Trial Outcomes & Findings for Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC) (NCT NCT02969356)

Last Updated: 2025-02-19

Results Overview

Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the second injection).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

157 participants

Primary outcome timeframe

At Week 6, Cycle 2

Results posted on

2025-02-19

Participant Flow

This multicenter, single-arm study was conducted in 18 centers in 4 countries between 22 December 2016 and 18 July 2018 in participants with spastic hemiparesis due to acquired brain injury. Study had 2 treatment cycles separated by at least 12 (maximum 20) weeks and combined with Guided Self-Rehabilitation Contract (GSC) for whole study duration.

A total of 157 participants were treated in this study. At baseline (Cycle 1, Day 1), the primary treatment target (TT) limb (upper limb \[UL\] or lower limb \[LL\]) was defined by the investigator, following discussion with the participant. If the primary TT limb was the UL, the secondary TT limb was the LL (and vice versa).

Participant milestones

Participant milestones
Measure	Dysport Dysport (AbobotulinumtoxinA) 1500 units (U) intramuscular (IM) injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Overall Study STARTED	157
Overall Study Intent-to-Treat (ITT) Population	153
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Dysport Dysport (AbobotulinumtoxinA) 1500 units (U) intramuscular (IM) injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Overall Study Adverse Event	7
Overall Study Consent withdrawn	2
Overall Study Lost to Follow-up	3
Overall Study Did not need to be reinjected	6
Overall Study Personal reasons	5

Baseline Characteristics

Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age, Continuous	52.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Race/Ethnicity, Customized Race: White	126 Participants n=5 Participants
Race/Ethnicity, Customized Race: Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Race: Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race: Missing	18 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic/Latino	135 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Missing	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 6, Cycle 2

Population: The modified ITT (mITT) population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study, for whom a primary TT limb had been defined and who had the primary efficacy outcome assessed at Week 6, Cycle 2.

Outcome measures

Outcome measures
Measure	Dysport n=136 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb	72.1 percentage of participants Interval 64.0 to 78.9

SECONDARY outcome

Timeframe: At Week 6, Cycle 1

Population: The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined.

Percentage of responder participants according to composite AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the first injection).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Percentage of Responder Participants at Week 6 After the First Injection, According to Composite AROM in the Primary TT Limb	58.2 percentage of participants Interval 50.2 to 65.7

SECONDARY outcome

Timeframe: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

The AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. The angle of joint movement was measured in 10 prespecified muscle groups (injected or noninjected); UL: shoulder extensors (SE), elbow flexors (EF), wrist flexors (WF), extrinsic finger flexors (FF) and pronator teres (PT), LL: soleus (Sol), gastrocnemius (GN), gluteus maximus (GM), hamstrings (HS) and rectus femoris (RF). The reinjection cycle visit corresponds to Week 12, 16 or 20 of injection Cycle 1. The last study visit corresponds to the last post-baseline visit performed by the participant (including the early withdrawal visit).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL SE: Week 6, Cycle 1	8.9 degrees Standard Deviation 16.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL SE: Week 12, Cycle 1	15.8 degrees Standard Deviation 22.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL SE: Reinjection cycle visit	13.4 degrees Standard Deviation 22.5
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL EF: Week 12, Cycle 2	15.4 degrees Standard Deviation 28.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL PT: Week 6, Cycle 1	9.0 degrees Standard Deviation 32.6
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL PT: Last study visit	8.7 degrees Standard Deviation 41.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GN: Week 12, Cycle 1	9.9 degrees Standard Deviation 14.6
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL HS: Week 12, Cycle 2	10.3 degrees Standard Deviation 26.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GN: Reinjection cycle visit	7.5 degrees Standard Deviation 15.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GN: Week 6, Cycle 2	12.6 degrees Standard Deviation 16.8
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GN: Week 12, Cycle 2	11.8 degrees Standard Deviation 17.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GN: Last study visit	11.9 degrees Standard Deviation 17.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GM: Week 6, Cycle 1	5.1 degrees Standard Deviation 15.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GM: Week 12, Cycle 1	5.2 degrees Standard Deviation 15.2
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GM: Reinjection cycle visit	5.1 degrees Standard Deviation 14.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GM: Week 6, Cycle 2	6.1 degrees Standard Deviation 15.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GM: Week 12, Cycle 2	7.3 degrees Standard Deviation 15.2
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GM: Last study visit	6.6 degrees Standard Deviation 16.5
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL HS: Week 6, Cycle 1	0.9 degrees Standard Deviation 34.2
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL HS: Week 12, Cycle 1	4.0 degrees Standard Deviation 34.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL HS: Reinjection cycle visit	5.6 degrees Standard Deviation 30.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL HS: Week 6, Cycle 2	8.2 degrees Standard Deviation 25.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL HS: Last study visit	6.8 degrees Standard Deviation 31.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL RF: Week 6, Cycle 1	4.5 degrees Standard Deviation 15.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL RF: Week 12, Cycle 1	4.4 degrees Standard Deviation 23.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL RF: Reinjection cycle visit	5.1 degrees Standard Deviation 25.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL RF: Week 6, Cycle 2	8.9 degrees Standard Deviation 24.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL RF: Week 12, Cycle 2	9.6 degrees Standard Deviation 23.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL RF: Last study visit	8.6 degrees Standard Deviation 23.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL SE: Week 6, Cycle 2	19.3 degrees Standard Deviation 25.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL SE: Week 12, Cycle 2	21.1 degrees Standard Deviation 27.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL SE: Last study visit	19.0 degrees Standard Deviation 24.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL EF: Week 6, Cycle 1	8.7 degrees Standard Deviation 25.5
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL EF: Week 12, Cycle 1	12.0 degrees Standard Deviation 27.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL EF: Reinjection cycle visit	10.9 degrees Standard Deviation 28.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL EF: Week 6, Cycle 2	14.9 degrees Standard Deviation 26.2
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL EF: Last study visit	13.0 degrees Standard Deviation 28.2
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL WF: Week 6, Cycle 1	11.0 degrees Standard Deviation 16.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL WF: Week 12, Cycle 1	10.9 degrees Standard Deviation 20.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL WF: Reinjection cycle visit	9.6 degrees Standard Deviation 20.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL WF: Week 6, Cycle 2	15.6 degrees Standard Deviation 24.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL WF: Week 12, Cycle 2	13.6 degrees Standard Deviation 22.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL WF: Last study visit	12.4 degrees Standard Deviation 22.3
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL FF: Week 6, Cycle 1	24.1 degrees Standard Deviation 37.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL FF: Week 12, Cycle 1	20.7 degrees Standard Deviation 36.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL FF: Reinjection cycle visit	14.5 degrees Standard Deviation 36.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL FF: Week 6, Cycle 2	29.5 degrees Standard Deviation 43.7
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL FF: Week 12, Cycle 2	27.9 degrees Standard Deviation 49.1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL FF: Last study visit	24.5 degrees Standard Deviation 44.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL PT: Week 12, Cycle 1	8.0 degrees Standard Deviation 38.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL PT: Reinjection cycle visit	7.4 degrees Standard Deviation 37.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL PT: Week 6, Cycle 2	11.0 degrees Standard Deviation 38.6
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL PT: Week 12, Cycle 2	9.4 degrees Standard Deviation 38.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL Sol: Week 6, Cycle 1	4.7 degrees Standard Deviation 9.6
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL Sol: Week 12, Cycle 1	5.2 degrees Standard Deviation 13.8
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL Sol: Reinjection cycle visit	4.5 degrees Standard Deviation 15.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL Sol: Week 6, Cycle 2	9.3 degrees Standard Deviation 17.9
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL Sol: Week 12, Cycle 2	9.0 degrees Standard Deviation 17.0
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL Sol: Last study visit	8.2 degrees Standard Deviation 16.4
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL GN: Week 6, Cycle 1	9.0 degrees Standard Deviation 14.8

SECONDARY outcome

Timeframe: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

Composite AROM (XA) was measured by goniometer in the primary TT limb (either UL or LL, depending on which one has been selected as the primary TT limb), composite AROM in the UL injected muscle groups was calculated as the sum of the AROM in the EF, WF and FF. Composite AROM in the LL injected muscle groups was calculated as the sum of the AROM in Sol and GN.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 6, Cycle 1	43.1 degrees Standard Deviation 49.9
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 12, Cycle 1	42.8 degrees Standard Deviation 56.7
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Reinjection cycle visit	34.1 degrees Standard Deviation 52.8
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 6, Cycle 2	59.5 degrees Standard Deviation 64.4
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 12, Cycle 2	56.3 degrees Standard Deviation 66.7
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Last study visit	49.3 degrees Standard Deviation 63.4
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 6, Cycle 1	13.7 degrees Standard Deviation 18.3
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 12, Cycle 1	15.1 degrees Standard Deviation 23.4
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Reinjection cycle visit	12.0 degrees Standard Deviation 24.5
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 6, Cycle 2	21.9 degrees Standard Deviation 28.8
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 12, Cycle 2	20.8 degrees Standard Deviation 28.8
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Last study visit	20.1 degrees Standard Deviation 27.6

SECONDARY outcome

Timeframe: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

Full composite AROM, regardless of whether the muscle groups was injected or not was measured by goniometer in the primary TT limb. Full Composite AROM in the UL was calculated as the sum of the AROM in the 5 UL muscle groups (SE+EF+WF+FF+PT). Full Composite AROM in the LL was calculated as the sum of the AROM in the 5 LL muscle groups (Sol+GN+GM+HS+RF).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 6, Cycle 2	45.1 degrees Standard Deviation 58.2
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 6, Cycle 1	60.6 degrees Standard Deviation 68.4
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 12, Cycle 1	66.3 degrees Standard Deviation 75.7
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Reinjection cycle visit	53.9 degrees Standard Deviation 69.9
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 6, Cycle 2	90.5 degrees Standard Deviation 90.1
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Week 12, Cycle 2	87.6 degrees Standard Deviation 94.8
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit UL: Last study visit	77.8 degrees Standard Deviation 89.6
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 6, Cycle 1	24.4 degrees Standard Deviation 42.7
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 12, Cycle 1	28.7 degrees Standard Deviation 55.9
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Reinjection cycle visit	28.0 degrees Standard Deviation 56.2
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Week 12, Cycle 2	48.1 degrees Standard Deviation 60.4
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit LL: Last study visit	42.2 degrees Standard Deviation 61.7

SECONDARY outcome

Timeframe: Week 12 of each treatment cycle and last study visit

The MFS was used to measure active function in the UL. The MFS consists of 10 tasks, each of which was evaluated locally by the site investigator and centrally by a blinded central reviewer at the coordinating investigators' site, on a 10-point visual analogue scale (VAS) ranging from "No movement" to "Normal". Higher score indicates a better outcome. The MFS overall scores were obtained by averaging all individual task scores, provided that at least 8 out of the 10 were not missing. The mean change from baseline was calculated for the local and central assessments and a positive change from baseline indicates an improvement in active function.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit Local assessment: Week 12, Cycle 1	0.44 units on a scale Standard Deviation 0.56
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit Local assessment: Last study visit	0.53 units on a scale Standard Deviation 0.63
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit Local assessment: Week 12, Cycle 2	0.55 units on a scale Standard Deviation 0.65
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit Central assessment: Week 12, Cycle 1	0.08 units on a scale Standard Deviation 0.49
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit Central assessment: Week 12, Cycle 2	0.18 units on a scale Standard Deviation 0.61
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit Central assessment: Last study visit	0.14 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Week 12 of each treatment cycle and last study visit

The 10-meter walking speed test (WST) was used to measure active function in the LL. The participant performed the WST barefoot without a walking aid. If it was absolutely necessary that the participant used a cane, this may have been permitted provided that the same cane was used at baseline and all other walking speed assessments for that participant. The participant was given instructions to walk at his/her maximum speed. The time taken for the participant to walk from the start to the end of the 10 meters was recorded.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Mean Change From Baseline in Maximal Walking Speed Barefoot at Week 12 of Each Treatment Cycle and at Last Study Visit Week 12, Cycle 1	0.081 meters per second Standard Deviation 0.161
Mean Change From Baseline in Maximal Walking Speed Barefoot at Week 12 of Each Treatment Cycle and at Last Study Visit Week 12, Cycle 2	0.116 meters per second Standard Deviation 0.159
Mean Change From Baseline in Maximal Walking Speed Barefoot at Week 12 of Each Treatment Cycle and at Last Study Visit Last study visit	0.097 meters per second Standard Deviation 0.187

SECONDARY outcome

Timeframe: At baseline (for participants who had GSC previously only), Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

Each participant received a personalised rehabilitation programme. The physiotherapist taught each participant the stretching postures and exercises to perform on a daily basis throughout the study. These were tailored to the individual participant's needs and formed the GSC therapy. The main focus was on the primary TT limb and then the other limb. Participant satisfaction was determined by asking the question "How satisfied are you TODAY regarding the GSC?" Responses were recorded using a 5-level Likert scale, as follows: completely satisfied (+2), rather satisfied (+1), neither satisfied nor dissatisfied (0), rather dissatisfied (-1), and completely dissatisfied (-2).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 12, Cycle 1	1.4 units on a scale Standard Deviation 0.8
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Reinjection cycle visit	1.4 units on a scale Standard Deviation 0.7
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Baseline for non-naïve participants to GSC only	1.8 units on a scale Standard Deviation 0.5
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 6, Cycle 1	1.3 units on a scale Standard Deviation 0.9
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 6, Cycle 2	1.4 units on a scale Standard Deviation 0.7
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 12, Cycle 2	1.4 units on a scale Standard Deviation 0.8
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Last study visit	1.4 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

Participants were asked the following question: "Do you believe that GSC will help to improve your arm and leg function?" Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 6, Cycle 1	-0.2 units on a scale Standard Deviation 0.9
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 12, Cycle 1	-0.1 units on a scale Standard Deviation 0.8
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Reinjection cycle visit	-0.2 units on a scale Standard Deviation 0.8
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 6, Cycle 2	-0.1 units on a scale Standard Deviation 0.7
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 12, Cycle 2	-0.3 units on a scale Standard Deviation 0.8
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Last study visit	-0.2 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit

Physiotherapists were asked the following question: "Do you believe that GSC will help to improve your patient's arm and leg function?" Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Last study visit	-0.2 units on a scale Standard Deviation 0.7
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 6, Cycle 1	-0.2 units on a scale Standard Deviation 0.6
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 12, Cycle 1	-0.2 units on a scale Standard Deviation 0.6
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Reinjection cycle visit	-0.1 units on a scale Standard Deviation 0.6
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 6, Cycle 2	-0.2 units on a scale Standard Deviation 0.6
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit Week 12, Cycle 2	-0.2 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: From baseline to end of the study, up to 280 days

The investigator counted the number of days when GSC therapy was not performed since the last visit. Using the total number of study days and the total number of days when GSC therapy was not performed, the number of days when GSC was performed was calculated.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Percentage of Days Over Study Period When GSC Therapy Was Performed	92.80 percentage of study days Standard Deviation 9.85

SECONDARY outcome

Timeframe: At reinjection cycle visit (Week 12, 16 or 20) and last study visit (Week 24 or 40)

A global assessment of the benefits of the study therapy was made by the investigator and the participant (or the caregiver). The participant's caregiver performed the global assessment only in those cases when the participant was not capable to do this. Participants were asked the following question: "How would you rate the overall response to study therapy since baseline?" Responses on the global assessment were recorded on a 5-level Likert scale, as follows: much better (+2), a bit better (+1), the same (0), a bit worse (-1), and much worse (-2).

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Global Assessment of Benefits of the Study Therapy Investigator: Reinjection cycle visit	1.4 units on a scale Standard Deviation 0.6
Global Assessment of Benefits of the Study Therapy Investigator: Last study visit	1.3 units on a scale Standard Deviation 0.7
Global Assessment of Benefits of the Study Therapy Participant: Reinjection cycle visit	1.4 units on a scale Standard Deviation 0.6
Global Assessment of Benefits of the Study Therapy Participant: Last study visit	1.4 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: At reinjection cycle visit (Week 16 or 20) and last study visit (Week 24 or 40)

Participants who were not reinjected at Week 12 of a given cycle, recorded their satisfaction with a longer interval between 2 injections collected at the corresponding reinjection visit or the last cycle visit (Week 16 or Week 20 for each cycle). To assess this, the participants were asked the following question: "Are you satisfied with a longer interval between 2 injections?". The possible answers were: Yes, No or No opinion.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Last study visit · Yes	42 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Last study visit · No	14 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Last study visit · No opinion	12 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Reinjection cycle visit · Yes	52 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Reinjection cycle visit · No	6 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Reinjection cycle visit · No opinion	12 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Reinjection cycle visit · Missing	0 Participants
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles Last study visit · Missing	6 Participants

SECONDARY outcome

Timeframe: At last study visit (Week 24 or 40)

Participants were asked to complete EQ-5D-5L questionnaire to assess their current health status. The EQ-5D-5L was a generic, preference-based measure of health-related quality of life (QoL). Questions were answered based on how the participant was feeling "Today". The EQ-5D-5L consists of 2 parts: EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system included questions for each of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS recorded participant's self-rated health on a vertical 20-centimeter VAS where the endpoints were labelled "The best health you can imagine" and "The worst health you can imagine". The EQ-5D-5L questionnaire scores range from 0-100, where 0= worst self-perceived health and 100= best self-perceived health. Positive change from baseline indicates an improvement in QoL.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit Pain/discomfort: Last study visit	-0.3 units on a scale Standard Deviation 0.9
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit Anxiety/depression: Last study visit	-0.1 units on a scale Standard Deviation 0.9
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit Mobility: Last study visit	-0.3 units on a scale Standard Deviation 0.8
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit Self-care: Last study visit	-0.0 units on a scale Standard Deviation 0.8
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit Usual activities: Last study visit	-0.3 units on a scale Standard Deviation 1.0
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit EQ VAS: Last study visit	4.27 units on a scale Standard Deviation 18.71

SECONDARY outcome

Timeframe: At last study visit (Week 24 or 40)

The SF-12 was a short form questionnaire survey consisting of 12 questions, which were a subset of the SF-36 health survey. Most of the questions were answered based on how the participant had felt over the previous 4 weeks. The SF-12 covers 8 domains, including physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional and mental health. The SF-12 questionnaire survey scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Positive change from baseline indicates an improvement in QoL.

Outcome measures

Outcome measures
Measure	Dysport n=153 Participants Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Change From Baseline in Short Form 12 (SF-12) Scales at Last Study Visit Physical score: Last study visit	3.985 units on a scale Standard Deviation 7.358
Change From Baseline in Short Form 12 (SF-12) Scales at Last Study Visit Mental score: Last study visit	-0.008 units on a scale Standard Deviation 9.631

Adverse Events

Dysport

Serious events: 19 serious events

Other events: 72 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dysport n=157 participants at risk Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Nervous system disorders Epilepsy	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Brain stem stroke	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Dysarthria	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Ischaemic stroke	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Myasthenic syndrome	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Vith nerve paralysis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Cardiac disorders Myocardial infarction	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Cardiac disorders Ventricular extrasystoles	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Pneumonia	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Intervertebral discitis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Tracheobronchitis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Fatigue	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Pyrexia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Depression	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Mental status changes	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Hepatobiliary disorders Cholelithiasis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Fall	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Rib fracture	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.

Other adverse events

Other adverse events
Measure	Dysport n=157 participants at risk Dysport 1500 U IM injection, was administered as a split dose, in both the UL and LL on Day 1 of each treatment cycle. The dose given in each limb was based on which was considered the primary TT limb at baseline. At least half the total dose must have been injected in the primary TT limb and a maximum of 1000 U could be injected in an UL (even if it was the primary TT limb). There was no maximum dose that could have been injected in a LL, provided that some out of the 1500 U total was used for the UL injection. The second Dysport injection (Cycle 2) may have been given in a different split to the first injection (Cycle 1), at the discretion of the investigator. However, the same minimal/maximal rules applied. The primary TT remained the same for both Dysport injections. Participants were also asked to perform daily GSC therapy throughout the study.
Musculoskeletal and connective tissue disorders Back pain	7.0% 11/157 • Number of events 13 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 5/157 • Number of events 6 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	2.5% 4/157 • Number of events 4 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Neck pain	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Bronchitis	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Respiratory tract infection	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Urinary tract infection	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Viral infection	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Viral upper respiratory tract infection	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Influenza	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Fatigue	3.2% 5/157 • Number of events 5 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Asthenia	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Oedema peripheral	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Injection site haematoma	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Pyrexia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Dizziness	2.5% 4/157 • Number of events 4 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Headache	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Fall	6.4% 10/157 • Number of events 12 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Contusion	2.5% 4/157 • Number of events 9 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Joint injury	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Ligament sprain	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Depression	2.5% 4/157 • Number of events 4 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Insomnia	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Dyspepsia	1.9% 3/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Eye disorders Diplopia	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Eye disorders Photopsia	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Eye disorders Vision blurred	1.3% 2/157 • Number of events 3 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Investigations Weight decreased	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Vascular disorders Hypertension	1.3% 2/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Gastroenteritis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Respiratory tract infection viral	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Rhinitis	0.64% 1/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Tooth infection	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Infections and infestations Upper respiratory tract infection	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Gait disturbance	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Influenza like illness	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Injection site rash	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Pain	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Peripheral swelling	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
General disorders Therapeutic product ineffective	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Lip injury	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Tooth injury	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Injury, poisoning and procedural complications Traumatic haematoma	0.64% 1/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Clonic convulsion	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Monoparesis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Seizure	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Slow speech	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Syncope	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Tension headache	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Transient ischaemic attack	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Vocal cord paralysis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Nervous system disorders Vocal cord paresis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Agitation	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Anxiety	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Depressed mood	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Psychiatric disorders Mental status changes	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Diarrhoea	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Dry mouth	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Dysphagia	0.64% 1/157 • Number of events 2 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Gastritis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Nausea	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Gastrointestinal disorders Toothache	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Investigations Angiogram abnormal	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Investigations ECG signs of myocardial ischaemia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Investigations Transaminases increased	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Vascular disorders Haematoma	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Vascular disorders Hypotension	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Surgical and medical procedures Abscess drainage	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Surgical and medical procedures Dental implantation	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Surgical and medical procedures Sinus operation	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Cardiac disorders Cardiac failure	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Cardiac disorders Intracardiac thrombus	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Cardiac disorders Myocardial ischaemia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Ear and labyrinth disorders Hypoacusis	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Ear and labyrinth disorders Vertigo	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Metabolism and nutrition disorders Hypochloraemia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Metabolism and nutrition disorders Iron deficiency	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Renal and urinary disorders Renal colic	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Renal and urinary disorders Urinary incontinence	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Endocrine disorders Thyroid disorder	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Hepatobiliary disorders Liver disorder	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.
Skin and subcutaneous tissue disorders Erythema	0.64% 1/157 • Number of events 1 • From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks. The safety population included all participants who were injected at least once with the study treatment.

Additional Information

Medical Director

Ipsen

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place