Trial Outcomes & Findings for INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs (NCT NCT00902486)

Last Updated: 2018-09-04

Results Overview

The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

127 participants

Primary outcome timeframe

Week 12

Results posted on

2018-09-04

Participant Flow

The study population included participants diagnosed with RA who had failed to respond adequately to any DMARD therapy, including biologics.

The study was divided into 3 distinct phases: Screening Phase (up to 28 days before randomization), Treatment Phase (12 weeks + 12-week extension period), and the Follow-up (4 ± 1 weeks following final dose of study medication).

Participant milestones

Participant milestones
Measure	Placebo INCB028050 was administered once daily (QD), orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	Placebo Crossing Over to 7 mg INCB028050 QD Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD.	Placebo Crossing Over to 10 mg INCB028050 QD Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.	INCB028050 4 mg QD INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Treatment Period (Weeks 0 Through 12) STARTED	31	0	0	32	32	32
Treatment Period (Weeks 0 Through 12) Safety Evaluable Participants	31	0	0	31	32	31
Treatment Period (Weeks 0 Through 12) Modified Intent-to-Treat Participants	31	0	0	31	32	30
Treatment Period (Weeks 0 Through 12) COMPLETED	29	0	0	29	30	27
Treatment Period (Weeks 0 Through 12) NOT COMPLETED	2	0	0	3	2	5
Extension Period (Weeks 12 Through 24) STARTED	0	14	15	29	30	27
Extension Period (Weeks 12 Through 24) COMPLETED	0	14	13	27	29	24
Extension Period (Weeks 12 Through 24) NOT COMPLETED	0	0	2	2	1	3
Follow-up (After Week 24) STARTED	0	14	13	27	29	24
Follow-up (After Week 24) Safety Evaluable Participants	0	14	15	29	30	27
Follow-up (After Week 24) COMPLETED	0	14	13	26	29	24
Follow-up (After Week 24) NOT COMPLETED	0	0	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo INCB028050 was administered once daily (QD), orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	Placebo Crossing Over to 10 mg INCB028050 QD Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.	INCB028050 4 mg QD INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Treatment Period (Weeks 0 Through 12) Adverse Event	1	0	1	1	2
Treatment Period (Weeks 0 Through 12) Consent Withdrawn	1	0	0	0	2
Treatment Period (Weeks 0 Through 12) Protocol Deviation	0	0	0	1	1
Treatment Period (Weeks 0 Through 12) Lost to Follow-up	0	0	1	0	0
Treatment Period (Weeks 0 Through 12) corrected QT (QTc) exclusion criteria	0	0	1	0	0
Extension Period (Weeks 12 Through 24) Adverse Event	0	0	0	1	2
Extension Period (Weeks 12 Through 24) Consent Withdrawn	0	1	1	0	0
Extension Period (Weeks 12 Through 24) Protocol Deviation	0	0	0	0	1
Extension Period (Weeks 12 Through 24) Disease Progression	0	0	1	0	0
Extension Period (Weeks 12 Through 24) Lost to Follow-up	0	1	0	0	0
Follow-up (After Week 24) Lost to Follow-up	0	0	1	0	0

Baseline Characteristics

INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INCB028050 4 mg QD n=32 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=32 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	Total n=127 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 12.28 • n=5 Participants	53.7 years STANDARD_DEVIATION 10.92 • n=7 Participants	57.3 years STANDARD_DEVIATION 10.38 • n=5 Participants	55.2 years STANDARD_DEVIATION 10.09 • n=4 Participants	55.8 years STANDARD_DEVIATION 10.92 • n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	22 Participants n=4 Participants	102 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	25 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement	10 Participants	16 Participants	19 Participants	16 Participants	—

PRIMARY outcome

Timeframe: From Baseline through week 12

Population: Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=31 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Participants With at Least 1 Adverse Event From Baseline Through Week 12	19 Participants	15 Participants	20 Participants	23 Participants	—

SECONDARY outcome

Timeframe: Week 12 to Week 24

Population: Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=15 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=29 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=27 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Participants With at Least 1 Adverse Event From Week 12 to Week 24	6 Participants	5 Participants	12 Participants	16 Participants	16 Participants

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: Modified Intent-to-Treat (mITT) population included all participants who were assigned to active treatment at baseline and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=30 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=25 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24	18 Participants	20 Participants	18 Participants	—	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 Week 12	13.0 percentage of participants	35.0 percentage of participants	31.0 percentage of participants	30.0 percentage of participants	—
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 Week 24	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	33.0 percentage of participants	37.0 percentage of participants	44.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 Week 12	3.0 percentage of participants	16.0 percentage of participants	9.0 percentage of participants	10.0 percentage of participants	—
The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 Week 24	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	26.0 percentage of participants	30.0 percentage of participants	28.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

The ACR 90 is defined greater than or equal to (\>=) 90 percent (%) improvement in painful and tender joint count; \>= 90% improvement in swollen joint count; and \>= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP) at each visit.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 Week 12	0.0 percentage of participants	3.0 percentage of participants	0.0 percentage of participants	3.0 percentage of participants	—
The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 Week 24	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	11.0 percentage of participants	10.0 percentage of participants	12.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\>5.1=high disease activity; \<3.2=low disease activity; \<2.6=remission).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 Baseline	5.71 Units on a scale Standard Deviation 0.875	5.64 Units on a scale Standard Deviation 1.098	5.76 Units on a scale Standard Deviation 0.925	5.64 Units on a scale Standard Deviation 0.774	—
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 Change from baseline at Week 12	-1.01 Units on a scale Standard Deviation 1.245	-1.87 Units on a scale Standard Deviation 1.231	-1.83 Units on a scale Standard Deviation 1.534	-1.84 Units on a scale Standard Deviation 1.143	—
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA Units on a scale Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-2.13 Units on a scale Standard Deviation 1.355	-2.23 Units on a scale Standard Deviation 1.548	-2.75 Units on a scale Standard Deviation 1.234	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 Baseline	6.56 Units on a scale Standard Deviation 0.840	6.41 Units on a scale Standard Deviation 1.024	6.35 Units on a scale Standard Deviation 0.968	6.37 Units on a scale Standard Deviation 0.851	—
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 Change from baseline at Week 12	-1.25 Units on a scale Standard Deviation 1.489	-1.87 Units on a scale Standard Deviation 1.342	-1.97 Units on a scale Standard Deviation 1.613	-1.90 Units on a scale Standard Deviation 1.481	—
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA Units on a scale Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-2.17 Units on a scale Standard Deviation 1.524	-2.29 Units on a scale Standard Deviation 1.455	-2.79 Units on a scale Standard Deviation 1.394	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

Participants who achieved low disease activity based on the DAS 28 ESR (score ≤3.2). Participants who achieved low disease activity were classified as responders in this analysis.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 Week 12	19.0 percentage of participants	23.0 percentage of participants	31.0 percentage of participants	13.0 percentage of participants	—
Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 Week 24	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	48.0 percentage of participants	53.0 percentage of participants	65.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

Participants who achieved inactive disease based on the DAS 28 ESR (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=16 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=31 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=32 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 Week 12	6.7 percentage of participants	18.8 percentage of participants	16.0 percentage of participants	19.0 percentage of participants	7.0 percentage of participants
Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 Week 24	21.4 percentage of participants	23.1 percentage of participants	22.0 percentage of participants	27.0 percentage of participants	26.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12 and Week 24

Participants who achieved inactive disease based on DAS 28 CRP (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=32 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=30 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 Week 12	23.0 percentage of participants	25.0 percentage of participants	17.0 percentage of participants	—	—
Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 Week 24	30.0 percentage of participants	40.0 percentage of participants	48.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 Baseline	15.9 Tender joints Standard Deviation 6.67	14.4 Tender joints Standard Deviation 6.58	14.7 Tender joints Standard Deviation 6.70	15.9 Tender joints Standard Deviation 6.37	—
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 Change from baseline at Week 12	-5.3 Tender joints Standard Deviation 6.40	-7.4 Tender joints Standard Deviation 6.21	-6.4 Tender joints Standard Deviation 7.98	-8.8 Tender joints Standard Deviation 8.86	—
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 Change from baseline at Week 24	NA Tender joints Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-8.3 Tender joints Standard Deviation 6.17	-8.7 Tender joints Standard Deviation 7.42	-12.0 Tender joints Standard Deviation 8.19	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 Baseline	11.0 Swollen joints Standard Deviation 5.28	12.0 Swollen joints Standard Deviation 5.48	10.6 Swollen joints Standard Deviation 4.57	12.9 Swollen joints Standard Deviation 5.12	—
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 Change from baseline at Week 12	-3.7 Swollen joints Standard Deviation 4.02	-6.1 Swollen joints Standard Deviation 4.43	-5.4 Swollen joints Standard Deviation 5.85	-7.2 Swollen joints Standard Deviation 5.57	—
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 Change from baseline at Week 24	NA Swollen joints Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-7.3 Swollen joints Standard Deviation 5.14	-6.2 Swollen joints Standard Deviation 5.04	-9.1 Swollen joints Standard Deviation 5.10	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Participants were to assess their current level of pain on a 100 mm horizontal Visual Analog Scale (VAS). The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "most imaginable pain".

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 Baseline	62.37 millimeter (mm) Standard Deviation 21.079	57.08 millimeter (mm) Standard Deviation 24.716	63.25 millimeter (mm) Standard Deviation 18.656	57.00 millimeter (mm) Standard Deviation 22.995	—
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 Change from baseline at Week 12	-6.24 millimeter (mm) Standard Deviation 22.065	-21.98 millimeter (mm) Standard Deviation 26.275	-22.19 millimeter (mm) Standard Deviation 25.631	-22.97 millimeter (mm) Standard Deviation 37.691	—
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA millimeter (mm) Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-22.13 millimeter (mm) Standard Deviation 27.294	-27.62 millimeter (mm) Standard Deviation 25.015	-30.39 millimeter (mm) Standard Deviation 30.847	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no arthritis activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "extremely active arthritis" (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA millimeter (mm) Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-24.02 millimeter (mm) Standard Deviation 26.921	-31.53 millimeter (mm) Standard Deviation 23.891	-34.08 millimeter (mm) Standard Deviation 27.518	—
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 Baseline	66.19 millimeter (mm) Standard Deviation 20.522	59.02 millimeter (mm) Standard Deviation 26.314	69.69 millimeter (mm) Standard Deviation 18.893	62.25 millimeter (mm) Standard Deviation 21.346	—
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 Change from baseline at Week 12	-8.61 millimeter (mm) Standard Deviation 22.569	-22.06 millimeter (mm) Standard Deviation 27.366	-27.41 millimeter (mm) Standard Deviation 21.990	-25.48 millimeter (mm) Standard Deviation 32.879	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Physicians were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no arthritis activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "extremely active arthritis" (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 Baseline	63.45 millimeter (mm) Standard Deviation 16.903	61.94 millimeter (mm) Standard Deviation 19.162	59.80 millimeter (mm) Standard Deviation 17.185	59.32 millimeter (mm) Standard Deviation 16.890	—
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 Change from baseline at Week 12	-20.23 millimeter (mm) Standard Deviation 19.824	-33.87 millimeter (mm) Standard Deviation 24.283	-29.95 millimeter (mm) Standard Deviation 25.741	-30.88 millimeter (mm) Standard Deviation 19.334	—
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA millimeter (mm) Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-38.78 millimeter (mm) Standard Deviation 22.527	-36.94 millimeter (mm) Standard Deviation 21.235	-38.94 millimeter (mm) Standard Deviation 21.776	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 Baseline	1.61 Score on a scale Standard Deviation 0.494	1.50 Score on a scale Standard Deviation 0.601	1.67 Score on a scale Standard Deviation 0.474	1.50 Score on a scale Standard Deviation 0.590	—
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 Change from baseline at Week 12 (n=31, 31, 30, 30)	-0.20 Score on a scale Standard Deviation 0.367	-0.38 Score on a scale Standard Deviation 0.568	-0.48 Score on a scale Standard Deviation 0.613	-0.33 Score on a scale Standard Deviation 0.539	—
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA Score on a scale Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-0.56 Score on a scale Standard Deviation 0.673	-0.63 Score on a scale Standard Deviation 0.563	-0.39 Score on a scale Standard Deviation 0.469	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 Baseline	40.8 mm/hr Standard Deviation 15.40	42.8 mm/hr Standard Deviation 17.62	37.3 mm/hr Standard Deviation 21.56	34.8 mm/hr Standard Deviation 29.05	—
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 Change from baseline at Week 12	-6.1 mm/hr Standard Deviation 15.76	-7.5 mm/hr Standard Deviation 23.17	-10.7 mm/hr Standard Deviation 21.52	-5.9 mm/hr Standard Deviation 32.35	—
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA mm/hr Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-11.5 mm/hr Standard Deviation 21.96	-12.8 mm/hr Standard Deviation 20.74	-11.1 mm/hr Standard Deviation 26.00	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA mg/L Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-6.74 mg/L Standard Deviation 18.086	-7.90 mg/L Standard Deviation 16.713	-5.52 mg/L Standard Deviation 9.017	—
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 Baseline	10.89 mg/L Standard Deviation 11.556	15.63 mg/L Standard Deviation 17.327	15.64 mg/L Standard Deviation 16.113	7.52 mg/L Standard Deviation 8.581	—
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 Change from baseline at Week 12	0.18 mg/L Standard Deviation 10.063	-9.76 mg/L Standard Deviation 16.053	-4.01 mg/L Standard Deviation 26.799	-0.73 mg/L Standard Deviation 13.488	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 Baseline	78.5 Minutes Standard Deviation 61.36	179.8 Minutes Standard Deviation 347.48	125.5 Minutes Standard Deviation 246.75	79.2 Minutes Standard Deviation 56.83	—
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 Change from baseline at Week 12	2.6 Minutes Standard Deviation 69.23	-51.1 Minutes Standard Deviation 94.80	-92.6 Minutes Standard Deviation 250.51	-42.2 Minutes Standard Deviation 63.97	—
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA Minutes Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	-120.6 Minutes Standard Deviation 245.35	-99.3 Minutes Standard Deviation 254.05	-51.5 Minutes Standard Deviation 70.84	—

SECONDARY outcome

Timeframe: Week 12

EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12	19.0 percentage of participants	23.0 percentage of participants	31.0 percentage of participants	13.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=16 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=27 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=23 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24	21.0 percentage of participants	15.0 percentage of participants	33.0 percentage of participants	43.0 percentage of participants	39.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12	26.0 percentage of participants	39.0 percentage of participants	34.0 percentage of participants	33.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=30 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=23 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24	48.0 percentage of participants	53.0 percentage of participants	65.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 Baseline	71.08 scores on a scale Standard Deviation 27.534	69.03 scores on a scale Standard Deviation 28.181	78.41 scores on a scale Standard Deviation 30.329	78.62 scores on a scale Standard Deviation 24.160	—
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 Change from baseline at Week 12	2.92 scores on a scale Standard Deviation 19.613	7.87 scores on a scale Standard Deviation 19.547	2.21 scores on a scale Standard Deviation 17.814	6.36 scores on a scale Standard Deviation 25.203	—
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA scores on a scale Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	7.72 scores on a scale Standard Deviation 17.543	4.60 scores on a scale Standard Deviation 17.146	2.29 scores on a scale Standard Deviation 28.869	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 Baseline	29.14 scores on a scale Standard Deviation 14.330	34.67 scores on a scale Standard Deviation 16.006	26.71 scores on a scale Standard Deviation 14.642	28.82 scores on a scale Standard Deviation 14.212	—
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 Change from baseline at Week 12	3.72 scores on a scale Standard Deviation 11.027	9.57 scores on a scale Standard Deviation 14.960	12.97 scores on a scale Standard Deviation 17.932	8.35 scores on a scale Standard Deviation 13.947	—
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 Change from baseline at Week 24	NA scores on a scale Standard Deviation NA Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	11.60 scores on a scale Standard Deviation 14.503	15.56 scores on a scale Standard Deviation 16.144	11.77 scores on a scale Standard Deviation 13.387	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 Week 12 (n=31, 31, 30, 30)	45.0 percentage of participants	61.0 percentage of participants	63.0 percentage of participants	43.0 percentage of participants	—
Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 Week 24	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	67.0 percentage of participants	75.0 percentage of participants	60.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "most imaginable pain". MCID for the pain score is a decrease of at least 10 mm on a 100 mm scale.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 Week 12	35.0 percentage of participants	58.0 percentage of participants	69.0 percentage of participants	67.0 percentage of participants	—
Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 Week 24	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	59.0 percentage of participants	70.0 percentage of participants	72.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12 and Week 24

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD n=31 Participants INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD n=32 Participants INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD n=30 Participants INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 Week 24 Physical Components	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	67.0 percentage of participants	77.0 percentage of participants	76.0 percentage of participants	—
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 Week 12 Mental Components	52.0 percentage of participants	58.0 percentage of participants	41.0 percentage of participants	50.0 percentage of participants	—
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 Week 24 Mental Components	NA percentage of participants Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.	63.0 percentage of participants	57.0 percentage of participants	52.0 percentage of participants	—
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 Week 12 Physical Components	52.0 percentage of participants	68.0 percentage of participants	69.0 percentage of participants	57.0 percentage of participants	—

Adverse Events

Placebo (Weeks 0-12)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

INCB028050 4 mg QD (Weeks 0-12)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

INCB028050 7 mg QD (Weeks 0-12)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

INCB028050 10 mg QD (Weeks 0-12)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo to INCB028050 7 mg QD

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo to INCB028050 10 mg QD

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

INCB028050 4 mg QD (Weeks 12-24)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

INCB028050 7 mg QD (Weeks 12-24)

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

INCB028050 10 mg QD (Weeks 12-24)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo to INCB028050 7 mg QD (After Week 24 to Week 28)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo to INCB028050 10 mg QD (After Week 24 to Week 28)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

INCB028050 4 mg QD (After Week 24 to Week 28)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

INCB028050 7 mg QD (After Week 24 to Week 28)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

INCB028050 10 mg QD (After Week 24 to Week 28)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Weeks 0-12) n=31 participants at risk INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD (Weeks 0-12) n=31 participants at risk INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD (Weeks 0-12) n=32 participants at risk INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD (Weeks 0-12) n=31 participants at risk INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	Placebo to INCB028050 7 mg QD n=14 participants at risk 12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	Placebo to INCB028050 10 mg QD n=15 participants at risk 12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	INCB028050 4 mg QD (Weeks 12-24) n=29 participants at risk 12-week extension period	INCB028050 7 mg QD (Weeks 12-24) n=30 participants at risk 12-week extension period	INCB028050 10 mg QD (Weeks 12-24) n=27 participants at risk 12-week extension period	Placebo to INCB028050 7 mg QD (After Week 24 to Week 28) n=14 participants at risk Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	Placebo to INCB028050 10 mg QD (After Week 24 to Week 28) n=15 participants at risk Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	INCB028050 4 mg QD (After Week 24 to Week 28) n=29 participants at risk Follow-up	INCB028050 7 mg QD (After Week 24 to Week 28) n=30 participants at risk Follow-up	INCB028050 10 mg QD (After Week 24 to Week 28) n=27 participants at risk Follow-up
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.1% 1/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Vascular disorders Thrombophlebitis	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.1% 1/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Nervous system disorders Cerebrovascular accident	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.

Other adverse events

Other adverse events
Measure	Placebo (Weeks 0-12) n=31 participants at risk INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 4 mg QD (Weeks 0-12) n=31 participants at risk INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 7 mg QD (Weeks 0-12) n=32 participants at risk INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	INCB028050 10 mg QD (Weeks 0-12) n=31 participants at risk INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.	Placebo to INCB028050 7 mg QD n=14 participants at risk 12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	Placebo to INCB028050 10 mg QD n=15 participants at risk 12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	INCB028050 4 mg QD (Weeks 12-24) n=29 participants at risk 12-week extension period	INCB028050 7 mg QD (Weeks 12-24) n=30 participants at risk 12-week extension period	INCB028050 10 mg QD (Weeks 12-24) n=27 participants at risk 12-week extension period	Placebo to INCB028050 7 mg QD (After Week 24 to Week 28) n=14 participants at risk Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	Placebo to INCB028050 10 mg QD (After Week 24 to Week 28) n=15 participants at risk Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.	INCB028050 4 mg QD (After Week 24 to Week 28) n=29 participants at risk Follow-up	INCB028050 7 mg QD (After Week 24 to Week 28) n=30 participants at risk Follow-up	INCB028050 10 mg QD (After Week 24 to Week 28) n=27 participants at risk Follow-up
Nervous system disorders Headache	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	12.9% 4/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	9.4% 3/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	9.7% 3/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Infections and infestations Upper respiratory tract infection	9.7% 3/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Gastrointestinal disorders Diarrhea	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Infections and infestations Sinusitis	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	9.4% 3/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Gastrointestinal disorders Nausea	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Infections and infestations Bronchitis	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	14.3% 2/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Respiratory, thoracic and mediastinal disorders Cough	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	9.4% 3/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 2/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Psychiatric disorders Insomnia	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.9% 2/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Skin and subcutaneous tissue disorders Acne	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Musculoskeletal and connective tissue disorders Back pain	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Gastrointestinal disorders Constipation	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Eye disorders Dry eye	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Skin and subcutaneous tissue disorders Rash	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.1% 1/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Investigations C-reactive protein increased	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Injury, poisoning and procedural complications Fall	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.1% 1/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Gastrointestinal disorders Mouth ulceration	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.1% 1/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.1% 1/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Infections and infestations Influenza	3.2% 1/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Nervous system disorders Paraesthesia	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.5% 2/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.2% 2/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
General disorders Pyrexia	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	13.3% 2/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Gastrointestinal disorders Vomiting	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 2/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.4% 2/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Blood and lymphatic system disorders Anemia	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	11.1% 3/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Infections and infestations Herpes zoster	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	10.0% 3/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Metabolism and nutrition disorders Hypercholesterolemia	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.7% 1/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Infections and infestations Urinary tract infection	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 2/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.7% 1/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Investigations Aspartate aminotransferase increased	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Investigations Blood creatinine increased	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
General disorders Chills	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 1/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Eye disorders Conjunctivitis	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	7.1% 1/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.3% 1/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
Immune system disorders Rheumatoid arthritis	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/32 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/31 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.9% 2/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/14 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	0.00% 0/15 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.4% 1/29 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	6.7% 2/30 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.	3.7% 1/27 • Screening through follow-up visit up to approximately 8 months. Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12. The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.

Additional Information

Study Director

Incyte Corporation

Phone: 855 463-3463

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER