Trial Outcomes & Findings for A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition (NCT NCT01557244)

Last Updated: 2021-02-02

Results Overview

Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of \>=40 centimeter (cm) water (H2O).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

181 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2021-02-02

Participant Flow

Study had 2 cohorts: cohort 1 had participants with body weight greater than (\>) 25 kilogram (kg) and cohort 2 had participants with body weight less than or equal to (\<=) 25 kg. There were 2 phases in each cohort: cohort 1- active comparator phase followed by safety extension phase; cohort 2- efficacy phase followed by safety extension phase.

Participant milestones

Participant milestones
Measure	Cohort 1: Fesoterodine 4 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 milligram (mg) prolonged release (PR) tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.	Cohort 1: Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.	Cohort 1: Oxybutynin Participants with body weight \>25 kg were randomized to receive oxybutynin extended release (ER) tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Cohort 1: Oxybutynin Then Fesoterodine 4 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1: Oxybutynin Then Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated then participants were withdrawn from the study.	Cohort 2: Fesoterodine 2 mg Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.	Cohort 2: Fesoterodine 2 mg Then 4 mg Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.
Active Comparator/Efficacy Phase:12Weeks STARTED	42	42	40	0	0	28	29
Active Comparator/Efficacy Phase:12Weeks Treated	42	42	40	0	0	28	29
Active Comparator/Efficacy Phase:12Weeks COMPLETED	33	40	36	0	0	21	28
Active Comparator/Efficacy Phase:12Weeks NOT COMPLETED	9	2	4	0	0	7	1
Safety Extension Phase: 12 Weeks STARTED	33	40	0	16	20	21	28
Safety Extension Phase: 12 Weeks Treated	30	37	0	16	20	20	28
Safety Extension Phase: 12 Weeks COMPLETED	30	36	0	15	20	20	28
Safety Extension Phase: 12 Weeks NOT COMPLETED	3	4	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Fesoterodine 4 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 milligram (mg) prolonged release (PR) tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.	Cohort 1: Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.	Cohort 1: Oxybutynin Participants with body weight \>25 kg were randomized to receive oxybutynin extended release (ER) tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Cohort 1: Oxybutynin Then Fesoterodine 4 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 2: Fesoterodine 2 mg Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.	Cohort 2: Fesoterodine 2 mg Then 4 mg Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.
Active Comparator/Efficacy Phase:12Weeks Adverse Event	2	0	0	0	2	0
Active Comparator/Efficacy Phase:12Weeks Protocol Violation	2	0	1	0	0	0
Active Comparator/Efficacy Phase:12Weeks Lost to Follow-up	1	0	0	0	0	0
Active Comparator/Efficacy Phase:12Weeks Withdrawal By Parent/Guardian	2	0	0	0	3	0
Active Comparator/Efficacy Phase:12Weeks Medication Error Without Associated AEs	0	1	0	0	0	0
Active Comparator/Efficacy Phase:12Weeks Insufficient Clinical Response	0	0	0	0	1	1
Active Comparator/Efficacy Phase:12Weeks Failure to Meet Randomization Criteria	0	1	1	0	1	0
Active Comparator/Efficacy Phase:12Weeks Other	2	0	2	0	0	0
Safety Extension Phase: 12 Weeks Adverse Event	1	1	0	0	1	0
Safety Extension Phase: 12 Weeks Withdrawal By Parent/Guardian	1	1	0	0	0	0
Safety Extension Phase: 12 Weeks Medication Error Without Associated AEs	0	0	0	1	0	0
Safety Extension Phase: 12 Weeks Insufficient Clinical Response	1	2	0	0	0	0

Baseline Characteristics

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg PR tablet orally once daily for another 12 weeks.	Cohort 1: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study. Active comparator phase was followed by safety extension phase, where participants continued to receive fesoterodine 8 mg PR tablet orally once daily for another 12 weeks.	Cohort 1: Oxybutynin n=40 Participants Participants with body weight \>25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Cohort 2: Fesoterodine 2 mg n=28 Participants Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg beads-in-capsule (BIC) capsule orally once daily for 12 weeks in efficacy phase. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 12 weeks.	Cohort 2: Fesoterodine 2 mg Then 4 mg n=29 Participants Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if this dose was tolerated well, participants received fesoterodine 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study. Efficacy phase was followed by safety extension phase, where participants continued to receive fesoterodine 4 mg BIC capsule orally once daily for another 12 weeks.	Total n=181 Participants Total of all reporting groups
Age, Customized >=6-9 Years	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	24 Participants n=4 Participants	23 Participants n=21 Participants	92 Participants n=10 Participants
Age, Customized >=10-12 Years	15 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	50 Participants n=10 Participants
Age, Customized >=13-17 Years	12 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	39 Participants n=10 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	22 Participants n=7 Participants	17 Participants n=5 Participants	12 Participants n=4 Participants	19 Participants n=21 Participants	86 Participants n=10 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	16 Participants n=4 Participants	10 Participants n=21 Participants	95 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	40 Participants n=7 Participants	39 Participants n=5 Participants	28 Participants n=4 Participants	27 Participants n=21 Participants	173 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	16 Participants n=4 Participants	16 Participants n=21 Participants	86 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	24 Participants n=7 Participants	17 Participants n=5 Participants	12 Participants n=4 Participants	11 Participants n=21 Participants	88 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of \>=40 centimeter (cm) water (H2O).

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=25 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase	87.17 milliliter Interval 56.82 to 117.53	23.49 milliliter Interval 3.03 to 43.95	40.17 milliliter Interval 20.84 to 59.5	—	58.12 milliliter Interval 28.84 to 87.39	83.36 milliliter Interval 54.22 to 112.49

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=25 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase	-2.39 cm H2O Interval -7.27 to 2.48	-2.74 cm H2O Interval -10.62 to 5.15	-9.73 cm H2O Interval -17.18 to -2.28	—	-2.86 cm H2O Interval -7.6 to 1.87	-1.57 cm H2O Interval -6.25 to 3.12

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=25 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase Baseline IDC = Yes; Week 12 IDC = Yes	18 Participants	19 Participants	16 Participants	—	18 Participants	18 Participants
Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase Baseline IDC = No; Week 12 IDC = No	6 Participants	0 Participants	1 Participants	—	12 Participants	4 Participants
Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase Baseline IDC = No; Week 12 IDC = Yes	0 Participants	0 Participants	0 Participants	—	2 Participants	1 Participants
Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase Baseline IDC = Yes; Week 12 IDC = No	14 Participants	6 Participants	11 Participants	—	9 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=32 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=25 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=27 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=26 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=36 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase	41.31 milliliter Interval 15.92 to 66.7	23.80 milliliter Interval -1.6 to 49.19	31.26 milliliter Interval 6.85 to 55.68	—	30.53 milliliter Interval 2.42 to 58.64	26.06 milliliter Interval 2.19 to 49.92

SECONDARY outcome

Timeframe: Baseline, Week 12

Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=25 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=40 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase	11.36 mL per cm H2O Interval 4.3 to 18.42	12.44 mL per cm H2O Interval -0.64 to 25.53	16.44 mL per cm H2O Interval 4.08 to 28.8	—	6.40 mL per cm H2O Interval -0.48 to 13.28	5.41 mL per cm H2O Interval -1.49 to 12.32

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with \>0 micturitions at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=26 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=14 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=17 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=18 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=21 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase	-0.97 micturitions per 24 hours Interval -1.65 to -0.29	-0.37 micturitions per 24 hours Interval -1.1 to 0.36	-0.70 micturitions per 24 hours Interval -1.36 to -0.04	—	-1.07 micturitions per 24 hours Interval -1.88 to -0.25	-0.68 micturitions per 24 hours Interval -1.44 to 0.08

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with \>0 catheterizations at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=31 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=22 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=24 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=33 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase	-0.34 catheterizations per 24 hours Interval -0.71 to 0.02	-0.10 catheterizations per 24 hours Interval -0.5 to 0.29	-0.22 catheterizations per 24 hours Interval -0.6 to 0.16	—	-0.30 catheterizations per 24 hours Interval -0.63 to 0.04	-0.32 catheterizations per 24 hours Interval -0.68 to 0.03

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations \>0 at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=23 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=26 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase	-0.75 micturitions and catheterizations/24 hrs Interval -1.24 to -0.26	-0.24 micturitions and catheterizations/24 hrs Interval -0.67 to 0.19	-0.28 micturitions and catheterizations/24 hrs Interval -0.68 to 0.12	—	-0.61 micturitions and catheterizations/24 hrs Interval -1.08 to -0.14	-0.60 micturitions and catheterizations/24 hrs Interval -1.09 to -0.11

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with \>0 incontinence episodes at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=35 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=22 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=33 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase	-1.01 incontinence episodes per 24 hours Interval -1.46 to -0.56	-0.38 incontinence episodes per 24 hours Interval -0.95 to 0.2	-0.69 incontinence episodes per 24 hours Interval -1.29 to -0.08	—	-0.46 incontinence episodes per 24 hours Interval -0.92 to 0.0	-0.89 incontinence episodes per 24 hours Interval -1.35 to -0.43

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with \>0 urgency episodes at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=26 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=13 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=26 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=18 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase	-0.14 urgency episodes per 24 hours Interval -0.7 to 0.42	-0.23 urgency episodes per 24 hours Interval -0.84 to 0.38	-0.62 urgency episodes per 24 hours Interval -1.35 to 0.12	—	-0.62 urgency episodes per 24 hours Interval -1.18 to -0.06	-0.50 urgency episodes per 24 hours Interval -1.17 to 0.17

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=8 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=10 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=15 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=15 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase	4.15 milliliter per micturition Interval -22.69 to 30.98	-12.72 milliliter per micturition Interval -34.96 to 9.52	-8.41 milliliter per micturition Interval -28.27 to 11.44	—	4.10 milliliter per micturition Interval -28.05 to 36.24	19.21 milliliter per micturition Interval -12.67 to 51.1

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=23 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=25 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=36 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=32 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase	45.90 milliliter per catheterization Interval 11.24 to 80.55	11.50 milliliter per catheterization Interval -9.87 to 32.88	1.74 milliliter per catheterization Interval -18.76 to 22.23	—	29.47 milliliter per catheterization Interval -1.38 to 60.32	47.18 milliliter per catheterization Interval 14.74 to 79.62

SECONDARY outcome

Timeframe: Baseline, Week 12

The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations \>0 at Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=24 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=39 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=38 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase	36.69 mL per micturition or catheterization Interval 6.95 to 66.43	7.12 mL per micturition or catheterization Interval -11.87 to 26.11	-2.65 mL per micturition or catheterization Interval -20.22 to 14.92	—	18.45 mL per micturition or catheterization Interval -11.49 to 48.4	55.55 mL per micturition or catheterization Interval 25.8 to 85.31

SECONDARY outcome

Timeframe: Baseline up to Week 12

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase Treatment Emergent AEs	30 Participants	19 Participants	18 Participants	—	26 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase Treatment Emergent SAEs	1 Participants	2 Participants	2 Participants	—	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 12 up to Week 26 (including 2 weeks of follow up after last dose)

Population: Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase Treatment emergent AEs	9 Participants	11 Participants	11 Participants	16 Participants	14 Participants	13 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase Treatment emergent SAEs	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase Right Eye: Baseline	0.03 logMAR unit Standard Deviation 0.11	0.15 logMAR unit Standard Deviation 0.21	0.10 logMAR unit Standard Deviation 0.18	—	0.09 logMAR unit Standard Deviation 0.16	0.11 logMAR unit Standard Deviation 0.19
Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase Right Eye: Change at Week 12	0.02 logMAR unit Standard Deviation 0.18	0.03 logMAR unit Standard Deviation 0.12	-0.00 logMAR unit Standard Deviation 0.09	—	0.01 logMAR unit Standard Deviation 0.11	-0.01 logMAR unit Standard Deviation 0.10
Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase Left Eye: Baseline	0.02 logMAR unit Standard Deviation 0.13	0.16 logMAR unit Standard Deviation 0.21	0.14 logMAR unit Standard Deviation 0.30	—	0.08 logMAR unit Standard Deviation 0.16	0.10 logMAR unit Standard Deviation 0.17
Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase Left Eye: Change at Week 12	0.00 logMAR unit Standard Deviation 0.13	-0.02 logMAR unit Standard Deviation 0.08	0.00 logMAR unit Standard Deviation 0.08	—	0.00 logMAR unit Standard Deviation 0.13	-0.01 logMAR unit Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline, Week 24

VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase Right Eye: Change at Week 24	-0.01 logMAR unit Standard Deviation 0.05	0.02 logMAR unit Standard Deviation 0.13	0.00 logMAR unit Standard Deviation 0.07	0.01 logMAR unit Standard Deviation 0.11	0.04 logMAR unit Standard Deviation 0.17	-0.02 logMAR unit Standard Deviation 0.11
Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase Left Eye: Change at Week 24	0.00 logMAR unit Standard Deviation 0.08	-0.04 logMAR unit Standard Deviation 0.09	-0.02 logMAR unit Standard Deviation 0.07	0.03 logMAR unit Standard Deviation 0.13	0.01 logMAR unit Standard Deviation 0.19	-0.01 logMAR unit Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, Week 12

The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase Right Eye: Baseline	9.59 centimeter Standard Deviation 5.05	9.67 centimeter Standard Deviation 16.71	8.17 centimeter Standard Deviation 6.89	—	11.88 centimeter Standard Deviation 7.39	15.94 centimeter Standard Deviation 18.64
Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase Right Eye: Change at Week 12	0.50 centimeter Standard Deviation 4.64	-1.04 centimeter Standard Deviation 6.79	1.02 centimeter Standard Deviation 3.89	—	1.74 centimeter Standard Deviation 7.45	7.77 centimeter Standard Deviation 45.53
Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase Left Eye: Baseline	9.69 centimeter Standard Deviation 5.13	8.81 centimeter Standard Deviation 14.89	8.04 centimeter Standard Deviation 7.17	—	12.31 centimeter Standard Deviation 8.67	15.83 centimeter Standard Deviation 17.85
Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase Left Eye: Change at Week 12	0.81 centimeter Standard Deviation 4.78	-1.45 centimeter Standard Deviation 9.60	0.90 centimeter Standard Deviation 3.38	—	0.27 centimeter Standard Deviation 4.29	5.79 centimeter Standard Deviation 36.75

SECONDARY outcome

Timeframe: Baseline, Week 24

The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase Right Eye: Change at Week 24	1.50 centimeter Standard Deviation 4.80	0.50 centimeter Standard Deviation 4.30	-1.35 centimeter Standard Deviation 13.03	0.96 centimeter Standard Deviation 4.38	0.73 centimeter Standard Deviation 5.47	4.33 centimeter Standard Deviation 28.89
Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase Left Eye: Change at Week 24	1.66 centimeter Standard Deviation 6.25	0.58 centimeter Standard Deviation 4.53	0.43 centimeter Standard Deviation 11.53	1.12 centimeter Standard Deviation 4.20	0.90 centimeter Standard Deviation 5.85	3.79 centimeter Standard Deviation 29.81

SECONDARY outcome

Timeframe: Baseline, Week 12

CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Somatic complaints: Change at Week 12	-0.87 T score Standard Deviation 7.16	-0.38 T score Standard Deviation 3.97	-1.69 T score Standard Deviation 5.90	—	-0.46 T score Standard Deviation 5.99	-1.28 T score Standard Deviation 6.35
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Thought problems: Baseline	56.73 T score Standard Deviation 7.64	51.9 T score Standard Deviation 2.81	54.9 T score Standard Deviation 5.60	—	55.00 T score Standard Deviation 6.19	53.54 T score Standard Deviation 5.93
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Thought problems: Change at Week 12	-1.59 T score Standard Deviation 3.65	-0.42 T score Standard Deviation 1.67	-1.38 T score Standard Deviation 5.42	—	-0.92 T score Standard Deviation 4.69	-0.48 T score Standard Deviation 4.25
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Aggressive behavior: Baseline	54.58 T score Standard Deviation 5.75	54.9 T score Standard Deviation 5.25	52.8 T score Standard Deviation 4.48	—	53.86 T score Standard Deviation 5.67	54.32 T score Standard Deviation 5.88
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Aggressive behavior: Change at Week 12	-1.28 T score Standard Deviation 2.77	-1.29 T score Standard Deviation 3.58	-0.03 T score Standard Deviation 2.96	—	-1.03 T score Standard Deviation 3.17	-0.95 T score Standard Deviation 3.71
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Anxious/depressed: Baseline	56.75 T score Standard Deviation 7.32	55.5 T score Standard Deviation 6.58	56.3 T score Standard Deviation 6.55	—	56.07 T score Standard Deviation 6.99	57.00 T score Standard Deviation 8.26
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Anxious/depressed: Change at Week 12	-1.92 T score Standard Deviation 4.66	-0.79 T score Standard Deviation 4.55	-3.21 T score Standard Deviation 5.27	—	-1.73 T score Standard Deviation 3.05	-1.38 T score Standard Deviation 5.25
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Attention problems: Baseline	56.30 T score Standard Deviation 5.68	55.4 T score Standard Deviation 5.06	55.3 T score Standard Deviation 5.74	—	56.29 T score Standard Deviation 5.32	56.66 T score Standard Deviation 7.47
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Attention problems: Change at week 12	-1.28 T score Standard Deviation 3.69	-1.29 T score Standard Deviation 3.61	-1.45 T score Standard Deviation 3.41	—	-1.97 T score Standard Deviation 3.79	-1.40 T score Standard Deviation 4.30
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Rule-breaking behavior: Baseline	53.43 T score Standard Deviation 4.96	54.5 T score Standard Deviation 4.96	52.3 T score Standard Deviation 3.74	—	53.26 T score Standard Deviation 3.52	53.80 T score Standard Deviation 5.53
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Rule-breaking behavior: Change at Week 12	-0.72 T score Standard Deviation 2.76	-1.71 T score Standard Deviation 4.84	-0.10 T score Standard Deviation 2.19	—	-0.92 T score Standard Deviation 2.99	-0.88 T score Standard Deviation 3.91
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Social problems : Baseline	57.95 T score Standard Deviation 7.90	57.9 T score Standard Deviation 6.66	55.8 T score Standard Deviation 5.90	—	57.52 T score Standard Deviation 5.42	58.54 T score Standard Deviation 9.43
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Social problems : Change at Week 12	-0.67 T score Standard Deviation 3.73	-2.21 T score Standard Deviation 4.38	-1.10 T score Standard Deviation 3.41	—	-1.35 T score Standard Deviation 3.90	-2.55 T score Standard Deviation 4.74
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Somatic complaints: Baseline	60.58 T score Standard Deviation 8.44	57.1 T score Standard Deviation 6.47	58.4 T score Standard Deviation 6.55	—	61.14 T score Standard Deviation 6.24	60.46 T score Standard Deviation 8.73
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Withdrawn: Baseline	58.25 T score Standard Deviation 7.93	55.7 T score Standard Deviation 5.96	55.0 T score Standard Deviation 7.11	—	54.60 T score Standard Deviation 5.17	57.54 T score Standard Deviation 8.34
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Withdrawn: Change at Week 12	-1.92 T score Standard Deviation 5.08	-1.75 T score Standard Deviation 3.97	-0.59 T score Standard Deviation 4.48	—	0.35 T score Standard Deviation 4.70	-1.25 T score Standard Deviation 5.13
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Externalizing: Baseline	50.10 T score Standard Deviation 9.73	51.1 T score Standard Deviation 9.83	48.0 T score Standard Deviation 7.84	—	49.48 T score Standard Deviation 8.68	49.46 T score Standard Deviation 10.00
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Externalizing: Change at Week 12	-1.95 T score Standard Deviation 4.62	-2.63 T score Standard Deviation 4.72	-1.45 T score Standard Deviation 4.56	—	-2.08 T score Standard Deviation 5.26	-2.33 T score Standard Deviation 5.28
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Internalizing: Baseline	57.25 T score Standard Deviation 11.00	53.9 T score Standard Deviation 10.34	54.6 T score Standard Deviation 10.14	—	56.45 T score Standard Deviation 8.06	55.93 T score Standard Deviation 12.84
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Internalizing: Change at Week 12	-3.05 T score Standard Deviation 7.12	-1.96 T score Standard Deviation 6.53	-3.52 T score Standard Deviation 6.38	—	-2.14 T score Standard Deviation 6.46	-2.35 T score Standard Deviation 6.98
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Total Problems: Baseline	55.45 T score Standard Deviation 10.28	53.4 T score Standard Deviation 10.70	52.7 T score Standard Deviation 9.37	—	55.05 T score Standard Deviation 8.20	53.61 T score Standard Deviation 11.98
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase Total Problems: Change at Week 12	-2.36 T score Standard Deviation 4.68	-2.17 T score Standard Deviation 5.05	-3.38 T score Standard Deviation 4.55	—	-2.51 T score Standard Deviation 4.63	-3.23 T score Standard Deviation 5.45

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Aggressive behavior: Change at Week 24	-1.25 T score Standard Deviation 3.40	-2.40 T score Standard Deviation 4.89	-1.70 T score Standard Deviation 3.40	-1.86 T score Standard Deviation 3.63	-1.59 T score Standard Deviation 3.85	-1.31 T score Standard Deviation 4.57
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Anxious/depressed: Change at Week 24	-1.50 T score Standard Deviation 3.76	-3.25 T score Standard Deviation 5.66	-2.60 T score Standard Deviation 5.24	-3.89 T score Standard Deviation 4.95	-3.45 T score Standard Deviation 4.86	-2.31 T score Standard Deviation 5.64
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Attention problems: Change at Week 24	-3.38 T score Standard Deviation 4.65	-1.70 T score Standard Deviation 3.01	-1.50 T score Standard Deviation 3.15	-1.71 T score Standard Deviation 3.29	-2.21 T score Standard Deviation 3.99	-2.64 T score Standard Deviation 5.72
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Rule-breaking behavior: Change at Week 24	-1.31 T score Standard Deviation 4.01	-0.90 T score Standard Deviation 2.36	-2.15 T score Standard Deviation 3.17	-0.36 T score Standard Deviation 2.63	-1.59 T score Standard Deviation 3.62	-1.47 T score Standard Deviation 5.12
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Social problems : Change at Week 24	-3.19 T score Standard Deviation 5.79	-2.65 T score Standard Deviation 3.28	-3.90 T score Standard Deviation 4.35	-2.36 T score Standard Deviation 4.17	-2.83 T score Standard Deviation 4.12	-2.56 T score Standard Deviation 4.15
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Somatic complaints: Change at Week 24	-1.69 T score Standard Deviation 9.20	-1.50 T score Standard Deviation 5.82	-0.60 T score Standard Deviation 3.12	-1.96 T score Standard Deviation 6.77	-4.38 T score Standard Deviation 6.59	-2.64 T score Standard Deviation 6.58
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Thought problems: Change at Week 24	-3.25 T score Standard Deviation 6.62	-2.30 T score Standard Deviation 3.50	-1.40 T score Standard Deviation 3.00	-1.75 T score Standard Deviation 3.99	-3.10 T score Standard Deviation 5.45	-1.03 T score Standard Deviation 4.52
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Withdrawn: Change at Week 24	-2.19 T score Standard Deviation 3.90	-4.35 T score Standard Deviation 5.24	-1.80 T score Standard Deviation 5.43	-0.43 T score Standard Deviation 3.75	-0.69 T score Standard Deviation 4.33	-1.50 T score Standard Deviation 5.98
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Externalizing: Change at Week 24	-1.81 T score Standard Deviation 5.42	-4.15 T score Standard Deviation 7.44	-4.20 T score Standard Deviation 5.15	-4.21 T score Standard Deviation 6.86	-5.21 T score Standard Deviation 8.20	-2.89 T score Standard Deviation 7.06
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Internalizing: Change at Week 24	-3.25 T score Standard Deviation 8.10	-5.35 T score Standard Deviation 7.21	-4.40 T score Standard Deviation 6.21	-4.32 T score Standard Deviation 6.70	-7.69 T score Standard Deviation 7.46	-4.14 T score Standard Deviation 7.62
Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase Total Problems: Change at Week 24	-3.69 T score Standard Deviation 6.74	-4.90 T score Standard Deviation 4.78	-5.20 T score Standard Deviation 4.32	-5.25 T score Standard Deviation 6.22	-7.03 T score Standard Deviation 7.77	-4.44 T score Standard Deviation 6.57

SECONDARY outcome

Timeframe: Baseline, Week 12

CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Aggressive behavior: Baseline	4.88 units on a scale Standard Deviation 4.35	5.1 units on a scale Standard Deviation 3.95	3.5 units on a scale Standard Deviation 3.37	—	4.19 units on a scale Standard Deviation 4.39	4.66 units on a scale Standard Deviation 4.46
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Aggressive behavior: Change at Week 12	-0.97 units on a scale Standard Deviation 2.08	-0.92 units on a scale Standard Deviation 2.39	-0.17 units on a scale Standard Deviation 1.85	—	-0.62 units on a scale Standard Deviation 2.35	-0.90 units on a scale Standard Deviation 2.56
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Anxious/depressed: Baseline	4.10 units on a scale Standard Deviation 3.53	3.8 units on a scale Standard Deviation 3.15	4.0 units on a scale Standard Deviation 3.35	—	3.83 units on a scale Standard Deviation 3.33	4.20 units on a scale Standard Deviation 4.06
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Anxious/depressed: Change at Week 12	-1.05 units on a scale Standard Deviation 2.26	-0.58 units on a scale Standard Deviation 2.28	-1.48 units on a scale Standard Deviation 2.43	—	-0.97 units on a scale Standard Deviation 1.46	-0.73 units on a scale Standard Deviation 2.43
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Attention problems: Baseline	4.85 units on a scale Standard Deviation 3.33	4.2 units on a scale Standard Deviation 2.78	3.9 units on a scale Standard Deviation 3.11	—	4.79 units on a scale Standard Deviation 3.18	4.49 units on a scale Standard Deviation 4.11
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Attention problems: Change at Week 12	-0.77 units on a scale Standard Deviation 2.03	-0.71 units on a scale Standard Deviation 1.90	-0.83 units on a scale Standard Deviation 1.63	—	-1.05 units on a scale Standard Deviation 2.25	-0.73 units on a scale Standard Deviation 2.16
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Rule-breaking behavior: Baseline	1.70 units on a scale Standard Deviation 1.87	1.9 units on a scale Standard Deviation 1.63	1.0 units on a scale Standard Deviation 1.30	—	1.64 units on a scale Standard Deviation 1.48	1.66 units on a scale Standard Deviation 1.98
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Rule-breaking behavior: Change at Week 12	-0.38 units on a scale Standard Deviation 0.99	-0.63 units on a scale Standard Deviation 1.56	0.52 units on a scale Standard Deviation 3.45	—	-0.43 units on a scale Standard Deviation 1.09	-0.30 units on a scale Standard Deviation 1.36
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Social problems: Baseline	3.80 units on a scale Standard Deviation 3.36	3.9 units on a scale Standard Deviation 2.99	3.2 units on a scale Standard Deviation 2.64	—	3.60 units on a scale Standard Deviation 2.30	4.07 units on a scale Standard Deviation 4.12
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Social problems: Change at Week 12	-0.26 units on a scale Standard Deviation 1.57	-0.83 units on a scale Standard Deviation 1.86	-0.62 units on a scale Standard Deviation 1.52	—	-0.54 units on a scale Standard Deviation 1.54	-1.13 units on a scale Standard Deviation 2.09
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Somatic complaints: Baseline	3.40 units on a scale Standard Deviation 3.23	2.1 units on a scale Standard Deviation 1.93	2.6 units on a scale Standard Deviation 2.16	—	3.40 units on a scale Standard Deviation 2.18	3.46 units on a scale Standard Deviation 3.26
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Somatic complaints: Change at Week 12	-0.51 units on a scale Standard Deviation 2.64	-0.04 units on a scale Standard Deviation 1.55	-0.55 units on a scale Standard Deviation 2.03	—	-0.05 units on a scale Standard Deviation 2.26	-0.53 units on a scale Standard Deviation 2.44
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Thought problems: Baseline	2.58 units on a scale Standard Deviation 2.92	1.0 units on a scale Standard Deviation 1.04	2.0 units on a scale Standard Deviation 1.79	—	2.05 units on a scale Standard Deviation 2.23	1.46 units on a scale Standard Deviation 2.34
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Thought problems: Change at Week 12	-0.51 units on a scale Standard Deviation 1.30	-0.21 units on a scale Standard Deviation 0.72	-0.45 units on a scale Standard Deviation 1.64	—	-0.46 units on a scale Standard Deviation 1.69	-0.10 units on a scale Standard Deviation 1.37
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Withdrawn: Baseline	2.75 units on a scale Standard Deviation 2.66	1.7 units on a scale Standard Deviation 1.81	1.6 units on a scale Standard Deviation 2.26	—	1.52 units on a scale Standard Deviation 1.77	2.49 units on a scale Standard Deviation 2.78
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Withdrawn: Change at Week 12	-0.64 units on a scale Standard Deviation 1.77	-0.50 units on a scale Standard Deviation 1.10	-0.17 units on a scale Standard Deviation 1.39	—	0.14 units on a scale Standard Deviation 1.44	-0.35 units on a scale Standard Deviation 1.59
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Externalizing: Baseline	6.53 units on a scale Standard Deviation 5.87	6.9 units on a scale Standard Deviation 5.16	4.5 units on a scale Standard Deviation 4.32	—	5.83 units on a scale Standard Deviation 5.23	6.32 units on a scale Standard Deviation 6.14
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Externalizing: Change at Week 12	-1.31 units on a scale Standard Deviation 2.30	-1.54 units on a scale Standard Deviation 3.50	-0.31 units on a scale Standard Deviation 2.33	—	-1.05 units on a scale Standard Deviation 2.85	-1.20 units on a scale Standard Deviation 3.42
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Internalizing: Baseline	10.25 units on a scale Standard Deviation 7.02	7.5 units on a scale Standard Deviation 5.61	8.2 units on a scale Standard Deviation 6.13	—	8.76 units on a scale Standard Deviation 5.56	10.15 units on a scale Standard Deviation 8.64
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Internalizing: Change at Week 12	-2.21 units on a scale Standard Deviation 4.35	-1.13 units on a scale Standard Deviation 3.85	-2.21 units on a scale Standard Deviation 3.91	—	-0.89 units on a scale Standard Deviation 3.62	-1.70 units on a scale Standard Deviation 5.16
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Total Problems: Baseline	34.18 units on a scale Standard Deviation 22.16	29.5 units on a scale Standard Deviation 17.41	27.0 units on a scale Standard Deviation 16.59	—	31.52 units on a scale Standard Deviation 16.84	31.88 units on a scale Standard Deviation 23.78
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase Total Problems: Change at Week 12	-5.85 units on a scale Standard Deviation 9.77	-5.33 units on a scale Standard Deviation 8.29	-5.10 units on a scale Standard Deviation 7.41	—	-4.92 units on a scale Standard Deviation 8.73	-5.83 units on a scale Standard Deviation 12.16

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=29 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=36 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Aggressive behavior: Change at Week 24	-0.81 units on a scale Standard Deviation 2.43	-1.75 units on a scale Standard Deviation 3.58	-1.40 units on a scale Standard Deviation 2.41	-1.57 units on a scale Standard Deviation 2.70	-1.34 units on a scale Standard Deviation 2.92	-1.17 units on a scale Standard Deviation 3.10
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Anxious/depressed: Change at Week 24	-1.06 units on a scale Standard Deviation 1.88	-1.60 units on a scale Standard Deviation 2.48	-1.70 units on a scale Standard Deviation 2.36	-1.75 units on a scale Standard Deviation 2.34	-1.93 units on a scale Standard Deviation 2.22	-1.28 units on a scale Standard Deviation 2.42
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Attention problems: Change at Week 24	-1.94 units on a scale Standard Deviation 2.35	-1.25 units on a scale Standard Deviation 1.77	-1.15 units on a scale Standard Deviation 1.76	-0.89 units on a scale Standard Deviation 1.69	-1.41 units on a scale Standard Deviation 2.31	-1.36 units on a scale Standard Deviation 2.77
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Rule-breaking behavior: Change at Week 24	-0.50 units on a scale Standard Deviation 1.21	-0.55 units on a scale Standard Deviation 0.94	-0.80 units on a scale Standard Deviation 1.01	-0.18 units on a scale Standard Deviation 0.94	-0.62 units on a scale Standard Deviation 1.29	-0.50 units on a scale Standard Deviation 1.65
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Social problems: Change at Week 24	-1.13 units on a scale Standard Deviation 2.33	-1.20 units on a scale Standard Deviation 1.36	-1.65 units on a scale Standard Deviation 1.81	-1.14 units on a scale Standard Deviation 1.74	-1.28 units on a scale Standard Deviation 1.53	-1.19 units on a scale Standard Deviation 1.97
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Somatic complaints: Change at Week 24	-0.88 units on a scale Standard Deviation 3.32	-0.45 units on a scale Standard Deviation 1.73	-0.15 units on a scale Standard Deviation 0.88	-0.68 units on a scale Standard Deviation 2.04	-1.34 units on a scale Standard Deviation 2.22	-0.89 units on a scale Standard Deviation 2.38
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Thought problems: Change at Week 24	-1.06 units on a scale Standard Deviation 2.14	-0.90 units on a scale Standard Deviation 1.21	-0.65 units on a scale Standard Deviation 1.04	-0.64 units on a scale Standard Deviation 1.28	-1.31 units on a scale Standard Deviation 1.95	-0.36 units on a scale Standard Deviation 1.40
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Withdrawn: Change at Week 24	-0.69 units on a scale Standard Deviation 1.35	-1.35 units on a scale Standard Deviation 1.66	-0.45 units on a scale Standard Deviation 1.50	-0.14 units on a scale Standard Deviation 1.04	-0.24 units on a scale Standard Deviation 1.43	-0.44 units on a scale Standard Deviation 2.01
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Externalizing: Change at Week 24	-1.19 units on a scale Standard Deviation 3.23	-2.30 units on a scale Standard Deviation 4.03	-2.20 units on a scale Standard Deviation 2.84	-1.79 units on a scale Standard Deviation 3.28	-1.97 units on a scale Standard Deviation 3.50	-1.67 units on a scale Standard Deviation 4.27
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Internalizing: Change at Week 24	-2.63 units on a scale Standard Deviation 4.65	-3.40 units on a scale Standard Deviation 4.68	-2.30 units on a scale Standard Deviation 3.64	-2.57 units on a scale Standard Deviation 3.63	-3.52 units on a scale Standard Deviation 4.00	-2.61 units on a scale Standard Deviation 4.95
Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase Total Problems: Change at Week 24	-9.00 units on a scale Standard Deviation 13.45	-10.10 units on a scale Standard Deviation 10.47	-9.45 units on a scale Standard Deviation 7.93	-8.39 units on a scale Standard Deviation 10.22	-10.90 units on a scale Standard Deviation 11.98	-8.58 units on a scale Standard Deviation 12.86

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=7 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=18 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=21 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=9 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=9 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Baseline	46.43 seconds Standard Deviation 16.28	69.56 seconds Standard Deviation 58.52	52.20 seconds Standard Deviation 31.06	—	61.11 seconds Standard Deviation 31.66	56.50 seconds Standard Deviation 32.09
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Change at Week 12	-5.33 seconds Standard Deviation 6.15	-11.20 seconds Standard Deviation 41.11	-10.26 seconds Standard Deviation 27.21	—	-7.71 seconds Standard Deviation 11.06	10.14 seconds Standard Deviation 37.18
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Baseline	48.00 seconds Standard Deviation 15.14	91.29 seconds Standard Deviation 110.76	76.29 seconds Standard Deviation 76.71	—	80.44 seconds Standard Deviation 41.45	114.00 seconds Standard Deviation 89.43
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Change at Week 12	-2.00 seconds Standard Deviation 12.25	-19.36 seconds Standard Deviation 81.03	-3.25 seconds Standard Deviation 22.53	—	-21.71 seconds Standard Deviation 25.44	15.33 seconds Standard Deviation 49.28

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=2 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=3 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=15 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=19 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=3 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=7 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase Dominant hand: Change at Week 24	-2.00 seconds Standard Deviation 8.49	-6.33 seconds Standard Deviation 3.06	-7.07 seconds Standard Deviation 6.80	-15.00 seconds Standard Deviation 28.54	-11.33 seconds Standard Deviation 9.07	-3.71 seconds Standard Deviation 22.94
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase Non-dominant hand: Change at Week 24	1.50 seconds Standard Deviation 10.61	-11.00 seconds Standard Deviation 5.00	-9.14 seconds Standard Deviation 14.33	-18.47 seconds Standard Deviation 38.13	-2.00 seconds Standard Deviation 13.75	-4.00 seconds Standard Deviation 29.09

SECONDARY outcome

Timeframe: Baseline, Week 12

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=10 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=34 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Baseline	82.64 seconds Standard Deviation 24.32	106.7 seconds Standard Deviation 64.07	124.7 seconds Standard Deviation 71.99	—	88.85 seconds Standard Deviation 24.22	92.15 seconds Standard Deviation 40.51
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Change at Week 12	1.21 seconds Standard Deviation 11.87	-14.38 seconds Standard Deviation 25.90	-18.44 seconds Standard Deviation 32.23	—	-5.40 seconds Standard Deviation 10.43	-8.88 seconds Standard Deviation 20.76
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Baseline	92.94 seconds Standard Deviation 25.05	130.30 seconds Standard Deviation 83.58	126.1 seconds Standard Deviation 48.93	—	110.61 seconds Standard Deviation 59.63	109.00 seconds Standard Deviation 49.75
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Change at Week 12	-1.97 seconds Standard Deviation 14.00	-13.50 seconds Standard Deviation 18.81	-12.50 seconds Standard Deviation 20.30	—	-9.10 seconds Standard Deviation 19.94	-4.10 seconds Standard Deviation 10.79

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=14 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=5 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=25 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase Dominant hand: Change at Week 24	-5.71 seconds Standard Deviation 9.55	-7.00 seconds Standard Deviation 13.25	-38.20 seconds Standard Deviation 31.67	-17.00 seconds Standard Deviation 33.16	-8.20 seconds Standard Deviation 11.67	-12.27 seconds Standard Deviation 18.28
Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase Non-dominant hand: Change at Week 24	-3.79 seconds Standard Deviation 11.89	-11.87 seconds Standard Deviation 14.15	-38.00 seconds Standard Deviation 29.35	-15.50 seconds Standard Deviation 29.11	-9.24 seconds Standard Deviation 15.79	-8.46 seconds Standard Deviation 10.42

SECONDARY outcome

Timeframe: Baseline, Week 12

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=7 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=18 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=21 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=9 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=9 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Baseline	0.29 pegs Standard Deviation 0.49	0.39 pegs Standard Deviation 1.24	0.10 pegs Standard Deviation 0.45	—	0.11 pegs Standard Deviation 0.33	0.75 pegs Standard Deviation 1.75
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Change at Week 12	-0.17 pegs Standard Deviation 0.75	0.00 pegs Standard Deviation 1.77	0.05 pegs Standard Deviation 0.52	—	0.29 pegs Standard Deviation 0.76	0.57 pegs Standard Deviation 1.13
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Baseline	0.00 pegs Standard Deviation 0.00	0.35 pegs Standard Deviation 0.86	0.76 pegs Standard Deviation 2.26	—	0.44 pegs Standard Deviation 0.53	1.22 pegs Standard Deviation 2.28
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Change at Week 12	0.17 pegs Standard Deviation 0.41	0.00 pegs Standard Deviation 0.68	0.60 pegs Standard Deviation 3.45	—	0.43 pegs Standard Deviation 1.27	1.00 pegs Standard Deviation 2.00

SECONDARY outcome

Timeframe: Baseline, Week 24

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=2 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=3 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=15 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=19 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=3 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=7 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase Dominant hand: Change at week 24	0.00 pegs Standard Deviation 0.00	-0.33 pegs Standard Deviation 0.58	-0.27 pegs Standard Deviation 1.39	-0.06 pegs Standard Deviation 0.54	0.33 pegs Standard Deviation 0.58	0.43 pegs Standard Deviation 0.79
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase Non-dominant hand: Change at week 24	0.50 pegs Standard Deviation 0.71	0.00 pegs Standard Deviation 0.00	-0.36 pegs Standard Deviation 0.74	0.11 pegs Standard Deviation 3.45	1.33 pegs Standard Deviation 2.31	0.00 pegs Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline, Week 12

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=10 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=34 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Baseline	0.24 pegs Standard Deviation 0.66	0.10 pegs Standard Deviation 0.32	0.11 pegs Standard Deviation 0.33	—	0.45 pegs Standard Deviation 1.20	0.24 pegs Standard Deviation 0.50
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Change at Week 12	0.09 pegs Standard Deviation 0.77	0.00 pegs Standard Deviation 0.53	0.44 pegs Standard Deviation 1.33	—	0.00 pegs Standard Deviation 1.05	-0.18 pegs Standard Deviation 0.58
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Baseline	0.36 pegs Standard Deviation 0.78	0.40 pegs Standard Deviation 0.97	0.13 pegs Standard Deviation 0.35	—	0.91 pegs Standard Deviation 2.36	0.28 pegs Standard Deviation 0.46
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Change at Week 12	0.21 pegs Standard Deviation 1.78	0.13 pegs Standard Deviation 0.35	0.00 pegs Standard Deviation 0.00	—	-0.33 pegs Standard Deviation 1.60	0.06 pegs Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline, Week 24

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=14 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=5 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=25 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase Dominant hand: Change at Week 24	0.14 pegs Standard Deviation 0.36	0.25 pegs Standard Deviation 1.24	0.00 pegs Standard Deviation 0.00	0.44 pegs Standard Deviation 1.33	0.00 pegs Standard Deviation 0.87	0.63 pegs Standard Deviation 4.63
Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase Non-dominant hand: Change at Week 24	0.00 pegs Standard Deviation 0.39	0.27 pegs Standard Deviation 1.67	0.60 pegs Standard Deviation 0.89	-0.13 pegs Standard Deviation 0.35	-0.28 pegs Standard Deviation 2.17	0.68 pegs Standard Deviation 4.79

SECONDARY outcome

Timeframe: Baseline, Week 12

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=7 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=18 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=21 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=9 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=9 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Change at Week 12	0.00 pegs Standard Deviation 0.00	0.00 pegs Standard Deviation 0.38	-0.11 pegs Standard Deviation 0.46	—	-0.29 pegs Standard Deviation 0.76	0.00 pegs Standard Deviation 0.00
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Baseline	10.00 pegs Standard Deviation 0.00	9.82 pegs Standard Deviation 0.73	9.62 pegs Standard Deviation 1.20	—	9.56 pegs Standard Deviation 1.01	9.00 pegs Standard Deviation 2.35
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Change at Week 12	0.00 pegs Standard Deviation 0.00	-0.07 pegs Standard Deviation 0.62	0.00 pegs Standard Deviation 0.32	—	-0.57 pegs Standard Deviation 1.13	0.00 pegs Standard Deviation 0.00
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Baseline	10.00 pegs Standard Deviation 0.00	9.89 pegs Standard Deviation 0.47	10.0 pegs Standard Deviation 0.00	—	9.56 pegs Standard Deviation 1.01	9.38 pegs Standard Deviation 1.77

SECONDARY outcome

Timeframe: Baseline, Week 24

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=2 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=3 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=15 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=19 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=3 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=7 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase Dominant hand: Change at Week 24	0.00 pegs Standard Deviation 0.00	0.00 pegs Standard Deviation 0.00	0.07 pegs Standard Deviation 0.26	0.00 pegs Standard Deviation 0.00	-0.33 pegs Standard Deviation 0.58	0.00 pegs Standard Deviation 0.00
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase Non-dominant hand: Change at Week 24	0.00 pegs Standard Deviation 0.00	0.00 pegs Standard Deviation 0.00	0.14 pegs Standard Deviation 0.53	0.21 pegs Standard Deviation 0.92	-1.33 pegs Standard Deviation 2.31	0.00 pegs Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline, Week 12

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=10 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=33 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=34 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Baseline	25.00 pegs Standard Deviation 0.00	25.00 pegs Standard Deviation 0.00	23.22 pegs Standard Deviation 3.83	—	25.00 pegs Standard Deviation 0.00	24.56 pegs Standard Deviation 1.89
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Dominant hand: Change at Week 12	-0.12 pegs Standard Deviation 0.70	-0.13 pegs Standard Deviation 0.35	0.11 pegs Standard Deviation 2.76	—	-0.07 pegs Standard Deviation 0.25	0.42 pegs Standard Deviation 1.77
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Baseline	24.88 pegs Standard Deviation 0.42	24.50 pegs Standard Deviation 1.58	24.25 pegs Standard Deviation 1.75	—	24.45 pegs Standard Deviation 2.09	24.75 pegs Standard Deviation 0.92
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase Non-dominant hand: Change at Week 12	0.03 pegs Standard Deviation 0.30	0.63 pegs Standard Deviation 1.77	-0.63 pegs Standard Deviation 1.77	—	0.53 pegs Standard Deviation 2.19	0.26 pegs Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline, Week 24

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=14 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=5 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=9 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=25 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase Dominant hand: Change at Week 24	0.00 pegs Standard Deviation 0.00	0.00 pegs Standard Deviation 0.00	0.00 pegs Standard Deviation 0.00	0.11 pegs Standard Deviation 2.76	0.00 pegs Standard Deviation 0.00	0.50 pegs Standard Deviation 2.01
Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase Non-dominant hand: Change at Week 24	0.14 pegs Standard Deviation 0.66	0.00 pegs Standard Deviation 0.00	0.60 pegs Standard Deviation 2.61	-0.50 pegs Standard Deviation 1.85	0.60 pegs Standard Deviation 2.40	0.21 pegs Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of \<90 millimeter of mercury (mmHg), b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of \<50 mmHg, b) change \>=20 mmHg increase, c) change \>=20 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate value \>120 bpm.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=24 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase SBP: <90 mmHg	0 Participants	7 Participants	4 Participants	—	2 Participants	2 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase SBP: Change >=30 mmHg increase	1 Participants	0 Participants	1 Participants	—	1 Participants	2 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase SBP: Change >=30 mmHg decrease	0 Participants	0 Participants	0 Participants	—	1 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase DBP: <50 mmHg	2 Participants	3 Participants	1 Participants	—	2 Participants	1 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase DBP: Change >=20 mmHg increase	1 Participants	3 Participants	4 Participants	—	1 Participants	2 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase DBP: Change >=20 mmHg decrease	1 Participants	2 Participants	0 Participants	—	1 Participants	1 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase Pulse rate: <40 bpm	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase Pulse rate: >120 bpm	0 Participants	2 Participants	3 Participants	—	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase DBP: Change >=20 mmHg decrease	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase Pulse rate: <40 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase Pulse rate: >120 bpm	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase SBP: <90 mmHg	2 Participants	1 Participants	4 Participants	2 Participants	0 Participants	3 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase SBP: Change >=30 mmHg increase	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase SBP: Change >=30 mmHg decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase DBP: <50 mmHg	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase DBP: Change >=20 mmHg increase	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1 up to Week 12

Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as \>=10\^5 colony forming unit per milliliter \[CFU/mL\]) and the presence of symptoms, or pyuria (defined as \>50 white blood cells \[WBC\] per high-pass filter \[hpf\]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase	4 Participants	3 Participants	4 Participants	—	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12 up to Week 26

Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) and the presence of symptoms, or pyuria (defined as \>50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as \>=10\^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase	2 Participants	0 Participants	1 Participants	5 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 1 up to Week 12

Population: Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN), platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN), leukocytes \<0.6\*LLN\>1.5\*ULN, lymphocytes, neutrophils, \<0.8\*LLN \>1.2\*ULN, basophils, eosinophils, monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct, bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase\>3.0\*ULN, protein, albumin, phosphate \<0.8\*LLN \>1.2\*ULN, blood urea nitrogen, creatinine \>1.3\*ULN, urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN, potassium, chloride, calcium bicarbonate\<0.9\*LLN\>1.1\*ULN, glucose\<0.6\*LLN\>1.5\*ULN, creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, \>=1, urine erythrocytes, urine leukocytes \>=20, epithelial cells \>=6, bacteria \>20.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=39 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=24 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=39 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=41 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase	27 Participants	19 Participants	19 Participants	—	30 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 12 up to Week 26

Population: Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=19 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=36 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase	7 Participants	12 Participants	15 Participants	21 Participants	19 Participants	22 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 12

Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=9 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=6 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=6 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=6 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=7 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase Baseline	5.78 milliliter Standard Deviation 7.98	14.7 milliliter Standard Deviation 14.31	10.7 milliliter Standard Deviation 7.94	—	7.00 milliliter Standard Deviation 8.20	9.57 milliliter Standard Deviation 12.54
Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase Change at Week 4	19.11 milliliter Standard Deviation 24.52	-2.00 milliliter Standard Deviation 6.24	10.25 milliliter Standard Deviation 34.40	—	5.40 milliliter Standard Deviation 7.60	-7.33 milliliter Standard Deviation 10.88
Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase Change at Week 12	12.86 milliliter Standard Deviation 43.48	2.50 milliliter Standard Deviation 16.05	0.75 milliliter Standard Deviation 17.46	—	25.60 milliliter Standard Deviation 53.42	-4.00 milliliter Standard Deviation 8.41

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=5 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=3 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=3 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=4 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=4 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=5 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase	18.00 milliliter Standard Deviation 31.36	36.67 milliliter Standard Deviation 59.23	21.67 milliliter Standard Deviation 20.21	2.75 milliliter Standard Deviation 14.50	11.50 milliliter Standard Deviation 23.67	11.60 milliliter Standard Deviation 29.43

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=40 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=28 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=29 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=38 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase	1 Participants	1 Participants	0 Participants	—	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg n=20 Participants Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 Participants Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 Participants Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=30 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=37 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic)

Population: The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=121 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Absorption Rate Constant (Ka) of Fesoterodine	—	—	—	—	0.0897 per hour Standard Error 5.99	—

SECONDARY outcome

Population: The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=121 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Apparent Oral Clearance (CL/F) of Fesoterodine	—	—	—	—	71.6 liter per hour Standard Error 6.7	—

SECONDARY outcome

Population: The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Outcome measures

Outcome measures
Measure	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=121 Participants Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.
Volume of Distribution (Vd) of Fesoterodine	—	—	—	—	68.1 liter Standard Error 29.7	—

Adverse Events

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort 1, Active Comparator Phase: Oxybutynin

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Cohort 1, Safety Extension Phase: Fesoterodine 4 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 2, Efficacy Phase: Fesoterodine 2 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort 2 Efficacy Phase: Fesoterodine 4 mg

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Cohort 2, Safety Extension Phase: Fesoterodine 2 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 2, Safety Extension Phase: Fesoterodine 4 mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 participants at risk Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 participants at risk Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Cohort 1, Active Comparator Phase: Oxybutynin n=40 participants at risk Participants with body weight \>25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg n=30 participants at risk Participants with body weight \>25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg n=37 participants at risk Participants with body weight \>25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 participants at risk Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg n=20 participants at risk Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Efficacy Phase: Fesoterodine 2 mg n=28 participants at risk Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Cohort 2 Efficacy Phase: Fesoterodine 4 mg n=29 participants at risk Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 participants at risk Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 participants at risk Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Infections and infestations Cellulitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Complicated appendicitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Epididymitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Peritonitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Pyelonephritis acute	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Urinary tract infection	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Viral infection	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Appendicitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Dengue fever	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Injury, poisoning and procedural complications Animal bite	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Epiphysiolysis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Acute kidney injury	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Hydronephrosis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Decubitus ulcer	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.

Other adverse events

Other adverse events
Measure	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg n=42 participants at risk Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in active comparator phase.	Cohort 1, Active Comparator Phase: Fesoterodine 4 mg Then 8 mg n=42 participants at risk Participants with body weight \>25 kg were randomized to receive fesoterodine 4 mg PR tablets orally once daily for first 1 week and if dose was tolerated well, participants received 8 mg PR tablet orally once daily for next 11 weeks in active comparator phase and if dose was not tolerated then participants were withdrawn from the study.	Cohort 1, Active Comparator Phase: Oxybutynin n=40 participants at risk Participants with body weight \>25 kg were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice. Dose titration was done for first 4 weeks. After Week 4, participants remained on the optimized daily dose for next 8 weeks, in active comparator phase.	Cohort 1, Safety Extension Phase: Fesoterodine 4 mg n=30 participants at risk Participants with body weight \>25 kg received fesoterodine 4 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Cohort 1, Safety Extension Phase (SEP): Fesoterodine 8 mg n=37 participants at risk Participants with body weight \>25 kg received fesoterodine 8 mg PR tablet orally once daily for 12 weeks in safety extension phase.	Cohort 1, SEP: Oxybutynin Then Fesoterodine 4 mg n=16 participants at risk Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for 12 weeks in the safety extension phase.	Cohort 1,SEP: Oxybutynin Then Fesoterodine 8 mg n=20 participants at risk Participants with body weight \>25 kg who were randomized to receive oxybutynin ER tablet, at a daily dose in accordance with approved pediatric labeling and accepted practice, in active comparator phase; were allocated by investigator to receive fesoterodine 4 mg PR tablet orally once daily for first 1 week followed by fesoterodine 8 mg PR tablet orally once daily for another 11 weeks (if the fesoterodine 4 mg dose was well tolerated) in the safety extension phase and if dose was not tolerated participants were withdrawn from the study.	Cohort 2, Efficacy Phase: Fesoterodine 2 mg n=28 participants at risk Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for 12 weeks in efficacy phase.	Cohort 2 Efficacy Phase: Fesoterodine 4 mg n=29 participants at risk Participants with body weight \<=25 kg were randomized to receive fesoterodine 2 mg BIC capsule orally once daily for first 1 week and if dose was tolerated well, participants received 4 mg BIC capsule orally once daily for next 11 weeks in efficacy phase and if dose was not tolerated then participants were withdrawn from the study.	Cohort 2, Safety Extension Phase: Fesoterodine 2 mg n=20 participants at risk Participants with body weight \<=25 kg received fesoterodine 2 mg BIC capsules orally once daily for 12 weeks in safety extension phase.	Cohort 2, Safety Extension Phase: Fesoterodine 4 mg n=28 participants at risk Participants with body weight \<=25 kg received fesoterodine 4 mg BIC capsules orally once daily for 12 weeks in safety extension phase.
Eye disorders Astigmatism	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Cardiac disorders Tachycardia	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Ear and labyrinth disorders Vertigo positional	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Eye disorders Myopia	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Eye disorders Strabismus	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Abdominal pain	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 2/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Abdominal pain upper	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 2/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Constipation	7.1% 3/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.1% 3/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	12.5% 5/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.9% 2/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Diarrhoea	11.9% 5/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.1% 3/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Dry mouth	7.1% 3/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	9.5% 4/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	27.5% 11/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Faeces soft	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Lip dry	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Nausea	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 2/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Vomiting	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 2/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Catheter site pain	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Fatigue	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Malaise	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Mass	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Non-cardiac chest pain	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Pyrexia	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	12.5% 2/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.9% 2/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.0% 2/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Immune system disorders Hypersensitivity	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Asymptomatic bacteriuria	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	14.3% 4/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.9% 2/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	15.0% 3/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Bacteriuria	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Conjunctivitis bacterial	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Escherichia urinary tract infection	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Gastroenteritis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.4% 2/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Gastroenteritis viral	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Impetigo	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Infection parasitic	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Influenza	9.5% 4/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Mastitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Nasopharyngitis	11.9% 5/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 2/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.4% 2/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.0% 2/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.7% 3/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.3% 3/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.0% 2/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Oral herpes	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Pharyngitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Pyelonephritis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 2/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Rhinitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Sinusitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Tonsillitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Upper respiratory tract infection	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.1% 2/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Urinary tract infection	7.1% 3/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.5% 3/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	12.5% 2/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.1% 2/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.3% 3/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	14.3% 4/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Varicella	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Viral upper respiratory tract infection	9.5% 4/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Bacterial test positive	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Blood glucose decreased	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Eosinophil count increased	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Heart rate increased	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Investigation abnormal	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Residual urine volume increased	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Urine analysis abnormal	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Weight increased	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Nervous system disorders Dizziness	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.1% 2/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Nervous system disorders Headache	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	7.1% 3/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	12.5% 5/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	8.1% 3/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.9% 2/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Psychiatric disorders Aggression	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Psychiatric disorders Anxiety	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Psychiatric disorders Behaviour disorder	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Haematuria	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Hypertonic bladder	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Incontinence	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Pollakiuria	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Renal failure	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Urinary incontinence	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.0% 4/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.2% 1/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.9% 2/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Urine odour abnormal	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	10.0% 2/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Reproductive system and breast disorders Genital pain	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	6.9% 2/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Acne	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Decubitus ulcer	4.8% 2/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	5.0% 1/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Toothache	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.6% 1/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.4% 1/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Ear and labyrinth disorders Ear pain	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Eye disorders Vision blurred	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Social circumstances Wheelchair user	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Vascular disorders Flushing	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Dermatitis infected	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Ear lobe infection	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	3.3% 1/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Blood and lymphatic system disorders Thrombocytopenia	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Eye disorders Accommodation disorder	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Eye disorders Eye pruritus	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Eye disorders Visual impairment	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Dental caries	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Dysphagia	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Enteritis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Flatulence	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Lip erythema	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Gastrointestinal disorders Stomatitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Adverse drug reaction	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Feeling cold	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Oedema peripheral	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Thirst	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Bronchitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Cellulitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Conjunctivitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Cystitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Cystitis bacterial	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Device related infection	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Ear infection	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Folliculitis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Fungal skin infection	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Hordeolum	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Paronychia	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Pharyngotonsillitis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Scrotal infection	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Injury, poisoning and procedural complications Contusion	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Urine output increased	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations White blood cells urine positive	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Metabolism and nutrition disorders Polydipsia	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Arthritis	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Musculoskeletal and connective tissue disorders Neck pain	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Nervous system disorders Cognitive disorder	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Nervous system disorders Syncope	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Psychiatric disorders Encopresis	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Psychiatric disorders Restlessness	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Urethral pain	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.5% 1/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Urinary tract disorder	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Renal and urinary disorders Urine flow decreased	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Dry throat	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Dermatitis allergic	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Rash macular	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
General disorders Temperature intolerance	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Skin and subcutaneous tissue disorders Rash	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.7% 1/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Infections and infestations Eye infection	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
Investigations Cystogram	0.00% 0/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	2.4% 1/42 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/40 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/30 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/37 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/16 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/29 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/20 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.	0.00% 0/28 • Baseline up to Week 26 (includes 2 week of follow up) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER