Trial Outcomes & Findings for A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008) (NCT NCT01314872)

Last Updated: 2019-02-04

Results Overview

Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1395 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2019-02-04

Participant Flow

This was a 2-Part, randomized, double blind placebo- and active-controlled, parallel-group study of vibegron in men and women with Overactive Bladder (OAB). Participants who enrolled in Part 1 were not eligible to participate in Part 2. Participants who completed Part 1 or Part 2 were eligible to enroll in an optional 1-year safety extension.

Participant milestones

Participant milestones
Measure	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.	Extension Study: Vibegron 50 mg Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 100 mg Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Tolterodine ER 4 mg Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
Treatment Period 1 STARTED	149	135	134	150	141	144	134	64	112	122	110	0	0	0	0
Treatment Period 1 COMPLETED	142	128	128	143	131	138	126	57	106	118	107	0	0	0	0
Treatment Period 1 NOT COMPLETED	7	7	6	7	10	6	8	7	6	4	3	0	0	0	0
Period 2 STARTED	0	0	0	0	0	0	0	0	0	0	0	223	248	240	134
Period 2 COMPLETED	0	0	0	0	0	0	0	0	0	0	0	175	188	187	110
Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	48	60	53	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.	Extension Study: Vibegron 50 mg Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 100 mg Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Tolterodine ER 4 mg Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
Treatment Period 1 Protocol Violation	1	0	1	0	2	1	0	0	0	1	1	0	0	0	0
Treatment Period 1 Physician Decision	0	0	0	1	0	1	0	0	0	1	0	0	0	0	0
Treatment Period 1 Lack of Efficacy	0	1	0	0	1	0	0	2	0	0	0	0	0	0	0
Treatment Period 1 Adverse event, non-fatal	2	4	3	2	4	2	4	2	3	0	1	0	0	0	0
Treatment Period 1 Withdrawal by Subject	3	1	0	2	3	1	3	2	2	2	1	0	0	0	0
Treatment Period 1 Lost to Follow-up	1	1	2	2	0	1	1	1	1	0	0	0	0	0	0
Period 2 Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	3	3	2	0
Period 2 Non-compliance with study drug	0	0	0	0	0	0	0	0	0	0	0	3	3	1	2
Period 2 Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	7	12	9	2
Period 2 Pregnancy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Period 2 Study terminated by Sponsor	0	0	0	0	0	0	0	0	0	0	0	2	2	3	0
Period 2 Adverse event, non-fatal	0	0	0	0	0	0	0	0	0	0	0	13	16	24	9
Period 2 Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	14	17	12	4
Period 2 Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	6	7	2	6

Baseline Characteristics

A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Placebo n=141 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=134 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=150 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=149 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=135 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo n=64 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg n=112 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg n=122 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg n=110 Participants Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.	Total n=1395 Participants Total of all reporting groups
Age, Continuous	58.6 Years STANDARD_DEVIATION 9.0 • n=5 Participants	59.4 Years STANDARD_DEVIATION 8.7 • n=7 Participants	58.6 Years STANDARD_DEVIATION 8.1 • n=5 Participants	60.3 Years STANDARD_DEVIATION 8.7 • n=4 Participants	60.3 Years STANDARD_DEVIATION 8.3 • n=21 Participants	59.1 Years STANDARD_DEVIATION 8.1 • n=10 Participants	59.4 Years STANDARD_DEVIATION 8.5 • n=115 Participants	56.3 Years STANDARD_DEVIATION 10.6 • n=24 Participants	57.2 Years STANDARD_DEVIATION 10.1 • n=42 Participants	57.9 Years STANDARD_DEVIATION 10.9 • n=42 Participants	55.5 Years STANDARD_DEVIATION 11.7 • n=42 Participants	58.6 Years STANDARD_DEVIATION 9.3 • n=42 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	131 Participants n=7 Participants	125 Participants n=5 Participants	129 Participants n=4 Participants	135 Participants n=21 Participants	121 Participants n=10 Participants	119 Participants n=115 Participants	57 Participants n=24 Participants	101 Participants n=42 Participants	110 Participants n=42 Participants	95 Participants n=42 Participants	1251 Participants n=42 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants	14 Participants n=21 Participants	14 Participants n=10 Participants	15 Participants n=115 Participants	7 Participants n=24 Participants	11 Participants n=42 Participants	12 Participants n=42 Participants	15 Participants n=42 Participants	144 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=141 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=132 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=148 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=148 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=134 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8	-1.16 Micturitions Interval -1.5 to -0.82	-1.62 Micturitions Interval -1.95 to -1.29	-1.61 Micturitions Interval -1.96 to -1.27	-1.80 Micturitions Interval -2.13 to -1.47	-2.07 Micturitions Interval -2.4 to -1.74	-1.71 Micturitions Interval -2.05 to -1.36	-2.05 Micturitions Interval -2.4 to -1.7	—	—	—	—

PRIMARY outcome

Timeframe: Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.

Population: All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=141 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=134 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=148 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=149 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=135 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo n=64 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg n=112 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg n=122 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg n=110 Participants Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)	66 Participants	55 Participants	70 Participants	62 Participants	70 Participants	68 Participants	69 Participants	22 Participants	37 Participants	48 Participants	40 Participants

PRIMARY outcome

Timeframe: Part 1: up to 8 weeks; Part 2: up to 4 weeks

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=141 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=134 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=148 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=149 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=135 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo n=64 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg n=112 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg n=122 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg n=110 Participants Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE	3 Participants	3 Participants	4 Participants	2 Participants	2 Participants	4 Participants	3 Participants	2 Participants	4 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Extension: up to 54 weeks (including 2-week follow-up)

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=223 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=248 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=240 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Extension Study: Number of Participants Who Experienced an Adverse Event (AE)	134 Participants	157 Participants	158 Participants	82 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Extension: up to 52 weeks

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=223 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=248 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=240 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE	11 Participants	14 Participants	24 Participants	7 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=118 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=113 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=111 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=121 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=122 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=100 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=111 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8	-1.24 Urge incontinence episodes Interval -1.52 to -0.95	-1.52 Urge incontinence episodes Interval -1.81 to -1.23	-1.81 Urge incontinence episodes Interval -2.1 to -1.51	-1.95 Urge incontinence episodes Interval -2.23 to -1.67	-1.95 Urge incontinence episodes Interval -2.23 to -1.67	-1.69 Urge incontinence episodes Interval -2.0 to -1.38	-1.71 Urge incontinence episodes Interval -2.01 to -1.42	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=118 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=113 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=111 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=121 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=122 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=100 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=111 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8	-1.52 Incontinence episodes Interval -1.84 to -1.21	-1.71 Incontinence episodes Interval -2.02 to -1.39	-2.01 Incontinence episodes Interval -2.33 to -1.69	-2.13 Incontinence episodes Interval -2.43 to -1.82	-2.11 Incontinence episodes Interval -2.41 to -1.8	-1.86 Incontinence episodes Interval -2.2 to -1.52	-2.00 Incontinence episodes Interval -2.32 to -1.68	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=141 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=132 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=148 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=148 Participants Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=134 Participants Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8	-1.59 Strong urge episodes Interval -2.07 to -1.11	-1.77 Strong urge episodes Interval -2.24 to -1.3	-2.27 Strong urge episodes Interval -2.76 to -1.78	-2.36 Strong urge episodes Interval -2.82 to -1.89	-2.83 Strong urge episodes Interval -3.3 to -2.37	-2.53 Strong urge episodes Interval -3.03 to -2.04	-2.73 Strong urge episodes Interval -3.22 to -2.24	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 52 of Extension Study

Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=223 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=246 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=240 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Extension Study: Change From Baseline in Average Daily Micturitions at Week 52	-2.53 Micturitions Interval -2.87 to -2.2	-2.77 Micturitions Interval -3.08 to -2.45	-2.15 Micturitions Interval -2.47 to -1.83	-3.25 Micturitions Interval -3.67 to -2.83	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 52 of Extension Study

Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=179 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=200 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=189 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=112 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52	-2.43 Urge incontinence episodes Interval -2.72 to -2.14	-2.15 Urge incontinence episodes Interval -2.43 to -1.87	-2.23 Urge incontinence episodes Interval -2.51 to -1.94	-2.44 Urge incontinence episodes Interval -2.79 to -2.09	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 52 of Extension Study

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=179 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=200 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=189 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=112 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52	-2.70 Incontinence episodes Interval -3.03 to -2.36	-2.42 Incontinence episodes Interval -2.74 to -2.09	-2.50 Incontinence episodes Interval -2.83 to -2.17	-2.48 Incontinence episodes Interval -2.89 to -2.07	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 52 of Extension Study

Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=223 Participants Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=246 Participants Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=240 Participants Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=134 Participants Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52	-3.11 Strong urge episodes Interval -3.55 to -2.67	-3.42 Strong urge episodes Interval -3.84 to -3.0	-2.94 Strong urge episodes Interval -3.36 to -2.52	-4.18 Strong urge episodes Interval -4.74 to -3.63	—	—	—	—	—	—	—

Adverse Events

Part 1: Placebo

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Part 1: Vibegron 3 mg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 1: Vibegron 15 mg

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Part 1: Vibegron 50 mg

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Part 1: Vibegron 100 mg

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Part 1: Tolterodine ER 4 mg

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: Vibegron 100 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: Tolterodine ER 4 mg

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 2: Vibegron 100 mg + Tolterodine ER 4 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Extension Study: Vibegron 50 mg

Serious events: 14 serious events

Other events: 59 other events

Deaths: 0 deaths

Extension Study: Vibegron 100 mg

Serious events: 8 serious events

Other events: 73 other events

Deaths: 0 deaths

Extension Study: Tolterodine ER 4 mg

Serious events: 18 serious events

Other events: 70 other events

Deaths: 0 deaths

Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Placebo n=141 participants at risk Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 participants at risk Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=134 participants at risk Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=148 participants at risk Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=149 participants at risk Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=135 participants at risk Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 participants at risk Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo n=64 participants at risk Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg n=112 participants at risk Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg n=122 participants at risk Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg n=110 participants at risk Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.	Extension Study: Vibegron 50 mg n=223 participants at risk Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 100 mg n=248 participants at risk Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Tolterodine ER 4 mg n=240 participants at risk Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg n=134 participants at risk Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Blood and lymphatic system disorders Autoimmune thrombocytopenia	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Cardiac disorders Atrial fibrillation	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.74% 1/135 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Cardiac disorders Myocardial infarction	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Cardiac disorders Myocardial ischaemia	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Immune system disorders Anaphylactic reaction	0.71% 1/141 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Gatrooesophageal reflux disease	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Ileus	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Ileus paralytic	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
General disorders Devise dislocation	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Appendicitis	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Borrelia infection	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.75% 1/134 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Cellulitis	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Pneumonia	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.83% 2/240 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Tracheobronchitis	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Contusion	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Metabolism and nutrition disorders Dehydration	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.90% 2/223 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Musculoskeletal and connective tissue disorders Periarthirits	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Nervous system disorders Cerebrovascluar accident	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.90% 2/223 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Nervous system disorders Loss of conciousness	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.45% 1/223 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Psychiatric disorders Anxiety	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.40% 1/248 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Overdose	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.75% 1/134 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.69% 1/144 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.68% 1/148 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Vascular disorders Hypertension	0.71% 1/141 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/122 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Nervous system disorders Dizziness	0.00% 0/141 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/144 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/149 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/135 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/223 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/248 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/240 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/134 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.

Other adverse events

Other adverse events
Measure	Part 1: Placebo n=141 participants at risk Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 3 mg n=144 participants at risk Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 15 mg n=134 participants at risk Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg n=148 participants at risk Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Vibegron 100 mg n=149 participants at risk Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.	Part 1: Tolterodine ER 4 mg n=135 participants at risk Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.	Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg n=134 participants at risk Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.	Part 2: Placebo n=64 participants at risk Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg n=112 participants at risk Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.	Part 2: Tolterodine ER 4 mg n=122 participants at risk Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.	Part 2: Vibegron 100 mg + Tolterodine ER 4 mg n=110 participants at risk Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.	Extension Study: Vibegron 50 mg n=223 participants at risk Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 100 mg n=248 participants at risk Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.	Extension Study: Tolterodine ER 4 mg n=240 participants at risk Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.	Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg n=134 participants at risk Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
Gastrointestinal disorders Diarrhoea	3.5% 5/141 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.8% 4/144 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.5% 2/134 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.68% 1/148 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.4% 5/149 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.2% 7/135 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.6% 2/122 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.91% 1/110 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.0% 9/223 • Number of events 9 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.6% 9/248 • Number of events 10 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.2% 10/240 • Number of events 10 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.5% 2/134 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Dry mouth	1.4% 2/141 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.5% 5/144 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.7% 7/148 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.0% 3/149 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	10.4% 14/135 • Number of events 14 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	8.2% 11/134 • Number of events 11 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.2% 4/64 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.89% 1/112 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.6% 8/122 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	11.8% 13/110 • Number of events 14 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.6% 8/223 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.2% 8/248 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	7.5% 18/240 • Number of events 18 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Nasopharyngitis	9.9% 14/141 • Number of events 15 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.1% 3/144 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.2% 7/134 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.4% 8/148 • Number of events 9 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.0% 6/149 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.2% 3/135 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.2% 3/134 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.6% 4/112 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.8% 2/110 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.4% 12/223 • Number of events 18 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	9.7% 24/248 • Number of events 30 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	8.3% 20/240 • Number of events 25 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	11.2% 15/134 • Number of events 19 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Urinary tract infection	3.5% 5/141 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.5% 5/144 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.7% 5/134 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.4% 8/148 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.0% 6/149 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.0% 4/135 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.2% 7/134 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.1% 2/64 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.8% 2/112 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.6% 8/122 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 5/110 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	12.1% 27/223 • Number of events 42 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	8.9% 22/248 • Number of events 33 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	11.2% 27/240 • Number of events 44 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.0% 8/134 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Injury, poisoning and procedural complications Accidental overdose	1.4% 2/141 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.1% 3/144 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.7% 4/148 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	7.4% 11/149 • Number of events 11 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.7% 5/135 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.5% 2/134 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/112 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.91% 1/110 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.1% 7/223 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.6% 4/248 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.42% 1/240 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.75% 1/134 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Nervous system disorders Headache	5.0% 7/141 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.1% 3/144 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.1% 6/148 • Number of events 8 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.7% 10/149 • Number of events 13 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.0% 4/135 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 7 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.1% 2/64 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.8% 2/112 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.1% 5/122 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.4% 7/110 • Number of events 7 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.8% 13/223 • Number of events 13 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.6% 4/248 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.5% 6/240 • Number of events 7 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.7% 5/134 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Gastrointestinal disorders Constipation	2.1% 3/141 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.5% 5/144 • Number of events 5 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.1% 6/148 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.67% 1/149 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.0% 4/135 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.5% 6/134 • Number of events 6 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.1% 2/64 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.89% 1/112 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.6% 4/110 • Number of events 4 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.90% 2/223 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.8% 7/248 • Number of events 7 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	3.8% 9/240 • Number of events 9 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.7% 9/134 • Number of events 9 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
Infections and infestations Upper respiratory tract infection	1.4% 2/141 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.4% 2/144 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.75% 1/134 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/148 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	2.0% 3/149 • Number of events 3 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	1.5% 2/135 • Number of events 2 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.75% 1/134 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/64 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.89% 1/112 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.82% 1/122 • Number of events 1 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	0.00% 0/110 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.0% 9/223 • Number of events 9 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	5.6% 14/248 • Number of events 14 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	4.2% 10/240 • Number of events 10 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.	6.7% 9/134 • Number of events 9 • Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up) All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER