During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. The number of participant analyzed represents participants with a non-missing change from baseline to last possible titration step.

Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.

Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 30 cmH20 detrusor pressure were included in the analysis.

Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 40 cmH20 detrusor pressure were included in the analysis.

Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The number of incontinence-free days was calculated from the 7-day micturition diary.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

The number of incontinence-free nights was calculated from the 7-day micturition diary.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.

A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.

The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.