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Benefit/Risk Assessment and related clinical phases
| Risks | Benefits | Next Step |
|---|---|---|
| + | + | Pilot, phase I or small mechanistic phase II trial to evaluate the risks |
| + | − | Revise research question |
| − | − | If feasible (costs and practicability) run a small trial to optimize treatment |
| − | + | Ideal scenario – phase II/III, phase III or pivotal trial |
