Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).

Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.

The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.