Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (NCT NCT02141997)

NCT ID: NCT02141997

Last Updated: 2016-11-11

Results Overview

Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 222 participants
• Primary outcome timeframe: Baseline (Day 1) and Week 12
• Results posted on: 2016-11-11

Participant Flow

The study included a 30-day screening period.

Participant milestones

Measure	Adalimumab 40 mg EOW Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW ABT-122 120 mg every week (EW) for 11 weeks.
Overall Study STARTED	56	55	56	55
Overall Study COMPLETED	53	49	53	54
Overall Study NOT COMPLETED	3	6	3	1

Reasons for withdrawal

Measure	Adalimumab 40 mg EOW Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW ABT-122 120 mg every week (EW) for 11 weeks.
Overall Study Adverse Event	0	2	0	1
Overall Study Participant noncompliance	1	0	0	0
Overall Study Withdrew consent	1	0	3	0
Overall Study Other	1	4	0	0

Baseline Characteristics

A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Baseline characteristics by cohort

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.	Total n=222 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 12.36 • n=5 Participants	55.2 years STANDARD_DEVIATION 11.81 • n=7 Participants	53.5 years STANDARD_DEVIATION 13.00 • n=5 Participants	55.6 years STANDARD_DEVIATION 12.34 • n=4 Participants	55.5 years STANDARD_DEVIATION 12.39 • n=21 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	45 Participants n=7 Participants	49 Participants n=5 Participants	45 Participants n=4 Participants	181 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	41 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: Full analysis set (FAS) defined as all randomized participants with at least 1 dose of study drug.

Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	73.2 percentage of participants	65.5 percentage of participants	76.8 percentage of participants	81.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 6, 8, and 12

Population: Subjects in the FAS with a baseline value and at least 1 post-baseline value

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) Week 4 (n=56,55,56,55)	-1.86 units on a scale Interval -2.17 to -1.55	-1.66 units on a scale Interval -1.97 to -1.34	-2.08 units on a scale Interval -2.39 to -1.78	-2.15 units on a scale Interval -2.46 to -1.84
Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) Week 2 (n=54,53,55,53)	-1.43 units on a scale Interval -1.71 to -1.15	-1.26 units on a scale Interval -1.54 to -0.97	-1.80 units on a scale Interval -2.08 to -1.52	-1.69 units on a scale Interval -1.97 to -1.41
Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) Week 6 (n=56,55,56,55)	-2.28 units on a scale Interval -2.6 to -1.96	-1.83 units on a scale Interval -2.16 to -1.51	-2.39 units on a scale Interval -2.71 to -2.07	-2.41 units on a scale Interval -2.74 to -2.09
Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) Week 8 (n=56,55,56,55)	-2.32 units on a scale Interval -2.64 to -2.0	-1.98 units on a scale Interval -2.31 to -1.65	-2.60 units on a scale Interval -2.93 to -2.28	-2.58 units on a scale Interval -2.91 to -2.25
Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) Week 12 (n=56,55,56,55)	-2.44 units on a scale Interval -2.75 to -2.12	-2.06 units on a scale Interval -2.38 to -1.74	-2.64 units on a scale Interval -2.95 to -2.33	-2.67 units on a scale Interval -2.98 to -2.35

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: Participants in the FAS population with a baseline value and at least 1 post-baseline value

Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=54 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12	51.8 percentage of participants	34.5 percentage of participants	48.2 percentage of participants	48.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: Participants in the FAS population with a baseline value and at least 1 post-baseline value

Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12	23.2 percentage of participants	23.6 percentage of participants	19.6 percentage of participants	36.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the FAS population with a baseline value and at least 1 post-baseline value

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12	50.0 percentage of participants	34.5 percentage of participants	53.6 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the FAS population with a baseline value and at least 1 post-baseline value

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12	32.1 percentage of participants	23.6 percentage of participants	39.3 percentage of participants	41.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the FAS population with a baseline value and at least 1 post-baseline value

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12	42.9 percentage of participants	36.4 percentage of participants	44.6 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the FAS population with a baseline value and at least 1 post-baseline value

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).

Outcome measures

Measure	Adalimumab 40 mg EOW n=56 Participants Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 Participants ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 Participants ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 Participants ABT-122 120 mg every week (EW) for 11 weeks.
Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12	8.9 percentage of participants	7.3 percentage of participants	10.7 percentage of participants	10.9 percentage of participants

Adverse Events

Adalimumab 40 mg EOW

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

ABT-122 60 mg EOW

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

ABT-122 120 mg EOW

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

ABT-122 120 mg EW

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab 40 mg EOW n=56 participants at risk Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 participants at risk ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 participants at risk ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 participants at risk ABT-122 120 mg every week (EW) for 11 weeks.
Cardiac disorders ANGINA PECTORIS	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Measure	Adalimumab 40 mg EOW n=56 participants at risk Adalimumab 40 mg every other week (EOW) for 11 weeks.	ABT-122 60 mg EOW n=55 participants at risk ABT-122 60 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EOW n=56 participants at risk ABT-122 120 mg every other week (EOW) for 11 weeks.	ABT-122 120 mg EW n=55 participants at risk ABT-122 120 mg every week (EW) for 11 weeks.
Gastrointestinal disorders DIARRHOEA	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders NAUSEA	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders FATIGUE	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations NASOPHARYNGITIS	5.4% 3/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.8% 1/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	7.3% 4/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations URINARY TRACT INFECTION	1.8% 1/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	9.1% 5/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	5.4% 3/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	5.4% 3/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders HEADACHE	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	5.5% 3/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders SOMNOLENCE	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders HYPERTENSION	3.6% 2/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.8% 1/56 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/55 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (25 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

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