## Protocol Section
### Identification Module
**NCT ID:** NCT03500679

**Brief Title:** A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older

**Official Title:** A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older

#### Organization Study ID Info
**ID:** CR108447
#### Organization
**Class:** INDUSTRY
**Full Name:** Janssen Research & Development, LLC
#### Secondary ID Infos
**Domain:** Janssen Research & Development, LLC
**ID:** 63871860BAC2003
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-06-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-11-26

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-11-26

**Type:** ACTUAL

**Results First Submit Date:** 2019-11-06

**Results First Submit QC Date:** 2019-11-06

#### Start Date
**Date:** 2018-05-09

**Type:** ACTUAL

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2018-04-18
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-10
**Study First Submit QC Date:** 2018-04-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Janssen Research & Development, LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive vaccination of ExPEC4V dose as an intramuscular (IM) injection into deltoid muscle on Days 1 and 181. The ExPEC4V doses contain polysaccharide antigen (4:4:4:8 microgram \[mcg\]) from the ExPEC4V serotypes O1A, O2, O6A, and O25B.

**Intervention Names:**

- Biological: ExPEC4V

**Label:** Group 1: ExPEC4V (JNJ-63871860)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive placebo matching to ExPEC4V as an IM injection on Days 1 and 181.

**Intervention Names:**

- Biological: Placebo

**Label:** Group 2: Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1: ExPEC4V (JNJ-63871860)

**Description:** Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.

**Name:** ExPEC4V

**Other Names:**

- JNJ-63871860

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Group 2: Placebo

**Description:** Participants will receive placebo as an IM injection on Days 1 and 181.

**Name:** Placebo

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.

**Measure:** Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination

**Time Frame:** 14 days after first vaccination (Day 1 to Day 15)

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

**Measure:** Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination

**Time Frame:** 14 days after first vaccination (Day 1 to Day 15)

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

**Measure:** Percentage of Participants With Unsolicited Adverse Events After First Vaccination

**Time Frame:** 29 days after first vaccination (Day 1 to Day 30)

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.

**Measure:** Number of Participants With Serious Adverse Events (SAEs) After First Vaccination

**Time Frame:** Up to Day 180

**Description:** Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported.

**Measure:** Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1

**Time Frame:** Day 1

**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported.

**Measure:** ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15

**Time Frame:** Day 15

**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.

**Measure:** ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1

**Time Frame:** Day 15/Day 1

**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported.

**Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15

**Time Frame:** Day 15

#### Secondary Outcomes

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.

**Measure:** Percentage of Participants With Solicited Local Adverse Events After Second Vaccination

**Time Frame:** 14 days after second vaccination (Day 181 to Day 195)

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

**Measure:** Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination

**Time Frame:** 14 days after second vaccination (Day 181 to Day 195)

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

**Measure:** Percentage of Participants With Unsolicited Adverse Events After Second Vaccination

**Time Frame:** 29 days after second vaccination (Day 181 to Day 210)

**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.

**Measure:** Number of Participants With Serious Adverse Events After Second Vaccination

**Time Frame:** Day 181 until Day 360

**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported.

**Measure:** Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15

**Time Frame:** Days 1 and 15

**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.

**Measure:** OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1

**Time Frame:** Day 15/Day 1

**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported.

**Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15

**Time Frame:** Day 15

**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.

**Measure:** ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195

**Time Frame:** Days 181 and 195

**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported.

**Measure:** ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1

**Time Frame:** Day 181/Day 1 and Day 195/Day 1

**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported.

**Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195

**Time Frame:** Days 181 and 195

**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.

**Measure:** OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195

**Time Frame:** Days 181 and 195

**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported.

**Measure:** OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1

**Time Frame:** Day 181/Day 1 and Day 195/Day 1

**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported.

**Measure:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195

**Time Frame:** Days 181 and 195

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
* Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination
* Participant must have a body mass index (BMI) of less than or equal to (\<=)35.0 kilogram per square meter (kg/m\^2)
* Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies
* All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination)

Exclusion Criteria:

* Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders
* Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients
* Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy
* Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy
* Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome)
* Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wichita

**Country:** United States

**Facility:** Heartland Clinical Research

**State:** Kansas

**Zip:** 67207

**Location 2:**

**City:** Knoxville

**Country:** United States

**Facility:** VGR & NOCCR - Knoxville

**State:** Tennessee

**Zip:** 37920

#### Overall Officials

**Official 1:**

**Affiliation:** Janssen Research & Development, LLC

**Name:** Janssen Research & Development, LLC Clinical Trial

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-12-19

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1191591

- Type Abbrev: Prot

- Upload Date: 2019-11-06T09:39

- Date: 2019-05-22

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 865145

- Type Abbrev: SAP

- Upload Date: 2019-11-06T09:39

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.

#### Event Groups

**Group ID:** EG000

**Title:** ExPEC4V

**Deaths Num At Risk:** 75

**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.

**ID:** EG000

**Other Num Affected:** 54

**Other Num at Risk:** 75

**Serious Number Affected:** 2

**Serious Number At Risk:** 75

**Title:** ExPEC4V

**Group ID:** EG001

**Title:** Placebo

**Deaths Num At Risk:** 25

**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.

**ID:** EG001

**Other Num Affected:** 17

**Other Num at Risk:** 25

**Serious Number Affected:** 1

**Serious Number At Risk:** 25

**Title:** Placebo

**Frequency Threshold:** 3

#### Other Events

**Term:** Bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Erythema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Pain/Tenderness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Herpes Zoster

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Blood Pressure Diastolic Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Blood Pressure Systolic Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Respiratory Rate Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Gout

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Oropharyngeal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Diastolic Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 21.1

**Term:** Systolic Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 21.1

#### Serious Events

**Term:** Osteoarthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA Version 21.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 75

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 25

**Term:** Breast Cancer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA Version 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 75

**Group ID:** EG001

**Num At Risk:** 25

**Term:** Deep Vein Thrombosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA Version 21.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 75

**Group ID:** EG001

**Num At Risk:** 25

**Time Frame:** Up to Day 360

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 75

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 100

**Units:** Participants

### Group

**ID:** BG000

**Title:** ExPEC4V

**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 18.86

**Value:** 55.7

#### Measurement

**Group ID:** BG001

**Spread:** 17.56

**Value:** 56.4

#### Measurement

**Group ID:** BG002

**Spread:** 18.45

**Value:** 55.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 52

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 48

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 69

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 92

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 63

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 85

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 8

**Class Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 61

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 82

**Class Title:** White Non-Hispanic

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 75

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 100

**Class Title:** UNITED STATES

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialDisclosure@its.jnj.com
**Organization:** Janssen Research & Development, LLC
**Phone:** 844-434-4210
**Title:** Senior Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 27.64
- **Spread:** 
- **Upper Limit:** 50.62
- **Value:** 38.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.83
- **Spread:** 
- **Upper Limit:** 40.70
- **Value:** 20.0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 37.58
- **Spread:** 
- **Upper Limit:** 61.14
- **Value:** 49.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.83
- **Spread:** 
- **Upper Limit:** 40.70
- **Value:** 20.0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.53
- **Spread:** 
- **Upper Limit:** 42.38
- **Value:** 30.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.95
- **Spread:** 
- **Upper Limit:** 53.50
- **Value:** 32.0
**Title:** 
#### Outcome Measure 4
**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
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2412.54
- **Spread:** 
- **Upper Limit:** 4185.68
- **Value:** 3177.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1910.56
- **Spread:** 
- **Upper Limit:** 5074.63
- **Value:** 3113.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2865.83
- **Spread:** 
- **Upper Limit:** 4517.54
- **Value:** 3598.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2182.46
- **Spread:** 
- **Upper Limit:** 7805.05
- **Value:** 4127.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 664.08
- **Spread:** 
- **Upper Limit:** 1125.58
- **Value:** 864.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 473.94
- **Spread:** 
- **Upper Limit:** 1411.46
- **Value:** 817.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 285.25
- **Spread:** 
- **Upper Limit:** 493.69
- **Value:** 375.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 288.87
- **Spread:** 
- **Upper Limit:** 1050.27
- **Value:** 550.8
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13048.22
- **Spread:** 
- **Upper Limit:** 22227.66
- **Value:** 17030.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1749.61
- **Spread:** 
- **Upper Limit:** 4604.01
- **Value:** 2838.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33459.35
- **Spread:** 
- **Upper Limit:** 59729.66
- **Value:** 44704.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2129.94
- **Spread:** 
- **Upper Limit:** 6643.37
- **Value:** 3761.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6241.05
- **Spread:** 
- **Upper Limit:** 10791.06
- **Value:** 8206.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 444.10
- **Spread:** 
- **Upper Limit:** 1253.75
- **Value:** 746.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4280.78
- **Spread:** 
- **Upper Limit:** 8784.88
- **Value:** 6132.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 249.47
- **Spread:** 
- **Upper Limit:** 874.61
- **Value:** 467.1
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.142
- **Spread:** 
- **Upper Limit:** 6.568
- **Value:** 5.22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.799
- **Spread:** 
- **Upper Limit:** 1.040
- **Value:** 0.91
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.221
- **Spread:** 
- **Upper Limit:** 15.771
- **Value:** 12.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.682
- **Spread:** 
- **Upper Limit:** 1.149
- **Value:** 0.89
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.515
- **Spread:** 
- **Upper Limit:** 11.379
- **Value:** 8.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.817
- **Spread:** 
- **Upper Limit:** 1.079
- **Value:** 0.94
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.460
- **Spread:** 
- **Upper Limit:** 17.090
- **Value:** 12.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.658
- **Spread:** 
- **Upper Limit:** 1.159
- **Value:** 0.87
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 71.47
- **Spread:** 
- **Upper Limit:** 90.16
- **Value:** 82.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 45.41
- **Spread:** 
- **Upper Limit:** 69.03
- **Value:** 57.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 82.96
- **Spread:** 
- **Upper Limit:** 96.92
- **Value:** 91.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 73.05
- **Spread:** 
- **Upper Limit:** 91.21
- **Value:** 83.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 74.64
- **Spread:** 
- **Upper Limit:** 92.23
- **Value:** 84.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 63.86
- **Spread:** 
- **Upper Limit:** 84.68
- **Value:** 75.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 79.54
- **Spread:** 
- **Upper Limit:** 95.15
- **Value:** 89.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 63.86
- **Spread:** 
- **Upper Limit:** 84.68
- **Value:** 75.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33.45
- **Spread:** 
- **Upper Limit:** 58.12
- **Value:** 45.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.11
- **Spread:** 
- **Upper Limit:** 21.12
- **Value:** 4.2
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 36.22
- **Spread:** 
- **Upper Limit:** 60.97
- **Value:** 48.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.62
- **Spread:** 
- **Upper Limit:** 51.09
- **Value:** 29.2
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.22
- **Spread:** 
- **Upper Limit:** 21.87
- **Value:** 11.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.03
- **Spread:** 
- **Upper Limit:** 27.00
- **Value:** 8.3
**Title:** 
#### Outcome Measure 12
**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
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 131.76
- **Spread:** 
- **Upper Limit:** 186.53
- **Value:** 156.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 116.55
- **Spread:** 
- **Upper Limit:** 256.69
- **Value:** 173.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 535.33
- **Spread:** 
- **Upper Limit:** 1010.75
- **Value:** 735.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 111.87
- **Spread:** 
- **Upper Limit:** 244.12
- **Value:** 165.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 167.79
- **Spread:** 
- **Upper Limit:** 255.74
- **Value:** 207.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 179.18
- **Spread:** 
- **Upper Limit:** 485.64
- **Value:** 295.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1896.34
- **Spread:** 
- **Upper Limit:** 3751.64
- **Value:** 2667.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 156.39
- **Spread:** 
- **Upper Limit:** 373.80
- **Value:** 241.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 229.09
- **Spread:** 
- **Upper Limit:** 405.46
- **Value:** 304.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 217.04
- **Spread:** 
- **Upper Limit:** 667.59
- **Value:** 380.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 632.29
- **Spread:** 
- **Upper Limit:** 1018.16
- **Value:** 802.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 241.48
- **Spread:** 
- **Upper Limit:** 908.80
- **Value:** 468.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 54.64
- **Spread:** 
- **Upper Limit:** 86.65
- **Value:** 68.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 39.08
- **Spread:** 
- **Upper Limit:** 90.08
- **Value:** 59.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 141.11
- **Spread:** 
- **Upper Limit:** 252.78
- **Value:** 188.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 35.59
- **Spread:** 
- **Upper Limit:** 75.63
- **Value:** 51.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.687
- **Spread:** 
- **Upper Limit:** 4.479
- **Value:** 3.47
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.959
- **Spread:** 
- **Upper Limit:** 1.009
- **Value:** 0.98
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.943
- **Spread:** 
- **Upper Limit:** 14.631
- **Value:** 10.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.629
- **Spread:** 
- **Upper Limit:** 1.132
- **Value:** 0.84
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.989
- **Spread:** 
- **Upper Limit:** 3.120
- **Value:** 2.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.834
- **Spread:** 
- **Upper Limit:** 1.816
- **Value:** 1.23
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.892
- **Spread:** 
- **Upper Limit:** 2.976
- **Value:** 2.37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.739
- **Spread:** 
- **Upper Limit:** 1.034
- **Value:** 0.87
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 52.31
- **Spread:** 
- **Upper Limit:** 75.25
- **Value:** 64.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 29.71
- **Spread:** 
- **Upper Limit:** 53.23
- **Value:** 41.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 76.25
- **Spread:** 
- **Upper Limit:** 93.23
- **Value:** 86.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 60.91
- **Spread:** 
- **Upper Limit:** 82.39
- **Value:** 72.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.80
- **Spread:** 
- **Upper Limit:** 58.63
- **Value:** 46.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.03
- **Spread:** 
- **Upper Limit:** 27.00
- **Value:** 8.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.19
- **Spread:** 
- **Upper Limit:** 34.65
- **Value:** 23.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.03
- **Spread:** 
- **Upper Limit:** 27.00
- **Value:** 8.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.80
- **Spread:** 
- **Upper Limit:** 58.63
- **Value:** 46.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.08
- **Spread:** 
- **Upper Limit:** 33.14
- **Value:** 21.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7931.32
- **Spread:** 
- **Upper Limit:** 13755.33
- **Value:** 10445.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1968.83
- **Spread:** 
- **Upper Limit:** 5351.07
- **Value:** 3245.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10821.68
- **Spread:** 
- **Upper Limit:** 19020.91
- **Value:** 14347.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1987.00
- **Spread:** 
- **Upper Limit:** 5200.52
- **Value:** 3214.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20310.07
- **Spread:** 
- **Upper Limit:** 37909.76
- **Value:** 27748.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2866.53
- **Spread:** 
- **Upper Limit:** 9388.63
- **Value:** 5187.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 26020.58
- **Spread:** 
- **Upper Limit:** 46653.16
- **Value:** 34841.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2980.81
- **Spread:** 
- **Upper Limit:** 9255.68
- **Value:** 5252.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3592.36
- **Spread:** 
- **Upper Limit:** 6042.17
- **Value:** 4658.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 596.31
- **Spread:** 
- **Upper Limit:** 1725.64
- **Value:** 1014.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6034.01
- **Spread:** 
- **Upper Limit:** 9868.80
- **Value:** 7716.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 635.59
- **Spread:** 
- **Upper Limit:** 1760.42
- **Value:** 1057.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1488.57
- **Spread:** 
- **Upper Limit:** 2931.67
- **Value:** 2089.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 286.50
- **Spread:** 
- **Upper Limit:** 1021.82
- **Value:** 541.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3010.69
- **Spread:** 
- **Upper Limit:** 5893.61
- **Value:** 4212.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 281.44
- **Spread:** 
- **Upper Limit:** 1005.88
- **Value:** 532.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.694
- **Spread:** 
- **Upper Limit:** 4.046
- **Value:** 3.30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.915
- **Spread:** 
- **Upper Limit:** 1.188
- **Value:** 1.04
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.571
- **Spread:** 
- **Upper Limit:** 5.466
- **Value:** 4.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.914
- **Spread:** 
- **Upper Limit:** 1.166
- **Value:** 1.03
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.965
- **Spread:** 
- **Upper Limit:** 10.154
- **Value:** 7.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.097
- **Spread:** 
- **Upper Limit:** 1.359
- **Value:** 1.22
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.608
- **Spread:** 
- **Upper Limit:** 12.832
- **Value:** 9.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.085
- **Spread:** 
- **Upper Limit:** 1.330
- **Value:** 1.20
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.879
- **Spread:** 
- **Upper Limit:** 6.070
- **Value:** 4.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.999
- **Spread:** 
- **Upper Limit:** 1.453
- **Value:** 1.20
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.631
- **Spread:** 
- **Upper Limit:** 10.183
- **Value:** 8.22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.018
- **Spread:** 
- **Upper Limit:** 1.464
- **Value:** 1.22
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.229
- **Spread:** 
- **Upper Limit:** 5.966
- **Value:** 4.39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.853
- **Spread:** 
- **Upper Limit:** 1.132
- **Value:** 0.98
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.153
- **Spread:** 
- **Upper Limit:** 11.773
- **Value:** 8.51
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.867
- **Spread:** 
- **Upper Limit:** 1.076
- **Value:** 0.97
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 51.53
- **Spread:** 
- **Upper Limit:** 75.53
- **Value:** 64.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.11
- **Spread:** 
- **Upper Limit:** 21.12
- **Value:** 4.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 69.54
- **Spread:** 
- **Upper Limit:** 89.92
- **Value:** 81.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 25.80
- **Spread:** 
- **Upper Limit:** 49.99
- **Value:** 37.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.00
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 44.82
- **Spread:** 
- **Upper Limit:** 70.06
- **Value:** 57.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 74.26
- **Spread:** 
- **Upper Limit:** 92.60
- **Value:** 85.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 86.91
- **Spread:** 
- **Upper Limit:** 99.02
- **Value:** 95.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 60.90
- **Spread:** 
- **Upper Limit:** 83.24
- **Value:** 73.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 71.32
- **Spread:** 
- **Upper Limit:** 91.10
- **Value:** 82.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 67.43
- **Spread:** 
- **Upper Limit:** 88.08
- **Value:** 79.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.03
- **Spread:** 
- **Upper Limit:** 27.00
- **Value:** 8.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 86.91
- **Spread:** 
- **Upper Limit:** 99.02
- **Value:** 95.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.03
- **Spread:** 
- **Upper Limit:** 27.00
- **Value:** 8.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 47.00
- **Spread:** 
- **Upper Limit:** 71.51
- **Value:** 59.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.11
- **Spread:** 
- **Upper Limit:** 21.12
- **Value:** 4.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 66.03
- **Spread:** 
- **Upper Limit:** 87.49
- **Value:** 78.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.11
- **Spread:** 
- **Upper Limit:** 21.12
- **Value:** 4.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 53.06
- **Spread:** 
- **Upper Limit:** 76.85
- **Value:** 65.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 74.98
- **Spread:** 
- **Upper Limit:** 93.36
- **Value:** 85.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 31.22
- **Spread:** 
- **Upper Limit:** 55.96
- **Value:** 43.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 54.31
- **Spread:** 
- **Upper Limit:** 78.41
- **Value:** 67.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 234.11
- **Spread:** 
- **Upper Limit:** 420.81
- **Value:** 313.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 104.05
- **Spread:** 
- **Upper Limit:** 225.12
- **Value:** 153.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 317.40
- **Spread:** 
- **Upper Limit:** 585.52
- **Value:** 431.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 103.91
- **Spread:** 
- **Upper Limit:** 220.32
- **Value:** 151.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 800.61
- **Spread:** 
- **Upper Limit:** 1638.42
- **Value:** 1145.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 142.75
- **Spread:** 
- **Upper Limit:** 367.06
- **Value:** 228.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 981.63
- **Spread:** 
- **Upper Limit:** 1901.43
- **Value:** 1366.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 138.74
- **Spread:** 
- **Upper Limit:** 350.58
- **Value:** 220.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 298.21
- **Spread:** 
- **Upper Limit:** 464.89
- **Value:** 372.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 202.09
- **Spread:** 
- **Upper Limit:** 519.30
- **Value:** 324.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 459.19
- **Spread:** 
- **Upper Limit:** 672.64
- **Value:** 555.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 200.93
- **Spread:** 
- **Upper Limit:** 535.47
- **Value:** 328.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 75.68
- **Spread:** 
- **Upper Limit:** 123.23
- **Value:** 96.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 37.78
- **Spread:** 
- **Upper Limit:** 87.00
- **Value:** 57.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 108.32
- **Spread:** 
- **Upper Limit:** 194.65
- **Value:** 145.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 35.96
- **Spread:** 
- **Upper Limit:** 84.27
- **Value:** 55.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.473
- **Spread:** 
- **Upper Limit:** 2.139
- **Value:** 1.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.842
- **Spread:** 
- **Upper Limit:** 1.043
- **Value:** 0.94
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.849
- **Spread:** 
- **Upper Limit:** 2.798
- **Value:** 2.27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.838
- **Spread:** 
- **Upper Limit:** 1.025
- **Value:** 0.93
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.703
- **Spread:** 
- **Upper Limit:** 6.704
- **Value:** 4.98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.717
- **Spread:** 
- **Upper Limit:** 0.943
- **Value:** 0.82
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.576
- **Spread:** 
- **Upper Limit:** 7.785
- **Value:** 5.97
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.694
- **Spread:** 
- **Upper Limit:** 0.905
- **Value:** 0.79
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.022
- **Spread:** 
- **Upper Limit:** 1.522
- **Value:** 1.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.660
- **Spread:** 
- **Upper Limit:** 1.036
- **Value:** 0.83
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.403
- **Spread:** 
- **Upper Limit:** 2.234
- **Value:** 1.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.676
- **Spread:** 
- **Upper Limit:** 1.037
- **Value:** 0.84
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.142
- **Spread:** 
- **Upper Limit:** 1.483
- **Value:** 1.30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.870
- **Spread:** 
- **Upper Limit:** 1.137
- **Value:** 0.99
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.555
- **Spread:** 
- **Upper Limit:** 2.297
- **Value:** 1.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.829
- **Spread:** 
- **Upper Limit:** 1.101
- **Value:** 0.95
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 27.14
- **Spread:** 
- **Upper Limit:** 51.50
- **Value:** 38.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 41.75
- **Spread:** 
- **Upper Limit:** 67.18
- **Value:** 54.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.40
- **Spread:** 
- **Upper Limit:** 25.74
- **Value:** 14.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.24
- **Spread:** 
- **Upper Limit:** 44.06
- **Value:** 31.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 64.14
- **Spread:** 
- **Upper Limit:** 85.69
- **Value:** 76.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 73.14
- **Spread:** 
- **Upper Limit:** 92.24
- **Value:** 84.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 45.52
- **Spread:** 
- **Upper Limit:** 70.15
- **Value:** 58.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 49.51
- **Spread:** 
- **Upper Limit:** 74.30
- **Value:** 62.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.92
- **Spread:** 
- **Upper Limit:** 32.57
- **Value:** 20.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 22.95
- **Spread:** 
- **Upper Limit:** 47.30
- **Value:** 34.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.36
- **Spread:** 
- **Upper Limit:** 18.48
- **Value:** 9.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.76
- **Spread:** 
- **Upper Limit:** 26.86
- **Value:** 15.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.40
- **Spread:** 
- **Upper Limit:** 25.74
- **Value:** 14.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 25.70
- **Spread:** 
- **Upper Limit:** 50.49
- **Value:** 37.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.93
- **Spread:** 
- **Upper Limit:** 12.53
- **Value:** 4.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.90
- **Spread:** 
- **Upper Limit:** 28.68
- **Value:** 17.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 14.25
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
**Reporting Status:** POSTED
**Time Frame:** 14 days after first vaccination (Day 1 to Day 15)
**Title:** Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
**Reporting Status:** POSTED
**Time Frame:** 14 days after first vaccination (Day 1 to Day 15)
**Title:** Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
**Reporting Status:** POSTED
**Time Frame:** 29 days after first vaccination (Day 1 to Day 30)
**Title:** Percentage of Participants With Unsolicited Adverse Events After First Vaccination
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 180
**Title:** Number of Participants With Serious Adverse Events (SAEs) After First Vaccination
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** The per-protocol immunogenicity (PPI) analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes.
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1
**Type:** PRIMARY
**Unit of Measure:** Titer
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Day 15
**Title:** ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15
**Type:** PRIMARY
**Unit of Measure:** Titer
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Day 15/Day 1
**Title:** ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1
**Type:** PRIMARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Day 15
**Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** 14 days after second vaccination (Day 181 to Day 195)
**Title:** Percentage of Participants With Solicited Local Adverse Events After Second Vaccination
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** 14 days after second vaccination (Day 181 to Day 195)
**Title:** Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** 29 days after second vaccination (Day 181 to Day 210)
**Title:** Percentage of Participants With Unsolicited Adverse Events After Second Vaccination
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Description:** An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Day 181 until Day 360
**Title:** Number of Participants With Serious Adverse Events After Second Vaccination
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Days 1 and 15
**Title:** Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15
**Type:** SECONDARY
**Unit of Measure:** Titer
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 14
**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Day 15/Day 1
**Title:** OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1
**Type:** SECONDARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 15
**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Day 15
**Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 16
**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Days 181 and 195
**Title:** ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195
**Type:** SECONDARY
**Unit of Measure:** Titer
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 17
**Description:** IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Day 181/Day 1 and Day 195/Day 1
**Title:** ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1
**Type:** SECONDARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 18
**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Days 181 and 195
**Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 19
**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Days 181 and 195
**Title:** OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195
**Type:** SECONDARY
**Unit of Measure:** Titer
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 20
**Description:** Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Day 181/Day 1 and Day 195/Day 1
**Title:** OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1
**Type:** SECONDARY
**Unit of Measure:** Ratio
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 21
**Description:** Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Days 181 and 195
**Title:** Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG000
**Title:** ExPEC4V
##### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Participants received a single 0.5 milliliter (mL) dose of ExPEC4V vaccine as an intramuscular (IM) injection into the deltoid muscle on Day 1 and Day 181.
**ID:** FG000
**Title:** ExPEC4V
#### Group
**Description:** Participants received placebo matching to ExPEC4V as an IM injection into the deltoid muscle on Day 1 and Day 181.
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 75
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 66
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Has Results:** True