Trial Outcomes & Findings for Efficacy and Safety Study of E2007 in Migraine Prophylaxis (NCT NCT00154063)

NCT ID: NCT00154063

Last Updated: 2015-06-08

Results Overview

A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 206 participants
• Primary outcome timeframe: Baseline to Week 19
• Results posted on: 2015-06-08

Participant Flow

Participant milestones

Measure	Placebo During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Overall Study STARTED	104	102
Overall Study COMPLETED	92	80
Overall Study NOT COMPLETED	12	22

Reasons for withdrawal

Measure	Placebo During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Overall Study Adverse Event	4	8
Overall Study Protocol Violation	1	1
Overall Study Investigator or Sponsor Request	0	1
Overall Study Withdrawal by Subject	4	9
Overall Study Other	3	3

Baseline Characteristics

Efficacy and Safety Study of E2007 in Migraine Prophylaxis

Baseline characteristics by cohort

Measure	Placebo n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 n=102 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Total n=206 Participants Total of all reporting groups
Age, Continuous	41.5 Years STANDARD_DEVIATION 11.5 • n=5 Participants	41.3 Years STANDARD_DEVIATION 12.5 • n=7 Participants	41.4 Years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	89 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 19

Population: The efficacy analysis was performed on the Intention to treat (ITT) Population, which was defined as all randomized subjects who received at least 1 dose of double-blind study medication, and had baseline and postbaseline migraine assessments in at least 1 phase.

A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)	-2.94 Migraine period Standard Error 0.32	-2.73 Migraine period Standard Error 0.39	-3.31 Migraine period Standard Error 0.39	-3.00 Migraine period Standard Error 0.50

SECONDARY outcome

Timeframe: Baseline to Week 19

Population: ITT Population

The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF)	0.69 Hours Standard Error 1.79	4.65 Hours Standard Error 3.27	-1.22 Hours Standard Error 2.16	3.70 Hours Standard Error 3.58

SECONDARY outcome

Timeframe: Baseline to Week 19

Population: ITT Population

The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF)	0.95 Units on a Scale Standard Error 1.23	0.26 Units on a Scale Standard Error 1.09	0.97 Units on a Scale Standard Error 1.22	0.19 Units on a Scale Standard Error 1.09

SECONDARY outcome

Timeframe: Baseline to Week 19

Population: ITT Population

Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)	-2.06 Migraine attack Standard Error 0.20	-1.95 Migraine attack Standard Error 0.24	-1.51 Migraine attack Standard Error 0.15	-1.49 Migraine attack Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, Week 11 to Week 19

Population: ITT Population

A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase	-2.9 Migraine period Standard Error 0.35	-2.91 Migraine period Standard Error 0.38	-3.27 Migraine period Standard Error 0.40	-3.52 Migraine period Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline to Week 19

Population: ITT Population

The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF)	-3.05 Days Standard Error 0.38	-2.74 Days Standard Error 0.44	-3.10 Days Standard Error 0.38	-2.68 Days Standard Error 0.48

SECONDARY outcome

Timeframe: Baseline to Week 19

Population: ITT Population

A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF)	-3.77 Days Standard Error 0.39	-3.27 Days Standard Error 0.47	-4.1 Days Standard Error 0.43	-3.48 Days Standard Error 0.56

SECONDARY outcome

Timeframe: Baseline to Week 23

Population: ITT Population

The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from "very much improved" with a score of 1 to "very much worse" with a score of 7. A responder is defined as being "very much improved" or "much improved". The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment)

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF) Very Much/Much Improved	40 Participants	41 Participants	—	—
Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF) No Change/Minimally Improved	56 Participants	52 Participants	—	—
Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF) Worsened	8 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful.

Outcome measures

Measure	Placebo (24 Hour Rule) n=95 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=90 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score	-0.83 units on a scale Standard Deviation 2	-0.28 units on a scale Standard Deviation 2	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation.

Outcome measures

Measure	Placebo (24 Hour Rule) n=95 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=91 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches	-6.80 Days Standard Deviation 13	-6.99 Days Standard Deviation 11	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation.

Outcome measures

Measure	Placebo (24 Hour Rule) n=95 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=91 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework	-3.4 Days Standard Deviation 8	-2.3 Days Standard Deviation 7	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation.

Outcome measures

Measure	Placebo (24 Hour Rule) n=94 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=90 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School	-1.76 Days Standard Deviation 7	-2.47 Days Standard Deviation 7	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.

Outcome measures

Measure	Placebo (24 Hour Rule) n=94 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=91 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework	-3.07 Days Standard Deviation 7	-2.45 Days Standard Deviation 7	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.

Outcome measures

Measure	Placebo (24 Hour Rule) n=95 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=91 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities	-1.34 Days Standard Deviation 4	-2.07 Days Standard Deviation 6	—	—

SECONDARY outcome

Timeframe: Baseline, Week 23

Population: ITT Population. Only patients with non-missing baseline data are summarized.

The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation.

Outcome measures

Measure	Placebo (24 Hour Rule) n=94 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=90 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School	-1.20 Days Standard Deviation 3	-0.82 Days Standard Deviation 3	—	—

SECONDARY outcome

Timeframe: Week 5 to Week 19

Population: ITT Population

Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)	46.2 Percentage of Participants	47.5 Percentage of Participants	36.5 Percentage of Participants	45.5 Percentage of Participants

SECONDARY outcome

Timeframe: Week 5 to Week 19

Population: ITT Population

A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants.

Outcome measures

Measure	Placebo (24 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (24 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	Placebo (48 Hour Rule) n=104 Participants During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 (48 Hour Rule) n=101 Participants During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)	48.1 Percentage of Participants	50.5 Percentage of Participants	51.9 Percentage of Participants	52.5 Percentage of Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 75 other events

Deaths: 0 deaths

E2007

Serious events: 1 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=104 participants at risk During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 n=102 participants at risk During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Infections and infestations Abscess	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Cellulitis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Wound	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.

Other adverse events

Measure	Placebo n=104 participants at risk During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).	E2007 n=102 participants at risk During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Blood and lymphatic system disorders Lymphadenopathy	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Cardiac disorders Palpitations	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Cardiac disorders Atrial tachycardia	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Cardiac disorders Bundle branch block left	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Ear and labyrinth disorders Ear pain	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Ear and labyrinth disorders Hypoacusis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Ear and labyrinth disorders Motion sickness	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Ear and labyrinth disorders Vertigo	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Endocrine disorders Goitre	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Endocrine disorders Hypothyroidism	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Eye disorders Conjunctivitis	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Eye disorders Eye pain	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Eye disorders Eye haemorrhage	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Eye disorders Vitreous detachment	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Nausea	8.7% 9/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	6.9% 7/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Diarrhoea	2.9% 3/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Dyspepsia	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Toothache	2.9% 3/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Abdominal pain	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Dry mouth	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Stomach discomfort	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Flatulence	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders ?Irritable bowel syndrome	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Vomiting	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Abdominal distension	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Constipation	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Gastrointestinal disorders Retching	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Fatigue	6.7% 7/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	5.9% 6/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Influenza like illness	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Pain	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Asthenia	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Chest pain	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Feeling cold	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Malaise	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Thirst	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Chills	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Exercise tolerance decreased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Granuloma	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Injected limb mobility decreased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Injection site pain	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Injection site swelling	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Oedema peripheral	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Pre-existing condition improved	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Sluggishness	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Swelling	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
General disorders Tenderness	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Hepatobiliary disorders Liver tenderness	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Immune system disorders Hypersensitivity	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Immune system disorders Multiple allergies	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Immune system disorders ?Seasonal allergy	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Nasopharyngitis	13.5% 14/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	9.8% 10/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Upper respiratory tract infection	8.7% 9/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	10.8% 11/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Urinary tract infection	7.7% 8/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	5.9% 6/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Sinusitis	4.8% 5/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	5.9% 6/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Fungal infection	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Gastroenteritis viral	4.8% 5/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Influenza	4.8% 5/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Bronchitis	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Streptococcal infection	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Viral infection	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Herpes zoster	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Abscess	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Bacterial infection	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Bronchitis viral	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Cellulitis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Dental caries	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Diverticulitis	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Ear infection	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Kidney infection	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Localised infection	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Lung infection	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Pharyngitis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Tooth abscess	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Vaginal candidiasis	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Vaginal infection	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Infections and infestations Wound infection	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Fall	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Joint sprain	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Procedural pain	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Skin laceration	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Arthropod bite	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications ?Back injury	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Contusion	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Foot fracture	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Muscle strain	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Road traffic accident	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Human bite	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Injury, poisoning and procedural complications Wound	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Blood creatine phosphokinase increased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	3.9% 4/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Protein urine present	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Alanine aminotransferase increased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Aspartate aminotransferase increased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Bacteria urine	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Blood creatinine increased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Blood urine present	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Crystal urine present	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations White blood cells urine positive	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Blood potassium abnormal	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Body temperature increased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Cardiac murmur functional	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Electrocardiogram abnormal	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Gastric pH decreased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Haematocrit decreased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Haematology test abnormal	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Haemoglobin decreased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Heart rate increased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Mean cell volume decreased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Platelet count increased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Urinary sediment present	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Urine analysis abnormal	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Weight decreased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations Weight increased	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Investigations White blood cell count decreased	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	5.8% 6/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	5.9% 6/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 6/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	4.9% 5/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	3.9% 4/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Neck pain	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Shoulder pain	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Joint swelling	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Muscle twitching	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Dizziness	8.7% 9/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	9.8% 10/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Somnolence	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	6.9% 7/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Migraine	2.9% 3/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Headache	3.8% 4/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Sinus headache	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Sedation	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.9% 3/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Lethargy	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Tremor	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Ageusia	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Anosmia	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Dysaesthesia	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Head discomfort	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Memory impairment	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders ?Mental impairment	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Muscle spasticity	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Paraesthesia	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Nervous system disorders Parosmia	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Insomnia	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	3.9% 4/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Depression	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Anxiety	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Nightmare	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Aggression	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Mood altered	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Sleep disorder	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Psychiatric disorders Thinking abnormal	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Renal and urinary disorders Nephrolithiasis	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Renal and urinary disorders Chromaturia	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Renal and urinary disorders Haematuria	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Reproductive system and breast disorders Dysmenorrhoea	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Reproductive system and breast disorders Genital rash	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Reproductive system and breast disorders Premenstrual syndrome	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.8% 6/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	4.9% 5/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	4.9% 5/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Acne	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders ?Dry skin	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Alopecia	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Rash	1.9% 2/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Onychorrhexis	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Rash macular	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Vascular disorders Hypertension	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	2.0% 2/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Vascular disorders Hot flush	0.00% 0/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.98% 1/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.
Vascular disorders Hypotension	0.96% 1/104 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.	0.00% 0/102 • From baseline (day 1) up to 30 days after participant's treatment end date or final study visit or up to week 23. Treatment emergent adverse events (TEAEs), defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section. The data presented in the other AE section includes serious adverse events.

Additional Information

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• Principal investigator is a sponsor employee
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