Trial Outcomes & Findings for Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 (NCT NCT02660359)

NCT ID: NCT02660359

Last Updated: 2022-09-28

Results Overview

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 258 participants
• Primary outcome timeframe: Baseline and Week 6 of DBPC Cycle
• Results posted on: 2022-09-28

Participant Flow

A total of 258 subjects with urinary incontinence (UI) caused by neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS) were enrolled at 67 study sites worldwide. One of the 258 randomised subjects did not receive any treatment. The study was terminated early by the sponsor due to lack of recruitment.

Subjects were randomised to 1 of 4 sequences: A) placebo in a double-blind placebo-controlled (DBPC) cycle then Dysport® 600 Units (U) in subsequent double-blind cycles: B) placebo in DBPC cycle then Dysport® 800 U in subsequent cycles: C) Dysport® 600 U in all cycles: D) Dysport® 800 U in all cycles. The minimum retreatment interval was 12 weeks.

Participant milestones

Measure	Placebo Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 millilitres (mL) divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Overall Study STARTED	86	86	85
Overall Study Subjects Entered in the Dysport Cycles	56	86	85
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	86	86	84

Reasons for withdrawal

Measure	Placebo Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 millilitres (mL) divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Overall Study Protocol Deviation	0	0	1
Overall Study Sponsor Decision to Terminate Study	73	75	71
Overall Study Lack of Efficacy	1	1	1
Overall Study Adverse Event	0	1	0
Overall Study Other	2	1	3
Overall Study Withdrawal by Subject	7	5	8
Overall Study Lost to Follow-up	3	3	0

Baseline Characteristics

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

Baseline characteristics by cohort

Measure	Placebo n=86 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=86 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=85 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Total n=257 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	82 Participants n=7 Participants	77 Participants n=5 Participants	239 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 13.16 • n=5 Participants	42.5 years STANDARD_DEVIATION 12.10 • n=7 Participants	42.0 years STANDARD_DEVIATION 14.72 • n=5 Participants	42.2 years STANDARD_DEVIATION 13.31 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	95 Participants n=4 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	57 Participants n=7 Participants	55 Participants n=5 Participants	162 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	52 Participants n=7 Participants	56 Participants n=5 Participants	163 Participants n=4 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	38 Participants n=4 Participants
Aetiology of NDO SCI	62 Participants n=5 Participants	64 Participants n=7 Participants	65 Participants n=5 Participants	191 Participants n=4 Participants
Aetiology of NDO MS	24 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	66 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.

Outcome measures

Measure	Placebo n=76 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=82 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=73 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle	-12.86 Weekly UI episodes Standard Error 1.95	-21.83 Weekly UI episodes Standard Error 1.91	-22.62 Weekly UI episodes Standard Error 1.88

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded. Percentage of subjects with no episodes of UI (≥100% Improvement) was calculated as: Total number of subjects with no weekly number of UI episodes at Week 6 / Total number of subjects with any number of UI events at Week 6.

Outcome measures

Measure	Placebo n=76 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=82 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=73 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle	1.3 Percentage of Subjects	36.6 Percentage of Subjects	26.0 Percentage of Subjects

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The percentage of subjects showing an improvement of ≥30%, ≥50% and ≥75% was calculated as: Total number of subjects with UI response level >=30% or >=50% or >=75% improvement at Week 6 / Total number of subjects with any UI response at Week 6.

Outcome measures

Measure	Placebo n=76 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=82 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=73 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle ≥75% Improvement	17.1 Percentage of Subjects	62.2 Percentage of Subjects	50.7 Percentage of Subjects
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle ≥30% Improvement	55.3 Percentage of Subjects	81.7 Percentage of Subjects	76.7 Percentage of Subjects
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle ≥50% Improvement	38.2 Percentage of Subjects	72.0 Percentage of Subjects	61.6 Percentage of Subjects

SECONDARY outcome

Timeframe: Day of first treatment (baseline) to day of retreatment, up to 2 years

Population: Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment).

Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined and subjects with no retreatment were censored at the last visit.

Outcome measures

Measure	Placebo n=86 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=86 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=85 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Median Time Between Treatments	132.0 Days Interval 8.0 to 644.0	238.5 Days Interval 57.0 to 651.0	210.0 Days Interval 56.0 to 649.0

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the mITT population (all randomised subjects who received at least 1 administration of study treatment). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis.

Outcome measures

Measure	Placebo n=74 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=77 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=72 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle	-6.00 mL Standard Error 17.80	90.14 mL Standard Error 17.45	84.78 mL Standard Error 17.22

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA).

Outcome measures

Measure	Placebo n=62 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=76 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=63 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle	3.5 mL Standard Error 22.83	178.5 mL Standard Error 21.38	171.9 mL Standard Error 21.58

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA.

Outcome measures

Measure	Placebo n=54 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=71 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=57 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle	-3.7 centimetres of water Standard Error 3.84	-36.7 centimetres of water Standard Error 3.48	-36.2 centimetres of water Standard Error 3.51

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA.

Outcome measures

Measure	Placebo n=60 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=72 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=58 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle	15.9 mL Standard Error 23.34	168.7 mL Standard Error 22.09	185.5 mL Standard Error 22.80

SECONDARY outcome

Timeframe: Baseline and Week 6 of DBPC Cycle

Population: Results are presented for the urodynamic population (all subjects in the mITT population included in the urodynamic subset at randomisation). Subjects were analysed as randomised (planned treatment). Only subjects with data available for analysis at Week 6 of DBPC cycle are presented.

Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the occurrence of IDCs. The percentage of subjects without IDCs at 6 weeks after the first study treatment was recorded.

Outcome measures

Measure	Placebo n=59 Participants Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=74 Participants Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=58 Participants Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle	3.4 Percentage of Subjects	52.7 Percentage of Subjects	50.0 Percentage of Subjects

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Dysport® 600 U

Serious events: 9 serious events

Other events: 40 other events

Deaths: 1 deaths

Dysport® 800 U

Serious events: 8 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=85 participants at risk Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=87 participants at risk Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=85 participants at risk Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Cerebrovascular accident	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Multiple sclerosis relapse	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Ataxia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Multiple sclerosis	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
General disorders Chest pain	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
General disorders Gait disturbance	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Renal and urinary disorders Haematuria	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Blood and lymphatic system disorders Anaemia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Urinary tract infection	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Diverticulitis	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Osteomyelitis	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Osteomyelitis chronic	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Perineal abscess	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Soft tissue infection	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Testicular abscess	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Urosepsis	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Orchitis	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).

Other adverse events

Measure	Placebo n=85 participants at risk Subjects were administered placebo on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 600 U n=87 participants at risk Subjects were administered Dysport® 600 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.	Dysport® 800 U n=85 participants at risk Subjects were administered Dysport® 800 U on Day 1 of the DBPC cycle. All study treatments were injected into the detrusor muscle via cystoscopy in a total volume of 15 mL divided into 30 injection points of 0.5 mL each. Subjects were followed-up by telephone at Week 1 and Week 4; and attended clinic visits at Week 2, Week 6 (primary study timepoint), and Week 12. Thereafter telephone visits were scheduled every 12 weeks until end of study, or until retreatment was required.
Nervous system disorders Neuralgia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Vascular disorders Haemorrhage	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Vascular disorders Hypotension	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Injury, poisoning and procedural complications Anaesthetic complication cardiac	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Investigations Nitrite urine present	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Investigations Blood urine present	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Blood and lymphatic system disorders Anaemia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Headache	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	3.5% 3/85 • Number of events 5 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Muscle spasticity	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Nervous system disorders Dizziness	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
General disorders Pyrexia	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	3.4% 3/87 • Number of events 5 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
General disorders Fatigue	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
General disorders Malaise	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Psychiatric disorders Depression	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Gastrointestinal disorders Diarrhoea	3.5% 3/85 • Number of events 3 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	3.4% 3/87 • Number of events 7 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	4.7% 4/85 • Number of events 4 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Gastrointestinal disorders Constipation	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	4.6% 4/87 • Number of events 4 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Gastrointestinal disorders Abdominal pain	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Gastrointestinal disorders Abdominal pain lower	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Gastrointestinal disorders Nausea	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Renal and urinary disorders Haematuria	4.7% 4/85 • Number of events 4 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	5.7% 5/87 • Number of events 5 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	4.7% 4/85 • Number of events 4 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Renal and urinary disorders Leukocyturia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 3 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Musculoskeletal and connective tissue disorders Back pain	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	3.4% 3/87 • Number of events 5 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	5.9% 5/85 • Number of events 6 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 3 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Urinary tract infection	20.0% 17/85 • Number of events 21 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	21.8% 19/87 • Number of events 24 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	25.9% 22/85 • Number of events 34 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Bacteriuria	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	6.9% 6/87 • Number of events 6 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Upper respiratory tract infection	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/87 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	4.7% 4/85 • Number of events 4 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Influenza	5.9% 5/85 • Number of events 5 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.3% 2/87 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Nasopharyngitis	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Infections and infestations Pharyngitis	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.2% 1/85 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).
Renal and urinary disorders Bladder pain	2.4% 2/85 • Number of events 2 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	1.1% 1/87 • Number of events 1 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).	0.00% 0/85 • Treatment emergent adverse events are presented for the full DBPC cycle (i.e. approximately 32 weeks for both Dysport® groups and approximately 19 weeks for the Placebo group). The safety population included all subjects who received at least 1 administration of study treatment (including only partial administration). Safety subjects were analysed according to their actual treatment received. One subject randomised to placebo received Dysport 600 U, and 1 subject randomised to Dysport 800 U did not receive treatment and was not included in the safety population. Number of deaths (all causes) is presented for the duration of the study (up to a maximum of 115 weeks).

Additional Information

Medical Director

Ipsen

Phone: See email

Email: clinical.trials@ipsen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place