Trial assessment flow chart
| Baseline | Treatment | Follow-up | |||||
| Visit | V1 | V2 | V3 | V4 | V5 | V6 | V7 |
| Day-visit | D1 (−4.5 h to 0 h) | D1 (0 h) | D2 (24 h ±2 h) | D4 (72 h ±6 h) | D8±l d | D31±3 d | D91±7 d |
| Informed consent | X | ||||||
| Demographic data | X | ||||||
| Weight | X | ||||||
| Medical history | X | ||||||
| Inclusion/exclusion criteria | X | ||||||
| Vital signs | X | X | X | X | X | X | |
| Physical examination | X | X | |||||
| Brain CT/MRI | X | X | |||||
| Pregnancy tests | X | ||||||
| Haematology | X | X | X | ||||
| Urinalysis | X | X | |||||
| Stool routine test | X | ||||||
| Blood chemistry | X | X | X | ||||
| Coagulation test | X | X | X | ||||
| Finger blood glucose Testm | X | ||||||
| ECG | X | X | X | ||||
| NIHSS | X | X | X | ||||
| mRS | X (prestroke) | X | X | ||||
| Barthel lndex | X | X | |||||
| Randomisation | X | ||||||
| Administration | X | ||||||
| Concomitant medications | X | ||||||
| Procedure | D1 (−4.5 h ±0 h) | D1 (0 h) | D2 (24 h ±2 h) | D4 (72 h ±6 h) | D8±l d | D31±3 d | D91±7 d |
| Adverse events | X | ||||||
CT, computed tomographic; D, day/days; h, hour/hours; MRI, Magnetic Resonance Imaging; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.