Schedule of study procedures
| Visit | Day 1 | Week 4 (telephone) | Week 12 | Week 24/end of study |
| Window | −24 hours | ±5 days | ±7 days | ±7 days |
| Informed consent | X | |||
| Eligibility | X | |||
| Demographics | X | |||
| Medical history | X | |||
| Height | X | |||
| Vital signs | X | X | X | |
| Physical examination, weight | X | X | X | |
| Pregnancy test* | X | |||
| ECG | X | X | X | |
| Laboratory tests | ||||
| Haematology | X | X | X | |
| Coagulation | X | X | X | |
| Clinical chemistry | X | X | X | |
| Urinalysis | X | X | X | |
| Clinical assessments | ||||
| National Institute of Health Stroke Scale | X | X | X | |
| Fugl-Meyer motor Assessment | X | X | X | |
| modified Rankin Scale | X (prestroke) | X | X | X |
| PROMIS-10 | X | X | X | |
| Adverse event | X | X | X | X |
| Randomisation | X | |||
| Investigational product dispensation | X | X | ||
| Investigational product intake | X | X | X | |
| Study treatment compliance | X | X | X | |
| Concomitant medications | X | X | X | X |
| Concomitant therapies | X | X | X | X |
*For women of childbearing potential, either urine or serum.
PROMIS-10, Patient-Reported Outcomes Measurement Information System–Global Health.