Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6

MCC was calculated by urodynamic assessment according to International Continence Society (ICS) standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6

PmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6

VPmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6

PdetMax was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS2 comprised all randomized participants who had at least 1 post-second treatment efficacy assessment after the second treatment.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS3 comprised all randomized participants who had at least 1 post-third treatment efficacy assessment after the third treatment.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 1 have been presented.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 2 have been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 3 have been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment

Participants can be considered for re-treatment beginning at the week 12 visit following the initial treatment or the week 12 visit following any re-treatment. Qualification criteria was; participants must have initiated request for re-treatment, participants experienced at least 4 episodes of urinary incontinence, with no more than one incontinence-free day, post-void residual (PVR) urine volume must have been \<200 mL for participants who micturated or had a mixed catheterization / spontaneous micturition pattern, body weight \>=40 kilogram; investigator deemed re-treatment appropriate. Time to the participant's first qualification for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants gave "Yes" response to the question of participants qualification for retreatment minus the day of first treatment plus 1.

Time frame: Up to 36 Weeks in Treatment Cycle 1

Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment

The time taken by the participants to request re-treatment was reported. Time to the participant's first request for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants provided "Yes" response to the question of participants request for retreatment minus the day of first treatment plus 1.

Time frame: Up to 36 Weeks in Treatment Cycle 1

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score

KHQ is a 21 item questionnaire, consisting of 9 domains:General health (GH) (1\[Very good\] to 5\[Very poor\]), Incontinence impact (Int Imp) (1\[Not at all\] to 4\[A lot\]), Role Limitations (RL) (1\[Not at all\] to 4\[A lot\]), Physical limitations (PL) (1\[Not at all\] to 4\[A lot\]), Social limitations (SL) (0\[not applicable\] to 4\[A lot\]), Personal relationships (PR) (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), Sleep or energy (S or E) (1\[Never\] to 4\[All the time\]) and Severity or Coping (S or C) (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score

KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S or E (1\[Never\] to 4\[All the time\]) and S or C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, Week 12, Week 24, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score

KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S or E (1\[Never\] to 4\[All the time\]) and S or C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, Week 12 and Week 24 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)

TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.

Time frame: Week 2, Week 6 , Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS

TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.

Time frame: Week 0, Week 2, Week 6, Week 12, Week 24, and Week 36 in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS

TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.

Time frame: Week 0, Week 2, Week 6, Week 12, and Week 24 in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.

Time frame: Up to Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population 1 comprised of all participants who received at least one dose of GSK1358820.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo / GSK1358820 200 U

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety Population 3 comprised of all participants who received three doses of GSK1358820.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP

Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP

Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate

Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate

Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate

Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature

Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature

Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature

Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, Hemoglobin (Hb), Hematocrit (Hct), Lymphocytes (Lympho), Monocytes, Neutrophil bands (N bands), Total Neutrophils (T neutro), Platelet count (PC), Red Blood Cell (RBC) count, and White Blood Cell count (WBC). Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.

Time frame: Week 12, and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.

Time frame: Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.

Time frame: Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alkaline Phosphatase (Alk Phosp), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin (Bil), Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein (T Protein), Urea/blood urea nitrogen (BUN) and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.

Time frame: Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.

Time frame: Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.

Time frame: Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.

Time frame: Baseline (Pre-dose on Day 1) and up to Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Urinary Tract Infection (UTI)

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 Colony Forming Unit per milliliter (CFU/mL) and leukocyturia with \>5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 200 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to Week 48 after 1st treatment

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 200 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both clean intermittent catheterization \[CIC\] and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. For participants who had a PVR urine volume measurement repeated, only the repeat value was recorded. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination

The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.

Time frame: Up to Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U

The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U

The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U

The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings

Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.

Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 in Treatment Cycle 1

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings

Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.

Time frame: Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings

Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.

Time frame: Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3