Trial Outcomes & Findings for Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder (NCT NCT02820844)

Results Overview

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

250 participants

Primary outcome timeframe

Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1

Results posted on

2020-11-27

Participant Flow

This study evaluated the efficacy and safety of GSK1358820 (botulinum toxin type A) in participants with overactive bladder. This was a multicenter study conducted in Japan.

A total 354 participants were screened, of which, 104 failed screening and 250 were randomized. Of the 250 randomized, 248 received GSK1358820 100 units (U) or placebo. One participant did not receive treatment due to defective investigational product vial and the other participant was met with protocol exclusion criteria before dosing.

Participant milestones

Participant milestones
Measure	Treatment Cycle 1: Placebo Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in the open-label Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 3: Placebo / GSK1358820 100 U Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
Double-blinded (Up to 48 Weeks) STARTED	124	124	0	0	0	0
Double-blinded (Up to 48 Weeks) COMPLETED	119	115	0	0	0	0
Double-blinded (Up to 48 Weeks) NOT COMPLETED	5	9	0	0	0	0
Open-label(2nd Treatment-Up to 48 Weeks) STARTED	0	0	108	88	0	0
Open-label(2nd Treatment-Up to 48 Weeks) COMPLETED	0	0	99	84	0	0
Open-label(2nd Treatment-Up to 48 Weeks) NOT COMPLETED	0	0	9	4	0	0
Open-label(3rd Treatment-Up to 48 Weeks) STARTED	0	0	0	0	56	43
Open-label(3rd Treatment-Up to 48 Weeks) COMPLETED	0	0	0	0	54	42
Open-label(3rd Treatment-Up to 48 Weeks) NOT COMPLETED	0	0	0	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Cycle 1: Placebo Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in the open-label Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 3: Placebo / GSK1358820 100 U Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).
Double-blinded (Up to 48 Weeks) Withdrawal by Subject	1	3	0	0	0	0
Double-blinded (Up to 48 Weeks) Reached stopping criteria	1	2	0	0	0	0
Double-blinded (Up to 48 Weeks) Protocol Violation	0	3	0	0	0	0
Double-blinded (Up to 48 Weeks) Adverse Event	2	1	0	0	0	0
Double-blinded (Up to 48 Weeks) Investigator discretion	1	0	0	0	0	0
Open-label(2nd Treatment-Up to 48 Weeks) Adverse Event	0	0	1	2	0	0
Open-label(2nd Treatment-Up to 48 Weeks) Investigator discretion	0	0	1	0	0	0
Open-label(2nd Treatment-Up to 48 Weeks) Withdrawal by Subject	0	0	7	2	0	0
Open-label(3rd Treatment-Up to 48 Weeks) Reached stopping criteria	0	0	0	0	2	0
Open-label(3rd Treatment-Up to 48 Weeks) Withdrawal by Subject	0	0	0	0	0	1

Baseline Characteristics

Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 milliliter \[mL\] each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1. Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment could receive re-treatment with GSK1358820 100 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 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1. Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment could receive re-treatment with GSK1358820 100 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=248 Participants Total of all reporting groups
Age, Continuous	66.2 Years STANDARD_DEVIATION 12.19 • n=5 Participants	65.6 Years STANDARD_DEVIATION 12.43 • n=7 Participants	65.9 Years STANDARD_DEVIATION 12.29 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	92 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	124 Participants n=5 Participants	124 Participants n=7 Participants	248 Participants n=5 Participants

PRIMARY outcome

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

Population: Full Analysis Set 1(FAS1) Population comprised of all randomized participants who had at least 1 post-Baseline efficacy assessment. Only those participants with data available at specified time point were analyzed.

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=122 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=122 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 12 After the First Treatment	-1.25 Episodes Standard Error 0.375	-3.42 Episodes Standard Error 0.381

SECONDARY outcome

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

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

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=122 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=122 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Average Volume Voided Per Micturition at Week 12 After the First Treatment	-0.22 Milliliter Standard Error 4.329	29.47 Milliliter Standard Error 4.390

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 2; n=124, 123	-0.84 Episodes Standard Deviation 2.883	-3.24 Episodes Standard Deviation 4.355
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 6; n=124, 120	-0.83 Episodes Standard Deviation 3.022	-3.62 Episodes Standard Deviation 4.447
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 12; n=122, 122	-0.92 Episodes Standard Deviation 3.402	-3.41 Episodes Standard Deviation 4.394
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 18; n=23, 64	-1.22 Episodes Standard Deviation 3.422	-4.07 Episodes Standard Deviation 3.477
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 24; n=17, 52	-2.51 Episodes Standard Deviation 1.704	-3.88 Episodes Standard Deviation 3.516
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 30; n=14, 46	-2.52 Episodes Standard Deviation 1.920	-3.05 Episodes Standard Deviation 3.826
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 36; n=12, 32	-2.03 Episodes Standard Deviation 2.153	-3.27 Episodes Standard Deviation 2.508
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 42; n=11, 27	-2.03 Episodes Standard Deviation 2.079	-3.42 Episodes Standard Deviation 3.022
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 48; n=11, 27	-1.73 Episodes Standard Deviation 2.732	-3.07 Episodes Standard Deviation 3.037

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS2 Population comprised all randomized participants who had at least 1 post-2nd treatment efficacy assessment after 2nd treatment.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 0; n=108,88	-0.54 Episodes Standard Deviation 3.645	-2.86 Episodes Standard Deviation 4.091
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 2; n=105,87	-4.34 Episodes Standard Deviation 3.880	-4.61 Episodes Standard Deviation 3.610
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 6; n=106,84	-3.92 Episodes Standard Deviation 3.760	-4.44 Episodes Standard Deviation 3.860
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 12; n=106,85	-3.77 Episodes Standard Deviation 3.776	-4.49 Episodes Standard Deviation 4.123
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 18; n=83,46	-3.75 Episodes Standard Deviation 3.639	-4.21 Episodes Standard Deviation 3.776
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 24; n=45,21	-3.93 Episodes Standard Deviation 4.202	-5.22 Episodes Standard Deviation 3.370
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 30; n=36,15	-3.91 Episodes Standard Deviation 4.366	-4.58 Episodes Standard Deviation 3.967
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 36; n=20,6	-4.63 Episodes Standard Deviation 4.142	-2.78 Episodes Standard Deviation 3.060

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS3 Population comprised of all randomized participants who had at least 1 post-3rd treatment efficacy assessment after 3rd treatment.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 0; n=56,43	-2.99 Episodes Standard Deviation 3.476	-3.92 Episodes Standard Deviation 4.376
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 2; n=55,43	-3.53 Episodes Standard Deviation 4.370	-4.57 Episodes Standard Deviation 4.684
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 6; n=53,42	-3.43 Episodes Standard Deviation 3.952	-5.10 Episodes Standard Deviation 4.689
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 12; n=53,41	-3.50 Episodes Standard Deviation 3.664	-4.60 Episodes Standard Deviation 4.504
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 18; n=22,29	-3.09 Episodes Standard Deviation 4.306	-3.80 Episodes Standard Deviation 5.103
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 24; n=2,4	-2.00 Episodes Standard Deviation 1.886	-0.83 Episodes Standard Deviation 1.232

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 2; n=124, 123	-12.68 Percent change Standard Deviation 45.315	-33.38 Percent change Standard Deviation 202.484
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 6; n=124, 120	-7.97 Percent change Standard Deviation 74.450	-38.84 Percent change Standard Deviation 201.345
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 12; n=122, 122	-8.82 Percent change Standard Deviation 61.933	-38.27 Percent change Standard Deviation 146.283
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 18; n=23, 64	-13.19 Percent change Standard Deviation 140.232	-64.41 Percent change Standard Deviation 37.980
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 24; n=17, 52	-58.96 Percent change Standard Deviation 46.668	-69.46 Percent change Standard Deviation 38.644
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 30; n=14, 46	-64.58 Percent change Standard Deviation 47.877	-47.52 Percent change Standard Deviation 60.743
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 36; n=12, 32	-61.62 Percent change Standard Deviation 44.722	-62.82 Percent change Standard Deviation 39.971
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 42; n=11, 27	-48.59 Percent change Standard Deviation 62.571	-63.46 Percent change Standard Deviation 46.638
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 48; n=11, 27	-34.51 Percent change Standard Deviation 91.409	-63.06 Percent change Standard Deviation 36.960

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 0; n=108,88	6.68 Percent change Standard Deviation 82.009	-29.45 Percent change Standard Deviation 51.218
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 2; n=105,87	-67.19 Percent change Standard Deviation 45.799	-65.02 Percent change Standard Deviation 34.778
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 6; n=106,84	-65.64 Percent change Standard Deviation 42.063	-61.88 Percent change Standard Deviation 43.428
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 12; n=106,85	-62.41 Percent change Standard Deviation 45.304	-57.43 Percent change Standard Deviation 45.561
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 18; n=83,46	-58.48 Percent change Standard Deviation 38.500	-59.90 Percent change Standard Deviation 47.789
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 24; n=45,21	-62.54 Percent change Standard Deviation 53.503	-79.20 Percent change Standard Deviation 24.398
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 36; n=20,6	-71.28 Percent change Standard Deviation 33.179	-65.09 Percent change Standard Deviation 42.285
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 30; n=36,15	-62.58 Percent change Standard Deviation 46.592	-72.34 Percent change Standard Deviation 29.508

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 6; n=53,42	-52.66 Percent change Standard Deviation 54.383	-60.40 Percent change Standard Deviation 35.855
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 12; n=53,41	-53.49 Percent change Standard Deviation 43.246	-54.62 Percent change Standard Deviation 33.369
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 18; n=22,29	-39.80 Percent change Standard Deviation 45.118	-44.10 Percent change Standard Deviation 43.035
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 24; n=2,4	-16.85 Percent change Standard Deviation 14.397	-29.06 Percent change Standard Deviation 37.514
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 0; n=56,43	-37.29 Percent change Standard Deviation 46.169	-41.20 Percent change Standard Deviation 30.656
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes Week 2; n=55,43	-48.51 Percent change Standard Deviation 63.535	-54.46 Percent change Standard Deviation 44.164

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Urinary Urgency Incontinence Episodes Week 2; n=124, 123	-0.64 Episodes Standard Deviation 2.709	-3.17 Episodes Standard Deviation 4.182
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 6; n=124, 120	-0.66 Episodes Standard Deviation 2.939	-3.44 Episodes Standard Deviation 4.274
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 12; n=122, 122	-0.69 Episodes Standard Deviation 3.228	-3.12 Episodes Standard Deviation 4.301
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 30; n=14, 46	-2.50 Episodes Standard Deviation 1.903	-2.99 Episodes Standard Deviation 3.659
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 36; n=12, 32	-2.28 Episodes Standard Deviation 1.650	-3.09 Episodes Standard Deviation 2.398
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 42; n=11, 27	-2.36 Episodes Standard Deviation 1.900	-3.42 Episodes Standard Deviation 2.951
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 48; n=11, 27	-2.27 Episodes Standard Deviation 1.965	-3.05 Episodes Standard Deviation 2.885
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 18; n=23, 64	-1.43 Episodes Standard Deviation 2.587	-3.78 Episodes Standard Deviation 3.272
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 24; n=17, 52	-2.43 Episodes Standard Deviation 1.686	-3.65 Episodes Standard Deviation 3.220

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Urinary Urgency Incontinence Episodes Week 0; n=108,88	-0.36 Episodes Standard Deviation 3.326	-2.65 Episodes Standard Deviation 4.075
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 2; n=105,87	-4.01 Episodes Standard Deviation 3.529	-4.41 Episodes Standard Deviation 3.560
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 6; n=106,84	-3.67 Episodes Standard Deviation 3.301	-4.21 Episodes Standard Deviation 3.733
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 12; n=106,85	-3.46 Episodes Standard Deviation 3.556	-4.24 Episodes Standard Deviation 4.094
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 18; n=83,46	-3.45 Episodes Standard Deviation 3.238	-3.88 Episodes Standard Deviation 3.640
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 24; n=45,21	-3.59 Episodes Standard Deviation 3.720	-4.84 Episodes Standard Deviation 3.359
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 30; n=36,15	-3.65 Episodes Standard Deviation 3.728	-4.56 Episodes Standard Deviation 3.945
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 36; n=20,6	-4.37 Episodes Standard Deviation 3.169	-2.78 Episodes Standard Deviation 3.060

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Urinary Urgency Incontinence Episodes Week 0; n=56,43	-2.69 Episodes Standard Deviation 3.554	-3.68 Episodes Standard Deviation 4.521
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 2; n=55,43	-3.38 Episodes Standard Deviation 4.221	-4.37 Episodes Standard Deviation 4.823
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 6; n=53,42	-3.31 Episodes Standard Deviation 3.592	-4.74 Episodes Standard Deviation 4.946
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 12; n=53,41	-3.31 Episodes Standard Deviation 3.567	-4.53 Episodes Standard Deviation 4.624
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 18; n=22,29	-2.67 Episodes Standard Deviation 4.505	-3.59 Episodes Standard Deviation 5.137
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 24; n=2,4	-2.17 Episodes Standard Deviation 1.650	-1.33 Episodes Standard Deviation 0.609

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 42; n=11, 27	-57.05 Percent change Standard Deviation 59.914	-72.13 Percent change Standard Deviation 45.202
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 2; n=124, 123	-12.65 Percent change Standard Deviation 47.510	-34.86 Percent change Standard Deviation 202.832
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 6; n=124, 120	-7.81 Percent change Standard Deviation 75.815	-40.56 Percent change Standard Deviation 193.346
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 12; n=122, 122	-5.35 Percent change Standard Deviation 67.599	-36.86 Percent change Standard Deviation 143.314
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 18; n=23, 64	-30.32 Percent change Standard Deviation 71.194	-66.24 Percent change Standard Deviation 37.732
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 24; n=17, 52	-60.58 Percent change Standard Deviation 47.367	-72.58 Percent change Standard Deviation 36.701
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 30; n=14, 46	-67.17 Percent change Standard Deviation 48.289	-50.68 Percent change Standard Deviation 60.176
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 36; n=12, 32	-66.48 Percent change Standard Deviation 33.584	-64.98 Percent change Standard Deviation 41.020
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 48; n=11, 27	-58.83 Percent change Standard Deviation 69.302	-69.56 Percent change Standard Deviation 35.673

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 0; n=108,88	7.31 Percent change Standard Deviation 67.536	-27.01 Percent change Standard Deviation 57.513
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 2; n=105,87	-64.76 Percent change Standard Deviation 61.700	-66.40 Percent change Standard Deviation 35.804
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 6; n=106,84	-66.00 Percent change Standard Deviation 42.442	-61.50 Percent change Standard Deviation 43.730
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 12; n=106,85	-61.39 Percent change Standard Deviation 49.370	-55.11 Percent change Standard Deviation 50.258
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 18; n=83,46	-57.93 Percent change Standard Deviation 39.299	-59.27 Percent change Standard Deviation 48.577
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 24; n=45,21	-59.10 Percent change Standard Deviation 72.369	-79.37 Percent change Standard Deviation 24.927
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 30; n=36,15	-63.64 Percent change Standard Deviation 51.577	-72.34 Percent change Standard Deviation 29.508
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 36; n=20,6	-74.12 Percent change Standard Deviation 32.549	-65.09 Percent change Standard Deviation 42.285

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 0; n=56,43	-35.51 Percent change Standard Deviation 47.233	-35.41 Percent change Standard Deviation 40.461
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 2; n=55,43	-49.97 Percent change Standard Deviation 61.305	-53.60 Percent change Standard Deviation 53.462
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 6; n=53,42	-54.12 Percent change Standard Deviation 48.948	-53.99 Percent change Standard Deviation 48.401
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 12; n=53,41	-54.34 Percent change Standard Deviation 44.946	-55.10 Percent change Standard Deviation 36.963
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 18; n=22,29	-37.88 Percent change Standard Deviation 49.474	-44.81 Percent change Standard Deviation 45.494
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes Week 24; n=2,4	-18.69 Percent change Standard Deviation 11.796	-34.56 Percent change Standard Deviation 31.169

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Voids Week 2; n=124, 123	-0.39 Voids Standard Deviation 2.419	-0.71 Voids Standard Deviation 3.363
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 6; n=124, 120	-0.26 Voids Standard Deviation 2.506	-1.90 Voids Standard Deviation 3.418
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 12; n=122, 122	-0.41 Voids Standard Deviation 2.681	-2.00 Voids Standard Deviation 3.447
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 18; n=23, 64	-1.00 Voids Standard Deviation 3.338	-2.46 Voids Standard Deviation 3.136
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 24; n=17, 52	-1.18 Voids Standard Deviation 2.703	-2.34 Voids Standard Deviation 3.334
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 30; n=14, 46	-1.29 Voids Standard Deviation 2.525	-1.40 Voids Standard Deviation 2.895
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 36; n=12, 32	-1.39 Voids Standard Deviation 2.777	-2.06 Voids Standard Deviation 2.667
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 42; n=11, 27	-1.39 Voids Standard Deviation 4.044	-2.06 Voids Standard Deviation 2.956
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids Week 48; n=11, 27	-0.36 Voids Standard Deviation 2.610	-1.14 Voids Standard Deviation 2.453

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Voids Week 6; n=106,84	-2.04 Voids Standard Deviation 3.199	-2.21 Voids Standard Deviation 2.879
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 0; n=108,88	-0.16 Voids Standard Deviation 2.579	-1.46 Voids Standard Deviation 2.556
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 2; n=105,87	-1.58 Voids Standard Deviation 3.473	-1.68 Voids Standard Deviation 3.394
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 12; n=106,85	-2.22 Voids Standard Deviation 3.164	-1.99 Voids Standard Deviation 2.575
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 18; n=83,46	-2.41 Voids Standard Deviation 2.312	-1.53 Voids Standard Deviation 2.789
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 24; n=45,21	-2.62 Voids Standard Deviation 2.169	-2.59 Voids Standard Deviation 2.738
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 30; n=36,15	-2.48 Voids Standard Deviation 3.051	-2.49 Voids Standard Deviation 2.597
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids Week 36; n=20,6	-2.73 Voids Standard Deviation 3.037	-0.39 Voids Standard Deviation 3.044

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Voids Week 0; n=56,43	-1.58 Voids Standard Deviation 3.166	-2.12 Voids Standard Deviation 2.495
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids Week 2; n=55,43	-1.57 Voids Standard Deviation 3.476	-2.29 Voids Standard Deviation 2.864
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids Week 6; n=53,42	-1.85 Voids Standard Deviation 2.917	-2.62 Voids Standard Deviation 2.623
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids Week 12; n=53,41	-1.95 Voids Standard Deviation 2.836	-2.02 Voids Standard Deviation 2.173
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids Week 18; n=22,29	-2.12 Voids Standard Deviation 3.766	-1.74 Voids Standard Deviation 2.327
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids Week 24; n=2,4	-1.33 Voids Standard Deviation 0.943	-1.08 Voids Standard Deviation 0.877

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Voids Week 2; n=124, 123	-1.65 Percent change Standard Deviation 19.992	-4.31 Percent change Standard Deviation 27.295
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 6; n=124, 120	-1.05 Percent change Standard Deviation 20.639	-12.81 Percent change Standard Deviation 25.192
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 12; n=122, 122	-2.59 Percent change Standard Deviation 21.271	-14.12 Percent change Standard Deviation 25.463
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 18; n=23, 64	-4.81 Percent change Standard Deviation 24.135	-18.70 Percent change Standard Deviation 20.675
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 24; n=17, 52	-6.21 Percent change Standard Deviation 18.990	-18.29 Percent change Standard Deviation 21.921
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 30; n=14, 46	-8.36 Percent change Standard Deviation 15.789	-10.35 Percent change Standard Deviation 21.713
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 36; n=12, 32	-8.33 Percent change Standard Deviation 15.374	-16.22 Percent change Standard Deviation 21.705
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 42; n=11, 27	-14.26 Percent change Standard Deviation 38.087	-15.40 Percent change Standard Deviation 22.368
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids Week 48; n=11, 27	-2.50 Percent change Standard Deviation 18.160	-7.82 Percent change Standard Deviation 22.261

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Voids Week 0; n=108,88	-0.31 Percent change Standard Deviation 20.076	-10.14 Percent change Standard Deviation 18.892
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 2; n=105,87	-11.53 Percent change Standard Deviation 26.466	-11.11 Percent change Standard Deviation 30.081
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 6; n=106,84	-14.87 Percent change Standard Deviation 23.844	-16.31 Percent change Standard Deviation 23.417
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 12; n=106,85	-15.78 Percent change Standard Deviation 26.649	-14.52 Percent change Standard Deviation 20.260
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 18; n=83,46	-19.08 Percent change Standard Deviation 18.022	-10.88 Percent change Standard Deviation 22.318
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 24; n=45,21	-22.08 Percent change Standard Deviation 16.561	-18.61 Percent change Standard Deviation 20.308
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 30; n=36,15	-19.22 Percent change Standard Deviation 21.626	-18.90 Percent change Standard Deviation 20.805
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids Week 36; n=20,6	-19.03 Percent change Standard Deviation 20.561	-2.57 Percent change Standard Deviation 24.843

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Voids Week 0; n=56,43	-9.68 Percent change Standard Deviation 30.804	-14.43 Percent change Standard Deviation 19.179
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids Week 2; n=55,43	-9.81 Percent change Standard Deviation 30.062	-15.98 Percent change Standard Deviation 22.524
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids Week 6; n=53,42	-12.53 Percent change Standard Deviation 25.204	-19.34 Percent change Standard Deviation 20.321
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids Week 12; n=53,41	-13.16 Percent change Standard Deviation 23.767	-15.30 Percent change Standard Deviation 17.431
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids Week 18; n=22,29	-11.60 Percent change Standard Deviation 32.168	-13.31 Percent change Standard Deviation 18.080
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids Week 24; n=2,4	-12.42 Percent change Standard Deviation 8.142	-9.07 Percent change Standard Deviation 5.887

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 12; n=122, 122	-1.69 Milliliter Standard Deviation 34.578	29.13 Milliliter Standard Deviation 46.480
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 2; n=124, 123	3.99 Milliliter Standard Deviation 29.762	14.74 Milliliter Standard Deviation 44.121
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 6; n=124, 120	0.95 Milliliter Standard Deviation 36.800	30.19 Milliliter Standard Deviation 52.077
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 18; n=23, 64	5.48 Milliliter Standard Deviation 31.328	30.67 Milliliter Standard Deviation 49.697
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 24; n=17, 52	2.37 Milliliter Standard Deviation 36.827	31.67 Milliliter Standard Deviation 51.061
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 30; n=14, 46	6.39 Milliliter Standard Deviation 32.508	32.08 Milliliter Standard Deviation 57.263
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 36; n=12, 32	9.73 Milliliter Standard Deviation 34.867	30.34 Milliliter Standard Deviation 44.953
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 42; n=11, 27	5.34 Milliliter Standard Deviation 31.688	17.48 Milliliter Standard Deviation 38.558
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition Week 48; n=11, 27	6.60 Milliliter Standard Deviation 32.580	14.41 Milliliter Standard Deviation 42.699

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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; n=108,88	-2.10 Milliliter Standard Deviation 34.115	25.74 Milliliter Standard Deviation 45.213
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 2; n=103,87	17.38 Milliliter Standard Deviation 44.216	20.44 Milliliter Standard Deviation 51.406
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 6; n=106,84	25.80 Milliliter Standard Deviation 50.630	29.03 Milliliter Standard Deviation 56.182
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 12; n=106,85	26.72 Milliliter Standard Deviation 49.861	24.04 Milliliter Standard Deviation 51.918
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 18; n=83,46	28.53 Milliliter Standard Deviation 43.876	12.34 Milliliter Standard Deviation 50.453
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 24; n=45,20	28.88 Milliliter Standard Deviation 50.296	22.34 Milliliter Standard Deviation 39.877
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 30; n=36,15	38.27 Milliliter Standard Deviation 57.547	26.74 Milliliter Standard Deviation 45.696
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition Week 36; n=20,6	43.99 Milliliter Standard Deviation 63.155	9.49 Milliliter Standard Deviation 69.972

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 0; n=56,43	19.49 Milliliter Standard Deviation 36.341	25.60 Milliliter Standard Deviation 35.923
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition Week 2; n=55,43	20.32 Milliliter Standard Deviation 38.050	25.01 Milliliter Standard Deviation 46.534
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition Week 6; n=53,41	28.13 Milliliter Standard Deviation 41.894	20.39 Milliliter Standard Deviation 47.654
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition Week 12; n=53,41	24.51 Milliliter Standard Deviation 39.670	17.33 Milliliter Standard Deviation 45.658
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition Week 18; n=22,29	23.51 Milliliter Standard Deviation 56.849	18.09 Milliliter Standard Deviation 35.324
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition Week 24; n=2,4	-6.79 Milliliter Standard Deviation 2.180	15.57 Milliliter Standard Deviation 45.613

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Average Volume Voided Per Micturition Week 2; n=124, 123	4.47 Percent change Standard Deviation 24.306	14.47 Percent change Standard Deviation 35.109
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 6; n=124, 120	3.10 Percent change Standard Deviation 28.671	28.73 Percent change Standard Deviation 43.846
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 12; n=122, 122	1.93 Percent change Standard Deviation 29.197	27.42 Percent change Standard Deviation 41.440
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 18; n=23, 64	7.61 Percent change Standard Deviation 27.947	28.64 Percent change Standard Deviation 48.898
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 24; n=17, 52	6.94 Percent change Standard Deviation 32.660	26.80 Percent change Standard Deviation 45.728
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 30; n=14, 46	9.87 Percent change Standard Deviation 31.384	24.39 Percent change Standard Deviation 36.838
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 36; n=12, 32	8.51 Percent change Standard Deviation 24.109	26.08 Percent change Standard Deviation 41.728
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 42; n=11, 27	8.41 Percent change Standard Deviation 32.804	14.91 Percent change Standard Deviation 32.231
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 48; n=11, 27	9.11 Percent change Standard Deviation 28.104	11.98 Percent change Standard Deviation 36.358

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Average Volume Voided Per Micturition Week 0; n=108,88	1.72 Percent change Standard Deviation 28.347	24.71 Percent change Standard Deviation 38.824
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 2; n=103,87	16.62 Percent change Standard Deviation 41.294	21.94 Percent change Standard Deviation 39.385
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 6; n=106,84	21.50 Percent change Standard Deviation 44.146	28.51 Percent change Standard Deviation 43.091
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 12; n=106,85	21.92 Percent change Standard Deviation 41.446	23.99 Percent change Standard Deviation 42.719
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 18; n=83,46	25.12 Percent change Standard Deviation 38.530	12.60 Percent change Standard Deviation 34.000
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 24; n=45,20	30.10 Percent change Standard Deviation 54.874	19.48 Percent change Standard Deviation 30.916
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 30; n=36,15	33.02 Percent change Standard Deviation 69.583	20.14 Percent change Standard Deviation 35.588
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 36; n=20,6	39.51 Percent change Standard Deviation 76.822	13.35 Percent change Standard Deviation 52.100

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Average Volume Voided Per Micturition Week 0; n=56,43	18.96 Percent change Standard Deviation 37.442	23.41 Percent change Standard Deviation 33.357
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 2; n=55,43	20.24 Percent change Standard Deviation 37.340	25.78 Percent change Standard Deviation 43.344
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 6; n=53,41	25.51 Percent change Standard Deviation 37.686	23.65 Percent change Standard Deviation 46.594
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 12; n=53,41	25.28 Percent change Standard Deviation 40.894	20.05 Percent change Standard Deviation 40.347
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 18; n=22,29	20.23 Percent change Standard Deviation 45.654	19.37 Percent change Standard Deviation 34.051
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition Week 24; n=2,4	-3.88 Percent change Standard Deviation 0.051	11.46 Percent change Standard Deviation 36.629

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Urgency Episodes Week 2; n=124, 123	-1.10 Episodes Standard Deviation 3.100	-2.09 Episodes Standard Deviation 4.826
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 6; n=124, 120	-1.39 Episodes Standard Deviation 3.607	-3.30 Episodes Standard Deviation 4.563
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 12; n=122, 122	-1.08 Episodes Standard Deviation 3.809	-3.39 Episodes Standard Deviation 4.471
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 18; n=23, 64	-2.46 Episodes Standard Deviation 3.726	-3.99 Episodes Standard Deviation 4.173
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 24; n=17, 52	-3.47 Episodes Standard Deviation 3.482	-4.60 Episodes Standard Deviation 4.204
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 30; n=14, 46	-3.93 Episodes Standard Deviation 4.172	-3.78 Episodes Standard Deviation 5.056
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 36; n=12, 32	-3.25 Episodes Standard Deviation 3.921	-4.22 Episodes Standard Deviation 4.514
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 42; n=11, 27	-2.88 Episodes Standard Deviation 4.822	-4.12 Episodes Standard Deviation 3.586
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes Week 48; n=11, 27	-2.52 Episodes Standard Deviation 3.659	-3.57 Episodes Standard Deviation 3.943

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Urgency Episodes Week 30; n=36,15	-4.06 Episodes Standard Deviation 5.020	-3.42 Episodes Standard Deviation 2.435
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 36; n=20,6	-5.08 Episodes Standard Deviation 5.582	-1.72 Episodes Standard Deviation 4.716
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 0; n=108,88	-0.79 Episodes Standard Deviation 3.639	-2.42 Episodes Standard Deviation 3.822
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 2; n=105,87	-3.63 Episodes Standard Deviation 4.580	-3.69 Episodes Standard Deviation 4.347
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 6; n=106,84	-4.28 Episodes Standard Deviation 4.074	-3.83 Episodes Standard Deviation 3.962
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 12; n=106,85	-4.10 Episodes Standard Deviation 4.118	-3.67 Episodes Standard Deviation 3.591
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 18; n=83,46	-3.86 Episodes Standard Deviation 3.972	-3.06 Episodes Standard Deviation 3.699
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes Week 24; n=45,21	-4.47 Episodes Standard Deviation 4.352	-3.49 Episodes Standard Deviation 2.662

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Urgency Episodes Week 0; n=56,43	-2.64 Episodes Standard Deviation 3.362	-3.22 Episodes Standard Deviation 3.668
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes Week 2; n=55,43	-3.28 Episodes Standard Deviation 4.476	-3.89 Episodes Standard Deviation 4.286
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes Week 6; n=53,42	-3.50 Episodes Standard Deviation 3.878	-4.40 Episodes Standard Deviation 4.257
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes Week 12; n=53,41	-3.28 Episodes Standard Deviation 3.300	-3.63 Episodes Standard Deviation 4.093
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes Week 18; n=22,29	-3.14 Episodes Standard Deviation 4.082	-2.97 Episodes Standard Deviation 3.654
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes Week 24; n=2,4	-2.17 Episodes Standard Deviation 1.650	-2.00 Episodes Standard Deviation 2.480

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urgency Episodes Week 2; n=124, 123	-11.62 Percent change Standard Deviation 36.556	-12.27 Percent change Standard Deviation 139.897
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 6; n=124, 120	-13.36 Percent change Standard Deviation 39.284	-29.25 Percent change Standard Deviation 99.826
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 12; n=122, 122	-6.15 Percent change Standard Deviation 55.275	-28.92 Percent change Standard Deviation 76.618
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 18; n=23, 64	-24.56 Percent change Standard Deviation 67.816	-41.72 Percent change Standard Deviation 54.362
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 24; n=17, 52	-44.53 Percent change Standard Deviation 46.229	-54.05 Percent change Standard Deviation 45.299
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 30; n=14, 46	-45.85 Percent change Standard Deviation 49.841	-39.11 Percent change Standard Deviation 59.666
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 36; n=12, 32	-41.35 Percent change Standard Deviation 47.808	-49.87 Percent change Standard Deviation 52.601
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 42; n=11, 27	-36.82 Percent change Standard Deviation 73.233	-51.54 Percent change Standard Deviation 44.338
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 48; n=11, 27	-35.81 Percent change Standard Deviation 56.080	-47.94 Percent change Standard Deviation 52.200

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urgency Episodes Week 0; n=108,88	-0.97 Percent change Standard Deviation 53.493	-17.59 Percent change Standard Deviation 52.475
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 2; n=105,87	-34.51 Percent change Standard Deviation 75.956	-43.19 Percent change Standard Deviation 48.933
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 6; n=106,84	-46.94 Percent change Standard Deviation 41.256	-42.81 Percent change Standard Deviation 48.411
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 12; n=106,85	-44.42 Percent change Standard Deviation 58.087	-37.61 Percent change Standard Deviation 44.355
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 18; n=83,46	-41.83 Percent change Standard Deviation 60.854	-37.30 Percent change Standard Deviation 57.929
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 24; n=45,21	-50.30 Percent change Standard Deviation 62.946	-50.18 Percent change Standard Deviation 36.257
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 30; n=36,15	-43.83 Percent change Standard Deviation 76.751	-47.11 Percent change Standard Deviation 35.298
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 36; n=20,6	-42.83 Percent change Standard Deviation 100.717	17.36 Percent change Standard Deviation 163.104

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Change From Baseline in Daily Average Number of Urgency Episodes Week 0; n=56,43	-25.28 Percent change Standard Deviation 38.080	-21.29 Percent change Standard Deviation 56.917
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 2; n=55,43	-31.32 Percent change Standard Deviation 58.360	-35.08 Percent change Standard Deviation 55.559
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 6; n=53,42	-36.80 Percent change Standard Deviation 45.867	-36.67 Percent change Standard Deviation 60.410
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 12; n=53,41	-33.95 Percent change Standard Deviation 35.729	-32.80 Percent change Standard Deviation 62.144
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 18; n=22,29	-28.72 Percent change Standard Deviation 37.453	-33.32 Percent change Standard Deviation 47.860
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes Week 24; n=2,4	-18.69 Percent change Standard Deviation 11.796	-18.03 Percent change Standard Deviation 21.046

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Nocturia Episodes Week 42; n=11, 27	0.30 Episodes Standard Deviation 1.574	-0.33 Episodes Standard Deviation 1.109
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 48; n=11, 27	0.36 Episodes Standard Deviation 1.487	-0.19 Episodes Standard Deviation 0.940
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 2; n=124, 123	-0.09 Episodes Standard Deviation 0.835	-0.09 Episodes Standard Deviation 1.275
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 6; n=124, 120	-0.13 Episodes Standard Deviation 1.091	-0.26 Episodes Standard Deviation 1.216
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 12; n=122, 122	-0.03 Episodes Standard Deviation 1.098	-0.29 Episodes Standard Deviation 1.447
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 18; n=23, 64	-0.16 Episodes Standard Deviation 1.247	-0.53 Episodes Standard Deviation 1.334
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 24; n=17, 52	0.04 Episodes Standard Deviation 1.224	-0.58 Episodes Standard Deviation 1.535
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 30; n=14, 46	0.14 Episodes Standard Deviation 1.357	-0.15 Episodes Standard Deviation 0.825
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes Week 36; n=12, 32	0.19 Episodes Standard Deviation 1.453	-0.21 Episodes Standard Deviation 1.148

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Nocturia Episodes Week 0; n=108,88	-0.10 Episodes Standard Deviation 1.079	-0.32 Episodes Standard Deviation 1.303
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 2; n=105,87	-0.32 Episodes Standard Deviation 1.020	-0.42 Episodes Standard Deviation 1.309
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 6; n=106,84	-0.45 Episodes Standard Deviation 1.079	-0.45 Episodes Standard Deviation 1.358
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 12; n=106,85	-0.36 Episodes Standard Deviation 1.266	-0.38 Episodes Standard Deviation 1.331
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 18; n=83,46	-0.33 Episodes Standard Deviation 1.032	-0.40 Episodes Standard Deviation 1.490
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 24; n=45,21	-0.24 Episodes Standard Deviation 0.831	-0.03 Episodes Standard Deviation 0.888
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 30; n=36,15	-0.01 Episodes Standard Deviation 0.964	0.02 Episodes Standard Deviation 0.831
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes Week 36; n=20,6	0.05 Episodes Standard Deviation 0.987	0.61 Episodes Standard Deviation 1.769

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Nocturia Episodes Week 0; n=56,43	-0.44 Episodes Standard Deviation 1.314	-0.29 Episodes Standard Deviation 1.032
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes Week 2; n=55,43	-0.44 Episodes Standard Deviation 1.410	-0.31 Episodes Standard Deviation 1.012
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes Week 6; n=53,42	-0.46 Episodes Standard Deviation 1.299	-0.29 Episodes Standard Deviation 1.070
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes Week 12; n=53,41	-0.72 Episodes Standard Deviation 1.396	-0.47 Episodes Standard Deviation 1.093
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes Week 18; n=22,29	-0.50 Episodes Standard Deviation 1.212	-0.34 Episodes Standard Deviation 1.449
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes Week 24; n=2,4	0.33 Episodes Standard Deviation 0.471	-0.33 Episodes Standard Deviation 0.720

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Changes From Baseline in Daily Average Number of Nocturia Episodes Week 2; n=112, 104	-2.92 Percent change Standard Deviation 78.249	-0.87 Percent change Standard Deviation 92.501
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 6; n=112, 102	-7.29 Percent change Standard Deviation 65.866	-7.81 Percent change Standard Deviation 86.301
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 12; n=111, 103	7.83 Percent change Standard Deviation 79.745	-7.23 Percent change Standard Deviation 114.564
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 18; n=20, 50	5.01 Percent change Standard Deviation 142.476	-29.88 Percent change Standard Deviation 58.668
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 24; n=15, 41	18.51 Percent change Standard Deviation 141.097	-21.27 Percent change Standard Deviation 97.052
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 30; n=11, 37	-3.25 Percent change Standard Deviation 142.123	-0.22 Percent change Standard Deviation 80.388
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 36; n=10, 26	35.52 Percent change Standard Deviation 206.821	-8.10 Percent change Standard Deviation 89.630
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 42; n=9, 22	29.63 Percent change Standard Deviation 224.354	-15.72 Percent change Standard Deviation 94.273
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 48; n=9, 22	38.52 Percent change Standard Deviation 189.877	-9.60 Percent change Standard Deviation 78.016

SECONDARY outcome

Timeframe: Baseline (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. All the participants in this population were analyzed (108, 88 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Changes From Baseline in Daily Average Number of Nocturia Episodes Week 36; n=16,6	-1.55 Percent change Standard Deviation 91.218	28.61 Percent change Standard Deviation 86.861
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 0; n=99,75	1.84 Percent change Standard Deviation 63.835	-12.98 Percent change Standard Deviation 68.669
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 2; n=96,74	-10.92 Percent change Standard Deviation 68.689	-19.95 Percent change Standard Deviation 56.983
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 6; n=97,71	-19.84 Percent change Standard Deviation 60.168	-16.88 Percent change Standard Deviation 71.816
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 12; n=97,72	-17.89 Percent change Standard Deviation 70.405	-15.74 Percent change Standard Deviation 65.355
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 18; n=75,39	-16.10 Percent change Standard Deviation 68.014	-12.99 Percent change Standard Deviation 55.055
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 24; n=38,19	-17.35 Percent change Standard Deviation 60.337	-4.88 Percent change Standard Deviation 52.277
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 30; n=30,14	-5.38 Percent change Standard Deviation 95.013	-4.66 Percent change Standard Deviation 59.940

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Changes From Baseline in Daily Average Number of Nocturia Episodes Week 0; n=54,38	-10.30 Percent change Standard Deviation 56.988	-12.92 Percent change Standard Deviation 66.778
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 2; n=53,38	-12.65 Percent change Standard Deviation 56.372	-17.41 Percent change Standard Deviation 72.146
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 6; n=51,37	-10.34 Percent change Standard Deviation 58.618	-15.84 Percent change Standard Deviation 67.482
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 12; n=51,37	-17.59 Percent change Standard Deviation 58.516	-23.85 Percent change Standard Deviation 69.048
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 18; n=21,26	-2.77 Percent change Standard Deviation 66.950	-13.64 Percent change Standard Deviation 71.573
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes Week 24; n=2,4	50.00 Percent change Standard Deviation 70.711	16.73 Percent change Standard Deviation 128.469

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Severe Urgency Episodes Week 2; n=124, 123	-0.56 Episodes Standard Deviation 2.702	-1.72 Episodes Standard Deviation 3.216
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 6; n=124, 120	-0.56 Episodes Standard Deviation 2.737	-1.92 Episodes Standard Deviation 3.992
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 12; n=122, 122	-0.11 Episodes Standard Deviation 2.624	-1.98 Episodes Standard Deviation 3.856
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 18; n=23, 64	-0.49 Episodes Standard Deviation 3.141	-2.02 Episodes Standard Deviation 3.597
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 24; n=17, 52	-1.57 Episodes Standard Deviation 4.441	-1.69 Episodes Standard Deviation 2.983
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 30; n=14, 46	-1.93 Episodes Standard Deviation 4.636	-1.59 Episodes Standard Deviation 2.877
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 36; n=12, 32	-1.78 Episodes Standard Deviation 5.426	-1.53 Episodes Standard Deviation 2.331
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 42; n=11, 27	-0.58 Episodes Standard Deviation 3.646	-1.46 Episodes Standard Deviation 2.935
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 48; n=11, 27	-1.24 Episodes Standard Deviation 4.600	-1.52 Episodes Standard Deviation 2.941

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Severe Urgency Episodes Week 0; n=108,88	-0.00 Episodes Standard Deviation 2.698	-1.90 Episodes Standard Deviation 3.799
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 2; n=105,87	-2.11 Episodes Standard Deviation 2.822	-2.26 Episodes Standard Deviation 4.424
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 6; n=106,84	-1.89 Episodes Standard Deviation 2.850	-2.37 Episodes Standard Deviation 3.952
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 12; n=106,85	-1.69 Episodes Standard Deviation 2.952	-2.52 Episodes Standard Deviation 4.031
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 18; n=83,46	-1.58 Episodes Standard Deviation 3.171	-1.92 Episodes Standard Deviation 3.794
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 24; n=45,21	-1.78 Episodes Standard Deviation 3.194	-3.00 Episodes Standard Deviation 4.603
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 30; n=36,15	-1.56 Episodes Standard Deviation 3.412	-3.27 Episodes Standard Deviation 4.823
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 36; n=20,6	-2.03 Episodes Standard Deviation 3.707	-1.00 Episodes Standard Deviation 3.502

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Severe Urgency Episodes Week 0; n=56,43	-1.58 Episodes Standard Deviation 2.357	-3.05 Episodes Standard Deviation 4.381
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 2; n=55,43	-1.66 Episodes Standard Deviation 2.658	-3.52 Episodes Standard Deviation 4.843
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 6; n=53,42	-1.42 Episodes Standard Deviation 2.245	-3.41 Episodes Standard Deviation 4.901
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 12; n=53,41	-1.24 Episodes Standard Deviation 2.350	-3.24 Episodes Standard Deviation 4.814
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 18; n=22,29	-1.32 Episodes Standard Deviation 2.466	-3.28 Episodes Standard Deviation 5.587
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes Week 24; n=2,4	-0.83 Episodes Standard Deviation 1.179	-1.92 Episodes Standard Deviation 1.424

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. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Severe or Moderate Urgency Episodes Week 30; n=14, 46	-2.98 Episodes Standard Deviation 3.037	-3.18 Episodes Standard Deviation 4.759
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 2; n=124, 123	-0.99 Episodes Standard Deviation 3.097	-2.28 Episodes Standard Deviation 4.692
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 6; n=124, 120	-1.17 Episodes Standard Deviation 3.290	-3.02 Episodes Standard Deviation 4.376
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 12; n=122, 122	-0.67 Episodes Standard Deviation 3.330	-2.89 Episodes Standard Deviation 4.269
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 18; n=23, 64	-1.43 Episodes Standard Deviation 3.441	-3.16 Episodes Standard Deviation 4.263
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 24; n=17, 52	-2.00 Episodes Standard Deviation 3.629	-3.51 Episodes Standard Deviation 4.645
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 36; n=12, 32	-2.83 Episodes Standard Deviation 4.707	-3.16 Episodes Standard Deviation 4.061
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 42; n=11, 27	-1.94 Episodes Standard Deviation 4.685	-3.21 Episodes Standard Deviation 3.688
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 48; n=11, 27	-1.91 Episodes Standard Deviation 3.944	-2.58 Episodes Standard Deviation 4.353

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Severe or Moderate Urgency Episodes Week 0; n=108,88	-0.40 Episodes Standard Deviation 3.300	-2.71 Episodes Standard Deviation 3.874
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 2; n=105,87	-3.35 Episodes Standard Deviation 3.819	-3.39 Episodes Standard Deviation 4.467
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 6; n=106,84	-3.19 Episodes Standard Deviation 4.063	-3.34 Episodes Standard Deviation 3.890
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 12; n=106,85	-3.10 Episodes Standard Deviation 3.785	-3.29 Episodes Standard Deviation 3.663
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 18; n=83,46	-3.03 Episodes Standard Deviation 3.626	-2.76 Episodes Standard Deviation 4.202
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 24; n=45,21	-3.33 Episodes Standard Deviation 3.980	-3.44 Episodes Standard Deviation 3.015
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 30; n=36,15	-2.73 Episodes Standard Deviation 5.063	-3.62 Episodes Standard Deviation 3.354
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 36; n=20,6	-4.12 Episodes Standard Deviation 4.747	-1.22 Episodes Standard Deviation 4.698

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Daily Average Number of Severe or Moderate Urgency Episodes Week 0; n=56,43	-2.11 Episodes Standard Deviation 3.132	-3.39 Episodes Standard Deviation 4.082
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 2; n=55,43	-2.47 Episodes Standard Deviation 3.603	-4.09 Episodes Standard Deviation 4.104
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 6; n=53,42	-2.58 Episodes Standard Deviation 2.819	-4.18 Episodes Standard Deviation 3.842
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 12; n=53,41	-2.23 Episodes Standard Deviation 2.734	-3.50 Episodes Standard Deviation 3.936
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 18; n=22,29	-1.89 Episodes Standard Deviation 3.155	-2.98 Episodes Standard Deviation 4.134
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes Week 24; n=2,4	-3.33 Episodes Standard Deviation 0.000	-3.33 Episodes Standard Deviation 4.815

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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Maximum Urgency Intensity Severe; Baseline (Pre-dose, Day 1); n=124, 124	99 Participants	105 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 36; n=12, 32	2 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Baseline (Pre-dose, Day 1); n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Baseline (Pre-dose, Day 1); n=124, 124	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Baseline (Pre-dose, Day 1); n=124, 124	24 Participants	16 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 2; n=124, 124	1 Participants	6 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 2; n=124, 124	11 Participants	21 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 2; n=124, 124	25 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 2; n=124, 124	87 Participants	61 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 6; n=124, 124	1 Participants	15 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 6; n=124, 124	14 Participants	20 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 6; n=124, 124	23 Participants	32 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 6; n=124, 124	86 Participants	57 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 12; n=124, 124	3 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 12; n=124, 124	9 Participants	16 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 12; n=124, 124	22 Participants	37 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 12; n=124, 124	90 Participants	63 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 18; n=23, 64	1 Participants	12 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 18; n=23, 64	3 Participants	11 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 18; n=23, 64	7 Participants	19 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 18; n=23, 64	12 Participants	22 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 24; n=17, 52	1 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 24; n=17, 52	1 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 24; n=17, 52	7 Participants	12 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 24; n=17, 52	8 Participants	20 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 30; n=14, 46	1 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 30; n=14, 46	3 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 30; n=14, 46	4 Participants	13 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 30; n=14, 46	6 Participants	16 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 36; n=12, 32	1 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 36; n=12, 32	5 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 36; n=12, 32	4 Participants	11 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 42; n=11, 27	1 Participants	6 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 42; n=11, 27	2 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 42; n=11, 27	5 Participants	7 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 42; n=11, 27	3 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity None; Week 48; n=11, 27	1 Participants	6 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Mild; Week 48; n=11, 27	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Moderate; Week 48; n=11, 27	6 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity Severe; Week 48; n=11, 27	3 Participants	9 Participants

SECONDARY outcome

Timeframe: 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 specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Maximum Urgency Intensity None; Week 0; n=108,88	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 0; n=108,88	6 Participants	10 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 0; n=108,88	20 Participants	24 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 0; n=108,88	82 Participants	54 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 2; n=105,87	12 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 2; n=105,87	21 Participants	17 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 2; n=105,87	35 Participants	24 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 2; n=105,87	37 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 6; n=106,84	13 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 6; n=106,84	27 Participants	12 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 6; n=106,84	25 Participants	27 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 6; n=106,84	41 Participants	36 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 12; n=106,85	13 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 12; n=106,85	23 Participants	11 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 12; n=106,85	28 Participants	25 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 12; n=106,85	42 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 18; n=83,46	11 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 18; n=83,46	16 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 18; n=83,46	21 Participants	10 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 18; n=83,46	35 Participants	23 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 24; n=45,21	13 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 24; n=45,21	8 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 24; n=45,21	15 Participants	6 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 24; n=45,21	9 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 30; n=36,15	9 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 30; n=36,15	6 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 30; n=36,15	10 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 30; n=36,15	11 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity None; Week 36; n=20,6	7 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Mild; Week 36; n=20,6	4 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Moderate; Week 36; n=20,6	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity Severe; Week 36; n=20,6	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Maximum Urgency Intensity Moderate; Week 6; n=53,42	12 Participants	15 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity None; Week 0; n=56,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Mild; Week 0; n=56,43	6 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Moderate; Week 0; n=56,43	14 Participants	16 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Severe; Week 0; n=56,43	36 Participants	25 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity None; Week 2; n=55,43	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Mild; Week 2; n=55,43	6 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Moderate; Week 2; n=55,43	15 Participants	19 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Severe; Week 2; n=55,43	32 Participants	17 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity None; Week 6; n=53,42	3 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Mild; Week 6; n=53,42	10 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Severe; Week 6; n=53,42	28 Participants	19 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity None; Week 12; n=53,41	3 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Mild; Week 12; n=53,41	8 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Moderate; Week 12; n=53,41	9 Participants	14 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Severe; Week 12; n=53,41	33 Participants	19 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity None; Week 18; n=22,29	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Mild; Week 18; n=22,29	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Moderate; Week 18; n=22,29	5 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Severe; Week 18; n=22,29	12 Participants	15 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity None; Week 24; n=2,4	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Mild; Week 24; n=2,4	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Moderate; Week 24; n=2,4	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity Severe; Week 24; n=2,4	2 Participants	2 Participants

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 specified time point were analyzed (represented by n=X in category titles).

Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 2 point worsening; n=12, 32	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 3 point improvement; n=124, 124	0 Participants	12 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 2 point improvement; n=124, 124	5 Participants	15 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 3 point improvement; n=124, 124	0 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 2 point improvement; n=124, 124	5 Participants	13 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 1 point improvement; n=124, 124	19 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; No change; n=124, 124	95 Participants	69 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 1 point improvement; n=124, 124	24 Participants	31 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; No change; n=124, 124	89 Participants	64 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 3 point improvement; n=124, 124	3 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 2 point improvement; n=124, 124	2 Participants	12 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 1 point improvement; n=124, 124	20 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; No change; n=124, 124	89 Participants	67 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 3 point improvement; n=23, 64	1 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 2 point improvement; n=23, 64	2 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 1 point improvement; n=23, 64	4 Participants	25 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; No change; n=23, 64	15 Participants	20 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 3 point improvement; n=17, 52	1 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 2 point improvement; n=17, 52	1 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 1 point improvement; n=17, 52	4 Participants	13 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; No change; n=17, 52	11 Participants	23 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 3 point improvement; n=14, 46	1 Participants	7 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 2 point improvement; n=14, 46	3 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 1 point improvement; n=14, 46	2 Participants	12 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; No change; n=14, 46	8 Participants	17 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 3 point improvement; n=12, 32	1 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 2 point improvement; n=12, 32	2 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 1 point improvement; n=12, 32	3 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; No change; n=12, 32	6 Participants	12 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; 3 point improvement; n=11, 27	1 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; 2 point improvement; n=11, 27	2 Participants	6 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; 1 point improvement; n=11, 27	3 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; No change; n=11, 27	5 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; 3 point improvement; n=11, 27	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; 2 point improvement; n=11, 27	1 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; 1 point improvement; n=11, 27	4 Participants	10 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; No change; n=11, 27	5 Participants	9 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 1 point worsening; n=124, 124	5 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 2 point worsening; n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 3 point worsening; n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 1 point worsening; n=124, 124	6 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6;2 point worsening; n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 3 point worsening; n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 1 point worsening; n=124, 124	10 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 2 point worsening; n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 3 point worsening; n=124, 124	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 1 point worsening; n=23, 64	1 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 2 point worsening; n=23, 64	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 3 point worsening; n=23, 64	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 1 point worsening; n=17, 52	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 2 point worsening; n=17, 52	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 3 point worsening; n=17, 52	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 1 point worsening; n=14, 46	0 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 2 point worsening; n=14, 46	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 3 point worsening; n=14, 46	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 1 point worsening; n=12, 32	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 3 point worsening; n=12, 32	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; 1 point worsening; n=11, 27	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; 2 point worsening; n=11, 27	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 42; 3 point worsening; n=11, 27	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; 1 point worsening; n=11, 27	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; 2 point worsening; n=11, 27	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 48; 3 point worsening; n=11, 27	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 1 point worsening; n=20, 6	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 2 point worsening; n=20, 6	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 3 point worsening; n=20, 6	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 3 point improvement; n=108,88	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 2 point improvement; n=108,88	1 Participants	6 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 1 point improvement; n=108,88	16 Participants	24 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; No change; n=108,88	83 Participants	54 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 3 point improvement; n=105,87	10 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 2 point improvement; n=105,87	14 Participants	14 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 1 point improvement; n=105,87	37 Participants	27 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; No change; n=105,87	41 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 3 point improvement; n=106,84	10 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 2 point improvement; n=106,84	20 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 1 point improvement; n=106,84	29 Participants	32 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; No change; n=106,84	44 Participants	34 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 3 point improvement; n=106,85	9 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 2 point improvement; n=106,85	17 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 1 point improvement; n=106,85	31 Participants	27 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; No change;n=106,85	48 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 3 point improvement; n=83,46	6 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 2 point improvement; n=83,46	14 Participants	6 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 1 point improvement; n=83,46	23 Participants	12 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; No change; n=83,46	37 Participants	22 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 3 point improvement; n=45,21	7 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 2 point improvement; n=45,21	11 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 1 point improvement; n=45,21	12 Participants	6 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; No change;n=45,21	15 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 3 point improvement; n=36,15	7 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 2 point improvement; n=36,15	5 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 1 point improvement; n=36,15	10 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; No change; n=36,15	13 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 3 point improvement; n=20,6	5 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 2 point improvement; n=20,6	6 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; 1 point improvement; n=20,6	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 36; No change; n=20,6	8 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 1 point worsening; n=108,88	8 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 2 point worsening; n=108,88	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 3 point worsening; n=108,88	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 1 point worsening; n=105,87	3 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 2 point worsening; n=105, 87	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 3 point worsening; n=105, 87	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 1 point worsening; n=106, 84	3 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6;2 point worsening; n=106, 84	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 3 point worsening; n=106, 84	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 1 point worsening; n=106, 85	1 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 2 point worsening; n=106, 85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 3 point worsening; n=106, 85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 3 point worsening; n=83, 46	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 1 point worsening; n=83, 46	3 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 2 point worsening; n=83, 46	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 1 point worsening; n=45, 21	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 2 point worsening; n=45, 21	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 3 point worsening; n=45, 21	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 1 point worsening; n=36, 15	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 2 point worsening; n=36, 15	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 30; 3 point worsening; n=36, 15	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 1 point improvement; n=53,41	10 Participants	13 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 2 point worsening; n=56,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 3 point improvement; n=56,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 2 point improvement; n=56,43	3 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 1 point improvement; n=56,43	13 Participants	14 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; No change; n=56,43	39 Participants	26 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 3 point improvement; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 2 point improvement; n=55,43	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 1 point improvement; n=55,43	13 Participants	19 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; No change; n=55,43	37 Participants	15 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 3 point improvement; n=53,42	1 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 2 point improvement; n=53,42	7 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 1 point improvement; n=53,42	16 Participants	12 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; No change; n=53,42	29 Participants	22 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 3 point improvement; n=53,41	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 2 point improvement; n=53,41	5 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; No change;n=53,41	36 Participants	20 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 3 point improvement; n=22,29	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 2 point improvement; n=22,29	1 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 1 point improvement; n=22,29	4 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; No change; n=22,29	15 Participants	18 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 3 point improvement; n=2,4	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 2 point improvement; n=2,4	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 1 point improvement; n=2,4	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; No change;n=2,4	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 1 point worsening; n=56,43	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 0; 3 point worsening; n=56,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 1 point worsening; n=55,43	0 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 2 point worsening; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 2; 3 point worsening; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 1 point worsening; n=53, 42	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6;2 point worsening; n=53, 42	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 6; 3 point worsening; n=53, 42	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 1 point worsening; n=53, 41	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 2 point worsening; n=53, 41	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 12; 3 point worsening; n=53, 41	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 1 point worsening; n=22, 29	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 2 point worsening; n=22, 29	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 18; 3 point worsening; n=22, 29	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 1 point worsening; n=2, 4	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 2 point worsening; n=2, 4	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline Week 24; 3 point worsening; n=2, 4	0 Participants	0 Participants

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 specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of "Did you have accidental urinary leakage?" divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 30; >=75%; n=14, 46	57 Percentage of participants	52 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%; n=14, 46	71 Percentage of participants	65 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 %; n=124, 124	3 Percentage of participants	18 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%; n=124, 124	9 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 2; >=50%; n=124, 124	23 Percentage of participants	55 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 %; n=124, 124	3 Percentage of participants	27 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%; n=124, 124	8 Percentage of participants	41 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%; n=124, 124	27 Percentage of participants	60 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 %; n=124, 124	3 Percentage of participants	19 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%; n=124, 124	14 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 12; >=50%; n=124, 124	24 Percentage of participants	58 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 %; n=23, 64	13 Percentage of participants	33 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%; n= 23, 64	35 Percentage of participants	56 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%; n=23, 64	52 Percentage of participants	66 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 %; n= 17, 52	24 Percentage of participants	38 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%; n=17, 52	53 Percentage of participants	63 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%; n=17, 52	71 Percentage of participants	77 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 %; n=14, 46	36 Percentage of participants	28 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 %; n=12, 32	25 Percentage of participants	34 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%; n=12, 32	58 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 36; >=50%; n=12, 32	75 Percentage of participants	66 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 %; n= 11, 27	18 Percentage of participants	33 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; >=75%; n=11, 27	55 Percentage of participants	56 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%; n=11, 27	64 Percentage of participants	70 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 %; n= 11, 27	27 Percentage of participants	33 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%; n=11, 27	55 Percentage of participants	48 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%; n=11, 27	73 Percentage of participants	63 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of "Did you have accidental urinary leakage?" divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 0; 100%; n=108,88	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%; n=108,88	6 Percentage of participants	17 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%; n=108,88	19 Percentage of participants	42 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 %; n=105, 87	30 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 2; >=75%; n=105, 87	57 Percentage of participants	53 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%; n=105, 87	81 Percentage of participants	71 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 %; n=106, 84	35 Percentage of participants	18 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%; n=106, 84	58 Percentage of participants	57 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%; n=106, 84	71 Percentage of participants	71 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 %; n=106, 85	27 Percentage of participants	19 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%; n=106, 85	53 Percentage of participants	41 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%; n=106, 85	74 Percentage of participants	64 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 %; n=83, 46	18 Percentage of participants	28 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%; n=83, 46	43 Percentage of participants	43 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%; n=83, 46	66 Percentage of participants	72 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 %; n=45, 21	40 Percentage of participants	38 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%; n=45, 21	56 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 24; >=50%; n=45, 21	71 Percentage of participants	86 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 %; n=36, 15	22 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 30; >=75%; n=36, 15	53 Percentage of participants	47 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%; n=36, 15	75 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 36; 100 %; n=20, 6	45 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 36; >=75%; n=20, 6	55 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 36; >=50%; n=20, 6	75 Percentage of participants	67 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of "Did you have accidental urinary leakage?" divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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; 100%; n=56,43	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; >=75%; n=56,43	21 Percentage of participants	7 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%; n=56,43	50 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 2; 100 %; n=55,43	13 Percentage of participants	16 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%; n=55,43	36 Percentage of participants	42 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%; n=55,43	64 Percentage of participants	58 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 %; n=53,42	13 Percentage of participants	12 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%; n=53,42	43 Percentage of participants	43 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%; n=53,42	70 Percentage of participants	76 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 %; n=53,41	13 Percentage of participants	10 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%; n=53,41	45 Percentage of participants	34 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%; n=53,41	62 Percentage of participants	54 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 %; n=22,29	18 Percentage of participants	3 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%; n=22,29	18 Percentage of participants	34 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%; n=22,29	50 Percentage of participants	55 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 24; 100 %; n=2,4	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 24; >=75%; n=2,4	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 24; >=50%; n=2,4	0 Percentage of participants	50 Percentage of participants

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 specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 30; 100 %; n=14, 46	43 Percentage of participants	30 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 2; 100 %; n=124, 124	3 Percentage of participants	19 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 2; >=75%; n=124, 124	10 Percentage of participants	44 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 2; >=50%; n=124, 124	25 Percentage of participants	56 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 6; 100 %; n=124, 124	4 Percentage of participants	30 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 6; >=75%; n=124, 124	9 Percentage of participants	44 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 6; >=50%; n=124, 124	27 Percentage of participants	61 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 12; 100 %; n=124, 124	5 Percentage of participants	21 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 12; >=75%; n=124, 124	13 Percentage of participants	42 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 12; >=50%; n=124, 124	26 Percentage of participants	58 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 18; 100 %; n=23, 64	13 Percentage of participants	36 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 18; >=75%; n= 23, 64	35 Percentage of participants	56 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 18; >=50%; n=23, 64	52 Percentage of participants	67 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 24; 100 %; n= 17, 52	29 Percentage of participants	40 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 24; >=75%; n=17, 52	53 Percentage of participants	67 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 24; >=50%; n=17, 52	76 Percentage of participants	81 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 30; >=75%; n=14, 46	64 Percentage of participants	54 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 30; >=50%; n=14, 46	71 Percentage of participants	70 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 36; 100 %; n=12, 32	25 Percentage of participants	38 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 36; >=75%; n=12, 32	58 Percentage of participants	53 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 36; >=50%; n=12, 32	75 Percentage of participants	72 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 42; 100 %; n= 11, 27	18 Percentage of participants	44 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 42; >=75%; n=11, 27	64 Percentage of participants	67 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 42; >=50%; n=11, 27	73 Percentage of participants	81 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 48; 100 %; n= 11, 27	36 Percentage of participants	37 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 48; >=75%; n=11, 27	64 Percentage of participants	56 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes Week 48; >=50%; n=11, 27	82 Percentage of participants	78 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (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 specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Urgency Incontinence Episodes Week 12; 100 %; n=106, 85	28 Percentage of participants	19 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 Urgency Incontinence Episodes Week 12; >=75%; n=106, 85	55 Percentage of participants	42 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 Urgency Incontinence Episodes Week 18; 100 %; n=83, 46	18 Percentage of participants	28 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 Urgency Incontinence Episodes Week 12; >=50%; n=106, 85	73 Percentage of participants	64 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 Urgency Incontinence Episodes Week 18; >=50%; n=83, 46	65 Percentage of participants	74 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 Urgency Incontinence Episodes Week 36; >=50%; n=20, 6	75 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 Urgency Incontinence Episodes Week 36; 100 %; n=20, 6	50 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 Urgency Incontinence Episodes Week 2; >=50%; n=105, 87	80 Percentage of participants	72 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 Urgency Incontinence Episodes Week 6; 100 %; n=106, 84	35 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 Urgency Incontinence Episodes Week 6; >=75%; n=106, 84	59 Percentage of participants	57 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 Urgency Incontinence Episodes Week 6; >=50%; n=106, 84	71 Percentage of participants	71 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 Urgency Incontinence Episodes Week 18; >=75%; n=83, 46	45 Percentage of participants	43 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 Urgency Incontinence Episodes Week 24; 100 %; n=45, 21	42 Percentage of participants	38 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 Urgency Incontinence Episodes Week 24; >=75%; n=45, 21	56 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 Urgency Incontinence Episodes Week 30; 100 %; n=36, 15	31 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 Urgency Incontinence Episodes Week 24; >=50%; n=45, 21	73 Percentage of participants	86 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 Urgency Incontinence Episodes Week 30; >=75%; n=36, 15	61 Percentage of participants	47 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 Urgency Incontinence Episodes Week 30; >=50%; n=36, 15	75 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 Urgency Incontinence Episodes Week 36; >=75%; n=20, 6	60 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 Urgency Incontinence Episodes Week 0; 100%; n=108,88	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 Urgency Incontinence Episodes Week 0; >=75%; n=108,88	6 Percentage of participants	17 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 Urgency Incontinence Episodes Week 0; >=50%; n=108,88	19 Percentage of participants	42 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 Urgency Incontinence Episodes Week 2; 100 %; n=105, 87	31 Percentage of participants	24 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 Urgency Incontinence Episodes Week 2; >=75%; n=105, 87	57 Percentage of participants	56 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Urgency Incontinence Episodes Week 0; 100%; n=56,43	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 Urgency Incontinence Episodes Week 0; >=75%; n=56,43	21 Percentage of participants	7 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 Urgency Incontinence Episodes Week 0; >=50%; n=56,43	48 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 Urgency Incontinence Episodes Week 2; 100 %; n=55,43	16 Percentage of participants	19 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 Urgency Incontinence Episodes Week 2; >=75%; n=55,43	35 Percentage of participants	42 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 Urgency Incontinence Episodes Week 2; >=50%; n=55,43	67 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 Urgency Incontinence Episodes Week 6; 100 %; n=53,42	15 Percentage of participants	14 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 Urgency Incontinence Episodes Week 6; >=75%; n=53,42	47 Percentage of participants	43 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 Urgency Incontinence Episodes Week 6; >=50%; n=53,42	68 Percentage of participants	69 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 Urgency Incontinence Episodes Week 12; 100 %; n=53,41	15 Percentage of participants	12 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 Urgency Incontinence Episodes Week 18; 100 %; n=22,29	18 Percentage of participants	3 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 Urgency Incontinence Episodes Week 12; >=75%; n=53,41	47 Percentage of participants	37 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 Urgency Incontinence Episodes Week 12; >=50%; n=53,41	64 Percentage of participants	59 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 Urgency Incontinence Episodes Week 18; >=75%; n=22,29	23 Percentage of participants	38 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 Urgency Incontinence Episodes Week 18; >=50%; n=22,29	55 Percentage of participants	59 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 Urgency Incontinence Episodes Week 24; 100 %; n=2,4	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 Urgency Incontinence Episodes Week 24; >=75%; n=2,4	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 Urgency Incontinence Episodes Week 24; >=50%; n=2,4	0 Percentage of participants	50 Percentage of participants

SECONDARY outcome

Timeframe: Up to 36 weeks in Treatment Cycle 1

Population: FAS1 Population.

Participants were 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 \>=2 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, post-void residual (PVR) urine volume must have been \<200 milliliter; 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 fulfilled the qualification for retreatment criteria minus the day of first treatment plus 1.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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	85.0 Days Interval 84.0 to 85.0	127.0 Days Interval 91.0 to 175.0

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 requested retreatment minus the day of first treatment plus 1.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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	85.0 Days Interval 84.0 to 85.0	92.0 Days Interval 85.0 to 128.0

SECONDARY outcome

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

Population: FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

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/ energy (S/ E) (1\[Never\] to 4\[All the time\]) and Severity/Coping (S/ 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/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ 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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Scores General Health Perception; Week 36;n=12, 32	-10.4 Scores on a scale Standard Deviation 19.82	-3.9 Scores on a scale Standard Deviation 18.08
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Role Limitations; Week 12;n= 121, 123	-3.03 Scores on a scale Standard Deviation 24.814	-18.56 Scores on a scale Standard Deviation 34.290
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Physical Limitations; Week 12;n=121, 123	-3.31 Scores on a scale Standard Deviation 26.581	-15.18 Scores on a scale Standard Deviation 35.388
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Physical Limitations; Week 36;n=12, 32	-16.67 Scores on a scale Standard Deviation 29.302	-24.48 Scores on a scale Standard Deviation 29.930
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Emotions; Week 36;n=12, 32	-22.22 Scores on a scale Standard Deviation 21.711	-23.26 Scores on a scale Standard Deviation 20.616
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Emotions; Week 48;n=11, 27	-20.20 Scores on a scale Standard Deviation 26.675	-20.58 Scores on a scale Standard Deviation 28.362
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Sleep/Energy; Week 12;n=122, 123	0.41 Scores on a scale Standard Deviation 23.223	-12.74 Scores on a scale Standard Deviation 25.792
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Sleep/Energy; Week 24;n=17, 54	-13.73 Scores on a scale Standard Deviation 30.752	-17.28 Scores on a scale Standard Deviation 26.886
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Sleep/Energy; Week 36;n=12, 32	-19.44 Scores on a scale Standard Deviation 23.391	-11.98 Scores on a scale Standard Deviation 27.835
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Sleep/Energy; Week 48;n=11, 27	-16.67 Scores on a scale Standard Deviation 24.721	-9.88 Scores on a scale Standard Deviation 28.592
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Severity/Coping Measures; Week 12;n=122, 123	-2.08 Scores on a scale Standard Deviation 16.950	-11.54 Scores on a scale Standard Deviation 26.032
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Severity/Coping Measures; Week 24;n=17, 54	-9.80 Scores on a scale Standard Deviation 19.020	-18.27 Scores on a scale Standard Deviation 28.260
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Severity/Coping Measures; Week 36;n=12, 32	-23.89 Scores on a scale Standard Deviation 18.740	-14.17 Scores on a scale Standard Deviation 24.466
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Severity/Coping Measures; Week 48;n=11, 27	-18.18 Scores on a scale Standard Deviation 19.112	-6.67 Scores on a scale Standard Deviation 26.667
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Personal Relationships; Week 48;n=8, 15	-22.92 Scores on a scale Standard Deviation 30.780	-13.33 Scores on a scale Standard Deviation 23.738
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores General Health Perception; Week 12;n=122, 123	4.9 Scores on a scale Standard Deviation 26.43	-1.8 Scores on a scale Standard Deviation 24.41
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores General Health Perception; Week 24;n=17, 54	-10.3 Scores on a scale Standard Deviation 19.88	-2.8 Scores on a scale Standard Deviation 17.95
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores General Health Perception; Week 48;n=11, 27	-6.8 Scores on a scale Standard Deviation 11.68	0.0 Scores on a scale Standard Deviation 19.61
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Incontinence Impact; Week 12;n=122, 123	-6.56 Scores on a scale Standard Deviation 27.320	-23.04 Scores on a scale Standard Deviation 36.497
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Incontinence Impact; Week 24;n=17, 54	-25.49 Scores on a scale Standard Deviation 25.082	-36.42 Scores on a scale Standard Deviation 32.550
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Incontinence Impact; Week 36;n=12, 32	-30.56 Scores on a scale Standard Deviation 17.164	-43.75 Scores on a scale Standard Deviation 24.593
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Incontinence Impact; Week 48;n=11, 27	-27.27 Scores on a scale Standard Deviation 25.025	-33.33 Scores on a scale Standard Deviation 24.460
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Role Limitations; Week 24;n=17, 54	-8.82 Scores on a scale Standard Deviation 26.430	-30.25 Scores on a scale Standard Deviation 32.710
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Role Limitations; Week 36;n=12, 32	-18.06 Scores on a scale Standard Deviation 25.084	-26.04 Scores on a scale Standard Deviation 33.317
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Role Limitations; Week 48;n=11, 27	-15.15 Scores on a scale Standard Deviation 36.098	-22.84 Scores on a scale Standard Deviation 33.059
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Physical Limitations; Week 24;n=17, 54	-13.73 Scores on a scale Standard Deviation 26.507	-27.47 Scores on a scale Standard Deviation 33.515
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Physical Limitations; Week 48;n=11, 27	-16.67 Scores on a scale Standard Deviation 27.889	-17.28 Scores on a scale Standard Deviation 32.186
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Social Limitations; Week 12;n=121, 123	-0.78 Scores on a scale Standard Deviation 25.952	-11.92 Scores on a scale Standard Deviation 30.326
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Social Limitations; Week 24;n=17, 54	-12.75 Scores on a scale Standard Deviation 28.175	-21.60 Scores on a scale Standard Deviation 34.019
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Social Limitations; Week 36;n=12, 32	-25.93 Scores on a scale Standard Deviation 30.089	-18.23 Scores on a scale Standard Deviation 33.756
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Emotions; Week 12;n=122, 123	-4.46 Scores on a scale Standard Deviation 22.841	-14.63 Scores on a scale Standard Deviation 28.922
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Social Limitations; Week 48;n=11, 27	-20.20 Scores on a scale Standard Deviation 27.585	-17.70 Scores on a scale Standard Deviation 27.087
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Personal Relationships; Week 12;n=91, 79	-3.85 Scores on a scale Standard Deviation 21.528	-5.06 Scores on a scale Standard Deviation 23.167
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Emotions; Week 24;n=17, 54	-22.22 Scores on a scale Standard Deviation 21.155	-27.98 Scores on a scale Standard Deviation 30.198
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Personal Relationships; Week 24;n=13, 35	-10.26 Scores on a scale Standard Deviation 23.113	-15.24 Scores on a scale Standard Deviation 30.883
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores Personal Relationships; Week 36;n=8, 20	-22.92 Scores on a scale Standard Deviation 30.780	-15.00 Scores on a scale Standard Deviation 28.562

SECONDARY outcome

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

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

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/ E (1\[Never\] to 4\[All the time\]) and S/ 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/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ 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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Scores Role Limitations; Week 0;n= 107,88	-0.31 Scores on a scale Standard Deviation 23.789	-7.39 Scores on a scale Standard Deviation 25.753
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores General Health Perception; Week 0;n=108,88	8.1 Scores on a scale Standard Deviation 24.84	2.3 Scores on a scale Standard Deviation 23.86
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores General Health Perception; Week 12;n=106,85	-0.2 Scores on a scale Standard Deviation 25.47	2.6 Scores on a scale Standard Deviation 25.30
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores General Health Perception; Week 24;n=47,22	3.2 Scores on a scale Standard Deviation 27.39	2.3 Scores on a scale Standard Deviation 24.29
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores General Health Perception; Week 36;n=25,8	1.0 Scores on a scale Standard Deviation 27.46	6.3 Scores on a scale Standard Deviation 29.12
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 0;n=108,88	-2.78 Scores on a scale Standard Deviation 26.229	-11.74 Scores on a scale Standard Deviation 31.171
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 12;n=106,85	-35.22 Scores on a scale Standard Deviation 35.584	-23.14 Scores on a scale Standard Deviation 34.512
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 24;n=47,22	-39.72 Scores on a scale Standard Deviation 35.193	-36.36 Scores on a scale Standard Deviation 30.704
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 36;n=25,8	-38.67 Scores on a scale Standard Deviation 38.103	-37.50 Scores on a scale Standard Deviation 41.547
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Role Limitations; Week 12;n= 105,85	-24.44 Scores on a scale Standard Deviation 33.178	-22.35 Scores on a scale Standard Deviation 28.701
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Role Limitations; Week 24;n=46,22	-27.17 Scores on a scale Standard Deviation 31.497	-26.52 Scores on a scale Standard Deviation 33.198
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Role Limitations; Week 36;n=25,8	-30.67 Scores on a scale Standard Deviation 32.872	-35.42 Scores on a scale Standard Deviation 38.253
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 0;n=107,88	0.31 Scores on a scale Standard Deviation 25.181	-4.73 Scores on a scale Standard Deviation 31.859
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 12;n=105,85	-24.76 Scores on a scale Standard Deviation 33.422	-15.88 Scores on a scale Standard Deviation 30.851
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 24;n=46,22	-23.19 Scores on a scale Standard Deviation 37.594	-17.42 Scores on a scale Standard Deviation 38.654
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 36;n=25,8	-28.67 Scores on a scale Standard Deviation 34.534	-31.25 Scores on a scale Standard Deviation 35.003
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Social Limitations; Week 0;n=107,88	2.96 Scores on a scale Standard Deviation 24.340	-4.23 Scores on a scale Standard Deviation 27.733
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Social Limitations; Week 12;n=105,85	-17.67 Scores on a scale Standard Deviation 31.283	-9.35 Scores on a scale Standard Deviation 28.845
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Social Limitations; Week 24;n=46,22	-17.51 Scores on a scale Standard Deviation 35.136	-9.09 Scores on a scale Standard Deviation 35.368
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Social Limitations; Week 36;n=25,8	-22.00 Scores on a scale Standard Deviation 33.120	-23.61 Scores on a scale Standard Deviation 21.771
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 0;n=80,57	-1.04 Scores on a scale Standard Deviation 20.600	-2.63 Scores on a scale Standard Deviation 23.944
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 12;n=79,54	-6.75 Scores on a scale Standard Deviation 24.390	-4.63 Scores on a scale Standard Deviation 26.385
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 24;n=33,17	-8.59 Scores on a scale Standard Deviation 27.677	-14.71 Scores on a scale Standard Deviation 18.524
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 36;n=19,6	-7.02 Scores on a scale Standard Deviation 32.544	-11.11 Scores on a scale Standard Deviation 13.608
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Emotions; Week 0;n=108,88	-2.67 Scores on a scale Standard Deviation 22.881	-8.08 Scores on a scale Standard Deviation 26.192
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Emotions; Week 12;n=106,85	-27.88 Scores on a scale Standard Deviation 29.347	-14.64 Scores on a scale Standard Deviation 28.131
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Emotions; Week 24;n=47,22	-28.84 Scores on a scale Standard Deviation 31.653	-18.69 Scores on a scale Standard Deviation 29.574
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Emotions; Week 36;n=25,8	-39.11 Scores on a scale Standard Deviation 29.766	-18.06 Scores on a scale Standard Deviation 25.845
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 0;n=108,88	3.40 Scores on a scale Standard Deviation 22.986	-8.90 Scores on a scale Standard Deviation 24.753
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 12;n=106,85	-14.31 Scores on a scale Standard Deviation 30.030	-13.92 Scores on a scale Standard Deviation 25.569
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 24;n=47,22	-11.70 Scores on a scale Standard Deviation 30.676	-21.97 Scores on a scale Standard Deviation 22.647
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 36;n=25,8	-13.33 Scores on a scale Standard Deviation 27.639	-12.50 Scores on a scale Standard Deviation 24.801
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 0;n=108,88	0.56 Scores on a scale Standard Deviation 14.757	-5.61 Scores on a scale Standard Deviation 23.573
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 12;n=106,85	-16.23 Scores on a scale Standard Deviation 25.845	-11.37 Scores on a scale Standard Deviation 21.938
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 24;n=47,22	-18.01 Scores on a scale Standard Deviation 28.041	-16.97 Scores on a scale Standard Deviation 17.785
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 36;n=25,8	-19.20 Scores on a scale Standard Deviation 31.465	-16.67 Scores on a scale Standard Deviation 28.284

SECONDARY outcome

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

Population: FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

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/ E (1\[Never\] to 4\[All the time\]) and S/ 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/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ 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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Scores General Health Perception; Week 0;n=55,43	3.6 Scores on a scale Standard Deviation 22.27	6.4 Scores on a scale Standard Deviation 26.78
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores General Health Perception; Week 12;n=54,42	-3.2 Scores on a scale Standard Deviation 19.45	-2.4 Scores on a scale Standard Deviation 29.64
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores General Health Perception; Week 24;n=2,7	37.5 Scores on a scale Standard Deviation 17.68	-7.1 Scores on a scale Standard Deviation 53.45
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 0;n=55,43	-24.24 Scores on a scale Standard Deviation 32.365	-10.08 Scores on a scale Standard Deviation 32.962
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 12;n=54,42	-34.57 Scores on a scale Standard Deviation 29.647	-16.67 Scores on a scale Standard Deviation 36.994
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Incontinence Impact; Week 24;n=2,7	0.00 Scores on a scale Standard Deviation 0.000	-14.29 Scores on a scale Standard Deviation 26.227
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Role Limitations; Week 0;n=55,43	-16.67 Scores on a scale Standard Deviation 26.058	-15.12 Scores on a scale Standard Deviation 27.892
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Role Limitations; Week 12;n=54,42	-25.62 Scores on a scale Standard Deviation 33.912	-10.32 Scores on a scale Standard Deviation 28.023
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Role Limitations; Week 24;n=2,7	0.00 Scores on a scale Standard Deviation 0.000	-7.14 Scores on a scale Standard Deviation 28.637
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 0;n=55,43	-19.09 Scores on a scale Standard Deviation 27.670	-13.95 Scores on a scale Standard Deviation 29.531
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 12;n=54,42	-29.32 Scores on a scale Standard Deviation 29.662	-12.70 Scores on a scale Standard Deviation 32.050
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Physical Limitations; Week 24;n=2,7	0.00 Scores on a scale Standard Deviation 0.000	-28.57 Scores on a scale Standard Deviation 39.340
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Social Limitations; Week 0;n=55,43	-17.68 Scores on a scale Standard Deviation 24.195	-6.07 Scores on a scale Standard Deviation 24.899
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Social Limitations; Week 12;n=54,42	-21.91 Scores on a scale Standard Deviation 28.724	-7.54 Scores on a scale Standard Deviation 26.311
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Social Limitations; Week 24;n=2,7	-5.56 Scores on a scale Standard Deviation 7.857	-7.94 Scores on a scale Standard Deviation 19.994
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 0;n=42,23	-7.14 Scores on a scale Standard Deviation 16.926	2.90 Scores on a scale Standard Deviation 17.875
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 12;n=40,24	-9.58 Scores on a scale Standard Deviation 19.203	4.17 Scores on a scale Standard Deviation 18.553
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Personal Relationships; Week 24;n=1,4	-16.67 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 56.108
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Emotions; Week 0;n=55,43	-19.39 Scores on a scale Standard Deviation 22.551	-10.08 Scores on a scale Standard Deviation 28.772
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Emotions; Week 12;n=54,42	-27.98 Scores on a scale Standard Deviation 28.776	-8.47 Scores on a scale Standard Deviation 26.749
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Emotions; Week 24;n=2,7	-22.22 Scores on a scale Standard Deviation 15.713	-7.94 Scores on a scale Standard Deviation 21.956
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 0;n=55,43	-10.61 Scores on a scale Standard Deviation 22.536	-7.75 Scores on a scale Standard Deviation 24.760
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 12;n=54,42	-17.28 Scores on a scale Standard Deviation 26.095	-10.71 Scores on a scale Standard Deviation 25.720
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Sleep/Energy; Week 24;n=2,7	-25.00 Scores on a scale Standard Deviation 11.785	-7.14 Scores on a scale Standard Deviation 26.972
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 0;n=55,43	-11.15 Scores on a scale Standard Deviation 18.417	-2.02 Scores on a scale Standard Deviation 17.429
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 12;n=54,42	-16.67 Scores on a scale Standard Deviation 20.992	-4.76 Scores on a scale Standard Deviation 23.013
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores Severity/Coping Measures; Week 24;n=2,7	-6.67 Scores on a scale Standard Deviation 9.428	-3.81 Scores on a scale Standard Deviation 18.402

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 specified time point were analyzed (represented by n=X in category titles).

Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 the Treatment Benefit Scale (TBS) Week 2; n=124 ,124	22 Percentage of participants	60 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS) Week 6; n=124 ,124	23 Percentage of participants	64 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS) Week 12; n=124 ,124	17 Percentage of participants	57 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS) Week 24; n=17, 54	53 Percentage of participants	69 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS) Week 36; n=12, 32	67 Percentage of participants	69 Percentage of participants
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS) Week 48; n=11, 27	45 Percentage of participants	70 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 specified time point were analyzed (represented by n=X in category titles).

Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 the TBS Week 0; n=108,88	7 Percentage of participants	40 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS Week 2; n=108,86	81 Percentage of participants	70 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS Week 6; n=108,86	79 Percentage of participants	69 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS Week 12; n=106,85	73 Percentage of participants	64 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS Week 24; n=47,22	72 Percentage of participants	55 Percentage of participants
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS Week 36; n=25,8	68 Percentage of participants	38 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 specified time point were analyzed (represented by n=X in category titles).

Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 the TBS Week 0; n=56,43	61 Percentage of participants	49 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS Week 2; n=56,43	64 Percentage of participants	60 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS Week 6; n=55,43	65 Percentage of participants	63 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS Week 12; n=54,42	63 Percentage of participants	55 Percentage of participants
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS Week 24; n=2,7	0 Percentage of participants	29 Percentage of participants

SECONDARY outcome

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

Population: FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score Week 12; n=122, 123	-0.7 Scores on a scale Standard Deviation 2.05	-3.4 Scores on a scale Standard Deviation 3.50
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score Week 24; n=17, 54	-2.7 Scores on a scale Standard Deviation 2.80	-4.4 Scores on a scale Standard Deviation 3.32
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score Week 36; n=12 ,32	-3.5 Scores on a scale Standard Deviation 2.02	-3.9 Scores on a scale Standard Deviation 3.26
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score Week 48; n=11, 27	-2.8 Scores on a scale Standard Deviation 2.68	-3.3 Scores on a scale Standard Deviation 3.02

SECONDARY outcome

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

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=88 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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): Changes From Baseline in OABSS Total Score Week 0; n=108,88	-0.2 Scores on a scale Standard Deviation 1.78	-1.5 Scores on a scale Standard Deviation 2.15
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score Week 12; n=106,85	-4.1 Scores on a scale Standard Deviation 3.73	-3.0 Scores on a scale Standard Deviation 2.89
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score Week 24;n=47,22	-5.1 Scores on a scale Standard Deviation 3.62	-3.3 Scores on a scale Standard Deviation 2.78
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score Week 36; n=25,8	-5.1 Scores on a scale Standard Deviation 4.04	-3.9 Scores on a scale Standard Deviation 3.48

SECONDARY outcome

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

Population: FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=43 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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): Changes From Baseline in OABSS Total Score Week 0; n=55,43	-1.8 Scores on a scale Standard Deviation 1.93	-1.5 Scores on a scale Standard Deviation 1.72
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score Week 12; n=54,42	-3.2 Scores on a scale Standard Deviation 3.29	-2.6 Scores on a scale Standard Deviation 2.89
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score Week 24;n=2,7	-2.0 Scores on a scale Standard Deviation 2.83	-1.6 Scores on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: Up to 48 weeks in Treatment Cycle 1

Population: Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.

An 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. SAE is defined as 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, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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-SAEs Any SAE	6 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Any non-SAE	29 Participants	53 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

An 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. SAE is defined as 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, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 1 comprised of all participants who received at least one dose of GSK1358820.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U Any SAE	5 Participants	—
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U Any non-SAE	49 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

An 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. SAE is defined as 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, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=88 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U Any SAE	5 Participants	—
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U Any non-SAE	40 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

An 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. SAE is defined as 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, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U Any SAE	0 Participants	—
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U Any non-SAE	22 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

An 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. SAE is defined as 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, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 3 comprised of all participants who received at least three doses of GSK1358820.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=43 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U Any SAE	1 Participants	—
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U Any non-SAE	19 Participants	—

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 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 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 specified time point were analyzed (represented by n=X) in category titles.

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: Placebo/GSK1358820 100 U SBP; Week 0; n=107	-1.4 Millimeter of mercury Standard Deviation 14.54	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 2; n=108	-2.0 Millimeter of mercury Standard Deviation 14.11	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 6; n=108	-2.9 Millimeter of mercury Standard Deviation 13.70	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 12; n=106	-0.8 Millimeter of mercury Standard Deviation 13.40	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 18; n=82	-2.6 Millimeter of mercury Standard Deviation 14.06	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 24; n=45	-1.4 Millimeter of mercury Standard Deviation 14.51	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 30; n=37	-2.8 Millimeter of mercury Standard Deviation 15.56	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 36; n=7	-1.9 Millimeter of mercury Standard Deviation 13.46	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 48; n=52	-1.4 Millimeter of mercury Standard Deviation 14.03	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 0; n=107	-0.7 Millimeter of mercury Standard Deviation 10.38	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 2; n=108	-0.7 Millimeter of mercury Standard Deviation 10.65	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 6; n=108	-1.5 Millimeter of mercury Standard Deviation 11.43	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 12; n=106	-1.5 Millimeter of mercury Standard Deviation 11.19	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 18; n=82	-1.6 Millimeter of mercury Standard Deviation 11.30	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 24; n=45	-1.8 Millimeter of mercury Standard Deviation 9.73	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 30; n=37	-1.3 Millimeter of mercury Standard Deviation 9.23	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 36; n=7	1.6 Millimeter of mercury Standard Deviation 7.18	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 48; n=52	-0.2 Millimeter of mercury Standard Deviation 8.30	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: GSK1358820 100 U/GSK1358820 100 U SBP; Week 0; n=87	-1.6 Millimeter of mercury Standard Deviation 12.72	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 2; n=87	-1.1 Millimeter of mercury Standard Deviation 15.93	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 6; n=86	-3.8 Millimeter of mercury Standard Deviation 16.05	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 12; n=85	-2.8 Millimeter of mercury Standard Deviation 13.94	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 18; n=39	-8.3 Millimeter of mercury Standard Deviation 12.85	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 24; n=19	1.2 Millimeter of mercury Standard Deviation 18.38	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 30; n=14	0.6 Millimeter of mercury Standard Deviation 10.80	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 48; n=45	-1.8 Millimeter of mercury Standard Deviation 16.33	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 0; n=87	-1.3 Millimeter of mercury Standard Deviation 9.59	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 2; n=87	-0.6 Millimeter of mercury Standard Deviation 10.17	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 6; n=86	-2.6 Millimeter of mercury Standard Deviation 11.67	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 12; n=85	-2.5 Millimeter of mercury Standard Deviation 10.55	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 18; n=39	-6.3 Millimeter of mercury Standard Deviation 9.93	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 24; n=19	-2.3 Millimeter of mercury Standard Deviation 11.57	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 30; n=14	-0.9 Millimeter of mercury Standard Deviation 9.53	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 48; n=45	-2.2 Millimeter of mercury Standard Deviation 9.74	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: Placebo/GSK1358820 100 U DBP; Week 0; n=56	-0.9 Millimeter of mercury Standard Deviation 10.19	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 0; n=56	-1.2 Millimeter of mercury Standard Deviation 14.48	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 2; n=56	-2.4 Millimeter of mercury Standard Deviation 12.28	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 6; n=55	-2.6 Millimeter of mercury Standard Deviation 15.91	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 12; n=53	-3.9 Millimeter of mercury Standard Deviation 17.70	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 18; n=19	-3.2 Millimeter of mercury Standard Deviation 12.08	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 24; n=1	-23.0 Millimeter of mercury 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 SBP and DBP: Placebo/GSK1358820 100 U SBP; Week 48; n=56	-1.7 Millimeter of mercury Standard Deviation 13.58	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 2; n=56	-2.5 Millimeter of mercury Standard Deviation 11.61	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 6; n=55	-1.4 Millimeter of mercury Standard Deviation 13.08	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 12; n=53	-3.2 Millimeter of mercury Standard Deviation 11.76	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 18; n=19	-2.3 Millimeter of mercury Standard Deviation 13.23	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 24; n=1	-19.0 Millimeter of mercury 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 SBP and DBP: Placebo/GSK1358820 100 U DBP; Week 48; n=56	-2.8 Millimeter of mercury Standard Deviation 11.24	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: GSK1358820 100 U/GSK1358820 100 U SBP; Week 0; n=43	-3.0 Millimeter of mercury Standard Deviation 15.49	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 2; n=43	-2.5 Millimeter of mercury Standard Deviation 16.00	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 6; n=43	-4.5 Millimeter of mercury Standard Deviation 15.85	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 12; n=40	-3.2 Millimeter of mercury Standard Deviation 17.50	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 18; n=27	-3.4 Millimeter of mercury Standard Deviation 13.58	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U SBP; Week 48; n=43	-4.7 Millimeter of mercury Standard Deviation 14.62	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 0; n=43	-1.1 Millimeter of mercury Standard Deviation 10.21	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 2; n=43	-3.1 Millimeter of mercury Standard Deviation 10.68	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 6; n=43	-3.7 Millimeter of mercury Standard Deviation 10.08	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 12; n=40	-1.2 Millimeter of mercury Standard Deviation 10.21	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 18; n=27	-1.5 Millimeter of mercury Standard Deviation 7.65	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U DBP; Week 48; n=43	-4.0 Millimeter of mercury Standard Deviation 10.95	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1) and Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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; n=124, 124	-2.2 Beats per minute Standard Deviation 8.39	-1.2 Beats per minute Standard Deviation 10.62
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 6; n=124, 123	-2.7 Beats per minute Standard Deviation 10.06	-0.8 Beats per minute Standard Deviation 10.56
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 12; n=122, 123	-3.8 Beats per minute Standard Deviation 9.18	-1.6 Beats per minute Standard Deviation 10.36
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 18; n=23, 65	-4.5 Beats per minute Standard Deviation 10.39	-3.8 Beats per minute Standard Deviation 10.11
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 24; n=17, 54	-6.6 Beats per minute Standard Deviation 13.24	-2.6 Beats per minute Standard Deviation 10.98
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 30; n=14, 47	-5.2 Beats per minute Standard Deviation 7.68	-2.7 Beats per minute Standard Deviation 9.94
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 36; n=12, 32	-5.7 Beats per minute Standard Deviation 8.58	-3.4 Beats per minute Standard Deviation 9.64
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 42; n=11, 27	2.3 Beats per minute Standard Deviation 10.69	-2.1 Beats per minute Standard Deviation 9.79
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate Week 48; n=16, 36	-3.8 Beats per minute Standard Deviation 8.69	-3.6 Beats per minute Standard Deviation 10.06

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36 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 specified time point were analyzed (represented by n=X) in category titles.

Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: Placebo/GSK1358820 100 U Week 0; n=107	-0.4 Beats per minute Standard Deviation 9.42	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 2; n=108	-1.8 Beats per minute Standard Deviation 10.06	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 6; n=108	-1.4 Beats per minute Standard Deviation 10.32	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 12; n=106	-4.3 Beats per minute Standard Deviation 10.03	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 18; n=82	-4.1 Beats per minute Standard Deviation 9.12	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 24; n=45	-0.9 Beats per minute Standard Deviation 9.43	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 30; n=37	-0.7 Beats per minute Standard Deviation 9.23	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 36; n=7	-0.6 Beats per minute Standard Deviation 5.88	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 48; n=52	-3.2 Beats per minute Standard Deviation 10.49	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: GSK1358820 100 U/GSK1358820 100 U Week 0; n=87	1.9 Beats per minute Standard Deviation 9.75	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 2; n=87	0.6 Beats per minute Standard Deviation 10.68	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 6; n=86	1.6 Beats per minute Standard Deviation 10.51	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 12; n=85	-1.8 Beats per minute Standard Deviation 11.01	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 18; n=39	-0.0 Beats per minute Standard Deviation 10.35	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 24; n=19	0.3 Beats per minute Standard Deviation 9.67	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 30; n=14	2.7 Beats per minute Standard Deviation 9.24	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 48; n=45	1.0 Beats per minute Standard Deviation 9.17	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: Placebo/GSK1358820 100 U Week 0; n=56	0.2 Beats per minute Standard Deviation 9.28	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 2; n=56	-2.3 Beats per minute Standard Deviation 9.26	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 6; n=55	-2.9 Beats per minute Standard Deviation 9.24	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 12; n=53	-3.8 Beats per minute Standard Deviation 10.28	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 18; n=19	-0.6 Beats per minute Standard Deviation 11.08	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U Week 24; n=1	6.0 Beats per minute 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 Heart Rate: Placebo/GSK1358820 100 U Week 48; n=56	-1.8 Beats per minute Standard Deviation 11.47	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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: GSK1358820 100 U/GSK1358820 100 U Week 0; n=43	1.2 Beats per minute Standard Deviation 12.33	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 2; n=43	-3.3 Beats per minute Standard Deviation 9.69	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 6; n=43	-3.1 Beats per minute Standard Deviation 10.19	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 12; n=40	-5.7 Beats per minute Standard Deviation 10.99	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 18; n=27	-3.7 Beats per minute Standard Deviation 11.57	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U Week 48; n=43	-2.5 Beats per minute Standard Deviation 11.20	—

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 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Temperature Week 2; n=124, 124	-0.04 Degree Celsius Standard Deviation 0.403	-0.02 Degree Celsius Standard Deviation 0.460
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 6; n=124, 123	-0.03 Degree Celsius Standard Deviation 0.452	-0.03 Degree Celsius Standard Deviation 0.497
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 12; n=122, 123	-0.13 Degree Celsius Standard Deviation 0.501	-0.04 Degree Celsius Standard Deviation 0.470
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 18; n=23, 65	-0.28 Degree Celsius Standard Deviation 0.540	-0.01 Degree Celsius Standard Deviation 0.571
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 24; n=17, 54	-0.26 Degree Celsius Standard Deviation 0.433	0.06 Degree Celsius Standard Deviation 0.497
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 30; n=14, 47	-0.17 Degree Celsius Standard Deviation 0.446	0.01 Degree Celsius Standard Deviation 0.450
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 36; n=12, 32	-0.11 Degree Celsius Standard Deviation 0.318	-0.03 Degree Celsius Standard Deviation 0.450
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 42; n=11, 27	-0.10 Degree Celsius Standard Deviation 0.436	-0.03 Degree Celsius Standard Deviation 0.525
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature Week 48; n=16, 36	0.05 Degree Celsius Standard Deviation 0.447	-0.01 Degree Celsius Standard Deviation 0.467

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 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 specified time point were analyzed (represented by n=X) in category titles.

Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Temperature: Placebo/GSK1358820 100 U Week 0; n=107	0.01 Degree Celsius Standard Deviation 0.505	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 2; n=108	-0.06 Degree Celsius Standard Deviation 0.485	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 6; n=108	-0.04 Degree Celsius Standard Deviation 0.433	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 12; n=106	-0.09 Degree Celsius Standard Deviation 0.446	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 18; n=82	-0.09 Degree Celsius Standard Deviation 0.469	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 24; n=45	-0.08 Degree Celsius Standard Deviation 0.526	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 30; n=37	-0.08 Degree Celsius Standard Deviation 0.458	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 36; n=7	0.06 Degree Celsius Standard Deviation 0.526	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 48; n=52	-0.12 Degree Celsius Standard Deviation 0.478	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Temperature: GSK1358820 100 U/GSK1358820 100 U Week 0; n=87	-0.01 Degree Celsius Standard Deviation 0.465	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 2; n=87	-0.02 Degree Celsius Standard Deviation 0.549	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 6; n=86	-0.02 Degree Celsius Standard Deviation 0.456	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 12; n=85	-0.02 Degree Celsius Standard Deviation 0.472	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 18; n=39	-0.02 Degree Celsius Standard Deviation 0.480	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 24; n=19	0.02 Degree Celsius Standard Deviation 0.459	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 30; n=14	-0.01 Degree Celsius Standard Deviation 0.403	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 48; n=45	0.02 Degree Celsius Standard Deviation 0.539	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Temperature: Placebo/GSK1358820 100 U Week 0; n=56	0.07 Degree Celsius Standard Deviation 0.507	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 2; n=56	0.01 Degree Celsius Standard Deviation 0.511	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 6; n=55	0.02 Degree Celsius Standard Deviation 0.471	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 12; n=53	0.01 Degree Celsius Standard Deviation 0.472	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 18; n=19	0.02 Degree Celsius Standard Deviation 0.527	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U Week 24; n=1	0.00 Degree Celsius 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 Temperature: Placebo/GSK1358820 100 U Week 48; n=56	-0.04 Degree Celsius Standard Deviation 0.500	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Temperature: GSK1358820 100 U/GSK1358820 100 U Week 0; n=43	-0.11 Degree Celsius Standard Deviation 0.429	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 2; n=43	-0.15 Degree Celsius Standard Deviation 0.502	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 6; n=43	-0.04 Degree Celsius Standard Deviation 0.530	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 12; n=40	-0.09 Degree Celsius Standard Deviation 0.471	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 18; n=27	-0.18 Degree Celsius Standard Deviation 0.481	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U Week 48; n=43	-0.17 Degree Celsius Standard Deviation 0.447	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Relative to Normal Range in Chemistry Results Week48:T Protein;To Normal or No Change; n=16,36	15 Participants	31 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To Normal or No Change; n=16,36	16 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid;To Normal or No Change; n=16,36	16 Participants	34 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid; To High; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week 12:Albumin; To Low; n=122, 122	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Albumin; To Normal or No Change; n=122, 122	122 Participants	121 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Albumin; To High; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week 48:Albumin; To Low; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Albumin; To Normal or No Change; n=16,36	16 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Albumin; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp; To Low; n=122, 122	1 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp;To Normal or No Change;n=122,122	116 Participants	117 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp; To High; n= 122 ,122	5 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp; To Low; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp;To Normal or No Change;n=16,36	15 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp; To High; n=16,36	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT;To Low; n= 122 ,122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT;To Normal or No Change; n=122, 122	120 Participants	117 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT; To High; n=122, 122	2 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT;To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT;To Normal or No Change; n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST;To Low; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST; To Normal or No Change; n=122, 122	122 Participants	119 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST; To High; n=122, 122	0 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST;To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST; To Normal or No Change; n=16,36	16 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST; To High; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil; To Low; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil;To Normal or No Change;n=122,122	122 Participants	122 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil; To High; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To Normal or No Change; n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil; To Low; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil;To Normal or NoChange; n=122,122	120 Participants	121 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil; To High; n=122, 122	2 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To Normal or No Change; n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To Low; n=122, 121	5 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To Normal or No Change; n=122, 121	117 Participants	117 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To High; n=122, 121	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To Low; n=16,35	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To Normal or No Change; n=16,35	15 Participants	32 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To High; n=16,35	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To Low; n=122, 122	0 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To Normal or No Change; n=122,122	121 Participants	119 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To High; n=122, 122	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To Low; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To Normal or No Change; n=16,36	16 Participants	34 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To High; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine; To Low; n=122, 122	4 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine;To Normal or NoChange; n=122,122	114 Participants	116 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine; To High; n=122, 122	4 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To Normal or No Change; n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To Low; n=122, 123	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To Normal or No Change; n=122, 123	101 Participants	106 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To High; n=122, 123	20 Participants	17 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To Normal or No Change; n=16,36	15 Participants	31 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To High; n=16,36	1 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium; To Low; n=122, 122	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium;To Normal or No Change; n=122,122	121 Participants	118 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium; To High; n=122, 122	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To Low; n=16,36	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To Normal or No Change; n=16,36	15 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium; To Low; n=122, 122	0 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium;To Normal or No Change; n=122, 122	122 Participants	116 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium; To High; n=122, 122	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium; To Low; n=16,36	0 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium;To Normal or No Change; n=16,36	16 Participants	32 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium; To High; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:T Protein; To Low; n=122, 122	14 Participants	14 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12: T Protein;To Normal or No Change;n=122,122	108 Participants	108 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:T Protein; To High; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein; To Low; n=16,36	1 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Urea/BUN; To Low; n=122, 122	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12Urea/BUN; To Normal or No Change; n=122, 122	119 Participants	116 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Urea/BUN; To High; n=122, 122	2 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To High; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid; To Low; n=122, 122	1 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid;To Normal or No Change;n=122, 122	116 Participants	117 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid; To High; n=122, 122	5 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid; To Low; n=16,36	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Relative to Normal Range in Chemistry Results Week48:Calcium; To High; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium; To Low; n=106,85	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid; To High; n=52,45	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week 12:Albumin; To Low; n=106,85	3 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Albumin; To Normal or No Change; n=106,85	103 Participants	85 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Albumin; To High; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week 48:Albumin; To Low; n=52,45	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Albumin; To Normal or No Change; n=52,45	52 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Albumin; To High; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp; To Low; n=106,85	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp;To Normal or No Change;n=106,85	98 Participants	81 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp; To High; n=106,85	7 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp; To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp;To Normal or No Change;n=52,45	49 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp; To High; n=52,45	3 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT;To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT;To Normal or No Change; n=106,85	104 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT; To High; n=106,85	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT;To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT;To Normal or No Change; n=52,45	50 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT; To High; n=52,45	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST;To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST; To Normal or No Change; n=106,85	103 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST; To High; n=106,85	3 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST;To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST; To Normal or No Change; n=52,45	50 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST; To High; n=52,45	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil; To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil;To Normal or No Change;n=106,85	106 Participants	84 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil; To High; n=106,85	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To Normal or No Change; n=52,45	52 Participants	45 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To High; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil; To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil;To Normal or NoChange; n=106,85	104 Participants	84 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil; To High; n=106,85	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To Normal or No Change; n=52,45	52 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To High; n=52,45	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To Low; n=106,85	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To Normal or No Change; n=106,85	105 Participants	84 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To High; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To Low; n=52,45	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To Normal or No Change; n=52,45	51 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To Low; n=106,85	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To Normal or No Change; n=106,85	103 Participants	82 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To High; n=106,85	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To Low; n=52,45	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To Normal or No Change; n=52,45	51 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To High; n=52,45	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine; To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine;To Normal or NoChange; n=106,85	104 Participants	84 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine; To High; n=106,85	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To Low; n=52,45	3 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To Normal or No Change; n=52,45	45 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To High; n=52,45	4 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To Low; n=106,85	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To Normal or No Change; n=106,85	90 Participants	72 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To High; n=106,85	15 Participants	11 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To Normal or No Change; n=52,45	44 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To High; n=52,45	8 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium;To Normal or No Change; n=106,85	105 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium; To High; n=106,85	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To Low; n=52,45	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To Normal or No Change; n=52,45	52 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To High; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium; To Low; n=106,85	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium;To Normal or No Change; n=106,85	105 Participants	84 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium; To High; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium; To Low; n=52,45	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium;To Normal or No Change; n=52,45	50 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium; To High; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:T Protein; To Low; n=106,85	10 Participants	14 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12: T Protein;To Normal or No Change;n=106,85	95 Participants	71 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:T Protein; To High; n=106,85	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein; To Low; n=52,45	2 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein;To Normal or No Change; n=52,45	50 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein; To High; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Urea/BUN; To Low; n=106,85	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12Urea/BUN; To Normal or No Change; n=106,85	101 Participants	78 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Urea/BUN; To High; n=106,85	3 Participants	5 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To Low; n=52,45	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To Normal or No Change; n=52,45	47 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To High; n=52,45	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid; To Low; n=106,85	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid;To Normal or No Change;n=106,85	98 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid; To High; n=106,85	6 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid; To Low; n=52,45	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid;To Normal or No Change; n=52,45	50 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Relative to Normal Range in Chemistry Results Week48:Albumin; To Normal or No Change; n=55,43	54 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week 12:Albumin; To Low; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Albumin; To Normal or No Change; n=53,40	52 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Albumin; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week 48:Albumin; To Low; n=55,43	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Albumin; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp; To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp;To Normal or No Change;n=53,40	49 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Alk Phosp; To High; n=53,40	4 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp; To Low; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp;To Normal or No Change;n=55,43	50 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Alk Phosp; To High; n=55,43	4 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT;To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT;To Normal or No Change; n=53,40	53 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:ALT; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT;To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT;To Normal or No Change; n=55,43	55 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:ALT; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST;To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST; To Normal or No Change; n=53,40	53 Participants	39 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:AST; To High; n=53,40	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST;To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST; To Normal or No Change; n=55,43	55 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:AST; To High; n=55,43	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil; To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil;To Normal or No Change;n=53,40	53 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Direct Bil; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To Normal or No Change; n=55,43	54 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Direct Bil; To High; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil; To Low; n=53,40	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil;To Normal or NoChange; n=53,40	51 Participants	39 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Total Bil; To High; n=53,40	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To Normal or No Change; n=55,43	54 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Total Bil; To High; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To Low; n=53,40	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To Normal or No Change; n=53,40	51 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Calcium; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To Low; n=55,43	3 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To Normal or No Change; n=55,43	52 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Calcium; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To Low; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To Normal or No Change; n=53,40	52 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Chloride; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To Low; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To Normal or No Change; n=55,43	53 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Chloride; To High; n=55,43	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine; To Low; n=53,40	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine;To Normal or NoChange; n=53,40	48 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Creatinine; To High; n=53,40	3 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To Low; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To Normal or No Change; n=55,43	51 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Creatinine; To High; n=55,43	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To Low; n=53,40	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To Normal or No Change; n=53,40	45 Participants	32 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Glucose; To High; n=53,40	6 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To Low; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To Normal or No Change; n=55,43	44 Participants	32 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Glucose; To High; n=55,43	10 Participants	11 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium; To Low; n=53,40	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium;To Normal or No Change; n=53,40	52 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Potassium; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To Low; n=55,43	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To Normal or No Change; n=55,43	54 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Potassium; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium; To Low; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium;To Normal or No Change; n=53,40	52 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Sodium; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium; To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium;To Normal or No Change; n=55,43	55 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Sodium; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:T Protein; To Low; n=53,40	3 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12: T Protein;To Normal or No Change;n=53,40	50 Participants	33 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:T Protein; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein; To Low; n=55,43	4 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein;To Normal or No Change; n=55,43	51 Participants	34 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:T Protein; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Urea/BUN; To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12Urea/BUN; To Normal or No Change; n=53,40	49 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Urea/BUN; To High; n=53,40	4 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To Low; n=55,43	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To Normal or No Change; n=55,43	53 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Urea/BUN; To High; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid; To Low; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid;To Normal or No Change;n=53,40	49 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week12:Uric acid; To High; n=53,40	3 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid; To Low; n=55,43	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid;To Normal or No Change; n=55,43	51 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results Week48:Uric acid; To High; n=55,43	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils (Eosino), 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Relative to Normal Range in Hematology Parameters Week48: Eosino;To Normal or No Change;n=16,36	15 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Eosino; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Eosino;To Normal or No Change;n=122,122	120 Participants	120 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Eosino; To High; n=122, 122	2 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Eosino; To High; n=16,36	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12: Hb;To Low;n=122, 123	5 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Hb; To Normal or No Change; n=122, 123	116 Participants	117 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12: Hb; To High; n=122, 123	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48: Hb;To Low;n=16,36	2 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Hb; To Normal or No Change; n=16,36	14 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48: Hb; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Hct; To Low; n=122, 123	1 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Hct;To Normal or No Change; n=122, 123	119 Participants	117 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Hct; To High; n=122, 123	2 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Hct; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Hct;To Normal or No Change; n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Hct; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Lympho; To Low; n=122, 122	0 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Lympho; To High; n=122, 122	1 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Lympho; To Normal or No Change; n=122, 122	121 Participants	115 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Lympho; To Low; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Lympho; To Normal or No Change; n=16,36	16 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Lympho; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Monocytes; To Low; n=122, 122	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Monocytes;To Normal or No Change;n=122,122	120 Participants	122 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Monocytes; To High; n=122, 122	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Monocytes; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Monocytes;To Normal or No Change;n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Monocytes; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:N bands; To Low; n=122, 122	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:N bands;To Normal or No Change;n=122,122	119 Participants	120 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:N bands; To High; n=122, 122	2 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:N bands; To Low; n=16,36	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:N bands;To Normal or No Change;n=16,36	15 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:N bands; To High; n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro; To Low; n=122, 122	2 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro;To Normal or No Change;n=122,122	120 Participants	118 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro; To High; n=122, 122	0 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro; To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro;To Normal or No Change;n=16,36	16 Participants	33 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro; To High; n=16,36	0 Participants	3 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:PC; To Low; n=122, 123	4 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:PC; To Normal or No Change; n=122, 123	116 Participants	118 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: PC; To High;n=122, 123	2 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:PC; To Low; n=16,36	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:PC; To Normal or No Change; n=16,36	15 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: PC; To High;n=16,36	0 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count; To Low;n=122, 123	6 Participants	7 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count;To Normal or No Change;n=122,123	114 Participants	114 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count;To High;n=122, 123	2 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count; To Low;n=16,36	1 Participants	2 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count;To Normal or No Change;n=16,36	15 Participants	34 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count;To High;n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count; To Low;n=122, 123	1 Participants	6 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count;To Normal or No Change;n=122,123	120 Participants	116 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count; To High; n=122,123	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count; To Low;n=16,36	1 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count;To Normal or No Change;n=16,36	15 Participants	35 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils;To Low; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils;To Normal or No Change;n=122,122	122 Participants	122 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils; To High; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils;To Low; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils;To Normal or No Change;n=16,36	16 Participants	36 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils; To High; n=16,36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Eosino; To Low; n=122, 122	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count; To High; n=16,36	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Relative to Normal Range in Hematology Parameters Week48:Monocytes; To High; n=52,44	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:N bands;To Normal or No Change;n=52,44	52 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils;To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils;To Normal or No Change;n=106,85	106 Participants	85 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils; To High; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils;To Low; n=52,44	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils;To Normal or No Change;n=52,44	52 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils; To High; n=52,44	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Eosino; To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Eosino;To Normal or No Change;n=106,85	105 Participants	85 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Eosino; To High; n=106,85	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Eosino; To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Eosino;To Normal or No Change;n=52,45	51 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Eosino; To High; n=52,45	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12: Hb;To Low;n=106,85	4 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Hb; To Normal or No Change; n=106,85	101 Participants	81 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12: Hb; To High; n=106,85	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48: Hb;To Low;n=52,45	3 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Hb; To Normal or No Change; n=52,45	49 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48: Hb; To High; n=52,45	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Hct; To Low; n=106,85	3 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Hct;To Normal or No Change; n=106,85	100 Participants	80 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Hct; To High; n=106,85	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Hct; To Low; n=52,45	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Hct;To Normal or No Change; n=52,45	48 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Hct; To High; n=52,45	3 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Lympho; To Low; n=106,85	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Lympho; To Normal or No Change; n=106,85	101 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Lympho; To High; n=106,85	5 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Lympho; To Low; n=52,44	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Lympho; To Normal or No Change; n=52,44	49 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Lympho; To High; n=52,44	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Monocytes; To Low; n=106,85	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Monocytes;To Normal or No Change;n=106,85	105 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Monocytes; To High; n=106,85	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Monocytes; To Low; n=52,44	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Monocytes;To Normal or No Change;n=52,44	52 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:N bands; To Low; n=106,85	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:N bands;To Normal or No Change;n=106,85	104 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:N bands; To High; n=106,85	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:N bands; To Low; n=52,44	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:N bands; To High; n=52,44	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro; To Low; n=106,85	3 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro;To Normal or No Change;n=106,85	103 Participants	82 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro; To High; n=106,85	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro; To Low; n=52,44	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro;To Normal or No Change;n=52,44	50 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro; To High; n=52,44	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:PC; To Low; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:PC; To Normal or No Change; n=106,85	105 Participants	83 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: PC; To High;n=106,85	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:PC; To Low; n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:PC; To Normal or No Change; n=52,45	51 Participants	45 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: PC; To High;n=52,45	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count; To Low;n=106,85	5 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count;To Normal or No Change;n=106,85	98 Participants	80 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count;To High;n=106,85	3 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count; To Low;n=52,45	5 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count;To Normal or No Change;n=52,45	47 Participants	44 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count;To High;n=52,45	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count; To Low;n=106,85	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count;To Normal or No Change;n=106,85	106 Participants	82 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count; To High; n=106,85	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count; To Low;n=52,45	0 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count;To Normal or No Change;n=52,45	52 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count; To High; n=52,45	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Relative to Normal Range in Hematology Parameters Week 12:Hct; To Low; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count;To Normal or No Change;n=53,40	50 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Lympho; To Normal or No Change; n=53,40	53 Participants	39 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Lympho; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Lympho; To Low; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Lympho; To Normal or No Change; n=55,43	51 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils;To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils;To Normal or No Change;n=53,40	53 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Basophils; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils;To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils;To Normal or No Change;n=55,43	55 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Basophils; To High; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Eosino; To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Eosino;To Normal or No Change;n=53,40	52 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Eosino; To High; n=53,40	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Eosino; To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Eosino;To Normal or No Change;n=55,43	54 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Eosino; To High; n=55,43	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12: Hb;To Low;n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Hb; To Normal or No Change; n=53,40	51 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12: Hb; To High; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48: Hb;To Low;n=55,43	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Hb; To Normal or No Change; n=55,43	54 Participants	39 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48: Hb; To High; n=55,43	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: Hct;To Normal or No Change; n=53,40	51 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Hct; To High; n=53,40	1 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Hct; To Low; n=55,43	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: Hct;To Normal or No Change; n=55,43	53 Participants	41 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Hct; To High; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Lympho; To Low; n=53,40	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Lympho; To High; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Monocytes; To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:Monocytes;To Normal or No Change;n=53,40	53 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:Monocytes; To High; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:Monocytes; To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Monocytes;To Normal or No Change;n=55,43	54 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:Monocytes; To High; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:N bands; To Low; n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:N bands;To Normal or No Change;n=53,40	50 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:N bands; To High; n=53,40	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:N bands; To Low; n=55,43	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:N bands;To Normal or No Change;n=55,43	52 Participants	43 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:N bands; To High; n=55,43	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro; To Low; n=53,40	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro;To Normal or No Change;n=53,40	53 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:T Neutro; To High; n=53,40	0 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro; To Low; n=55,43	2 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro;To Normal or No Change;n=55,43	52 Participants	39 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:T Neutro; To High; n=55,43	1 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:PC; To Low; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 12:PC; To Normal or No Change; n=53,40	52 Participants	40 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12: PC; To High;n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:PC; To Low; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week 48:PC; To Normal or No Change; n=55,43	54 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48: PC; To High;n=55,43	1 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count; To Low;n=53,40	2 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count;To Normal or No Change;n=53,40	51 Participants	38 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:RBC count;To High;n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count; To Low;n=55,43	1 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count;To Normal or No Change;n=55,43	54 Participants	37 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:RBC count;To High;n=55,43	0 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count; To Low;n=53,40	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week12:WBC count; To High; n=53,40	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count; To Low;n=55,43	3 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count;To Normal or No Change;n=55,43	51 Participants	42 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters Week48:WBC count; To High; n=55,43	1 Participants	0 Participants

SECONDARY outcome

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

Population: SPDB Population.

Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; No Change/Decreased	98 Participants	92 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Any Increase	26 Participants	32 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to Traces	7 Participants	11 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 1+	14 Participants	8 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 2+	4 Participants	7 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 3+	1 Participants	6 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 4+	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; No Change/Decreased	105 Participants	111 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Any Increase	19 Participants	13 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to Traces	7 Participants	5 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 1+	9 Participants	7 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 2+	3 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 3+	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 4+	0 Participants	0 Participants

SECONDARY outcome

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

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 3+, n=108,88	4 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; No Change/Decreased, n=108,88	70 Participants	54 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Any Increase, n=108,88	38 Participants	34 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to Traces, n=108,88	12 Participants	10 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 1+, n=108,88	11 Participants	10 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 2+, n=108,88	11 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 4+, n=108,88	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein;No Change/Decreased, n=108,88	80 Participants	72 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein;Any Increase, n=108,88	28 Participants	16 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to Traces, n=108,88	14 Participants	7 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 1+, n=108,88	8 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 2+, n=108,88	4 Participants	1 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 3+, n=108,88	2 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 4+, n=108,88	0 Participants	0 Participants

SECONDARY outcome

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

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to Traces, n=56,43	3 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; No Change/Decreased, n=56,43	40 Participants	25 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Any Increase, n=56,43	16 Participants	18 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 1+, n=56,43	5 Participants	8 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 2+, n=56,43	5 Participants	3 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 3+, n=56,43	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Occult Blood; Increase to 4+, n=56,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein;No Change/Decreased, n=56,43	44 Participants	37 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein;Any Increase, n=56,43	12 Participants	6 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to Traces, n=56,43	3 Participants	4 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 1+, n=56,43	4 Participants	2 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 2+, n=56,43	5 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 3+, n=56,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline Protein; Increase to 4+, n=56,43	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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)	10 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U	30 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=88 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U	19 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U	15 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.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=43 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U	14 Participants	—

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 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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; n=124, 123	1.02 Milliliter Standard Deviation 28.801	44.99 Milliliter Standard Deviation 76.009
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 6; n=124, 122	1.42 Milliliter Standard Deviation 36.387	25.62 Milliliter Standard Deviation 50.820
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 12; n=122, 123	4.05 Milliliter Standard Deviation 39.432	16.81 Milliliter Standard Deviation 35.717
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 18; n=23, 65	8.91 Milliliter Standard Deviation 52.093	16.10 Milliliter Standard Deviation 42.109
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 24; n=17, 54	2.92 Milliliter Standard Deviation 37.846	18.06 Milliliter Standard Deviation 45.829
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 30; n=14, 47	19.96 Milliliter Standard Deviation 78.149	13.33 Milliliter Standard Deviation 39.357
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 36; n=12, 32	2.25 Milliliter Standard Deviation 35.433	9.87 Milliliter Standard Deviation 36.672
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 42; n=11, 27	-15.26 Milliliter Standard Deviation 42.147	10.83 Milliliter Standard Deviation 38.952
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume Week 48; n=16, 36	10.93 Milliliter Standard Deviation 69.151	5.56 Milliliter Standard Deviation 35.878

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 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 specified time point were analyzed (represented by n=X) in category titles.

PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U Week 48; n=52	10.98 Milliliter Standard Deviation 40.499	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 2; n=108	34.87 Milliliter Standard Deviation 56.255	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 6; n=108	30.11 Milliliter Standard Deviation 53.625	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 12; n=106	19.33 Milliliter Standard Deviation 40.498	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 18; n=82	15.09 Milliliter Standard Deviation 46.604	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 24; n=45	19.11 Milliliter Standard Deviation 40.219	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 30; n=37	5.66 Milliliter Standard Deviation 29.172	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 36; n=7	3.69 Milliliter Standard Deviation 28.760	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U Week 2; n=86	36.72 Milliliter Standard Deviation 54.171	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 6; n=86	30.26 Milliliter Standard Deviation 43.818	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 12; n=85	17.06 Milliliter Standard Deviation 42.424	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 18; n=39	20.15 Milliliter Standard Deviation 48.934	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 24; n=19	5.38 Milliliter Standard Deviation 25.570	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 30; n=14	18.61 Milliliter Standard Deviation 31.086	—
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 48; n=45	12.18 Milliliter Standard Deviation 46.394	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U Week 2; n=56	49.97 Milliliter Standard Deviation 64.295	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 6; n=55	36.32 Milliliter Standard Deviation 49.891	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 12; n=53	25.20 Milliliter Standard Deviation 49.651	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 18; n=19	32.57 Milliliter Standard Deviation 59.514	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U Week 24; n=1	39.10 Milliliter 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 PVR Urine Volume: Placebo/GSK1358820 100 U Week 48; n=56	26.65 Milliliter Standard Deviation 54.171	—

SECONDARY outcome

Timeframe: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U Week 2; n=43	50.13 Milliliter Standard Deviation 59.960	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 6; n=43	28.09 Milliliter Standard Deviation 42.401	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 12; n=40	24.96 Milliliter Standard Deviation 42.308	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 18; n=27	14.54 Milliliter Standard Deviation 42.237	—
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U Week 48; n=43	22.85 Milliliter Standard Deviation 48.338	—

SECONDARY outcome

Timeframe: Up to 48 weeks in Treatment Cycle 1

Population: SPDB Population.

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 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR	2 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

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 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U	3 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

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 1: Placebo n=88 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U	3 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

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 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U	2 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

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 1: Placebo n=43 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U/GSK1358820 100 U	0 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks in Treatment Cycle 1

Population: SPDB Population.

The kidney and bladder ultrasound was performed 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 with abnormal findings after kidney and bladder ultrasound have been presented.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Undergoing Kidney and Bladder Ultrasound Kidney ultrasound	3 Participants	4 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound Bladder ultrasound	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

The kidney and bladder ultrasound was performed 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 with abnormal findings after kidney and bladder ultrasound have been presented.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U Kidney ultrasound	2 Participants	—
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U Bladder ultrasound	0 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

The kidney and bladder ultrasound was performed 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 with abnormal findings after kidney and bladder ultrasound have been presented.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=88 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U Kidney ultrasound	2 Participants	—
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U Bladder ultrasound	0 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

The kidney and bladder ultrasound was performed 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 with abnormal findings after kidney and bladder ultrasound have been presented.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=56 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U Kidney ultrasound	1 Participants	—
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U Bladder ultrasound	0 Participants	—

SECONDARY outcome

Timeframe: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

The kidney and bladder ultrasound was performed 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 with abnormal findings after kidney and bladder ultrasound have been presented.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=43 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U Kidney ultrasound	0 Participants	—
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U Bladder ultrasound	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 specified time point were analyzed (represented by n=X) in category titles.

Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QT interval corrected for heart rate (QTc) value is machine-read or manually over-read. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=124 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 Electrocardiogram (ECG) Findings Week 48; CS; n=16, 36	0 Participants	0 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings Baseline; NCS; n=124, 124	25 Participants	31 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings Baseline; CS; n=124, 124	3 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings Week 12; NCS; n=122, 123	28 Participants	28 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings Week 12; CS; n=122, 123	1 Participants	1 Participants
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings Week 48; NCS; n=16, 36	1 Participants	6 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. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 ECG Findings Week 48; CS; n=52,45	1 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings Week 12; NCS; n=106,85	29 Participants	25 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings Week 12; CS; n=106,85	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings Week 48; NCS; n=52,45	11 Participants	13 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. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1: Placebo n=108 Participants Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 Participants Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 ECG Findings Week 12; NCS; n=53,40	10 Participants	9 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings Week 48; CS; n=55,43	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings Week 12; CS; n=53,40	0 Participants	0 Participants
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings Week 48; NCS; n=55,43	17 Participants	12 Participants

Adverse Events

Treatment Cycle 1: Placebo

Serious events: 6 serious events

Other events: 29 other events

Deaths: 0 deaths

Treatment Cycle 1: GSK1358820 100 U

Serious events: 8 serious events

Other events: 53 other events

Deaths: 0 deaths

Treatment Cycle 2: Placebo / GSK1358820 100 U

Serious events: 5 serious events

Other events: 49 other events

Deaths: 0 deaths

Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U

Serious events: 5 serious events

Other events: 40 other events

Deaths: 0 deaths

Treatment Cycle 3: Placebo / GSK1358820 100 U

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Cycle 1: Placebo n=124 participants at risk Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 participants at risk Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U n=108 participants at risk Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U n=88 participants at risk Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) until Week 36 after the first treatment.	Treatment Cycle 3: Placebo / GSK1358820 100 U n=56 participants at risk Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U n=43 participants at risk Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 3) until Week 36 after the first treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.93% 1/108 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Nervous system disorders Cerebral infarction	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Nervous system disorders Dysarthria	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Hepatobiliary disorders Cholangitis acute	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Injury, poisoning and procedural complications Femur fracture	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Infections and infestations Chronic sinusitis	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Infections and infestations Pneumonia	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Infections and infestations Pyelonephritis acute	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Endocrine disorders Hypothyroidism	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Eye disorders Macular fibrosis	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.81% 1/124 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Nervous system disorders Parkinsonism	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.93% 1/108 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Renal and urinary disorders Nephrolithiasis	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.93% 1/108 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Ear and labyrinth disorders Vertigo positional	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.93% 1/108 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.93% 1/108 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Vascular disorders Aortic aneurysm	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.93% 1/108 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Gastrointestinal disorders Large intestine polyp	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	2.3% 1/43 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	2.3% 1/43 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Injury, poisoning and procedural complications Fractured ischium	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/108 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.1% 1/88 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).

Other adverse events

Other adverse events
Measure	Treatment Cycle 1: Placebo n=124 participants at risk Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1).	Treatment Cycle 1: GSK1358820 100 U n=124 participants at risk Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) 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 100 U n=108 participants at risk Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 2).	Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U n=88 participants at risk Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) until Week 36 after the first treatment.	Treatment Cycle 3: Placebo / GSK1358820 100 U n=56 participants at risk Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 mL each) 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 GSK1358820 100 U in Treatment Phase 2 (Treatment Cycle 3).	Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U n=43 participants at risk Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 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 100 U (open-label) in Treatment Phase 2 (Treatment Cycle 3) until Week 36 after the first treatment.
Infections and infestations Nasopharyngitis	10.5% 13/124 • Number of events 14 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	17.7% 22/124 • Number of events 26 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	13.0% 14/108 • Number of events 18 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	15.9% 14/88 • Number of events 14 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	8.9% 5/56 • Number of events 8 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	11.6% 5/43 • Number of events 6 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Infections and infestations Urinary tract infection	8.1% 10/124 • Number of events 11 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	17.7% 22/124 • Number of events 31 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	27.8% 30/108 • Number of events 40 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	21.6% 19/88 • Number of events 22 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	26.8% 15/56 • Number of events 19 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	32.6% 14/43 • Number of events 17 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Infections and infestations Cystitis	1.6% 2/124 • Number of events 2 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	7.3% 9/124 • Number of events 9 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	3.7% 4/108 • Number of events 5 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	5.7% 5/88 • Number of events 5 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	16.1% 9/56 • Number of events 13 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	7.0% 3/43 • Number of events 3 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Renal and urinary disorders Dysuria	2.4% 3/124 • Number of events 4 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	11.3% 14/124 • Number of events 15 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	3.7% 4/108 • Number of events 4 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	5.7% 5/88 • Number of events 5 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	5.4% 3/56 • Number of events 3 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	7.0% 3/43 • Number of events 3 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Renal and urinary disorders Urinary retention	1.6% 2/124 • Number of events 2 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	5.6% 7/124 • Number of events 7 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	3.7% 4/108 • Number of events 4 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/88 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/56 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	0.00% 0/43 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).
Investigations Residual urine volume increased	0.00% 0/124 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	5.6% 7/124 • Number of events 7 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	2.8% 3/108 • Number of events 3 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	6.8% 6/88 • Number of events 6 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	1.8% 1/56 • Number of events 1 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 U).	7.0% 3/43 • Number of events 4 • SAEs and Non-SAEs were collected from start of the first treatment up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycles 2 and 3 SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 100 U) and Safety Populations 1 (Treatment Cycle2:Placebo/GSK1358820 100 U), 2 (Treatment Cycle 2:GSK1358820 100 U/GSK1358820 100 U and Treatment Cycle 3: Placebo/GSK1358820 100 U) and 3 (Treatment Cycle3:GSK1358820 100 U/GSK1358820 100 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.
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