The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud's Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters. The questions are divided into eight component domains: Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain. Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation). The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).

Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.

Net ulcer burden at any given assessment was defined as the number of "new" or "active" ulcers at that assessment, plus the number of "indeterminate" ulcers at that assessment that had previously been classified as either "active" or "new" at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.

Efficacy was assessed using data obtained at each visit, if available, from all subjects enrolled in this study. Assessments performed after discontinuation of study drug were excluded from the summaries.

The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis. Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible). The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value. The mean change from study entry in CHFS scores at each scheduled assessment are summarized.

Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.

The total ulcer number includes all ulcers designated as "active", "indeterminate", or "new" for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.

Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.

The number and percentage of subjects who developed new ulcers during the study were summarized.

Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.