Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment | Allocationa | Monitoring during treatment | End of treatment | Follow-up since randomization (months) | ||||
Study phase | Admission to randomization | Weekly | Bi-weekly | 3 | 6 | 12b | ||
Enrolment | ||||||||
Eligibility screen | ✓ | |||||||
Informed consent | ✓ | |||||||
Cranial imaging | − 3 to 0 days | |||||||
Allocation | ✓ | |||||||
Intervention | ●-------------------------------------------------------------● | |||||||
Assessments | ||||||||
E-GOS | ✓ | ✓ | ✓ | ✓ | ||||
Clinical examination | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Cranial imaging | ✓ | ✓ | ✓ | ✓ | ||||
Morisky scores (oral arm) | ✓ | |||||||
Blood tests | ✓ | ✓ | ✓ | ✓ | ✓ | |||
SF-36 + EQ-5D-5L + MoCA | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Screening for immunodeficiency | ✓ | ✓ |