The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.

Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint.

Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a "catch" when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

The investigator's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

The patient's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.

Full Analysis Set

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.