Trial Outcomes & Findings for A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in India (NCT NCT05375929)

Last Updated: 2024-10-15

Results Overview

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)

Results posted on

2024-10-15

Participant Flow

A total of 200 participants aged greater than or equal to (\>=) 12 years with moderate to severe atopic dermatitis (AD) were enrolled in the study.

This study had main study and substudy. Adolescent participants consented for substudy at main study inform consent/assent. Eligible participants who consented for substudy continued to receive study intervention as assigned in the main study after the 12-week treatment period, until 1 year after randomization in the main study or until they turned 18 years of age. As per statistical analysis plan (SAP) participants' disposition, and discontinuation were to be summarized by treatment arm.

Participant milestones

Participant milestones
Measure	Main Study: Abrocitinib 200 mg QD Participants received abrocitinib 200 milligram (mg), orally once daily (QD) for 12 weeks.	Main Study: Abrocitinib 100 mg QD Participants received abrocitinib 100 mg, orally QD for 12 weeks.	Substudy: Abrocitinib 200 mg Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study and continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.	Substudy: Abrocitinib 100 mg Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study and continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
Main Study: Treatment Phase (12 Weeks) STARTED	99	101	0	0
Main Study: Treatment Phase (12 Weeks) Safety Analysis Set	99	101	0	0
Main Study: Treatment Phase (12 Weeks) Full Analysis Set	100	100	0	0
Main Study: Treatment Phase (12 Weeks) COMPLETED	91	94	0	0
Main Study: Treatment Phase (12 Weeks) NOT COMPLETED	8	7	0	0
Main Study: Follow-up (4 Weeks) STARTED	91	94	0	0
Main Study: Follow-up (4 Weeks) COMPLETED	90	93	0	0
Main Study: Follow-up (4 Weeks) NOT COMPLETED	1	1	0	0
Substudy: Treatment Phase (1 Year) STARTED	0	0	19	16
Substudy: Treatment Phase (1 Year) COMPLETED	0	0	12	15
Substudy: Treatment Phase (1 Year) NOT COMPLETED	0	0	7	1
Substudy: Follow-up (4 Weeks) STARTED	0	0	17	15
Substudy: Follow-up (4 Weeks) COMPLETED	0	0	17	15
Substudy: Follow-up (4 Weeks) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Study: Abrocitinib 200 mg QD Participants received abrocitinib 200 milligram (mg), orally once daily (QD) for 12 weeks.	Main Study: Abrocitinib 100 mg QD Participants received abrocitinib 100 mg, orally QD for 12 weeks.	Substudy: Abrocitinib 200 mg Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study and continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.	Substudy: Abrocitinib 100 mg Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study and continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
Main Study: Treatment Phase (12 Weeks) Adverse Event	1	0	0	0
Main Study: Treatment Phase (12 Weeks) Lost to Follow-up	1	1	0	0
Main Study: Treatment Phase (12 Weeks) Withdrawal by Subject	6	5	0	0
Main Study: Treatment Phase (12 Weeks) Withdrawal by parent/guardian	0	1	0	0
Main Study: Follow-up (4 Weeks) Lost to Follow-up	1	0	0	0
Main Study: Follow-up (4 Weeks) Did not complete study follow-up	0	1	0	0
Substudy: Treatment Phase (1 Year) Withdrawal by parent/guardian	0	0	0	1
Substudy: Treatment Phase (1 Year) Physician Decision	0	0	4	0
Substudy: Treatment Phase (1 Year) Lost to Follow-up	0	0	1	0
Substudy: Treatment Phase (1 Year) Adverse Event	0	0	2	0

Baseline Characteristics

The number analyzed in sub study refers to the number of participants enrolled in sub study.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)

Population: Safety analysis set included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=99 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=101 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study AEs	30 Participants	26 Participants
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study SAEs	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (prior to dosing on Day 1), Week 12

Population: Full analysis set (FAS) included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment arm they were randomized to. Non-responder imputation (NRI) was applied. "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

IGA assesses severity of AD on a 5-point scale (0 to 4: higher scores = more severity). Scores: 0= clear (no AD inflammatory signs except for any residual discolouration \[post-inflammatory hyperpigmentation and/or hypopigmentation\]); 1= almost clear (AD not entirely cleared- light pink residual lesions \[except post-inflammatory hyperpigmentation\], just barely perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting); 2= mild (AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting); 3= moderate (AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting); 4= severe (AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting). \>=2 points improvement from baseline: decrease of at least 2 points in IGA score from baseline at Week 12.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=99 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=100 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and >= 2 Points Improvement From Baseline at Week 12: Main Study	48.5 Percentage of participants Interval 38.6 to 58.3	50.0 Percentage of participants Interval 40.2 to 59.8

SECONDARY outcome

Timeframe: Baseline (prior to dosing on Day 1), Week 12

Population: FAS included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment arm they were randomized to. NRI was applied. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

EASI evaluates severity of participant's AD based on both severity of lesion clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\]-\[including axillae and groin\] and lower limbs \[l\]-\[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et + It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl +Ll); A = EASI area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. \>=75% improvement from baseline: decrease of 75% in EASI score from Baseline at Week 12.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=99 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=100 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >= 75% Improvement From Baseline at Week 12: Main Study	71.7 Percentage of participants Interval 62.8 to 80.6	69.0 Percentage of participants Interval 59.9 to 78.1

SECONDARY outcome

Timeframe: Baseline (prior to dosing on Day 1), Week 12

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. Score for each body region was added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; lichenification; dryness) assessed as none =0, mild =1, moderate =2, severe =3. Severity scores were added to give B (0-18). C: pruritus and sleep, each was scored by participant/caregiver using visual analogue scale (VAS) where 0= no itch/no sleeplessness and 10= worst imaginable itch/sleeplessness. Scores for itch and sleeplessness were added to give C (0-20). Total SCORAD was calculated: A/5 + 7\*B/2 + C; total SCORAD range from 0-103; higher SCORAD scores = greater severity of AD. \>=75% improvement from baseline: decrease of 75% in SCORAD score from Baseline at Week 12.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=99 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=100 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >= 75% Improvement From Baseline at Week 12: Main Study	47.5 Percentage of participants Interval 37.6 to 57.3	43.0 Percentage of participants Interval 33.3 to 52.7

SECONDARY outcome

Timeframe: Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12

Population: FAS evaluated. Participants were analyzed according to the treatment arm they were randomized to. All participants reported under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified timepoints.

POEM is a 7-item participant reported outcome (PRO) measure to assess the impact of AD over the past week. Items were: dryness or roughness of skin in day, skin being itchy in day, skin flaking off in day, skin cracking in day, skin bleeding in day, skin weeping or oozing in day and sleep disturbed in night. Each item is scored from 0 to 4, depending on number of days/night (for sleep items) over the past week symptoms happened, where 0= no days, 1= "1-2 days", 2= "3-4 days", 3= "5-6 days" and 4= "every day". Scores from all items are added up, which results in POEM score, ranging from 0 to 28, where higher scores indicate greater severity of AD and greater symptom burden.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=100 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=100 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study Week 2	-6.3 Units on a scale Standard Deviation 4.97	-5.1 Units on a scale Standard Deviation 5.12
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study Week 4	-9.4 Units on a scale Standard Deviation 5.42	-8.1 Units on a scale Standard Deviation 5.49
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study Week 8	-12.0 Units on a scale Standard Deviation 5.98	-10.3 Units on a scale Standard Deviation 5.55
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study Week 12	-14.2 Units on a scale Standard Deviation 5.88	-12.4 Units on a scale Standard Deviation 6.02

SECONDARY outcome

Timeframe: Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12

ADCT score is used to measure the participants perceived AD control. It consists of 6 questions (overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions) which are evaluated over the past week on scale from 0 to 4. Scores from all 6 questions are added up to provide ADCT score, ranging from 0 to 24, where higher scores indicate lower AD control.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=100 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=100 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study Week 12	-12.8 Units on a scale Standard Deviation 5.33	-11.5 Units on a scale Standard Deviation 5.64
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study Week 2	-5.2 Units on a scale Standard Deviation 4.06	-4.4 Units on a scale Standard Deviation 4.57
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study Week 4	-8.1 Units on a scale Standard Deviation 4.90	-7.4 Units on a scale Standard Deviation 4.64
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study Week 8	-10.7 Units on a scale Standard Deviation 4.80	-9.4 Units on a scale Standard Deviation 5.21

SECONDARY outcome

Timeframe: Up to 1 year from randomization on Day 1 of main study

Population: Substudy analysis set included all participants who entered the substudy and who took at least 1 dose of study intervention during the substudy.

MRI imaging session was performed when participant was in supine position in the confined space of the MRI scanner for approximately 30 mins. The assessments included evaluation of epiphyseal plate closure and mineralization of cartilage at the growth centers.

Outcome measures

Outcome measures
Measure	Main Study: Abrocitinib 200 mg n=19 Participants Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg n=16 Participants Participants received abrocitinib 100 mg, orally QD for 12 weeks.
Percentage of Participants With Bone Safety Findings in Knee Magnetic Resonance Imaging (MRI) at 1 Year After Randomization: Substudy	0 Percentage of participants Interval 0.0 to 17.6	0 Percentage of participants Interval 0.0 to 20.6

Adverse Events

Main Study: Abrocitinib 200 mg QD

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Main Study: Abrocitinib 100 mg QD

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Substudy: Abrocitinib 100 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Substudy: Abrocitinib 200 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Study: Abrocitinib 200 mg QD n=99 participants at risk Participants received abrocitinib 200 mg, orally QD for 12 weeks.	Main Study: Abrocitinib 100 mg QD n=101 participants at risk Participants received abrocitinib 100 mg, orally QD for 12 weeks.	Substudy: Abrocitinib 100 mg n=19 participants at risk Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study and continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.	Substudy: Abrocitinib 200 mg n=16 participants at risk Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study and continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/99 • Main Study: From Day 1 of dosing up to 4 weeks post last dose (last dose at Week 12, maximum follow-up till Week 16); Sub Study: From Day 1 of dosing (in main study) up to 4 weeks post last dose (last dose at Year 1, maximum follow-up till Year 1.08) Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. MedDRA version 26.0 was used for main study and 27.0 was used for substudy. Safety analysis set for Main study and substudy analysis set for substudy was evaluated.	0.99% 1/101 • Main Study: From Day 1 of dosing up to 4 weeks post last dose (last dose at Week 12, maximum follow-up till Week 16); Sub Study: From Day 1 of dosing (in main study) up to 4 weeks post last dose (last dose at Year 1, maximum follow-up till Year 1.08) Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. MedDRA version 26.0 was used for main study and 27.0 was used for substudy. Safety analysis set for Main study and substudy analysis set for substudy was evaluated.	0.00% 0/19 • Main Study: From Day 1 of dosing up to 4 weeks post last dose (last dose at Week 12, maximum follow-up till Week 16); Sub Study: From Day 1 of dosing (in main study) up to 4 weeks post last dose (last dose at Year 1, maximum follow-up till Year 1.08) Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. MedDRA version 26.0 was used for main study and 27.0 was used for substudy. Safety analysis set for Main study and substudy analysis set for substudy was evaluated.	0.00% 0/16 • Main Study: From Day 1 of dosing up to 4 weeks post last dose (last dose at Week 12, maximum follow-up till Week 16); Sub Study: From Day 1 of dosing (in main study) up to 4 weeks post last dose (last dose at Year 1, maximum follow-up till Year 1.08) Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. MedDRA version 26.0 was used for main study and 27.0 was used for substudy. Safety analysis set for Main study and substudy analysis set for substudy was evaluated.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Main Study: Abrocitinib 200 mg QD n=99 Participants Participants received at least 1 dose of abrocitinib 200 mg, orally QD in the study.	Main Study: Abrocitinib 100 mg QD n=101 Participants Participants received at least 1 dose of abrocitinib 100 mg, orally QD in the study.	Total n=200 Participants Total of all reporting groups
Age, Continuous Main Study	35.37 Years STANDARD_DEVIATION 17.19 • n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	37.50 Years STANDARD_DEVIATION 17.49 • n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	36.45 Years STANDARD_DEVIATION 17.33 • n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Age, Continuous Substudy	14.79 Years STANDARD_DEVIATION 2.25 • n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	14.44 Years STANDARD_DEVIATION 1.36 • n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	14.63 Years STANDARD_DEVIATION 1.88 • n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Sex: Female, Male Main Study · Female	61 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	48 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	109 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Sex: Female, Male Main Study · Male	38 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	53 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	91 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Sex: Female, Male Substudy · Female	12 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	7 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	19 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Sex: Female, Male Substudy · Male	7 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	9 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	16 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Ethnicity (NIH/OMB) Main Study · Hispanic or Latino	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Ethnicity (NIH/OMB) Main Study · Not Hispanic or Latino	99 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	101 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	200 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Ethnicity (NIH/OMB) Main Study · Unknown or Not Reported	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Ethnicity (NIH/OMB) Substudy · Hispanic or Latino	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Ethnicity (NIH/OMB) Substudy · Not Hispanic or Latino	19 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	16 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	35 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Ethnicity (NIH/OMB) Substudy · Unknown or Not Reported	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · American Indian or Alaska Native	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · Asian	99 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	101 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	200 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · Black or African American	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · White	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · More than one race	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Main Study · Unknown or Not Reported	0 Participants n=99 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=101 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=200 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · American Indian or Alaska Native	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · Asian	19 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	16 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	35 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · Black or African American	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · White	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · More than one race	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.
Race (NIH/OMB) Substudy · Unknown or Not Reported	0 Participants n=19 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=16 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.	0 Participants n=35 Participants • The number analyzed in sub study refers to the number of participants enrolled in sub study.