Table 1.

Regular Study Procedures

Baseline assessments Month 0	Month 6, 12, 18, 24, 30 and 36 after treatment initiation
• Demographic information (date of birth, gender)
• Determination and documentation of eligibility by the Investigator or authorized representative (according to eligibility criteria)
• Relevant medical history: e.g., lumbar puncture, MRI, medication history and current medications, medical conditions/surgical history, clinical episode history
• Physical examination and documentation of vital signs	• Physical examination and documentation of vital signs
• Adverse events and concomitant medication	• Adverse events and concomitant medication
• MSFC	• MSFC
• EDSS	• EDSS
• Collection of peripheral blood and serum for several in vitro and ex vivo assessments (8 × 9 ml EDTA blood, 2 × 9 ml serum) as part of the routine blood assessments (including complete blood count, serum creatinine levels, tests of thyroid function)	• Collection of peripheral blood and serum for several in vitro and ex vivo assessments (8 × 9 ml EDTA blood, 2 × 9 ml serum) as part of the routine blood assessments (including complete blood count, serum creatinine levels, tests of thyroid function)