40 mg/dL for women.

Key Exclusion Criteria

* Aspartate aminotransferase and/or alanine aminotransferase level \>3.0 times the upper limit of normal
* Serum total bilirubin level \>2 mg/dL
* Creatinine kinase level \>3 times upper limit of normal
* Symptoms of severely uncontrolled diabetes
* Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

**Maximum Age:** 77 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tempe

**Country:** United States

**Facility:** Clinical Research Advantage / Desert Clinical Res, Llc

**State:** Arizona

**Zip:** 85282

**Location 2:**

**City:** Encino

**Country:** United States

**Facility:** Medical Group Of Encino

**State:** California

**Zip:** 91436

**Location 3:**

**City:** Fresno

**Country:** United States

**Facility:** Valley Research

**State:** California

**Zip:** 93720

**Location 4:**

**City:** Los Angeles

**Country:** United States

**Facility:** Randall Shue, D.O.

**State:** California

**Zip:** 90023

**Location 5:**

**City:** Northridge

**Country:** United States

**Facility:** Diabetes Medical Center Of California

**State:** California

**Zip:** 91325

**Location 6:**

**City:** San Diego

**Country:** United States

**Facility:** Ritchken & First M.D.'S

**State:** California

**Zip:** 92117

**Location 7:**

**City:** Spring Valley

**Country:** United States

**Facility:** Encompass Clinical Research

**State:** California

**Zip:** 91978

**Location 8:**

**City:** Torrance

**Country:** United States

**Facility:** Raikhel, Marina

**State:** California

**Zip:** 90505

**Location 9:**

**City:** Colorado Springs

**Country:** United States

**Facility:** Express Care Clinical Res

**State:** Colorado

**Zip:** 80909

**Location 10:**

**City:** Denver

**Country:** United States

**Facility:** Denver Internal Medicine

**State:** Colorado

**Zip:** 80209

**Location 11:**

**City:** Golden

**Country:** United States

**Facility:** New West Physicians

**State:** Colorado

**Zip:** 80401

**Location 12:**

**City:** Altamonte Springs

**Country:** United States

**Facility:** Central Florida Clinical Trials, Inc.

**State:** Florida

**Zip:** 32701

**Location 13:**

**City:** Chipley

**Country:** United States

**Facility:** Family Care Associates Of Nw Florida

**State:** Florida

**Zip:** 32428

**Location 14:**

**City:** Minneapolis

**Country:** United States

**Facility:** Health Partners Research Foundation

**State:** Minnesota

**Zip:** 56440

**Location 15:**

**City:** Chesterfield

**Country:** United States

**Facility:** Woodlake Research

**State:** Missouri

**Zip:** 63017

**Location 16:**

**City:** Las Vegas

**Country:** United States

**Facility:** Nevada Alliance Against Diabetes

**State:** Nevada

**Zip:** 89101

**Location 17:**

**City:** Morehead City

**Country:** United States

**Facility:** Diabetes & Endocrinology Consultants, Pc

**State:** North Carolina

**Zip:** 28557

**Location 18:**

**City:** Newark

**Country:** United States

**Facility:** Newark Physician Associates

**State:** Ohio

**Zip:** 43055

**Location 19:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Integris Family Care S. Penn

**State:** Oklahoma

**Zip:** 73159

**Location 20:**

**City:** Carlisle

**Country:** United States

**Facility:** Cumberland Valley Endocrinology Center, Llc

**State:** Pennsylvania

**Zip:** 17013

**Location 21:**

**City:** Pittsburgh

**Country:** United States

**Facility:** Banksville Medical Pc

**State:** Pennsylvania

**Zip:** 15216

**Location 22:**

**City:** Summerville

**Country:** United States

**Facility:** Palmetto Clinical Research

**State:** South Carolina

**Zip:** 29485

**Location 23:**

**City:** Taylors

**Country:** United States

**Facility:** Southeastern Research Assoc

**State:** South Carolina

**Zip:** 29687

**Location 24:**

**City:** Houston

**Country:** United States

**Facility:** Texas Center For Drug Development, P.A.

**State:** Texas

**Zip:** 77081

**Location 25:**

**City:** San Antonio

**Country:** United States

**Facility:** Diabetes & Glandular Disease Research Associates, Inc.

**State:** Texas

**Zip:** 78229

**Location 26:**

**City:** San Antonio

**Country:** United States

**Facility:** S.A.M. Clinical Research Center

**State:** Texas

**Zip:** 78229

**Location 27:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Optimum Clinical Research

**State:** Utah

**Zip:** 84102

**Location 28:**

**City:** Spokane

**Country:** United States

**Facility:** Office Of Dr. Gray

**State:** Washington

**Zip:** 99216

**Location 29:**

**City:** Capital Federal

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** 1034

**Location 30:**

**City:** Capital Federal

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** 1429

**Location 31:**

**City:** Capital Federal

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** C1056ABJ

**Location 32:**

**City:** Capital Federal

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** C1425AGC

**Location 33:**

**City:** Ciudad Auton.

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** C1505CWB

**Location 34:**

**City:** Ciudad Auton

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** C1408INH

**Location 35:**

**City:** Mar Del Plata

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** 7600

**Location 36:**

**City:** Zarate

**Country:** Argentina

**Facility:** Local Institution

**State:** Buenos Aires

**Zip:** 2800

**Location 37:**

**City:** Villa Carlos Paz

**Country:** Argentina

**Facility:** Local Institution

**State:** Cordoba

**Zip:** 5152

**Location 38:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Local Institution

**Zip:** 1431

**Location 39:**

**City:** Cordoba

**Country:** Argentina

**Facility:** Local Institution

**Zip:** 5000

**Location 40:**

**City:** Fortaleza

**Country:** Brazil

**Facility:** Local Institution

**State:** Ceara

**Zip:** 60021

**Location 41:**

**City:** Itajuba

**Country:** Brazil

**Facility:** Local Institution

**State:** Minas Gerais

**Zip:** 37502

**Location 42:**

**City:** Belem

**Country:** Brazil

**Facility:** Local Institution

**State:** Para

**Zip:** 66073

**Location 43:**

**City:** Caxias Do Sul

**Country:** Brazil

**Facility:** Local Institution

**State:** Rio Grande Do Sul

**Zip:** 95070

**Location 44:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Local Institution

**State:** Rio Grande Do Sul

**Zip:** 90020090

**Location 45:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Local Institution

**State:** Rio Grande Do Sul

**Zip:** 90035

**Location 46:**

**City:** Marilia

**Country:** Brazil

**Facility:** Local Institution

**State:** Sao Paulo

**Zip:** 17519

**Location 47:**

**City:** Rio De Janeiro

**Country:** Brazil

**Facility:** Local Institution

**Zip:** 20211

**Location 48:**

**City:** Calgary

**Country:** Canada

**Facility:** Local Institution

**State:** Alberta

**Zip:** T2R 0X7

**Location 49:**

**City:** Kelowna

**Country:** Canada

**Facility:** Local Institution

**State:** British Columbia

**Zip:** V1Y 2H4

**Location 50:**

**City:** Winnipeg

**Country:** Canada

**Facility:** Local Institution

**State:** Manitoba

**Zip:** R3E 3P4

**Location 51:**

**City:** Bathurst

**Country:** Canada

**Facility:** Local Institution

**State:** New Brunswick

**Zip:** E2A 4X7

**Location 52:**

**City:** Mount Pearl

**Country:** Canada

**Facility:** Local Institution

**State:** Newfoundland and Labrador

**Zip:** A1N 1W7

**Location 53:**

**City:** St-John

**Country:** Canada

**Facility:** Local Institution

**State:** Newfoundland and Labrador

**Zip:** A1E 2E2

**Location 54:**

**City:** Sarnia

**Country:** Canada

**Facility:** Local Institution

**State:** Ontario

**Zip:** N7T 4X3

**Location 55:**

**City:** Thornhill

**Country:** Canada

**Facility:** Local Institution

**State:** Ontario

**Zip:** L4J 8L7

**Location 56:**

**City:** Toronto

**Country:** Canada

**Facility:** Local Institution

**State:** Ontario

**Zip:** M4R 2G4

**Location 57:**

**City:** Toronto

**Country:** Canada

**Facility:** Local Institution

**State:** Ontario

**Zip:** M9W 4L6

**Location 58:**

**City:** Charlottetown

**Country:** Canada

**Facility:** Local Institution

**State:** Prince Edward Island

**Zip:** C1A 5Y9

**Location 59:**

**City:** Drummondville

**Country:** Canada

**Facility:** Local Institution

**State:** Quebec

**Zip:** J2B 7T1

**Location 60:**

**City:** Granby

**Country:** Canada

**Facility:** Local Institution

**State:** Quebec

**Zip:** J2G 8Z9

**Location 61:**

**City:** L'Ancienne Lorette

**Country:** Canada

**Facility:** Local Institution

**State:** Quebec

**Zip:** G2E 2X1

**Location 62:**

**City:** Mirabel

**Country:** Canada

**Facility:** Local Institution

**State:** Quebec

**Zip:** J7J 2K8

**Location 63:**

**City:** St-Leonard

**Country:** Canada

**Facility:** Local Institution

**State:** Quebec

**Zip:** H1S 3A9

**Location 64:**

**City:** Saskatoon

**Country:** Canada

**Facility:** Local Institution

**State:** Saskatchewan

**Zip:** S7K 3H3

**Location 65:**

**City:** Saskatoon

**Country:** Canada

**Facility:** Local Institution

**State:** Saskatchewan

**Zip:** S7K 7H9

**Location 66:**

**City:** Df

**Country:** Mexico

**Facility:** Local Institution

**State:** Distrito Federal

**Zip:** 11800

**Location 67:**

**City:** Guadalajara

**Country:** Mexico

**Facility:** Local Institution

**State:** Distrito Federal

**Zip:** 44670

**Location 68:**

**City:** Zapopan

**Country:** Mexico

**Facility:** Local Institution

**State:** Distrito Federal

**Zip:** 45150

**Location 69:**

**City:** Guadalajara

**Country:** Mexico

**Facility:** Local Institution

**State:** Jalisco

**Zip:** 44650

**Location 70:**

**City:** Guadalajara

**Country:** Mexico

**Facility:** Local Institution

**State:** Jalisco

**Zip:** 44670

**Location 71:**

**City:** Monterrey

**Country:** Mexico

**Facility:** Local Institution

**State:** Nuevo Leon

**Zip:** 64460

**Location 72:**

**City:** Monterrey

**Country:** Mexico

**Facility:** Local Institution

**State:** Nuevo Leon

**Zip:** 64710

**Location 73:**

**City:** Monterrrey

**Country:** Mexico

**Facility:** Local Institution

**State:** Nuevo Leon

**Zip:** 64700

**Location 74:**

**City:** Tampico

**Country:** Mexico

**Facility:** Local Institution

**State:** Tamaulipas

**Zip:** 89109

**Location 75:**

**City:** Durango

**Country:** Mexico

**Facility:** Local Institution

**Zip:** 64710

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.

**PMID:** 33368935

**Citation:** Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.

**PMID:** 31364269

**Citation:** Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.

**PMID:** 27461213

**Citation:** Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.

**PMID:** 26894924

**Citation:** Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43. Erratum In: BMC Med. 2013;11:193.

**PMID:** 23425012

**Citation:** Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.

**PMID:** 20609968

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Type 2 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000077203

- Term: Sodium-Glucose Transporter 2 Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11667

- Name: Metformin

- Relevance: HIGH

- As Found: Assessment

- ID: M348449

- Name: Dapagliflozin

- Relevance: HIGH

- As Found: Intramuscular

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1691

- Name: Sodium-Glucose Transporter 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008687

- Term: Metformin

- ID: C000529054

- Term: Dapagliflozin

### Misc Info Module

#### Removed Countries

- Country: Russian Federation

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo + Metformin

**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**ID:** EG000

**Other Num Affected:** 84

**Other Num at Risk:** 137

**Serious Number Affected:** 14

**Serious Number At Risk:** 137

**Title:** Placebo + Metformin

**Group ID:** EG001

**Title:** Dapagliflozin, 2.5 mg + Metformin

**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**ID:** EG001

**Other Num Affected:** 87

**Other Num at Risk:** 137

**Serious Number Affected:** 15

**Serious Number At Risk:** 137

**Title:** Dapagliflozin, 2.5 mg + Metformin

**Group ID:** EG002

**Title:** Dapagliflozin, 5.0 mg + Metformin

**Description:** Participants received dapagliflozin, 5.0 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**ID:** EG002

**Other Num Affected:** 77

**Other Num at Risk:** 137

**Serious Number Affected:** 9

**Serious Number At Risk:** 137

**Title:** Dapagliflozin, 5.0 mg + Metformin

**Group ID:** EG003

**Title:** Dapagliflozin, 10 mg + Metformin

**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

**ID:** EG003

**Other Num Affected:** 83

**Other Num at Risk:** 135

**Serious Number Affected:** 14

**Serious Number At Risk:** 135

**Title:** Dapagliflozin, 10 mg + Metformin

**Frequency Threshold:** 5

#### Other Events

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

**Term:** Dyslipidaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

#### Serious Events

**Term:** Breast cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Cervical cord compression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Dengue fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Face injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Intervertebral disc protrusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Loss of consciousness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Malignant melanoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Necrobiosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Renal cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Rotator cuff syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Spinal cord injury cervical

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Transient ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Angina pectoris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Lymphocytic leukaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Angina unstable

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Calculus ureteric

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Spinal osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Urethral injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Coronary artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Head injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Inguinal hernia, obstructive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Myocardial ischaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Open fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Rectosigmoid cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Arteriosclerosis coronary artery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Bladder transitional cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Diabetic gastroparesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Ischaemic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Lung neoplasm malignant

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Urinary incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Cardio-respiratory arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Renal failure acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Atrioventricular block second degree

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

**Term:** Basal cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Breast mass

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 135

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 135

**Term:** Postoperative wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 137

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 137

**Group ID:** EG002

**Num At Risk:** 137

**Group ID:** EG003

**Num At Risk:** 135

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 137

**Group ID:** BG001

**Value:** 137

**Group ID:** BG002

**Value:** 137

**Group ID:** BG003

**Value:** 135

**Group ID:** BG004

**Value:** 546

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo + Metformin

**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

### Group

**ID:** BG001

**Title:** Dapagliflozin, 2.5 mg + Metformin

**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

### Group

**ID:** BG002

**Title:** Dapagliflozin, 5 mg + Metformin

**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

### Group

**ID:** BG003

**Title:** Dapagliflozin, 10 mg + Metformin

**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 30

**Upper Limit:** 74

**Value:** 53.7

#### Measurement

**Group ID:** BG001

**Lower Limit:** 30

**Upper Limit:** 76

**Value:** 55.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 33

**Upper Limit:** 75

**Value:** 54.3

#### Measurement

**Group ID:** BG003

**Lower Limit:** 29

**Upper Limit:** 76

**Value:** 52.7

#### Measurement

**Group ID:** BG004

**Lower Limit:** 29

**Upper Limit:** 76

**Value:** 53.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 114

#### Measurement

**Group ID:** BG001

**Value:** 116

#### Measurement

**Group ID:** BG002

**Value:** 119

#### Measurement

**Group ID:** BG003

**Value:** 118

#### Measurement

**Group ID:** BG004

**Value:** 467

**Class Title:** Younger than 65 years

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 17

#### Measurement

**Group ID:** BG003

**Value:** 16

#### Measurement

**Group ID:** BG004

**Value:** 75

**Class Title:** 65 to younger than 75 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 4

**Class Title:** 75 years and older

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 61

#### Measurement

**Group ID:** BG001

**Value:** 67

#### Measurement

**Group ID:** BG002

**Value:** 68

#### Measurement

**Group ID:** BG003

**Value:** 58

#### Measurement

**Group ID:** BG004

**Value:** 254

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 76

#### Measurement

**Group ID:** BG001

**Value:** 70

#### Measurement

**Group ID:** BG002

**Value:** 69

#### Measurement

**Group ID:** BG003

**Value:** 77

#### Measurement

**Group ID:** BG004

**Value:** 292

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 124

#### Measurement

**Group ID:** BG001

**Value:** 117

#### Measurement

**Group ID:** BG002

**Value:** 118

#### Measurement

**Group ID:** BG003

**Value:** 121

#### Measurement

**Group ID:** BG004

**Value:** 480

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 17

**Class Title:** Black/African American

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 11

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 1

**Class Title:** Native Hawaiian/Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 9

**Class Title:** American Indian/Alaskan Native

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 28

**Class Title:** Other

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 22

#### Measurement

**Group ID:** BG003

**Value:** 22

#### Measurement

**Group ID:** BG004

**Value:** 87

**Class Title:** 50 Years and younger

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 49

#### Measurement

**Group ID:** BG002

**Value:** 46

#### Measurement

**Group ID:** BG003

**Value:** 36

#### Measurement

**Group ID:** BG004

**Value:** 167

**Class Title:** Older than 50 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 12

#### Measurement

**Group ID:** BG003

**Value:** 12

#### Measurement

**Group ID:** BG004

**Value:** 37

**Class Title:** <25 kg/m^2

#### Measurement

**Group ID:** BG000

**Value:** 128

#### Measurement

**Group ID:** BG001

**Value:** 133

#### Measurement

**Group ID:** BG002

**Value:** 125

#### Measurement

**Group ID:** BG003

**Value:** 123

#### Measurement

**Group ID:** BG004

**Value:** 509

**Class Title:** ≥25 kg/m^2

#### Measurement

**Group ID:** BG000

**Value:** 115

#### Measurement

**Group ID:** BG001

**Value:** 120

#### Measurement

**Group ID:** BG002

**Value:** 111

#### Measurement

**Group ID:** BG003

**Value:** 106

#### Measurement

**Group ID:** BG004

**Value:** 452

**Class Title:** ≥27 kg/m^2

#### Measurement

**Group ID:** BG000

**Value:** 79

#### Measurement

**Group ID:** BG001

**Value:** 77

#### Measurement

**Group ID:** BG002

**Value:** 81

#### Measurement

**Group ID:** BG003

**Value:** 75

#### Measurement

**Group ID:** BG004

**Value:** 312

**Class Title:** ≥30 kg/m^2

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Female Age
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Body Mass Index
**Unit of Measure:** Participants
**Population Description:** All randomized participants who received at least 1 dose of study medication
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** Clinical.Trials@bms.com
**Organization:** Bristol-Myers Squibb
**Title:** Bristol-Myers Squibb Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.1014
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** Tested at alpha=0.019, applying the Dunnett adjustment
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.38
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.1016
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Tested at alpha=0.019, applying the Dunnett adjustment
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.41
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.1021
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Tested at alpha=0.019, applying the Dunnett adjustment
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.54
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.774
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0019
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -11.8
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.781
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -15.5
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 3.819
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -17.5
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3344
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.32
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3344
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.16
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3365
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.97
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1775
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Median Difference (Final Values)
**Parameter Value:** 7.1
**Statistical Comment:** 
**Statistical Method:** Modified logistic regression
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0275
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 11.7
**Statistical Comment:** 
**Statistical Method:** Modified logistic regression
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0062
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 14.7
**Statistical Comment:** 
**Statistical Method:** Modified logistic regression
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3515
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.68
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3022
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0068
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.84
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3535
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0290
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.78
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3681
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.38
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3745
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.19
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.3791
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.08
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.1109
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.38
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.1129
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0004
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.40
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.1146
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.57
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.769
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -7.1
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.762
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -13.1
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.808
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -17.7
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.9
**Statistical Comment:** 
**Statistical Method:** Modified logistic regression
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8627
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.7
**Statistical Comment:** 
**Statistical Method:** Modified logistic regression
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0149
**P-Value Comment:** Statistically significant according to hierarchical testing procedure (p\<0.05).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 11.3
**Statistical Comment:** 
**Statistical Method:** Modified logistic regression
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0718
- **Upper Limit:** 
- **Value:** -0.30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0715
- **Upper Limit:** 
- **Value:** -0.67
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.0722
- **Upper Limit:** 
- **Value:** -0.70
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.0724
- **Upper Limit:** 
- **Value:** -0.84
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.673
- **Upper Limit:** 
- **Value:** -6.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.663
- **Upper Limit:** 
- **Value:** -17.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.679
- **Upper Limit:** 
- **Value:** -21.5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 2.721
- **Upper Limit:** 
- **Value:** -23.5
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.2368
- **Upper Limit:** 
- **Value:** -0.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.2357
- **Upper Limit:** 
- **Value:** -2.21
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.2358
- **Upper Limit:** 
- **Value:** -3.04
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.2392
- **Upper Limit:** 
- **Value:** -2.86
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37.5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.6
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.2345
- **Upper Limit:** 
- **Value:** -0.53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.2660
- **Upper Limit:** 
- **Value:** -1.21
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.1875
- **Upper Limit:** 
- **Value:** -1.37
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.2595
- **Upper Limit:** 
- **Value:** -1.32
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.2630
- **Upper Limit:** 
- **Value:** -1.01
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.2564
- **Upper Limit:** 
- **Value:** -2.39
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.2661
- **Upper Limit:** 
- **Value:** -3.21
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.2737
- **Upper Limit:** 
- **Value:** -3.09
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 111
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.216
- **Upper Limit:** 
- **Value:** -0.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.380
- **Upper Limit:** 
- **Value:** -1.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.206
- **Upper Limit:** 
- **Value:** -4.0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.230
- **Upper Limit:** 
- **Value:** -3.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.229
- **Upper Limit:** 
- **Value:** -0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.126
- **Upper Limit:** 
- **Value:** -2.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.270
- **Upper Limit:** 
- **Value:** -4.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.329
- **Upper Limit:** 
- **Value:** -5.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.440
- **Upper Limit:** 
- **Value:** 1.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.281
- **Upper Limit:** 
- **Value:** -0.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** -2.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.472
- **Upper Limit:** 
- **Value:** -1.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.610
- **Upper Limit:** 
- **Value:** 1.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.825
- **Upper Limit:** 
- **Value:** 0.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.412
- **Upper Limit:** 
- **Value:** -1.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.544
- **Upper Limit:** 
- **Value:** -0.3
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.763
- **Upper Limit:** 
- **Value:** -0.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.794
- **Upper Limit:** 
- **Value:** -1.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.714
- **Upper Limit:** 
- **Value:** -2.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.758
- **Upper Limit:** 
- **Value:** -1.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.744
- **Upper Limit:** 
- **Value:** -0.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.863
- **Upper Limit:** 
- **Value:** -1.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.769
- **Upper Limit:** 
- **Value:** -2.5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.842
- **Upper Limit:** 
- **Value:** -1.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.861
- **Upper Limit:** 
- **Value:** 0.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.714
- **Upper Limit:** 
- **Value:** -0.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.840
- **Upper Limit:** 
- **Value:** -2.4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** -1.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.929
- **Upper Limit:** 
- **Value:** -1.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.914
- **Upper Limit:** 
- **Value:** -0.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.861
- **Upper Limit:** 
- **Value:** -1.5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.041
- **Upper Limit:** 
- **Value:** -1.2
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0792
- **Upper Limit:** 
- **Value:** -0.31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0774
- **Upper Limit:** 
- **Value:** -0.69
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.0806
- **Upper Limit:** 
- **Value:** -0.71
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.0826
- **Upper Limit:** 
- **Value:** -0.88
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.934
- **Upper Limit:** 
- **Value:** 1.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.981
- **Upper Limit:** 
- **Value:** -6.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.976
- **Upper Limit:** 
- **Value:** -12.0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 2.030
- **Upper Limit:** 
- **Value:** -16.5
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.5
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** PRIMARY
**Unit of Measure:** Percent
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 2
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 3
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication and had nonmissing total body weights at baseline and Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** Kilograms
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 4
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 5
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c \> 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication, who had baseline HbA1c ≥9.0%, and who had nonmissing HbA1c values at Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** Percent
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 6
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication, who had baseline BMI ≥27 kg/m\^2, and who had nonmissing total body weight measurements at Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** Kilograms
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 7
**Description:** AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least 1 dose of blinded study medication
**Reporting Status:** POSTED
**Time Frame:** From Baseline to end of Long-term Period (Week 102)
**Title:** Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 8
**Description:** BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least 1 dose of study medication and who had nonmissing laboratory values at baseline and Week 102.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Week 102
**Title:** Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 9
**Description:** 12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least 1 dose of study medication and who had nonmissing baseline and Week 102 (LOCF) values
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 102
**Title:** Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 10
**Description:** Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 102
**Title:** Mean Changes From Baseline in Seated Systolic Blood Pressure
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** mm Hg
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 11
**Description:** Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 102
**Title:** Mean Changes From Baseline in Seated Diastolic Blood Pressure
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** mm Hg
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 12
**Description:** Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of \>20 mm Hg in systolic blood pressure or \>10 mm Hg in diastolic blood pressure.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received treatment; n=the number of participants who were not missing blood pressure measurements.
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 102
**Title:** Number of Participants With Orthostatic Hypotension
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 13
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication, who had a BMI ≥27 kg/m\^2 at baseline, and who had nonmissing HbA1c values at Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** Percent
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 14
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 1 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 1
**Title:** Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Outcome Measure 15
**Description:** Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received study medication and who had HbA1c values at Baseline and Week 24 (LOCF)
**Reporting Status:** POSTED
**Time Frame:** From Baseline to Week 24
**Title:** Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG000
**Title:** Placebo + Metformin
##### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG002
**Title:** Dapagliflozin, 5 mg + Metformin
##### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** OG003
**Title:** Dapagliflozin, 10 mg + Metformin
### Participant Flow Module
#### Group
**Description:** Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** FG000
**Title:** Placebo + Metformin
#### Group
**Description:** Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** FG001
**Title:** Dapagliflozin, 2.5 mg + Metformin
#### Group
**Description:** Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** FG002
**Title:** Dapagliflozin, 5 mg + Metformin
#### Group
**Description:** Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
**ID:** FG003
**Title:** Dapagliflozin, 10 mg + Metformin
#### Period
**Title:** Short-term Period (Day 1 to Week 24)
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 4
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 5
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 4
###### Reason
**Group ID:** FG003
**Number of Subjects:** 5
##### Withdraw
**Type:** Poor compliance/noncompliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** No longer meets study criteria
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
##### Withdraw
**Type:** Administrative reason by author
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 137
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 137
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 137
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 135
##### Milestone
**Type:** Completed the Period
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 119
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 121
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 122
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 121
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 115
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 120
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 122
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 119
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 15
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 16
#### Period
**Title:** Long-term Period (Weeks 24 to 102)
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 27
###### Reason
**Group ID:** FG001
**Number of Subjects:** 16
###### Reason
**Group ID:** FG002
**Number of Subjects:** 17
###### Reason
**Group ID:** FG003
**Number of Subjects:** 9
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
###### Reason
**Group ID:** FG003
**Number of Subjects:** 4
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 7
##### Withdraw
**Type:** Poor compliance/noncompliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** No longer meets study criteria
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 115
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 120
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 122
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 119
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 73
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 82
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 89
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 95
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 33
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 24
**Pre-Assignment Details:** Of 915 participants enrolled, 562 completed a qualification period. Of these 562 participants, 546 were randomized and received treatment and 16 were excluded due to adverse events (1), no longer meeting study criteria (7), poor compliance or noncompliance (3), withdrawn consent (4), and lost to follow-up (1).
**Has Results:** True