Trial Outcomes & Findings for Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NCT NCT02849418)

Results Overview

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. Adjusted mean and standard error of adjusted mean has been reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

21 participants

Primary outcome timeframe

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

Results posted on

2021-07-14

Participant Flow

This study evaluated the efficacy and safety of GSK1358820 (botulinum toxin type A) in participants with urinary incontinence due to neurogenic detrusor overactivity. This was a multicenter study conducted at 7 centers in Japan.

A total of 30 participants were screened of which 21 participants were randomized (11 participants in the GSK1358820 200 Unit \[U\] group and 10 participants in the placebo group).

Participant milestones

Participant milestones
Measure	Treatment Cycle 1: Placebo Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 milliliter \[mL\] each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 200U Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 2: Placebo / GSK1358820 200 U Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 3: Placebo / GSK1358820 200 U Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
Double-blinded (Up to 48 Weeks) STARTED	10	11	0	0	0	0
Double-blinded (Up to 48 Weeks) COMPLETED	10	11	0	0	0	0
Double-blinded (Up to 48 Weeks) NOT COMPLETED	0	0	0	0	0	0
Open-label(2nd Treatment-Week 12 to 48) STARTED	0	0	10	6	0	0
Open-label(2nd Treatment-Week 12 to 48) COMPLETED	0	0	10	6	0	0
Open-label(2nd Treatment-Week 12 to 48) NOT COMPLETED	0	0	0	0	0	0
Open-label(3rd Treatment-Week 12 to 48) STARTED	0	0	0	0	5	3
Open-label(3rd Treatment-Week 12 to 48) COMPLETED	0	0	0	0	5	3
Open-label(3rd Treatment-Week 12 to 48) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met retreatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.	GSK1358820 200U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met retreatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.	Total n=21 Participants Total of all reporting groups
Age, Continuous	47.2 Years STANDARD_DEVIATION 18.29 • n=5 Participants	50.9 Years STANDARD_DEVIATION 14.12 • n=7 Participants	49.1 Years STANDARD_DEVIATION 15.93 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese/East Asian (EA)/South EA Heritage	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

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

Population: FAS1 Population

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. Adjusted mean and standard error of adjusted mean has been reported.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 6	-3.20 Episodes Standard Error 0.911	-0.18 Episodes Standard Error 0.957

SECONDARY outcome

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

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6	157.09 Milliliter Standard Deviation 161.159	62.05 Milliliter Standard Deviation 104.783

SECONDARY outcome

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

Population: FAS1 Population. Only those participants with data available at the indicated time point were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=8 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (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	-21.000 Centimeter of water (cmH2O) Standard Deviation 27.7705	-0.005 Centimeter of water (cmH2O) Standard Deviation 15.1414

SECONDARY outcome

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

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6	188.9 Milliliter Standard Deviation 157.43	67.7 Milliliter Standard Deviation 68.28

SECONDARY outcome

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

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (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	-31.18 cmH2O Standard Deviation 28.067	-13.72 cmH2O Standard Deviation 29.141

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 24	-3.79 Episodes Standard Deviation 2.295	-2.50 Episodes Standard Deviation 2.593
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 30	-3.42 Episodes Standard Deviation 2.195	-3.33 Episodes Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 2	-2.67 Episodes Standard Deviation 2.530	-0.90 Episodes Standard Deviation 2.658
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 6	-3.12 Episodes Standard Deviation 2.469	-0.27 Episodes Standard Deviation 3.321
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 12	-2.82 Episodes Standard Deviation 2.518	-0.40 Episodes Standard Deviation 2.459
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 18	-3.46 Episodes Standard Deviation 2.513	-2.33 Episodes Standard Deviation 0.943
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 36	-3.94 Episodes Standard Deviation 2.832	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 42	-3.47 Episodes Standard Deviation 2.181	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 48	-3.80 Episodes Standard Deviation 2.008	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 0	-0.89 Episodes Standard Deviation 1.026	-0.33 Episodes Standard Deviation 2.439
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 2	-1.06 Episodes Standard Deviation 1.124	-2.77 Episodes Standard Deviation 2.735
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 6	-1.67 Episodes Standard Deviation 0.919	-3.17 Episodes Standard Deviation 2.602
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 12	-1.50 Episodes Standard Deviation 0.983	-2.56 Episodes Standard Deviation 2.939
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 18	-1.00 Episodes Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-2.67 Episodes Standard Deviation 2.041
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 24	-1.33 Episodes Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-2.27 Episodes Standard Deviation 3.157
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 30	—	-1.11 Episodes Standard Deviation 3.657
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 36	—	0.33 Episodes Standard Deviation 4.243

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 0	-1.00 Episodes Standard Deviation 0.577	-1.47 Episodes Standard Deviation 2.168
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 2	-1.44 Episodes Standard Deviation 0.509	-3.50 Episodes Standard Deviation 1.732
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 6	-1.11 Episodes Standard Deviation 0.839	-3.87 Episodes Standard Deviation 1.865
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 12	-1.56 Episodes Standard Deviation 0.385	-2.87 Episodes Standard Deviation 2.219
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 18	-1.50 Episodes Standard Deviation 0.236	-1.67 Episodes Standard Deviation 0.943

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 6	-74.71 Percent change Standard Deviation 36.316	-10.58 Percent change Standard Deviation 61.416
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 24	-91.07 Percent change Standard Deviation 11.453	-35.00 Percent change Standard Deviation 21.213
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 2	-59.07 Percent change Standard Deviation 35.043	-24.07 Percent change Standard Deviation 38.593
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 12	-67.64 Percent change Standard Deviation 38.644	-4.77 Percent change Standard Deviation 60.523
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 18	-79.82 Percent change Standard Deviation 24.361	-42.31 Percent change Standard Deviation 10.879
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 30	-79.99 Percent change Standard Deviation 20.033	-38.46 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 36	-78.83 Percent change Standard Deviation 34.519	—
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 42	-78.70 Percent change Standard Deviation 37.029	—
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 48	-80.67 Percent change Standard Deviation 26.390	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 30	—	1.28 Percent change Standard Deviation 130.221
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 36	—	52.56 Percent change Standard Deviation 161.365
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 0	-33.80 Percent change Standard Deviation 37.522	-2.77 Percent change Standard Deviation 59.552
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 2	-46.30 Percent change Standard Deviation 48.390	-61.89 Percent change Standard Deviation 45.317
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 6	-60.53 Percent change Standard Deviation 32.686	-67.47 Percent change Standard Deviation 43.984
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 12	-53.24 Percent change Standard Deviation 36.701	-43.22 Percent change Standard Deviation 65.093
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 18	-33.33 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-57.56 Percent change Standard Deviation 36.509
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 24	-44.44 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-33.05 Percent change Standard Deviation 113.201

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 0	-28.70 Percent change Standard Deviation 14.254	-25.47 Percent change Standard Deviation 47.584
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 2	-45.83 Percent change Standard Deviation 18.162	-73.55 Percent change Standard Deviation 36.601
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 6	-43.29 Percent change Standard Deviation 49.263	-76.76 Percent change Standard Deviation 33.447
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 12	-56.48 Percent change Standard Deviation 38.922	-51.18 Percent change Standard Deviation 31.930
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes Week 18	-48.96 Percent change Standard Deviation 25.043	-21.29 Percent change Standard Deviation 1.825

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 2	-0.79 Voids Standard Deviation 1.905	-0.15 Voids Standard Deviation 1.253
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 6	-2.15 Voids Standard Deviation 3.354	0.10 Voids Standard Deviation 1.406
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 12	-2.24 Voids Standard Deviation 3.742	0.37 Voids Standard Deviation 1.869
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 18	-3.04 Voids Standard Deviation 3.827	-0.83 Voids Standard Deviation 1.650
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 24	-2.88 Voids Standard Deviation 3.788	-1.83 Voids Standard Deviation 0.707
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 30	-2.54 Voids Standard Deviation 3.616	-3.00 Voids Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 36	-2.83 Voids Standard Deviation 3.698	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 42	-2.20 Voids Standard Deviation 3.024	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids Week 48	-2.47 Voids Standard Deviation 3.548	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 0	-0.22 Voids Standard Deviation 1.601	0.10 Voids Standard Deviation 2.091
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 2	-0.72 Voids Standard Deviation 1.652	-0.90 Voids Standard Deviation 1.343
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 6	-1.28 Voids Standard Deviation 1.819	-1.33 Voids Standard Deviation 1.305
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 12	0.06 Voids Standard Deviation 1.902	-0.96 Voids Standard Deviation 1.679
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 18	2.67 Voids Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	0.80 Voids Standard Deviation 0.869
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 24	0.33 Voids Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	0.67 Voids Standard Deviation 1.247
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 30	—	1.33 Voids Standard Deviation 2.000
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids Week 36	—	2.17 Voids Standard Deviation 1.650

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids Week 18	0.17 Voids Standard Deviation 0.707	-1.83 Voids Standard Deviation 3.064
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids Week 0	0.56 Voids Standard Deviation 1.018	0.27 Voids Standard Deviation 1.722
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids Week 2	0.22 Voids Standard Deviation 0.509	-0.50 Voids Standard Deviation 1.908
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids Week 6	1.00 Voids Standard Deviation 1.155	-0.47 Voids Standard Deviation 1.626
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids Week 12	0.11 Voids Standard Deviation 0.509	-1.33 Voids Standard Deviation 2.789

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 30	-19.61 Percent change Standard Deviation 28.811	-27.27 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 2	-5.62 Percent change Standard Deviation 20.907	-0.40 Percent change Standard Deviation 14.219
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 6	-19.57 Percent change Standard Deviation 26.762	1.10 Percent change Standard Deviation 16.719
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 12	-19.59 Percent change Standard Deviation 29.442	6.71 Percent change Standard Deviation 20.180
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 18	-26.61 Percent change Standard Deviation 27.085	-7.01 Percent change Standard Deviation 15.803
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 24	-24.02 Percent change Standard Deviation 26.580	-18.94 Percent change Standard Deviation 3.214
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 36	-20.61 Percent change Standard Deviation 29.216	—
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 42	-14.15 Percent change Standard Deviation 26.549	—
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids Week 48	-16.20 Percent change Standard Deviation 27.755	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 0	-1.67 Percent change Standard Deviation 18.046	3.72 Percent change Standard Deviation 22.732
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 2	-7.31 Percent change Standard Deviation 18.173	-8.40 Percent change Standard Deviation 13.821
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 6	-16.44 Percent change Standard Deviation 25.830	-13.12 Percent change Standard Deviation 11.015
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 12	1.97 Percent change Standard Deviation 22.031	-8.49 Percent change Standard Deviation 16.813
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 18	25.00 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	10.33 Percent change Standard Deviation 10.827
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 24	3.13 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	8.18 Percent change Standard Deviation 15.795
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 30	—	17.53 Percent change Standard Deviation 25.469
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids Week 36	—	28.33 Percent change Standard Deviation 18.856

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids Week 0	8.79 Percent change Standard Deviation 16.889	7.42 Percent change Standard Deviation 15.640
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids Week 2	2.42 Percent change Standard Deviation 6.042	-0.38 Percent change Standard Deviation 12.695
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids Week 6	12.95 Percent change Standard Deviation 16.327	-2.36 Percent change Standard Deviation 16.615
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids Week 12	2.19 Percent change Standard Deviation 8.054	-7.14 Percent change Standard Deviation 16.624
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids Week 18	3.28 Percent change Standard Deviation 11.071	-6.82 Percent change Standard Deviation 16.071

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 18	84.11 Milliliter Standard Deviation 74.478	55.19 Milliliter Standard Deviation 44.989
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 2	61.12 Milliliter Standard Deviation 50.470	-3.68 Milliliter Standard Deviation 55.395
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 6	107.53 Milliliter Standard Deviation 79.483	0.98 Milliliter Standard Deviation 86.368
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 12	69.98 Milliliter Standard Deviation 64.010	6.85 Milliliter Standard Deviation 77.905
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 24	82.77 Milliliter Standard Deviation 61.992	53.65 Milliliter Standard Deviation 72.444
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 30	66.37 Milliliter Standard Deviation 48.478	165.22 Milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 36	70.07 Milliliter Standard Deviation 26.988	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 42	80.47 Milliliter Standard Deviation 42.477	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition Week 48	59.98 Milliliter Standard Deviation 6.616	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 0	21.59 Milliliter Standard Deviation 38.130	7.83 Milliliter Standard Deviation 84.215
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 2	76.01 Milliliter Standard Deviation 71.370	37.32 Milliliter Standard Deviation 78.467
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 6	66.35 Milliliter Standard Deviation 76.721	54.67 Milliliter Standard Deviation 68.852
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 12	77.25 Milliliter Standard Deviation 68.182	51.28 Milliliter Standard Deviation 76.675
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 18	60.33 Milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-10.38 Milliliter Standard Deviation 60.659
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 24	57.00 Milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	78.17 Milliliter Standard Deviation 96.434
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 30	—	65.55 Milliliter Standard Deviation 196.119
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition Week 36	—	-42.23 Milliliter Standard Deviation 114.691

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition Week 2	71.52 Milliliter Standard Deviation 51.555	-17.78 Milliliter Standard Deviation 114.257
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition Week 0	68.62 Milliliter Standard Deviation 58.163	-3.56 Milliliter Standard Deviation 78.698
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition Week 6	59.27 Milliliter Standard Deviation 85.777	-1.29 Milliliter Standard Deviation 116.143
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition Week 12	79.73 Milliliter Standard Deviation 26.835	-0.96 Milliliter Standard Deviation 77.369
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition Week 18	49.03 Milliliter Standard Deviation 21.572	-0.72 Milliliter Standard Deviation 3.020

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 2	45.29 Percent change Standard Deviation 38.910	4.14 Percent change Standard Deviation 28.531
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 6	76.99 Percent change Standard Deviation 58.964	10.88 Percent change Standard Deviation 53.306
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 12	53.75 Percent change Standard Deviation 53.789	12.56 Percent change Standard Deviation 49.011
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 18	71.03 Percent change Standard Deviation 66.792	39.79 Percent change Standard Deviation 36.933
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 24	68.36 Percent change Standard Deviation 54.836	40.43 Percent change Standard Deviation 55.177
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 30	58.16 Percent change Standard Deviation 51.203	125.17 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 36	61.77 Percent change Standard Deviation 46.781	—
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 42	64.19 Percent change Standard Deviation 34.387	—
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 48	50.60 Percent change Standard Deviation 24.805	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 2	48.31 Percent change Standard Deviation 37.054	25.73 Percent change Standard Deviation 51.374
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 18	42.19 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-0.52 Percent change Standard Deviation 25.276
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 0	13.97 Percent change Standard Deviation 26.244	13.72 Percent change Standard Deviation 54.613
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 6	42.20 Percent change Standard Deviation 50.162	37.32 Percent change Standard Deviation 36.603
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 12	49.41 Percent change Standard Deviation 50.110	30.25 Percent change Standard Deviation 41.977
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 24	39.86 Percent change Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	60.12 Percent change Standard Deviation 78.234
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 30	—	68.58 Percent change Standard Deviation 141.433
Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 36	—	-6.52 Percent change Standard Deviation 52.333

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 0	35.49 Percent change Standard Deviation 21.018	1.72 Percent change Standard Deviation 36.379
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 2	43.15 Percent change Standard Deviation 37.740	-3.15 Percent change Standard Deviation 50.796
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 6	27.90 Percent change Standard Deviation 39.969	3.41 Percent change Standard Deviation 53.078
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 12	46.12 Percent change Standard Deviation 7.004	3.29 Percent change Standard Deviation 33.790
Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition Week 18	30.61 Percent change Standard Deviation 23.706	-0.27 Percent change Standard Deviation 1.970

SECONDARY outcome

Timeframe: 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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
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 Week 42; >=75%	80 Percentage of participants	—
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 Week 48; >=50%	80 Percentage of participants	—
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 Week 2, 100%	18 Percentage of participants	0 Percentage of participants
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 Week 2, >=75%	36 Percentage of participants	0 Percentage of participants
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 Week 2, >=50%	73 Percentage of participants	40 Percentage of participants
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 Week 6, 100%	36 Percentage of participants	0 Percentage of participants
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 Week 6, >=75%	64 Percentage of participants	20 Percentage of participants
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 Week 6, >=50%	91 Percentage of participants	30 Percentage of participants
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 Week 12, 100%	27 Percentage of participants	0 Percentage of participants
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 Week 12, >=75%	64 Percentage of participants	0 Percentage of participants
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 Week 12, >=50%	73 Percentage of participants	20 Percentage of participants
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 Week 18, 100%	38 Percentage of participants	0 Percentage of participants
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 Week 18, >=75%	63 Percentage of participants	0 Percentage of participants
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 Week 18, >=50%	88 Percentage of participants	50 Percentage of participants
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 Week 24, 100%	38 Percentage of participants	0 Percentage of participants
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 Week 24 >=75%	88 Percentage of participants	0 Percentage of participants
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 Week 24 >=50%	100 Percentage of participants	50 Percentage of participants
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 Week 30; 100%	13 Percentage of participants	0 Percentage of participants
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 Week 30; >=75%	75 Percentage of participants	0 Percentage of participants
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 Week 30; >=50%	88 Percentage of participants	0 Percentage of participants
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 Week 36; 100%	50 Percentage of participants	—
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 Week 36; >=75%	67 Percentage of participants	—
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 Week 36; >=50%	83 Percentage of participants	—
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 Week 42; 100%	40 Percentage of participants	—
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 Week 42; >=50%	80 Percentage of participants	—
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 Week 48; 100%	20 Percentage of participants	—
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 Week 48; >=75%	80 Percentage of participants	—

SECONDARY outcome

Timeframe: 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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (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 Week 2, >=75%	33 Percentage of participants	60 Percentage of participants
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 Week 2, >=50%	50 Percentage of participants	80 Percentage of participants
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 Week 6, >=75%	33 Percentage of participants	60 Percentage of participants
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 Week 12, 100%	17 Percentage of participants	33 Percentage of participants
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 Week 12, >=50%	50 Percentage of participants	67 Percentage of participants
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 Week 18, >=75%	0 Percentage of participants	40 Percentage of participants
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 Week 18, >=50%	0 Percentage of participants	60 Percentage of participants
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 Week 24, 100%	0 Percentage of participants	40 Percentage of participants
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 Week 24 >=75%	0 Percentage of participants	60 Percentage of participants
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 Week 24 >=50%	0 Percentage of participants	80 Percentage of participants
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 Week 30; 100%	—	0 Percentage of participants
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 Week 30; >=75%	—	33 Percentage of participants
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 Week 30; >=50%	—	67 Percentage of participants
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 Week 36; 100%	—	0 Percentage of participants
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 Week 36; >=75%	—	0 Percentage of participants
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 Week 0, >=50%	33 Percentage of participants	20 Percentage of participants
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 Week 0, 100%	0 Percentage of participants	0 Percentage of participants
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 Week 0, >=75%	17 Percentage of participants	0 Percentage of participants
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 Week 2, 100%	33 Percentage of participants	20 Percentage of participants
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 Week 6, 100%	33 Percentage of participants	40 Percentage of participants
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 Week 6, >=50%	67 Percentage of participants	80 Percentage of participants
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 Week 12, >=75%	33 Percentage of participants	44 Percentage of participants
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 Week 18, 100%	0 Percentage of participants	0 Percentage of participants
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 Week 36; >=50%	—	50 Percentage of participants

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
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 Week 0, >=75%	0 Percentage of participants	0 Percentage of participants
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 Week 2, 100%	0 Percentage of participants	20 Percentage of participants
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 Week 2, >=75%	0 Percentage of participants	80 Percentage of participants
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 Week 2, >=50%	33 Percentage of participants	80 Percentage of participants
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 Week 6, 100%	33 Percentage of participants	40 Percentage of participants
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 Week 6, >=75%	33 Percentage of participants	80 Percentage of participants
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 Week 6, >=50%	33 Percentage of participants	80 Percentage of participants
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 Week 12, 100%	33 Percentage of participants	20 Percentage of participants
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 Week 12, >=75%	33 Percentage of participants	20 Percentage of participants
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 Week 12, >=50%	33 Percentage of participants	40 Percentage of participants
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 Week 0, 100%	0 Percentage of participants	0 Percentage of participants
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 Week 0, >=50%	0 Percentage of participants	60 Percentage of participants
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 Week 18, 100%	0 Percentage of participants	0 Percentage of participants
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 Week 18, >=75%	0 Percentage of participants	0 Percentage of participants
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 Week 18, >=50%	50 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 Weeks in Treatment Cycle 1

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment	246.0 Days Interval 84.0 to The data and very small number of participants did not allow calculation of the upper limit of 95% Confidence Interval.	85.0 Days Interval 79.0 to 91.0

SECONDARY outcome

Timeframe: Up to 36 Weeks in Treatment Cycle 1

Population: FAS1 Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment	246.0 Days Interval 84.0 to The data and very small number of participants did not allow calculation of the upper limit of 95% Confidence Interval.	84.5 Days Interval 79.0 to 86.0

SECONDARY outcome

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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score General Health Perception, Week 12	9.1 Scores on a scale Standard Deviation 12.61	2.5 Scores on a scale Standard Deviation 18.45
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Incontinence impact, Week 48	-26.67 Scores on a scale Standard Deviation 36.515	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Role Limitations, Week 6	-12.12 Scores on a scale Standard Deviation 27.979	-21.67 Scores on a scale Standard Deviation 20.861
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Role Limitations, Week 36	-27.78 Scores on a scale Standard Deviation 25.092	-33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Physical Limitations, Week 12	-15.15 Scores on a scale Standard Deviation 37.605	-20.00 Scores on a scale Standard Deviation 24.595
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Social Limitations, Week 6	-7.07 Scores on a scale Standard Deviation 47.212	-16.67 Scores on a scale Standard Deviation 22.981
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score General Health perception, Week 6	6.8 Scores on a scale Standard Deviation 25.23	12.5 Scores on a scale Standard Deviation 13.18
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score General Health Perception, Week 24	0.0 Scores on a scale Standard Deviation 13.36	12.5 Scores on a scale Standard Deviation 17.68
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score General Health Perception, Week 36	16.7 Scores on a scale Standard Deviation 12.91	25.0 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score General Health Perception, Week 48	15.0 Scores on a scale Standard Deviation 13.69	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Incontinence impact, Week 6	-30.30 Scores on a scale Standard Deviation 43.345	-6.67 Scores on a scale Standard Deviation 21.082
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Incontinence impact, Week 12	-30.30 Scores on a scale Standard Deviation 40.701	-3.33 Scores on a scale Standard Deviation 33.148
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Incontinence impact, Week 24	-29.17 Scores on a scale Standard Deviation 33.034	-16.67 Scores on a scale Standard Deviation 23.570
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Incontinence impact, Week 36	-38.89 Scores on a scale Standard Deviation 38.968	-33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Role Limitations, Week 12	-12.12 Scores on a scale Standard Deviation 27.979	-13.33 Scores on a scale Standard Deviation 29.187
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Role Limitations, Week 24	-25.00 Scores on a scale Standard Deviation 30.861	-16.67 Scores on a scale Standard Deviation 23.570
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Role Limitations, Week 48	-10.00 Scores on a scale Standard Deviation 14.907	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Physical Limitations, Week 6	-4.55 Scores on a scale Standard Deviation 44.778	-20.00 Scores on a scale Standard Deviation 18.922
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Physical Limitations, Week 24	-27.08 Scores on a scale Standard Deviation 34.431	-25.00 Scores on a scale Standard Deviation 58.926
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Physical Limitations, Week 36	-22.22 Scores on a scale Standard Deviation 32.773	-83.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Physical Limitations, Week 48	-6.67 Scores on a scale Standard Deviation 9.129	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Social Limitations, Week 12	-2.02 Scores on a scale Standard Deviation 41.520	-24.44 Scores on a scale Standard Deviation 18.739
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Social Limitations, Week 24	-25.00 Scores on a scale Standard Deviation 43.946	-22.22 Scores on a scale Standard Deviation 15.713
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Social Limitations, Week 36	-11.11 Scores on a scale Standard Deviation 54.433	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Social Limitations, Week 48	-0.00 Scores on a scale Standard Deviation 27.217	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Personal Relationships, Week 6	12.50 Scores on a scale Standard Deviation 38.576	-10.42 Scores on a scale Standard Deviation 21.708
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Personal Relationships, Week 12	-4.17 Scores on a scale Standard Deviation 19.416	4.17 Scores on a scale Standard Deviation 45.207
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Personal Relationships, Week 24	2.38 Scores on a scale Standard Deviation 17.817	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Personal Relationships, Week 36	6.67 Scores on a scale Standard Deviation 14.907	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Personal Relationships, Week 48	8.33 Scores on a scale Standard Deviation 28.868	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Emotions, Week 6	-9.09 Scores on a scale Standard Deviation 22.672	3.33 Scores on a scale Standard Deviation 27.242
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Emotions, Week 12	-8.08 Scores on a scale Standard Deviation 24.890	-3.33 Scores on a scale Standard Deviation 24.595
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Emotions, Week 24	-19.44 Scores on a scale Standard Deviation 23.570	0.00 Scores on a scale Standard Deviation 31.427
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Emotions, Week 36	-16.67 Scores on a scale Standard Deviation 29.606	11.11 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Emotions, Week 48	-17.78 Scores on a scale Standard Deviation 18.592	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Sleep/energy, Week 6	-7.58 Scores on a scale Standard Deviation 36.027	-10.00 Scores on a scale Standard Deviation 23.831
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Sleep/energy, Week 12	-9.09 Scores on a scale Standard Deviation 35.248	-11.67 Scores on a scale Standard Deviation 20.861
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Sleep/energy, Week 24	-18.75 Scores on a scale Standard Deviation 35.003	8.33 Scores on a scale Standard Deviation 11.785
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Sleep/energy, Week 36	-16.67 Scores on a scale Standard Deviation 27.889	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Sleep/energy, Week 48	-0.00 Scores on a scale Standard Deviation 23.570	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Severity/Coping measures, Week 6	-10.30 Scores on a scale Standard Deviation 20.519	-9.33 Scores on a scale Standard Deviation 8.999
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Severity/Coping measures, Week 12	-14.55 Scores on a scale Standard Deviation 18.355	-14.00 Scores on a scale Standard Deviation 15.854
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Severity/Coping measures, Week 24	-15.83 Scores on a scale Standard Deviation 23.077	-6.67 Scores on a scale Standard Deviation 18.856
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Severity/Coping measures, Week 36	-15.56 Scores on a scale Standard Deviation 17.213	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score Severity/Coping measures, Week 48	-6.67 Scores on a scale Standard Deviation 13.333	—

SECONDARY outcome

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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score General Health perception, Week 0	12.5 Scores on a scale Standard Deviation 20.92	2.5 Scores on a scale Standard Deviation 18.45
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score General Health perception, Week 6	4.2 Scores on a scale Standard Deviation 18.82	5.0 Scores on a scale Standard Deviation 15.81
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score General Health Perception, Week 12	12.5 Scores on a scale Standard Deviation 34.46	5.6 Scores on a scale Standard Deviation 20.83
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score General Health Perception, Week 24	-25.0 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	10.0 Scores on a scale Standard Deviation 13.69
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score General Health Perception, Week 36	—	8.3 Scores on a scale Standard Deviation 14.43
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 0	-16.67 Scores on a scale Standard Deviation 34.960	-6.67 Scores on a scale Standard Deviation 34.427
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 6	-33.33 Scores on a scale Standard Deviation 47.140	-26.67 Scores on a scale Standard Deviation 40.976
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 12	-33.33 Scores on a scale Standard Deviation 47.140	-25.93 Scores on a scale Standard Deviation 27.778
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 24	-33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-33.33 Scores on a scale Standard Deviation 40.825
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 36	—	-33.33 Scores on a scale Standard Deviation 33.333
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Role Limitations; Week 0	2.78 Scores on a scale Standard Deviation 35.616	-13.33 Scores on a scale Standard Deviation 29.187
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Role Limitations; Week 6	-5.56 Scores on a scale Standard Deviation 37.515	-36.67 Scores on a scale Standard Deviation 36.683
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Role Limitations; Week 12	0.00 Scores on a scale Standard Deviation 38.006	-37.04 Scores on a scale Standard Deviation 40.635
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Role Limitations; Week 24	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-43.33 Scores on a scale Standard Deviation 34.561
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Role Limitations; Week 36	—	-27.78 Scores on a scale Standard Deviation 25.459
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 0	2.78 Scores on a scale Standard Deviation 41.388	-21.67 Scores on a scale Standard Deviation 28.382
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 6	0.00 Scores on a scale Standard Deviation 55.777	-38.33 Scores on a scale Standard Deviation 29.450
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 12	-5.56 Scores on a scale Standard Deviation 51.280	-40.74 Scores on a scale Standard Deviation 36.430
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 24	16.67 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-26.67 Scores on a scale Standard Deviation 30.277
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 36	—	-38.89 Scores on a scale Standard Deviation 25.459
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Social Limitations; Week 0	3.70 Scores on a scale Standard Deviation 58.654	-21.11 Scores on a scale Standard Deviation 19.209
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Social Limitations; Week 6	-2.78 Scores on a scale Standard Deviation 57.922	-35.56 Scores on a scale Standard Deviation 35.058
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Social Limitations; Week 12	-8.33 Scores on a scale Standard Deviation 57.494	-44.44 Scores on a scale Standard Deviation 24.845
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Social Limitations; Week 24	33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-44.44 Scores on a scale Standard Deviation 28.328
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Social Limitations; Week 36	—	-37.04 Scores on a scale Standard Deviation 46.259
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 0	5.56 Scores on a scale Standard Deviation 25.459	4.17 Scores on a scale Standard Deviation 45.207
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 6	27.78 Scores on a scale Standard Deviation 63.099	-20.83 Scores on a scale Standard Deviation 50.198
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 12	22.22 Scores on a scale Standard Deviation 67.358	-14.29 Scores on a scale Standard Deviation 45.571
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 24	66.67 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-16.67 Scores on a scale Standard Deviation 59.317
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 36	—	-22.22 Scores on a scale Standard Deviation 38.490
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Emotions; Week 0	-3.70 Scores on a scale Standard Deviation 25.010	-3.33 Scores on a scale Standard Deviation 22.253
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Emotions; Week 6	-5.56 Scores on a scale Standard Deviation 38.968	-16.67 Scores on a scale Standard Deviation 35.234
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Emotions; Week 12	-7.41 Scores on a scale Standard Deviation 38.915	-9.88 Scores on a scale Standard Deviation 35.765
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Emotions; Week 24	-33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-24.44 Scores on a scale Standard Deviation 39.597
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Emotions; Week 36	—	-3.70 Scores on a scale Standard Deviation 39.021
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 0	-0.00 Scores on a scale Standard Deviation 36.515	-10.00 Scores on a scale Standard Deviation 21.082
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 6	-5.56 Scores on a scale Standard Deviation 29.187	-23.33 Scores on a scale Standard Deviation 21.082
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 12	-16.67 Scores on a scale Standard Deviation 34.960	-16.67 Scores on a scale Standard Deviation 16.667
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 24	-33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-20.00 Scores on a scale Standard Deviation 27.386
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 36	—	0.00 Scores on a scale Standard Deviation 16.667
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 0	-12.22 Scores on a scale Standard Deviation 19.513	-15.33 Scores on a scale Standard Deviation 13.717
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 6	-11.11 Scores on a scale Standard Deviation 22.178	-25.33 Scores on a scale Standard Deviation 23.476
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 12	-11.11 Scores on a scale Standard Deviation 22.965	-25.93 Scores on a scale Standard Deviation 25.483
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 24	-33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-32.00 Scores on a scale Standard Deviation 21.807
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 36	—	-24.44 Scores on a scale Standard Deviation 20.367

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 12	-22.22 Scores on a scale Standard Deviation 19.245	-20.00 Scores on a scale Standard Deviation 29.814
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 24	—	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Role Limitations; Week 0	5.56 Scores on a scale Standard Deviation 9.623	-30.00 Scores on a scale Standard Deviation 29.814
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Role Limitations; Week 6	-5.56 Scores on a scale Standard Deviation 25.459	-50.00 Scores on a scale Standard Deviation 35.355
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Role Limitations; Week 12	5.56 Scores on a scale Standard Deviation 41.944	-33.33 Scores on a scale Standard Deviation 33.333
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Role Limitations; Week 24	—	0.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 0	16.67 Scores on a scale Standard Deviation 0.000	-30.00 Scores on a scale Standard Deviation 21.731
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 6	11.11 Scores on a scale Standard Deviation 9.623	-43.33 Scores on a scale Standard Deviation 32.489
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 12	16.67 Scores on a scale Standard Deviation 33.333	-36.67 Scores on a scale Standard Deviation 27.386
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Physical Limitations; Week 24	—	-16.67 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Social Limitations; Week 0	9.26 Scores on a scale Standard Deviation 25.051	-37.78 Scores on a scale Standard Deviation 23.040
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Social Limitations; Week 6	7.41 Scores on a scale Standard Deviation 39.021	-46.67 Scores on a scale Standard Deviation 24.088
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Social Limitations; Week 12	18.52 Scores on a scale Standard Deviation 51.620	-40.00 Scores on a scale Standard Deviation 21.660
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Social Limitations; Week 24	—	-11.11 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 0	66.67 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-12.50 Scores on a scale Standard Deviation 45.896
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 6	66.67 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-33.33 Scores on a scale Standard Deviation 66.667
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 12	100.00 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-16.67 Scores on a scale Standard Deviation 43.033
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Personal Relationships; Week 24	—	33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Emotions; Week 0	7.41 Scores on a scale Standard Deviation 39.021	-8.89 Scores on a scale Standard Deviation 30.832
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Emotions; Week 6	7.41 Scores on a scale Standard Deviation 16.973	-20.00 Scores on a scale Standard Deviation 30.832
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Emotions; Week 12	7.41 Scores on a scale Standard Deviation 16.973	-15.56 Scores on a scale Standard Deviation 26.759
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Emotions; Week 24	—	22.22 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 0	-5.56 Scores on a scale Standard Deviation 25.459	-16.67 Scores on a scale Standard Deviation 16.667
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 6	-5.56 Scores on a scale Standard Deviation 25.459	-30.00 Scores on a scale Standard Deviation 13.944
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 12	0.00 Scores on a scale Standard Deviation 16.667	-20.00 Scores on a scale Standard Deviation 13.944
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Sleep/Energy; Week 24	—	33.33 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 0	-4.44 Scores on a scale Standard Deviation 26.943	-22.67 Scores on a scale Standard Deviation 12.111
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 6	4.44 Scores on a scale Standard Deviation 16.777	-22.67 Scores on a scale Standard Deviation 13.824
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 12	0.00 Scores on a scale Standard Deviation 11.547	-24.00 Scores on a scale Standard Deviation 12.996
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Severity/Coping Measures; Week 24	—	-26.67 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score General Health perception, Week 0	-16.7 Scores on a scale Standard Deviation 14.43	5.0 Scores on a scale Standard Deviation 20.92
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score General Health perception, Week 6	-8.3 Scores on a scale Standard Deviation 14.43	5.0 Scores on a scale Standard Deviation 20.92
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score General Health Perception, Week 12	-8.3 Scores on a scale Standard Deviation 14.43	10.0 Scores on a scale Standard Deviation 13.69
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score General Health Perception, Week 24	—	25.0 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 0	-33.33 Scores on a scale Standard Deviation 0.000	-20.00 Scores on a scale Standard Deviation 29.814
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score Incontinence Impact; Week 6	-11.11 Scores on a scale Standard Deviation 38.490	-40.00 Scores on a scale Standard Deviation 27.889

SECONDARY outcome

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

Population: FAS1 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS) Week 2	55 Percentage of participants	10 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS) Week 6	91 Percentage of participants	20 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS) Week 12	73 Percentage of participants	30 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS) Week 24	100 Percentage of participants	0 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS) Week 36	100 Percentage of participants	0 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS) Week 48	100 Percentage of participants	—

SECONDARY outcome

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

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS Week 36	—	67 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS Week 0	33 Percentage of participants	30 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS Week 2	67 Percentage of participants	70 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS Week 6	83 Percentage of participants	80 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS Week 12	67 Percentage of participants	67 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS Week 24	100 Percentage of participants	80 Percentage of participants

SECONDARY outcome

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS Week 0	33 Percentage of participants	40 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS Week 2	33 Percentage of participants	100 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS Week 6	67 Percentage of participants	80 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS Week 12	67 Percentage of participants	60 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS Week 24	—	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 48 in Treatment Cycle 1

Population: SPDB Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE SAEs	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE Non-SAEs	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 1

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U SAEs	—	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U Non-SAEs	—	5 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=6 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U Non-SAEs	—	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U SAEs	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo / GSK1358820 200 U SAEs	—	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo / GSK1358820 200 U Non-SAEs	—	4 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=3 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U SAEs	—	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U Non-SAEs	—	3 Participants

SECONDARY outcome

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 2	7.3 Millimeters of mercury Standard Deviation 11.24	0.0 Millimeters of mercury Standard Deviation 16.31
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 6	7.4 Millimeters of mercury Standard Deviation 14.60	1.9 Millimeters of mercury Standard Deviation 11.87
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 12	6.2 Millimeters of mercury Standard Deviation 20.76	1.4 Millimeters of mercury Standard Deviation 13.94
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 24	11.6 Millimeters of mercury Standard Deviation 12.87	-15.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 36	2.7 Millimeters of mercury Standard Deviation 9.71	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 48	7.4 Millimeters of mercury Standard Deviation 16.58	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 2	1.5 Millimeters of mercury Standard Deviation 9.77	-1.8 Millimeters of mercury Standard Deviation 9.15
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 6	4.6 Millimeters of mercury Standard Deviation 9.20	1.7 Millimeters of mercury Standard Deviation 8.78
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 12	1.7 Millimeters of mercury Standard Deviation 12.45	-0.4 Millimeters of mercury Standard Deviation 8.10
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 24	3.3 Millimeters of mercury Standard Deviation 8.80	-9.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 36	3.2 Millimeters of mercury Standard Deviation 5.15	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 48	1.6 Millimeters of mercury Standard Deviation 6.91	—

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP SBP, Week 24	-1.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	3.5 Millimeters of mercury Standard Deviation 15.26
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP DBP, Week 12	5.2 Millimeters of mercury Standard Deviation 7.44	-4.6 Millimeters of mercury Standard Deviation 7.73
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP SBP, Week 0	0.3 Millimeters of mercury Standard Deviation 8.19	3.3 Millimeters of mercury Standard Deviation 9.57
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP SBP, Week 2	8.2 Millimeters of mercury Standard Deviation 8.95	-2.3 Millimeters of mercury Standard Deviation 16.64
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP SBP, Week 6	12.3 Millimeters of mercury Standard Deviation 8.09	2.6 Millimeters of mercury Standard Deviation 12.52
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP SBP, Week 12	6.0 Millimeters of mercury Standard Deviation 2.76	-1.2 Millimeters of mercury Standard Deviation 12.71
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP SBP, Week 48	16.0 Millimeters of mercury Standard Deviation 12.17	-0.2 Millimeters of mercury Standard Deviation 13.85
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP DBP, Week 0	-1.3 Millimeters of mercury Standard Deviation 7.26	-0.4 Millimeters of mercury Standard Deviation 10.70
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP DBP, Week 2	4.3 Millimeters of mercury Standard Deviation 10.61	-3.5 Millimeters of mercury Standard Deviation 12.55
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP DBP, Week 6	4.2 Millimeters of mercury Standard Deviation 10.76	1.0 Millimeters of mercury Standard Deviation 8.25
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP DBP, Week 24	6.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	4.5 Millimeters of mercury Standard Deviation 9.95
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP DBP, Week 48	11.3 Millimeters of mercury Standard Deviation 10.07	3.8 Millimeters of mercury Standard Deviation 10.38

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP SBP, Week 0	14.7 Millimeters of mercury Standard Deviation 8.50	-5.0 Millimeters of mercury Standard Deviation 5.87
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP SBP, Week 2	8.3 Millimeters of mercury Standard Deviation 6.66	2.6 Millimeters of mercury Standard Deviation 13.22
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP SBP, Week 6	5.0 Millimeters of mercury Standard Deviation 6.08	1.8 Millimeters of mercury Standard Deviation 9.55
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP SBP, Week 12	2.5 Millimeters of mercury Standard Deviation 3.54	4.3 Millimeters of mercury Standard Deviation 11.98
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP SBP, Week 48	5.7 Millimeters of mercury Standard Deviation 15.50	6.0 Millimeters of mercury Standard Deviation 3.74
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP DBP, Week 0	1.3 Millimeters of mercury Standard Deviation 3.21	-1.4 Millimeters of mercury Standard Deviation 4.22
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP DBP, Week 2	2.0 Millimeters of mercury Standard Deviation 12.49	-1.0 Millimeters of mercury Standard Deviation 11.25
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP DBP, Week 6	6.3 Millimeters of mercury Standard Deviation 6.66	-0.6 Millimeters of mercury Standard Deviation 8.32
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP DBP, Week 12	3.5 Millimeters of mercury Standard Deviation 0.71	-4.5 Millimeters of mercury Standard Deviation 5.00
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP DBP, Week 48	4.0 Millimeters of mercury Standard Deviation 15.52	-2.4 Millimeters of mercury Standard Deviation 5.86

SECONDARY outcome

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate Week 2	-1.0 Beats per minute Standard Deviation 10.80	-1.3 Beats per minute Standard Deviation 14.28
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate Week 6	4.5 Beats per minute Standard Deviation 15.21	1.7 Beats per minute Standard Deviation 12.64
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate Week 12	3.1 Beats per minute Standard Deviation 6.01	-1.4 Beats per minute Standard Deviation 9.96
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate Week 24	-9.3 Beats per minute Standard Deviation 9.79	-10.0 Beats per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate Week 36	0.2 Beats per minute Standard Deviation 12.86	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate Week 48	-13.0 Beats per minute Standard Deviation 7.48	—

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate Week 0	-3.5 Beats per minute Standard Deviation 13.47	3.7 Beats per minute Standard Deviation 12.57
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate Week 2	0.5 Beats per minute Standard Deviation 13.87	0.1 Beats per minute Standard Deviation 15.21
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate Week 6	2.2 Beats per minute Standard Deviation 11.97	0.7 Beats per minute Standard Deviation 16.75
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate Week 12	-1.8 Beats per minute Standard Deviation 14.86	-2.9 Beats per minute Standard Deviation 16.59
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate Week 24	26.0 Beats per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	-5.3 Beats per minute Standard Deviation 14.86
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate Week 48	1.3 Beats per minute Standard Deviation 1.53	-8.6 Beats per minute Standard Deviation 7.83

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate Week 0	-5.0 Beats per minute Standard Deviation 8.89	8.4 Beats per minute Standard Deviation 12.90
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate Week 2	-3.7 Beats per minute Standard Deviation 23.71	5.4 Beats per minute Standard Deviation 15.71
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate Week 6	-7.0 Beats per minute Standard Deviation 10.54	10.8 Beats per minute Standard Deviation 19.07
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate Week 12	-4.0 Beats per minute Standard Deviation 8.49	8.5 Beats per minute Standard Deviation 10.63
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate Week 48	2.7 Beats per minute Standard Deviation 16.50	13.8 Beats per minute Standard Deviation 12.62

SECONDARY outcome

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature Week 2	-0.06 Degree Celsius Standard Deviation 0.391	0.29 Degree Celsius Standard Deviation 0.438
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature Week 6	-0.15 Degree Celsius Standard Deviation 0.401	0.05 Degree Celsius Standard Deviation 0.375
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature Week 12	0.03 Degree Celsius Standard Deviation 0.535	0.14 Degree Celsius Standard Deviation 0.460
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature Week 24	-0.22 Degree Celsius Standard Deviation 0.471	0.30 Degree Celsius Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature Week 36	-0.25 Degree Celsius Standard Deviation 0.550	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature Week 48	-0.20 Degree Celsius Standard Deviation 0.400	—

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature Week 6	0.03 Degree Celsius Standard Deviation 0.344	0.15 Degree Celsius Standard Deviation 0.387
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature Week 0	-0.23 Degree Celsius Standard Deviation 0.186	0.16 Degree Celsius Standard Deviation 0.440
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature Week 2	-0.07 Degree Celsius Standard Deviation 0.388	0.05 Degree Celsius Standard Deviation 0.536
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature Week 12	0.02 Degree Celsius Standard Deviation 0.264	-0.02 Degree Celsius Standard Deviation 0.315
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature Week 24	0.10 Degree Celsius Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.	0.53 Degree Celsius Standard Deviation 0.629
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature Week 48	-0.10 Degree Celsius Standard Deviation 0.173	0.26 Degree Celsius Standard Deviation 0.559

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature Week 0	-0.03 Degree Celsius Standard Deviation 0.153	0.06 Degree Celsius Standard Deviation 0.114
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature Week 2	0.23 Degree Celsius Standard Deviation 0.577	0.24 Degree Celsius Standard Deviation 0.270
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature Week 6	0.17 Degree Celsius Standard Deviation 0.351	0.20 Degree Celsius Standard Deviation 0.485
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature Week 12	0.10 Degree Celsius Standard Deviation 0.283	0.15 Degree Celsius Standard Deviation 0.370
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature Week 48	0.13 Degree Celsius Standard Deviation 0.666	0.08 Degree Celsius Standard Deviation 0.476

SECONDARY outcome

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Monocytes, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:Monocytes, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:N bands, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:N bands, High	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week48: N bands, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:WBC count, Low	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:T neutro, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Basophils, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Basophils, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Eosinophils, Normal or no change	11 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Eosinophils, High	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Eosinophils, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: Hb,Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Hb, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Hct, Normal or No change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Hct, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:Lympho, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:Lympho, High	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:Lympho, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48:T neutro, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, Low	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, Normal or no change	10 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, High	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:PC, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:RBC count, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:RBC count, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: WBC count, Normal to no change	11 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:WBC count, Normal or no change	5 Participants	—

SECONDARY outcome

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=9 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:Monocytes, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:N bands, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48: N bands, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:T neutro, Normal or no change	6 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:T neutro, High	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48:T neutro, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, Normal or no change	6 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:PC, Normal or No change	3 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:PC, High	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:RBC count, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:RBC count, Normal or No Change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: WBC count, Low	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: WBC count, Normal to no change	5 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: WBC count, High	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:WBC count, Normal to no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Basophils, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Basophils, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Eosinophils, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Eosinophils, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Hb,Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: Hb,Normal or no change	6 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Hb, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Hct, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Hct, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:Lympho, Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:Lympho, Normal or no change	6 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:Lympho, Normal or No change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Monocytes, Normal or no change	6 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Monocytes, High	0 Participants	1 Participants

SECONDARY outcome

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Basophils, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Basophils, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12: Eosinophils, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Eosinophils, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: Hb,Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48: Hb,Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Hb, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Hct, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48: Hct, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:Lympho, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:Lympho, Normal or No change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:Monocytes, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:Monocytes, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 12:N bands, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48: N bands, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:T neutro, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week 48:T neutro, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:PC, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:PC, Normal or No change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:PC, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12:RBC count, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:RBC count, Normal or No Change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:RBC count, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: WBC count, Low	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week12: WBC count, Normal to no change	1 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48: WBC count, Low	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48: WBC count, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters Week48:WBC count, High	0 Participants	1 Participants

SECONDARY outcome

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Albumin, Low	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Albumin, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Albumin, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Alk phosp, Low	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Alk phosp, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Alk phosp, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:ALT, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:ALT, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:AST, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:AST, High	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:AST, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Direct Bil, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Direct Bil, High	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Direct Bil, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Total Bil, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Total Bil, High	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Total Bil, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Calcium, Low	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Calcium, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Calcium, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Chloride, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Chloride, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Creatinine, Low	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Creatinine, Normal or no change	10 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Creatinine, High	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Creatinine, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Glucose, Normal or no change	7 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Glucose, High	4 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Glucose, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Potassium, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Potassium, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Sodium, Normal or no change	11 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Sodium, Normal or no change	5 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:T protein, Low	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:T protein, Normal or no change	10 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:T protein, Low	1 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:T protein, Normal or no change	4 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Urea/BUN, Normal or no change	11 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Urea/BUN, High	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Urea/BUN, Low	1 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Urea/BUN, Normal or no change	4 Participants	—
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Uric acid, Normal or no change	11 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Uric acid, High	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Uric acid, Normal or no change	5 Participants	—

SECONDARY outcome

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=9 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Direct Bil, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12: Albumin, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Albumin, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Alk phosp, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Alk phosp, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Alk phosp, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:ALT, Normal or no change	5 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:ALT, High	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:ALT, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:AST, Normal or no change	5 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:AST, High	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:AST, Normal or no change	2 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:AST, High	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Direct Bil, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Total Bil, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Total Bil, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Calcium, Low	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Calcium, Normal or no change	5 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Calcium, Low	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Calcium, Normal or no change	2 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Chloride, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Chloride, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Creatinine, Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Creatinine, Normal or no change	6 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Creatinine, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Glucose, Normal or no change	4 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Glucose, High	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Glucose, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Glucose, High	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Potassium, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Potassium, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Sodium, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Sodium, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:T protein, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:T protein, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Urea/BUN, Normal or no change	6 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Urea/BUN, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Uric acid, Normal or no change	6 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Uric acid, High	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Uric acid, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Uric acid, High	0 Participants	1 Participants

SECONDARY outcome

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Albumin, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Uric acid, Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Albumin, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Alk phosp, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Alk phosp, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:ALT, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:ALT, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:ALT, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:ALT, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:AST, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:AST, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:AST, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:AST, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Direct Bil, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Direct Bil, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Total Bil, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Total Bil, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Calcium, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Calcium, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Chloride, Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Chloride, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Chloride, Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Chloride, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Creatinine, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Creatinine, Low	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Creatinine, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Glucose, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Glucose, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Glucose, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Glucose, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Potassium, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Potassium, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Sodium, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Sodium, Normal or no change	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:T protein, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:T protein, High	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:T protein, Normal or no change	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:T protein	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Urea/BUN, Normal or no change	2 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Urea/BUN, Low	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Urea/BUN, Normal or no change	2 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 12:Uric acid, Normal or no change	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters Week 48:Uric acid, Normal or no change	3 Participants	5 Participants

SECONDARY outcome

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

Population: SPDB Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 4+	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Any Increase	6 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to Trace	1 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to 1+	4 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 2+	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 3+	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 4+	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Any Increase	2 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to Trace	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 1+	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 2+	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 3+	0 Participants	0 Participants

SECONDARY outcome

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

Population: Safety Population 1

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (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 Occult blood, Any Increase	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to Trace	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to 1+	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 2+	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 3+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 4+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Any Increase	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to Trace	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 1+	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 2+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 3+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 4+	0 Participants	0 Participants

SECONDARY outcome

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

Population: Safety Population 1

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Any Increase	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 4+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to Trace	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Occult blood, Increase to 1+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 2+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Increase to 3+	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 1+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to Trace	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 2+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 3+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Increase to 4+	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis Protein, Any Increase	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 48 in Treatment Cycle 1

Population: SPDB Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Urinary Tract Infection (UTI)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48 after 1st treatment

Population: Safety Population 1

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 200 U	—	3 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=6 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U	—	1 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 200 U	—	2 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=3 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U	—	2 Participants

SECONDARY outcome

Timeframe: 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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=3 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume Week 2	166.50 Milliliter Standard Deviation 244.340	6.25 Milliliter Standard Deviation 8.839
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume Week 6	87.00 Milliliter Standard Deviation 175.997	25.33 Milliliter Standard Deviation 22.143
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume Week 12	177.03 Milliliter Standard Deviation 245.670	-30.73 Milliliter Standard Deviation 47.963
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume Week 24	208.85 Milliliter Standard Deviation 45.891	24.00 Milliliter Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume Week 36	206.65 Milliliter Standard Deviation 196.081	—
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume Week 48	207.10 Milliliter Standard Deviation 231.648	—

SECONDARY outcome

Timeframe: 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

Population: Safety Population 1. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=2 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Week 2	—	46.5 Milliliter Interval 0.0 to 93.0
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Week 6	—	42 Milliliter Interval 0.0 to 84.0
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Week 12	—	1 Milliliter Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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

Population: Safety Population 2. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=1 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 2	—	-129.8 Milliliter
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 6	—	-129.8 Milliliter
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 12	—	-144.8 Milliliter

SECONDARY outcome

Timeframe: 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

Population: Safety Population 2. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=1 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Participant 1: Week 2	—	47 Milliliter
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Participant 1: Week 6	—	84 Milliliter
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Participant 1: Week 12	—	0 Milliliter
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U Participant 1: Week 48	—	0 Milliliter

SECONDARY outcome

Timeframe: 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

Population: Safety Population 3. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=1 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 2	—	-129.8 Milliliter
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 6	—	-134.8 Milliliter
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 12	—	-12.5 Milliliter
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U Participant 1: Week 48	—	-90.8 Milliliter

SECONDARY outcome

Timeframe: Up to Week 48 in Treatment Cycle 1

Population: SPDB Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 1

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=6 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=3 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48 in Treatment Cycle 1

Population: SPDB Population

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 1

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (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	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=6 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=3 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U	—	0 Participants

SECONDARY outcome

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=11 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=10 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
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 Baseline: A-NCS	0 Participants	1 Participants
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 Baseline: A-CS	0 Participants	0 Participants
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 Week 12: A-NCS	1 Participants	1 Participants
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 Week 12: ACS	0 Participants	0 Participants
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 Week 48: A-NCS	1 Participants	—
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 Week 48: A-CS	0 Participants	—

SECONDARY outcome

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=9 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings Week 12: A-NCS	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings Week 12: A-CS	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings Week 48: A-NCS	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings Week 48: A-CS	0 Participants	0 Participants

SECONDARY outcome

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=3 Participants Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 1: Placebo n=5 Participants Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings Week 12: A-NCS	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings Week 12: A-CS	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings Week 48: A-NCS	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings Week 48: A-CS	0 Participants	0 Participants

Adverse Events

Treatment Cycle 1: Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment Cycle 1: GSK1358820 200U

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment Cycle 2: Placebo / GSK1358820 200 U

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment Cycle 3: Placebo / GSK1358820 200 U

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Cycle 1: Placebo n=10 participants at risk Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 200U n=11 participants at risk Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 2: Placebo / GSK1358820 200 U n=10 participants at risk Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 participants at risk Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 3: Placebo / GSK1358820 200 U n=5 participants at risk Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U n=3 participants at risk Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
Gastrointestinal disorders Ileus	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Infections and infestations Appendicitis	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .

Other adverse events

Other adverse events
Measure	Treatment Cycle 1: Placebo n=10 participants at risk Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 200U n=11 participants at risk Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 2: Placebo / GSK1358820 200 U n=10 participants at risk Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U n=6 participants at risk Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 3: Placebo / GSK1358820 200 U n=5 participants at risk Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U n=3 participants at risk Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3).
Skin and subcutaneous tissue disorders Decubitus ulcer	20.0% 2/10 • Number of events 4 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	40.0% 2/5 • Number of events 2 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Skin and subcutaneous tissue disorders Eczema	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	18.2% 2/11 • Number of events 2 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Skin and subcutaneous tissue disorders Nail disorder	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Skin and subcutaneous tissue disorders Urticaria	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Infections and infestations Urinary tract infection	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	18.2% 2/11 • Number of events 3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	30.0% 3/10 • Number of events 5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	40.0% 2/5 • Number of events 2 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	66.7% 2/3 • Number of events 2 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Infections and infestations Influenza	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Infections and infestations Nasopharyngitis	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Renal and urinary disorders Urinary retention	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Gastrointestinal disorders Tooth loss	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Injury, poisoning and procedural complications Autonomic dysreflexia	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Injury, poisoning and procedural complications Skin abrasion	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Cardiac disorders Cardiac failure	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
General disorders Pyrexia	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	33.3% 1/3 • Number of events 2 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Nervous system disorders Dizziness	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Nervous system disorders Headache	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Renal and urinary disorders Haematuria	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	33.3% 1/3 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Eye disorders Retinal tear	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	9.1% 1/11 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Psychiatric disorders Delirium	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Infections and infestations Epididymitis	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Infections and infestations Nasal herpes	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Injury, poisoning and procedural complications Thermal burn	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Renal and urinary disorders Urethral polyp	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
General disorders Muscle spasticity	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	10.0% 1/10 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Investigations Alanine aminotransferase increased	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Investigations Occult blood	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Renal and urinary disorders Urethral stenosis	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	20.0% 1/5 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/6 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	20.0% 1/5 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Endocrine disorders Thyroiditis subacute	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Gastrointestinal disorders Large intestine polyp	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/11 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/10 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	16.7% 1/6 • Number of events 1 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/5 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .	0.00% 0/3 • SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER