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| • Dose selection based on phase 1 and II data plasma concentrations |
| • Time window for drug initiation |
| • Patient selection based on mechanisms of action |
| • Outcome measures |
| • Severity of stroke population to be studied |
| • Length of follow-up period |
| • Use of surrogate markers to provide support for drug efficacy |
| • Prespecification of covariate analysis |
| • Fostering of appropriate and effective relationships between sponsors, academics and investigators |
