Baseline assessments Month 0 | Month 6, 12, 18, 24, 30 and 36 after treatment initiation |
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• 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) |