Outcome measures
treatment-emergent adverse events, Stroke
SECONDARY, STROKE
The primary outcome was the safety of afamelanotide in AIS patients as assessed by monitoring and recording of treatment-emergent adverse events (TEAEs), recorded regularly up to D42. The secondary outcome was the signal of efficacy as assessed clinically by using the standardised National Institutes of Health Stroke Scale (NIHSS) up to D42 and radiologically by measuring the changes in the volumes of Tmax and FLAIR lesions.