This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

Change From Baseline to EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.

Time frame: Baseline and EoT (up to 12 weeks)

Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT

The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

Time frame: Baseline and weeks 4, 8 and 12

Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours

Time frame: Baseline and weeks 4, 8 and 12

Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition

Time frame: Baseline and weeks 4, 8 and 12

Change From Baseline to EoT in Corrected Micturition Frequency

Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.

Time frame: Baseline and Week 12

Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT

A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes

Time frame: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Number of Pads Used at Weeks 4, 8, 12 and EoT

The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Weeks 4, 8 and 12 (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used

Time frame: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours

The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8 and 12 (up to 12 weeks)

Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT

The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.

Time frame: Weeks 4, 8,12 and EoT (up to 12 weeks)

Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

The number of incontinence-free days with \< 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with \< 8 micturitions per day.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.

Time frame: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8 and 12

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping

The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern

The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep

The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social

The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT

The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).

Time frame: Week 12 and EoT (up to 12 weeks)

PGIC Scale: Impression in General Health at Week 12 and EoT

The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).

Time frame: Week 12 and EoT (up to 12 weeks)

Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and EoT (up to 12 weeks)

Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 8 and 12 in TS-VAS

The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.

Time frame: Baseline and week 4, 8 and 12

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT

The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT

The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8 , 12 and EoT (up to 12 weeks)

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT

The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.

Time frame: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)

Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume

PVR volume was assessed by ultrasonography or a bladder scanner.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)

Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)

Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)