Investigators will inject the reconstituted solution into foot muscles.

The foot function index (FFI) was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI disability subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents "no difficulty" and 10 represents "so difficult unable to do". For each item, the participant was asked to record the number value which best corresponded to effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.

The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI pain subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst pain imaginable". For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.

The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into three subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI items are rated using numeric rating scales ranging from 0 to 10, where 0 represents "no pain/no difficulty/none of the time" and 10 represents "worst pain imaginable/so difficult unable to do/all of the time" for pain, disability and activity limitation subscales, respectively. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a total score, the scores of all 3 subscales were totaled and divided by 3. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.

The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI activity limitation subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents "none of the time" and 10 represents "all of the time". For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.

The HV angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 centimeters (cm).

The intermetatarsal angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 cm.

Time to retreatment was calculated as ([Date of retreatment - previous injection date] + 1) / 7 (week). Time to retreatment was calculated for each cycle and the data presented here for the double-blind treatment period.

An assessment of PGI-S of foot pain was conducted by the participant using a 4-point Likert scale ranging from 0= no pain to 3= severe pain. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: "How severe was your foot pain while performing physical activities (example, standing, walking or running) over the past week?" (0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain).

An assessment of PGI-S of disability was conducted by the participant using a 4-point Likert scale ranging from 0= no disability to 3= severe disability. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: "How severe was your disability while performing physical activities (example, standing, walking or running) over the past week?" (0=no disability; 1=mild disability; 2=moderate disability; 3=severe disability).

An assessment of PGI-I of foot pain was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: "Compared to your foot pain prior to the study treatment initiation, your foot pain while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse".

An assessment of PGI-I of the participant's disability was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: "Compared to your disability prior to the study treatment initiation, your disability while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse".

The SF-36 is a 36-item questionnaire which measures the extent to which physical health impacts an individual's functional ability and perceived wellbeing in mental, social, and physical aspects of life. The SF-36 has 8 subscales: physical function, role physical, bodily pain, global health, vitality, social function, role emotional and mental health. Each scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Scores on these subscales can be aggregated into the physical component summary (physical function, role physical, bodily pain and global health) and mental component summary (mental health, vitality, social function and role emotional). Physical component summary score ranges from 0.65 to 80.73 and mental component summary score ranges from -8.81 to 81.65, where low score indicates lowest level of health and high score indicates highest level of health. Positive change from Baseline indicates an improvement in quality of life.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

Completed the double-blind treatment cycle 1.

Dysport 500 U versus Placebo.

One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 300 U intramuscular injection distributed between 4 injection points (75 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.

On Cycle 1 Day 1 in the double-blind treatment period, participants received a single dose of Dysport 500 U intramuscular injection distributed between 4 injection points (125 U each) in the 4 targeted muscles of the study foot.

Following the double-blind treatment period, all participants who met retreatment criteria were treated during the open-label period with Dysport 300 U on Cycle 2 Day 1 and either Dysport 300 U or 500 U on Cycle 3 Day 1.

The 4 targeted muscles of the study foot were the oblique head of the adductor hallucis muscle, the transverse head of the adductor hallucis muscle, the flexor hallucis brevis muscle and the extensor hallucis brevis muscle.