Trial Outcomes & Findings for A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (NCT NCT04784533)

NCT ID: NCT04784533

Last Updated: 2024-10-09

Results Overview

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 317 participants
• Primary outcome timeframe: From Week 24 to Week 48
• Results posted on: 2024-10-09

Participant Flow

Participants were enrolled at study centers in the United States from 26 February 2021 to 16 May 2023.

429 participants were screened, out of which 317 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.

Participant milestones

Measure	Part A: Period 1 - CTP-543 8 mg BID Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.	Part A: Period 1 - CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A: Period 1 (Day 1 to Week 24) STARTED	180	137	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) Efficacy Population	178	135	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) COMPLETED	162	118	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) NOT COMPLETED	18	19	0	0	0	0	0	0	0	0
Part A: Period 2 (Week 24 to Week 48) STARTED	0	0	18	25	18	25	0	0	0	0
Part A: Period 2 (Week 24 to Week 48) COMPLETED	0	0	17	25	18	25	0	0	0	0
Part A: Period 2 (Week 24 to Week 48) NOT COMPLETED	0	0	1	0	0	0	0	0	0	0
Part B (Day 1 to Week 24) STARTED	0	0	0	0	0	0	5	8	15	19
Part B (Day 1 to Week 24) COMPLETED	0	0	0	0	0	0	5	8	13	18
Part B (Day 1 to Week 24) NOT COMPLETED	0	0	0	0	0	0	0	0	2	1

Reasons for withdrawal

Measure	Part A: Period 1 - CTP-543 8 mg BID Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.	Part A: Period 1 - CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A: Period 1 (Day 1 to Week 24) Treatment Emergent or Worsening Adverse Event	6	3	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) Lack of Efficacy	1	1	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) Non-compliance With Study Drug	0	2	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) Protocol Violation	1	0	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) Reason not Specified	5	7	0	0	0	0	0	0	0	0
Part A: Period 1 (Day 1 to Week 24) Lost to Follow-up	5	6	0	0	0	0	0	0	0	0
Part A: Period 2 (Week 24 to Week 48) Lost to Follow-up	0	0	1	0	0	0	0	0	0	0
Part B (Day 1 to Week 24) Lost to Follow-up	0	0	0	0	0	0	0	0	1	0
Part B (Day 1 to Week 24) Reason not Specified	0	0	0	0	0	0	0	0	1	1

Baseline Characteristics

A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Baseline characteristics by cohort

Measure	Part A: Period 1 - CTP-543 8 mg BID n=180 Participants Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 1 - CTP-543 12 mg BID n=137 Participants Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.	Total n=317 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 14.05 • n=5 Participants	39.6 years STANDARD_DEVIATION 13.21 • n=7 Participants	39.8 years STANDARD_DEVIATION 13.68 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	93 Participants n=7 Participants	212 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	44 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants n=5 Participants	126 Participants n=7 Participants	293 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	41 Participants n=5 Participants	24 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	121 Participants n=5 Participants	102 Participants n=7 Participants	223 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Week 24 to Week 48

Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=18 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=25 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction	27.8 Percentage of participants Interval 7.1 to 48.5	32.0 Percentage of participants Interval 13.7 to 50.3	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Week 24 to Week 48

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=18 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=25 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation	83.3 Percentage of participants Interval 66.1 to 100.0	80.0 Percentage of participants Interval 64.3 to 95.7	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 24 of re-treatment

Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=5 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=8 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=15 Participants Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=19 Participants Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24	60.0 Percentage of participants Interval 17.1 to 100.0	50.0 Percentage of participants Interval 15.4 to 84.6	66.7 Percentage of participants Interval 54.0 to 99.8	73.7 Percentage of participants Interval 58.6 to 97.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, and 48

Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=18 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=25 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 44	7.7 Percentage of participants Interval 0.2 to 36.0	0 Percentage of participants Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 48	7.7 Percentage of participants Interval 0.2 to 36.0	5.6 Percentage of participants Interval 0.1 to 27.3	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 28	0 Percentage of participants Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20	12 Percentage of participants Interval 2.5 to 31.2	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 32	6.3 Percentage of participants Interval 0.2 to 30.2	4.5 Percentage of participants Interval 0.1 to 22.8	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 36	0 Percentage of participants Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20	4.8 Percentage of participants Interval 0.1 to 23.8	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 40	12.5 Percentage of participants Interval 1.6 to 38.3	10.5 Percentage of participants Interval 1.3 to 33.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, and 48

Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=18 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=25 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 28	0 Percentage of participants Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20	16.7 Percentage of participants Interval 4.7 to 37.4	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 32	16.7 Percentage of participants Interval 3.6 to 41.4	14.3 Percentage of participants Interval 3.0 to 36.3	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 36	26.7 Percentage of participants Interval 7.8 to 55.1	43.8 Percentage of participants Interval 19.8 to 70.1	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 40	36.4 Percentage of participants Interval 10.9 to 69.2	22.2 Percentage of participants Interval 2.8 to 60.0	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 44	28.6 Percentage of participants Interval 3.7 to 71.0	0 Percentage of participants Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20	—	—	—	—	—	—	—	—
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 Week 48	40.0 Percentage of participants Interval 5.3 to 85.3	28.6 Percentage of participants Interval 3.7 to 71.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=178 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=135 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 Week 16	26.9 Percentage of participants Interval 20.2 to 33.7	39.1 Percentage of participants Interval 30.6 to 47.5	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 Week 20	25.6 Percentage of participants Interval 18.9 to 32.3	52.0 Percentage of participants Interval 43.2 to 60.9	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 Week 12	24.0 Percentage of participants Interval 17.6 to 30.4	40.2 Percentage of participants Interval 31.6 to 48.7	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 Week 24	28.8 Percentage of participants Interval 21.9 to 35.8	48.7 Percentage of participants Interval 39.8 to 57.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=178 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=135 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 Week 4	0 Percentage of participants Not estimable as 0 participants achieved SALT score criteria of ≤20	0 Percentage of participants Not estimable as 0 participants achieved SALT score criteria of ≤20	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 Week 8	1.7 Percentage of participants Interval 0.0 to 3.7	2.3 Percentage of participants Interval 0.0 to 5.0	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 Week 12	5.8 Percentage of participants Interval 2.3 to 9.3	16.4 Percentage of participants Interval 10.0 to 22.8	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 Week 16	10.2 Percentage of participants Interval 5.6 to 14.8	24.2 Percentage of participants Interval 16.8 to 31.6	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 Week 20	15.9 Percentage of participants Interval 10.3 to 21.4	35.2 Percentage of participants Interval 26.8 to 43.7	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 Week 24	22.1 Percentage of participants Interval 15.7 to 28.5	42.9 Percentage of participants Interval 34.0 to 51.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.

SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score). Negative change indicates no hair loss.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=177 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=132 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 4	-0.5 Percent change Standard Deviation 11.17	-1.0 Percent change Standard Deviation 8.73	—	—	—	—	—	—	—	—
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 8	-7.4 Percent change Standard Deviation 18.41	-14.8 Percent change Standard Deviation 21.67	—	—	—	—	—	—	—	—
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 12	-18.1 Percent change Standard Deviation 27.42	-30.9 Percent change Standard Deviation 33.69	—	—	—	—	—	—	—	—
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 16	-26.3 Percent change Standard Deviation 31.68	-39.9 Percent change Standard Deviation 36.24	—	—	—	—	—	—	—	—
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 20	-32.1 Percent change Standard Deviation 34.26	-49.0 Percent change Standard Deviation 37.44	—	—	—	—	—	—	—	—
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 24	-38.2 Percent change Standard Deviation 36.85	-55.3 Percent change Standard Deviation 38.01	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=178 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=135 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 Week 12	26.7 Percentage of responders Interval 20.1 to 33.4	47.6 Percentage of responders Interval 38.9 to 56.3	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 Week 16	37.7 Percentage of responders Interval 30.4 to 45.1	51.6 Percentage of responders Interval 42.9 to 60.2	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 Week 20	47.6 Percentage of responders Interval 39.2 to 55.2	63.1 Percentage of responders Interval 54.6 to 71.7	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 Week 24	50.3 Percentage of responders Interval 42.6 to 58.0	64.7 Percentage of responders Interval 56.1 to 73.3	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved). PGI responder is a response of 'very much improved' or 'much improved'.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=178 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=135 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 Week 12	29.8 Percentage of responders Interval 23.0 to 36.7	52.8 Percentage of responders Interval 44.1 to 61.4	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 Week 16	33.5 Percentage of responders Interval 26.4 to 40.7	55.5 Percentage of responders Interval 46.9 to 64.1	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 Week 20	40.9 Percentage of responders Interval 33.3 to 48.4	63.4 Percentage of responders Interval 54.9 to 71.9	—	—	—	—	—	—	—	—
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 Week 24	46.0 Percentage of responders Interval 38.4 to 53.7	65.5 Percentage of responders Interval 57.0 to 74.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.

The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=172 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=130 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 12	-0.8 Score on a scale Standard Deviation 1.15	-1.4 Score on a scale Standard Deviation 1.63	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 16	-1.1 Score on a scale Standard Deviation 1.37	-1.8 Score on a scale Standard Deviation 1.74	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 20	-1.3 Score on a scale Standard Deviation 1.38	-2.1 Score on a scale Standard Deviation 1.84	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Baseline	6.4 Score on a scale Standard Deviation 0.78	6.3 Score on a scale Standard Deviation 0.95	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 24	-1.6 Score on a scale Standard Deviation 1.64	-2.4 Score on a scale Standard Deviation 1.92	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 20, and 24

Population: The Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.

The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=172 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=130 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Baseline	6.4 Score on a scale Standard Deviation 0.75	6.4 Score on a scale Standard Deviation 0.84	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 12	-0.8 Score on a scale Standard Deviation 1.31	-1.1 Score on a scale Standard Deviation 1.56	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 24	-1.4 Score on a scale Standard Deviation 1.66	-2.3 Score on a scale Standard Deviation 1.95	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 16	-1.0 Score on a scale Standard Deviation 1.41	-1.6 Score on a scale Standard Deviation 1.74	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 Change From Baseline at Week 20	-1.1 Score on a scale Standard Deviation 1.41	-2.1 Score on a scale Standard Deviation 1.78	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 20, and 24

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.

The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=172 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=130 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Thickness Hair Coverage: Baseline	4.6 Score on a scale Standard Deviation 0.74	4.6 Score on a scale Standard Deviation 0.67	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Thickness Hair Coverage: Change From Baseline at Week 12	-0.9 Score on a scale Standard Deviation 1.17	-1.3 Score on a scale Standard Deviation 1.15	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Thickness Hair Coverage: Change From Baseline at Week 16	-1.0 Score on a scale Standard Deviation 1.15	-1.5 Score on a scale Standard Deviation 1.14	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Thickness Hair Coverage: Change From Baseline at Week 20	-1.1 Score on a scale Standard Deviation 1.23	-1.7 Score on a scale Standard Deviation 1.16	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Thickness Hair Coverage: Change From Baseline at Week 24	-1.2 Score on a scale Standard Deviation 1.38	-1.7 Score on a scale Standard Deviation 1.25	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Evenness Hair Coverage: Change From Baseline at Week 12	-0.8 Score on a scale Standard Deviation 1.09	-1.3 Score on a scale Standard Deviation 1.09	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Evenness Hair Coverage: Change From Baseline at Week 24	-1.1 Score on a scale Standard Deviation 1.22	-1.7 Score on a scale Standard Deviation 1.18	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyebrows: Change From Baseline at Week 20	-1.0 Score on a scale Standard Deviation 1.28	-1.5 Score on a scale Standard Deviation 1.32	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyelashes: Change From Baseline at Week 16	-0.8 Score on a scale Standard Deviation 1.25	-1.3 Score on a scale Standard Deviation 1.42	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyelashes: Change From Baseline at Week 20	-0.8 Score on a scale Standard Deviation 1.22	-1.4 Score on a scale Standard Deviation 1.37	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyelashes: Change From Baseline at Week 24	-0.9 Score on a scale Standard Deviation 1.28	-1.5 Score on a scale Standard Deviation 1.41	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Evenness Hair Coverage: Baseline	4.7 Score on a scale Standard Deviation 0.62	4.7 Score on a scale Standard Deviation 0.64	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Evenness Hair Coverage: Change From Baseline at Week 16	-0.9 Score on a scale Standard Deviation 1.07	-1.4 Score on a scale Standard Deviation 1.14	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 Satisfied Evenness Hair Coverage: Change From Baseline at Week 20	-1.0 Score on a scale Standard Deviation 1.11	-1.6 Score on a scale Standard Deviation 1.19	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyebrows: Baseline	4.0 Score on a scale Standard Deviation 1.23	4.1 Score on a scale Standard Deviation 1.35	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyebrows: Change From Baseline at Week 12	-0.8 Score on a scale Standard Deviation 1.20	-1.4 Score on a scale Standard Deviation 1.43	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyebrows: Change From Baseline at Week 16	-1.0 Score on a scale Standard Deviation 1.17	-1.4 Score on a scale Standard Deviation 1.44	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyebrows: Change From Baseline at Week 24	-1.1 Score on a scale Standard Deviation 1.29	-1.7 Score on a scale Standard Deviation 1.42	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyelashes: Baseline	3.7 Score on a scale Standard Deviation 1.40	3.7 Score on a scale Standard Deviation 1.44	—	—	—	—	—	—	—	—
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 How Satisfied With Your Eyelashes: Change From Baseline at Week 12	-0.7 Score on a scale Standard Deviation 1.12	-1.1 Score on a scale Standard Deviation 1.42	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24 of re-treatment

Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=5 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=8 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=15 Participants Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=19 Participants Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 Week 12	80.0 Percentage of participants Interval 44.9 to 100.0	62.5 Percentage of participants Interval 29.0 to 96.0	30.8 Percentage of participants Interval 5.7 to 55.9	43.8 Percentage of participants Interval 19.4 to 68.1	—	—	—	—	—	—
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 Week 4	60.0 Percentage of participants Interval 17.1 to 100.0	62.5 Percentage of participants Interval 29.0 to 96.0	26.7 Percentage of participants Interval 4.3 to 49.0	15.8 Percentage of participants Interval 0.0 to 32.2	—	—	—	—	—	—
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 Week 8	100.0 Percentage of participants Interval 100.0 to 100.0	62.5 Percentage of participants Interval 29.0 to 96.0	23.1 Percentage of participants Interval 0.2 to 46.0	16.7 Percentage of participants Interval 0.0 to 33.9	—	—	—	—	—	—
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 Week 16	60.0 Percentage of participants Interval 17.1 to 100.0	62.5 Percentage of participants Interval 29.0 to 96.0	50.0 Percentage of participants Interval 21.7 to 78.3	61.1 Percentage of participants Interval 38.6 to 83.6	—	—	—	—	—	—
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 Week 20	60.0 Percentage of participants Interval 17.1 to 100.0	62.5 Percentage of participants Interval 29.0 to 96.0	69.2 Percentage of participants Interval 44.1 to 94.3	70.6 Percentage of participants Interval 48.9 to 92.2	—	—	—	—	—	—
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 Week 24	60.0 Percentage of participants Interval 17.1 to 100.0	50.0 Percentage of participants Interval 15.4 to 84.6	76.9 Percentage of participants Interval 54.0 to 99.8	77.8 Percentage of participants Interval 58.6 to 97.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment

Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.

SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=5 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=8 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=15 Participants Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=19 Participants Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 16	-48.8 Percent change Standard Deviation 52.66	-11.4 Percent change Standard Deviation 78.88	-13.4 Percent change Standard Deviation 95.31	-15.2 Percent change Standard Deviation 116.20	—	—	—	—	—	—
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 4	-20.8 Percent change Standard Deviation 15.27	-1.5 Percent change Standard Deviation 69.43	12.1 Percent change Standard Deviation 39.44	47.8 Percent change Standard Deviation 71.19	—	—	—	—	—	—
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 8	-39.6 Percent change Standard Deviation 20.33	26.2 Percent change Standard Deviation 109.97	10.5 Percent change Standard Deviation 48.10	47.1 Percent change Standard Deviation 94.35	—	—	—	—	—	—
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 12	-42.6 Percent change Standard Deviation 27.06	-2.6 Percent change Standard Deviation 78.81	-7.2 Percent change Standard Deviation 84.41	33.9 Percent change Standard Deviation 119.41	—	—	—	—	—	—
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 20	-54.8 Percent change Standard Deviation 43.90	-7.8 Percent change Standard Deviation 83.35	-29.2 Percent change Standard Deviation 93.24	-31.5 Percent change Standard Deviation 108.97	—	—	—	—	—	—
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 Relative Change From Baseline at Week 24	-39.3 Percent change Standard Deviation 53.48	-7.9 Percent change Standard Deviation 81.41	-39.3 Percent change Standard Deviation 84.49	-38.4 Percent change Standard Deviation 105.80	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug up to last follow up visit (Week 76)

Population: Safety population included all participants who received study drug during the treatment period.

An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs.

Outcome measures

Measure	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=180 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=137 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=18 Participants Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=25 Participants Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo n=18 Participants Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo n=25 Participants Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID n=5 Participants Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID n=8 Participants Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=15 Participants Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=19 Participants Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)	124 Participants	100 Participants	9 Participants	12 Participants	7 Participants	11 Participants	2 Participants	5 Participants	12 Participants	14 Participants

Adverse Events

Part A: Period 1 - CTP-543 8 mg BID

Serious events: 1 serious events

Other events: 91 other events

Deaths: 0 deaths

Part A: Period 1 - CTP-543 12 mg BID

Serious events: 5 serious events

Other events: 82 other events

Deaths: 0 deaths

Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part A: Period 2 - CTP-543 8 mg BID to Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A: Period 2 - CTP-543 12 mg BID to Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B: CTP-543 8 mg BID to Placebo to 8 mg BID

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part B: CTP-543 12 mg BID to Placebo to 12 mg BID

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Period 1 - CTP-543 8 mg BID n=180 participants at risk Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 1 - CTP-543 12 mg BID n=137 participants at risk Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=18 participants at risk Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=25 participants at risk Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo n=18 participants at risk Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo n=25 participants at risk Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID n=5 participants at risk Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID n=8 participants at risk Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=15 participants at risk Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=19 participants at risk Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma in Situ	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Electrocardiogram T Wave Inversion	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Gastrointestinal disorders Crohn's Disease	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Psychiatric disorders Suicidal Ideation	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.

Other adverse events

Measure	Part A: Period 1 - CTP-543 8 mg BID n=180 participants at risk Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 1 - CTP-543 12 mg BID n=137 participants at risk Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID n=18 participants at risk Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID n=25 participants at risk Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 8 mg BID to Placebo n=18 participants at risk Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part A: Period 2 - CTP-543 12 mg BID to Placebo n=25 participants at risk Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID n=5 participants at risk Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID n=8 participants at risk Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 8 mg BID to Placebo to 8 mg BID n=15 participants at risk Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.	Part B: CTP-543 12 mg BID to Placebo to 12 mg BID n=19 participants at risk Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Infections and infestations Asymptomatic COVID-19	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Candida infection	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	20.0% 1/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Conjunctivitis	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations COVID-19	12.8% 23/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	15.3% 21/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	16.7% 3/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	20.0% 5/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	26.7% 4/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	21.1% 4/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Folliculitis	2.2% 4/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Fungal skin infection	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Influenza	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Nasopharyngitis	6.1% 11/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	7.3% 10/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.0% 3/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.0% 3/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Upper respiratory tract infection	6.1% 11/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.2% 3/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.0% 3/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	13.3% 2/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Urinary tract infection	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.9% 4/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	10.5% 2/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	20.0% 1/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Musculoskeletal and connective tissue disorders Tendonitis	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Skin and subcutaneous tissue disorders Acne	12.8% 23/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.4% 17/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	20.0% 1/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Skin and subcutaneous tissue disorders Eczema	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Skin and subcutaneous tissue disorders Pruritus	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.9% 4/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	8.0% 2/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Nervous system disorders Dysaesthesia	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Nervous system disorders Headache	10.6% 19/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	14.6% 20/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	13.3% 2/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Nervous system disorders Memory impairment	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Nervous system disorders Migraine	1.7% 3/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Nervous system disorders Paraesthesia	1.7% 3/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Injury, poisoning and procedural complications Contusion	1.7% 3/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Injury, poisoning and procedural complications Joint injury	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Injury, poisoning and procedural complications Sunburn	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Alanine aminotransferase increased	1.7% 3/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Amylase increased	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Aspartate aminotransferase increased	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations C-reactive protein increased	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Haemoglobin decreased	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.2% 3/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Lipase increased	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Neutrophil count decreased	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Neutrophil percentage decreased	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Platelet count increased	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Red blood cell count decreased	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Weight increased	4.4% 8/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.8% 8/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations White blood cell count decreased	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
General disorders Fatigue	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.6% 9/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Respiratory, thoracic and mediastinal disorders Cough	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	8.0% 2/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.7% 3/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.2% 3/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.4% 6/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Respiratory, thoracic and mediastinal disorders Tonsillolith	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Psychiatric disorders Depression	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Psychiatric disorders Suicidal ideation	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Eye disorders Eye disorder	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Eye disorders Visual impairment	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	8.0% 2/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Gastrointestinal disorders Abdominal pain	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Gastrointestinal disorders Crohn's disease	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Gastrointestinal disorders Diarrhoea	2.2% 4/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.9% 4/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Gastrointestinal disorders Vomiting	2.2% 4/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Blood and lymphatic system disorders Anaemia	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	1.5% 2/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	4.0% 1/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	12.5% 1/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Blood and lymphatic system disorders Thrombocytosis	1.1% 2/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	2.9% 4/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Cardiac disorders Bundle branch block left	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Metabolism and nutrition disorders Hyperlipidaemia	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Reproductive system and breast disorders Uterine polyp	0.00% 0/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Investigations Blood creatine phosphokinase increased	2.2% 4/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.73% 1/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	6.7% 1/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.3% 1/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Infections and infestations Gastroenteritis	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.56% 1/180 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/137 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	5.6% 1/18 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/25 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/5 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/8 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/15 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.	0.00% 0/19 • From first dose of study drug up to last follow up visit (Week 76) All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.

Additional Information

Colleen E. Hamilton

Concert Pharmaceuticals, Inc.

Phone: 781-860-0045

Email: AAclinicaltrial_inquiries@concertpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
• Publication restrictions are in place

Restriction type: OTHER