Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O).

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data.

Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 micturitions at Baseline.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with >0 urgency episodes at Baseline.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.

Full analysis set included all participants who were randomized in the study and received at least 1 dose of study medication and had provided baseline primary endpoint data. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.

Safety analysis set population for active comparator phase and efficacy phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows.

CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.

Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 10-peg assessment was done only in participants below age of 9 years. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure, "Number Analyzed": participants evaluable for specified rows. There was 1 participant who inadvertently did the 10-peg test with non-dominant hand and 25-peg test with dominant hand. This participant was counted in both 10 peg and 25 peg assessment.

The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.

Safety analysis set population for active comparator phase and efficacy phase analyzed. 25-peg assessment was done only in participants of age 9 years and above. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure and "Number Analyzed": participants evaluable for specified rows.

Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.

Analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 colony forming unit per milliliter [CFU/mL]) and the presence of symptoms, or pyuria (defined as >50 white blood cells [WBC] per high-pass filter [hpf]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study.

Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) and the presence of symptoms, or pyuria (defined as >50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.

Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure; "Number Analyzed": participants evaluable at specified time points.

Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.

Safety analysis set population for safety extension phase: all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.

Safety analysis set population for active comparator phase and efficacy phase: all participants of respective cohorts who received at least 1 dose of study medication in relevant phase of the study. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.

Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.

Safety analysis set population for safety extension phase included all participants of respective cohorts who received at least 1 dose of study medication in the relevant phase of the study.

Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

The PK analysis population included all participants randomized and treated with fesoterodine and who had at least 1 of the PK parameters of primary interest during the study.