Trial Outcomes & Findings for BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence (NCT NCT03320850)

NCT ID: NCT03320850

Last Updated: 2021-08-13

Results Overview

The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 383 participants
• Primary outcome timeframe: Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
• Results posted on: 2021-08-13

Participant Flow

Participant milestones

Measure	Stage 1: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 100U + Hydrogel Admixture BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Overall Study STARTED	18	12	18	22	19	58	57	60	60	59
Overall Study Safety Population	18	12	18	22	19	57	57	60	60	58
Overall Study COMPLETED	18	12	18	21	17	49	50	53	50	50
Overall Study NOT COMPLETED	0	0	0	1	2	9	7	7	10	9

Reasons for withdrawal

Measure	Stage 1: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 100U + Hydrogel Admixture BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Overall Study Lost to Follow-up	0	0	0	0	1	2	2	0	6	4
Overall Study Withdrawal by Subject	0	0	0	0	1	2	4	5	2	1
Overall Study Lack of Efficacy	0	0	0	1	0	1	0	2	0	3
Overall Study Failure to Meet Randomization Criteria	0	0	0	0	0	1	0	0	0	0
Overall Study Adverse Event	0	0	0	0	0	2	1	0	2	0
Overall Study Reason Not Specified	0	0	0	0	0	1	0	0	0	1

Baseline Characteristics

Stage 1: Safety Analysis Set included all participants who were randomized and treated.

Baseline characteristics by cohort

Measure	Stage 1: Placebo + Hydrogel Admixture n=18 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 100U + Hydrogel Admixture n=12 Participants BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 300U + Hydrogel Admixture n=18 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 400U + Hydrogel Admixture n=22 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 500U + Hydrogel Admixture n=19 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture n=58 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=57 Participants BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=60 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=60 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=59 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Total n=383 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 13.8 • n=18 Participants • Stage 1: Safety Analysis Set included all participants who were randomized and treated.	54.7 years STANDARD_DEVIATION 13.0 • n=12 Participants • Stage 1: Safety Analysis Set included all participants who were randomized and treated.	56.2 years STANDARD_DEVIATION 12.1 • n=18 Participants • Stage 1: Safety Analysis Set included all participants who were randomized and treated.	62.4 years STANDARD_DEVIATION 8.6 • n=22 Participants • Stage 1: Safety Analysis Set included all participants who were randomized and treated.	55.3 years STANDARD_DEVIATION 13.2 • n=19 Participants • Stage 1: Safety Analysis Set included all participants who were randomized and treated.	57.9 years STANDARD_DEVIATION 11.17 • n=58 Participants • Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.	60.4 years STANDARD_DEVIATION 9.93 • n=57 Participants • Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.	59.1 years STANDARD_DEVIATION 11.33 • n=60 Participants • Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.	59.8 years STANDARD_DEVIATION 9.10 • n=60 Participants • Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.	60.7 years STANDARD_DEVIATION 9.38 • n=59 Participants • Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.	59.6 years STANDARD_DEVIATION 10.20 • n=294 Participants • Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.
Sex: Female, Male Female	17 Participants n=18 Participants	12 Participants n=12 Participants	15 Participants n=18 Participants	18 Participants n=22 Participants	17 Participants n=19 Participants	53 Participants n=58 Participants	53 Participants n=57 Participants	54 Participants n=60 Participants	54 Participants n=60 Participants	54 Participants n=59 Participants	347 Participants n=383 Participants
Sex: Female, Male Male	1 Participants n=18 Participants	0 Participants n=12 Participants	3 Participants n=18 Participants	4 Participants n=22 Participants	2 Participants n=19 Participants	5 Participants n=58 Participants	4 Participants n=57 Participants	6 Participants n=60 Participants	6 Participants n=60 Participants	5 Participants n=59 Participants	36 Participants n=383 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=18 Participants	2 Participants n=12 Participants	3 Participants n=18 Participants	1 Participants n=22 Participants	0 Participants n=19 Participants	5 Participants n=58 Participants	9 Participants n=57 Participants	5 Participants n=60 Participants	11 Participants n=60 Participants	7 Participants n=59 Participants	45 Participants n=383 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=18 Participants	10 Participants n=12 Participants	15 Participants n=18 Participants	21 Participants n=22 Participants	19 Participants n=19 Participants	53 Participants n=58 Participants	48 Participants n=57 Participants	55 Participants n=60 Participants	49 Participants n=60 Participants	52 Participants n=59 Participants	338 Participants n=383 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=57 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=59 Participants	0 Participants n=383 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=57 Participants	0 Participants n=60 Participants	1 Participants n=60 Participants	0 Participants n=59 Participants	1 Participants n=383 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	0 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	1 Participants n=58 Participants	0 Participants n=57 Participants	1 Participants n=60 Participants	1 Participants n=60 Participants	0 Participants n=59 Participants	3 Participants n=383 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=57 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=59 Participants	0 Participants n=383 Participants
Race (NIH/OMB) Black or African American	4 Participants n=18 Participants	4 Participants n=12 Participants	4 Participants n=18 Participants	1 Participants n=22 Participants	7 Participants n=19 Participants	12 Participants n=58 Participants	13 Participants n=57 Participants	10 Participants n=60 Participants	9 Participants n=60 Participants	16 Participants n=59 Participants	80 Participants n=383 Participants
Race (NIH/OMB) White	13 Participants n=18 Participants	8 Participants n=12 Participants	14 Participants n=18 Participants	20 Participants n=22 Participants	11 Participants n=19 Participants	44 Participants n=58 Participants	44 Participants n=57 Participants	48 Participants n=60 Participants	49 Participants n=60 Participants	43 Participants n=59 Participants	294 Participants n=383 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=12 Participants	0 Participants n=18 Participants	1 Participants n=22 Participants	1 Participants n=19 Participants	1 Participants n=58 Participants	0 Participants n=57 Participants	0 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=59 Participants	3 Participants n=383 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants	0 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=22 Participants	0 Participants n=19 Participants	0 Participants n=58 Participants	0 Participants n=57 Participants	1 Participants n=60 Participants	0 Participants n=60 Participants	0 Participants n=59 Participants	2 Participants n=383 Participants
Stage 1: Average Number of Urinary Incontinence Episodes (UIE)	7.1 episodes per day STANDARD_DEVIATION 3.4 • n=18 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	4.7 episodes per day STANDARD_DEVIATION 2.5 • n=12 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	5.8 episodes per day STANDARD_DEVIATION 2.7 • n=18 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	4.4 episodes per day STANDARD_DEVIATION 2.7 • n=22 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	5.3 episodes per day STANDARD_DEVIATION 3.0 • n=19 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	—	—	—	—	—	5.5 episodes per day STANDARD_DEVIATION 3.0 • n=89 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.
Stage 2: Average Number of Urinary Incontinence Episodes	—	—	—	—	—	6.06 episodes per day STANDARD_DEVIATION 3.162 • n=57 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	5.60 episodes per day STANDARD_DEVIATION 4.267 • n=57 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	4.46 episodes per day STANDARD_DEVIATION 2.738 • n=60 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	4.56 episodes per day STANDARD_DEVIATION 3.073 • n=60 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	5.92 episodes per day STANDARD_DEVIATION 3.302 • n=59 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	5.30 episodes per day STANDARD_DEVIATION 3.386 • n=293 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.
Stage 1: Average Number of Micturition Episodes per Day	10.6 episodes per day STANDARD_DEVIATION 2.4 • n=18 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	10.9 episodes per day STANDARD_DEVIATION 3.5 • n=12 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	10.0 episodes per day STANDARD_DEVIATION 1.6 • n=18 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	11.3 episodes per day STANDARD_DEVIATION 2.4 • n=22 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	11.8 episodes per day STANDARD_DEVIATION 2.9 • n=19 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	—	—	—	—	—	10.9 episodes per day STANDARD_DEVIATION 2.6 • n=89 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.
Stage 2: Average Number of Micturition Episodes per Day	—	—	—	—	—	11.12 episodes per day STANDARD_DEVIATION 3.049 • n=57 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	10.97 episodes per day STANDARD_DEVIATION 2.938 • n=57 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	10.91 episodes per day STANDARD_DEVIATION 2.678 • n=60 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	9.88 episodes per day STANDARD_DEVIATION 2.030 • n=60 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	10.70 episodes per day STANDARD_DEVIATION 2.822 • n=59 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	10.71 episodes per day STANDARD_DEVIATION 2.738 • n=293 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.
Stage 1: Average Volume Voided per Micturition	189.2 milliliter (mL) STANDARD_DEVIATION 64.1 • n=18 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	189.8 milliliter (mL) STANDARD_DEVIATION 94.0 • n=12 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	182.5 milliliter (mL) STANDARD_DEVIATION 79.3 • n=18 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	150.0 milliliter (mL) STANDARD_DEVIATION 54.7 • n=22 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	199.4 milliliter (mL) STANDARD_DEVIATION 70.0 • n=19 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.	—	—	—	—	—	180.4 milliliter (mL) STANDARD_DEVIATION 71.9 • n=89 Participants • Safety Analysis Set included all participants who were randomized and treated in Stage 1.
Stage 2: Average Volume Voided per Micturition	—	—	—	—	—	179.10 mL STANDARD_DEVIATION 59.421 • n=57 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	173.28 mL STANDARD_DEVIATION 66.615 • n=57 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	167.10 mL STANDARD_DEVIATION 67.940 • n=60 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	194.50 mL STANDARD_DEVIATION 67.414 • n=60 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	199.58 mL STANDARD_DEVIATION 74.154 • n=59 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.	182.79 mL STANDARD_DEVIATION 68.025 • n=293 Participants • ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.

PRIMARY outcome

Timeframe: Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12

Population: Participants from the Intent-to-treat (ITT) Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms.

The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.

Outcome measures

Measure	Stage 2: Placebo + Hydrogel Admixture n=57 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=57 Participants BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=60 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=60 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=58 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day	-2.72 episodes per day Standard Error 0.534	-1.62 episodes per day Standard Error 0.539	-0.89 episodes per day Standard Error 0.521	-1.52 episodes per day Standard Error 0.520	-1.85 episodes per day Standard Error 0.530	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)

Population: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.

An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.

Outcome measures

Measure	Stage 2: Placebo + Hydrogel Admixture n=18 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=12 Participants BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=18 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=22 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=19 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture n=57 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=57 Participants BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=60 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=60 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=58 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period	6 Participants	4 Participants	4 Participants	10 Participants	6 Participants	25 Participants	30 Participants	30 Participants	38 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12

Population: Participants from the ITT Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms.

The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.

Outcome measures

Measure	Stage 2: Placebo + Hydrogel Admixture n=46 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=49 Participants BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=52 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=55 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=52 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day	-1.64 episodes per day Standard Error 0.519	-0.91 episodes per day Standard Error 0.514	-0.86 episodes per day Standard Error 0.486	-1.00 episodes per day Standard Error 0.480	-1.11 episodes per day Standard Error 0.492	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12

Population: Participants from the ITT Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms.

Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary. The volume voided during each 24-hour period was divided by the number of micturitions during the period. The average volume voided per micturition is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.

Outcome measures

Measure	Stage 2: Placebo + Hydrogel Admixture n=46 Participants BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=49 Participants BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=52 Participants BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=55 Participants BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=51 Participants BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Stage 2: Change From Baseline in the Average Volume Voided Per Micturition	12.61 mL Standard Error 11.251	5.56 mL Standard Error 11.214	4.61 mL Standard Error 10.576	11.28 mL Standard Error 10.349	21.94 mL Standard Error 10.779	—	—	—	—	—

Adverse Events

Stage 1: Placebo + Hydrogel Admixture

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Stage 1: BOTOX® 100U + Hydrogel Admixture

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Stage 1: BOTOX® 300U + Hydrogel Admixture

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Stage 1: BOTOX® 400U + Hydrogel Admixture

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Stage 1: BOTOX® 500U + Hydrogel Admixture

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Stage 2: Placebo + Hydrogel Admixture

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Stage 2: BOTOX® 100U + Hydrogel Admixture

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Stage 2: BOTOX® 300U + Hydrogel Admixture

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Stage 2: BOTOX® 400U + Hydrogel Admixture

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Stage 2: BOTOX® 500U + Hydrogel Admixture

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stage 1: Placebo + Hydrogel Admixture n=18 participants at risk BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 100U + Hydrogel Admixture n=12 participants at risk BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 300U + Hydrogel Admixture n=18 participants at risk BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 400U + Hydrogel Admixture n=22 participants at risk BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 500U + Hydrogel Admixture n=19 participants at risk BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture n=57 participants at risk BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=57 participants at risk BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=60 participants at risk BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=60 participants at risk BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=58 participants at risk BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Cardiac disorders Supraventricular tachycardia	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Cellulitis	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Influenza	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Injury, poisoning and procedural complications Fall	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Nervous system disorders Cerebrovascular accident	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Vascular disorders Peripheral artery thrombosis	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Vascular disorders Peripheral vascular disorder	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.

Other adverse events

Measure	Stage 1: Placebo + Hydrogel Admixture n=18 participants at risk BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 100U + Hydrogel Admixture n=12 participants at risk BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 300U + Hydrogel Admixture n=18 participants at risk BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 400U + Hydrogel Admixture n=22 participants at risk BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 1: BOTOX® 500U + Hydrogel Admixture n=19 participants at risk BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: Placebo + Hydrogel Admixture n=57 participants at risk BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 100U + Hydrogel Admixture n=57 participants at risk BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 300U + Hydrogel Admixture n=60 participants at risk BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 400U + Hydrogel Admixture n=60 participants at risk BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.	Stage 2: BOTOX® 500U + Hydrogel Admixture n=58 participants at risk BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.
Renal and urinary disorders Haematuria	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	4.5% 1/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Reproductive system and breast disorders Pelvic pain	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Gastrointestinal disorders Gastric ulcer	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.5% 2/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.0% 3/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
General disorders Asthenia	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
General disorders Instillation site discomfort	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Upper respiratory tract infection	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	4.5% 1/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 3/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 3/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.3% 2/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Asymptomatic bacteriuria	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	4.5% 1/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.8% 5/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	14.0% 8/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	13.3% 8/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	6.7% 4/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	15.5% 9/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Urinary tract infection	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 3/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.5% 2/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.3% 2/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.2% 3/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/17 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/15 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/17 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/53 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/53 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/54 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/54 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/54 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Bronchitis	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	6.7% 4/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Nasopharyngitis	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Pneumonia	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Infections and infestations Bacteriuria	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 5/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	6.9% 4/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Metabolism and nutrition disorders Acetonaemia	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.3% 1/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Nervous system disorders Dysgeusia	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Nervous system disorders Headache	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Renal and urinary disorders Leukocyturia	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.3% 2/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.6% 5/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Renal and urinary disorders Proteinuria	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Renal and urinary disorders Dysuria	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.8% 1/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.5% 2/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	1.7% 1/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.0% 3/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	3.4% 2/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Renal and urinary disorders Urethral pain	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.
Vascular disorders Hypertension	5.6% 1/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	8.3% 1/12 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/18 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/22 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/19 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/57 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/60 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.	0.00% 0/58 • Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: IR-CTRegistration@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER