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Proposed Criteria for Regulatory Decision-Making.
| Scenario | Status | Description | Regulatory Decision |
|---|---|---|---|
| 1 | No/yes | There is no shift in patient population | Success |
| Results are reproducible | |||
| 2 | No/no | There is no shift in patient population | May adjust for |
| Results are not reproducible | |||
| 3 | Yes/yes | There is shift in patient population | May adjust for shift |
| Results are reproducible | |||
| 4 | Yes/no | There is shift in patient population | Fail |
| Results are not reproducible |
