The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.

Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.

The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.

FAS. N=number of participants with analyzable data.

Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.

FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.

FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.

FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.

FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.

FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.

FAS; participants reporting this symptom at baseline (number of participants with urgency episodes >=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.

FAS; participants reporting this symptom at baseline (participants with urgency episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.

FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.

FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.

FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.

FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.

FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.

FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.

FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.

OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.

FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.

ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.

FAS. N=number of participants with analyzable data.

BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).

FAS, LOCF.

TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.

FAS. N=number of participants with analyzable data.

KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.

FAS. n=number of participants with analyzable data.