Trial Outcomes & Findings for Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia (NCT NCT01753336)

Last Updated: 2019-08-07

Results Overview

Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

Results posted on

2019-08-07

Participant Flow

This was an open label extension (OLE) study for study A-TL-52120-169 (Study 169). First subject enrolled: 14 March 2013; last subject completed: 13 October 2015. A-TL-52120-170 (Study 170) was conducted in 36 centres in the United States that had participated in Study 169 and enrolled adult subjects with cervical dystonia (CD).

Subjects who completed Study 169 and had no on-going Adverse Events (AEs) or whose Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score between Weeks 4 and 8 was reduced by ≤15% from baseline were invited to participate in this OLE study. 112 of the 134 subjects in Study 169 were enrolled into Study 170 (signed informed consent).

Participant milestones

Participant milestones
Measure	Total Dysport® Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
Overall Study STARTED	112
Overall Study Cycle 1	112
Overall Study Cycle 2	98
Overall Study Cycle 3	93
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Dysport® Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
Overall Study Patient decision	12
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	2
Overall Study Sponsor's decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Dysport® n=112 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Age, Customized 18-24 years	0 Participants n=5 Participants
Age, Customized 25-34 years	1 Participants n=5 Participants
Age, Customized 35-44 years	13 Participants n=5 Participants
Age, Customized 45-54 years	34 Participants n=5 Participants
Age, Customized 55-64 years	33 Participants n=5 Participants
Age, Customized 65-74 years	26 Participants n=5 Participants
Age, Customized +75 years	5 Participants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

Population: The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.

Outcome measures

Outcome measures
Measure	Total Dysport® n=112 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 1-Day 1	37.7 units on a scale Standard Deviation 13.58
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 1-Week 12/Cycle 2-Day 1	32.6 units on a scale Standard Deviation 11.96
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 3-Week 12	30.1 units on a scale Standard Deviation 12.76
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 1-Week 4	30.1 units on a scale Standard Deviation 13.16
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 2-Week 4	27.0 units on a scale Standard Deviation 12.07
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 2-Week 12/Cycle 3-Day 1	31.1 units on a scale Standard Deviation 12.51
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 3-Week 4	27.4 units on a scale Standard Deviation 13.10

SECONDARY outcome

Timeframe: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.

Outcome measures

Outcome measures
Measure	Total Dysport® n=112 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at baseline for Study 169	42.2 units on a scale Standard Deviation 10.30
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 3-Week 4	27.4 units on a scale Standard Deviation 13.10
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 3-Week 12	30.1 units on a scale Standard Deviation 12.76
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 1-Week 4	30.1 units on a scale Standard Deviation 13.16
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 1-Week 12	32.6 units on a scale Standard Deviation 11.96
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 2-Week 4	27.0 units on a scale Standard Deviation 12.07
TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean TWSTRS score at Cycle 2-Week 12	31.1 units on a scale Standard Deviation 12.51

SECONDARY outcome

Timeframe: Week 4 Treatment Cycle 3

Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.

Outcome measures

Outcome measures
Measure	Total Dysport® n=91 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Treatment Response in Treatment Cycle 3 Week 4.	51.6 percentage of participants Interval 40.93 to 62.26

SECONDARY outcome

Timeframe: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)

Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.

Outcome measures

Outcome measures
Measure	Total Dysport® n=112 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score Cycle 1-Week 12/Cycle 2-Day 1	15.7 units on a scale Standard Deviation 4.97
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score at Cycle 2-Week 4	12.8 units on a scale Standard Deviation 4.97
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score Cycle 2-Week12/Cycle 3-Day 1	15.3 units on a scale Standard Deviation 4.87
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score at Cycle 1-Day 1	17.3 units on a scale Standard Deviation 4.69
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score at Cycle 1-Week 4	13.9 units on a scale Standard Deviation 5.21
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score at Cycle 3-Week 4	12.7 units on a scale Standard Deviation 5.78
TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean severity score at Cycle 3-Week 12	14.3 units on a scale Standard Deviation 5.29

SECONDARY outcome

Timeframe: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)

Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.

Outcome measures

Outcome measures
Measure	Total Dysport® n=112 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score Cycle1-Week 12/Cycle 2-Day 1	9.4 units on a scale Standard Deviation 5.64
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score at Cycle 2-Week 4	7.9 units on a scale Standard Deviation 5.76
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score at Cycle 3-Week 12	8.6 units on a scale Standard Deviation 6.41
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score at Cycle 1-Day 1	11.5 units on a scale Standard Deviation 6.63
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score at Cycle1-Week 4	8.8 units on a scale Standard Deviation 6.41
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score Cycle2-Week 12/Cycle 3-Day 1	8.7 units on a scale Standard Deviation 5.82
TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean disability score at Cycle 3-Week 4	8.1 units on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.

Outcome measures

Outcome measures
Measure	Total Dysport® n=112 Participants Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 1-Week 4	7.4 units on a scale Standard Deviation 5.10
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 1-Week 12/Cycle 2-Day 1	7.5 units on a scale Standard Deviation 5.03
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 1-Day 1	9.0 units on a scale Standard Deviation 5.32
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 2- Week 4	6.3 units on a scale Standard Deviation 5.11
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 2-Week 12/Cycle 3-Day 1	7.2 units on a scale Standard Deviation 4.98
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 3-Week 4	6.5 units on a scale Standard Deviation 5.01
TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. Mean pain score at Cycle 3-Week 12	7.1 units on a scale Standard Deviation 4.85

Adverse Events

Total Dysport®

Serious events: 7 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total Dysport® n=112 participants at risk Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Gastrointestinal disorders Colitis ischaemic	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Hepatobiliary disorders Cholecystitis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Appendicitis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Transient ischaemic attack	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Dysphagia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.

Other adverse events

Other adverse events
Measure	Total Dysport® n=112 participants at risk Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Musculoskeletal and connective tissue disorders Muscular Weakness	10.7% 12/112 • Number of events 16 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Neck Pain	10.7% 12/112 • Number of events 13 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Back Pain	2.7% 3/112 • Number of events 3 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Muscle Spasms	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Muscle Tightness	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Muscle Weakness	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Myalgia	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Bursitis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Muscle Twitching	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Myofascial Pain Syndrome	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Osteopenia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Sensation of Heaviness	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Spinal Deformity	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Synovial Cyst	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Musculoskeletal and connective tissue disorders Torticollis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Headache	5.4% 6/112 • Number of events 7 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Dizziness	2.7% 3/112 • Number of events 5 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Migraine	2.7% 3/112 • Number of events 3 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Aphasia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Balance Disorder	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Burning Sensation	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Dysarthria	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Head Discomfort	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Hyporeflexia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Movement Disorder	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Presyncope	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Sciatica	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Tension Headache	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Nervous system disorders Tremor	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Dysphagia	10.7% 12/112 • Number of events 15 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Abdominal Pain	1.8% 2/112 • Number of events 3 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Dry Mouth	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Nausea	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Constipation	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Diarrhoea	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Diverticulum Intestinal	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Flatulence	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Impaired Gastric Emptying	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Nasopharyngitis	3.6% 4/112 • Number of events 4 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Influenza	2.7% 3/112 • Number of events 3 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Upper Respiratory Tract Infection	2.7% 3/112 • Number of events 3 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Urinary Tract Infection	2.7% 3/112 • Number of events 3 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Bronchitis	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Sinusitis	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Candidiasis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Ear Infection	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Gastrointestinal Viral Infection	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Infections and infestations Herpes Zoster	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Fall	4.5% 5/112 • Number of events 5 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Clavicle Fracture	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Concussion	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Craniocerebral Injury	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Facial Bones Fracture	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Laceration	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Ligament Injury	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Meniscus Lesion	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Muscle Strain	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Road Traffic Accident	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Thermal Burn	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Injury, poisoning and procedural complications Tooth Injury	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Alopecia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.89% 1/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Erythema	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Pruritus	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Rash	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Skin and subcutaneous tissue disorders Seborrhoeic Dermatitis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
General disorders Chest Discomfort	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
General disorders Fatigue	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
General disorders Injection Site Pain	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
General disorders Injection Site Reaction	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
General disorders Pain	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
General disorders Pyrexia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Eye disorders Vision Blurred	3.6% 4/112 • Number of events 4 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Eye disorders Dry Eye	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Eye disorders Eye Pain	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Eye disorders Ocular Hyperaemia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Eye disorders Visual Acuity Reduced	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Investigations Barium Swallow	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Investigations Blood Bilirubin Increased	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Investigations Blood Cholesterol Increased	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Investigations Blood Testosterone Decreased	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Investigations Blood Triglycerides Increased	0.89% 1/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Respiratory, thoracic and mediastinal disorders Choking	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Respiratory, thoracic and mediastinal disorders Cough	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.89% 1/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Metabolism and nutrition disorders Decreased Appetite	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Metabolism and nutrition disorders Dehydration	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Metabolism and nutrition disorders Hypomagnesaemia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Metabolism and nutrition disorders Hypophosphataemia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Psychiatric disorders Depression	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Psychiatric disorders Anxiety	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Psychiatric disorders Insomnia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Psychiatric disorders Sleep Disorder	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Psychiatric disorders Tic	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Reproductive system and breast disorders Breast Mass	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Reproductive system and breast disorders Ovarian Cyst	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Reproductive system and breast disorders Pelvic Fluid Collection	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Reproductive system and breast disorders Prostatitis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Cardiac disorders Tachycardia	1.8% 2/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Ear and labyrinth disorders Ear Pain	0.89% 1/112 • Number of events 2 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Ear and labyrinth disorders Motion Sickness	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Renal and urinary disorders Hydronephrosis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Renal and urinary disorders Nephrolithiasis	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Renal and urinary disorders Urinary Incontinence	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Surgical and medical procedures Endodontic Procedure	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Surgical and medical procedures Rotator Cuff Repair	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Vascular disorders Hematoma	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Vascular disorders Hypertension	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Blood and lymphatic system disorders Anaemia	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Immune system disorders Drug Hypersensitivity	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Gastrointestinal disorders Vomiting	0.89% 1/112 • Number of events 1 • In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks). Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.

Additional Information

Medical Director

Ipsen Biopharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place