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Saturday, 12/03/2022 9:34:30 AM

Saturday, December 03, 2022 9:34:30 AM

Post# of 461358
https://www.fda.gov/media/133660/download

602 4. Statistical considerations
603
604 A typical criterion for concluding that a trial is positive (showed an effect) is a p value of < 0.05
605 (two sided). A lower p value, for example, would often be expected for reliance on a single trial.
606 For a serious disease with no available therapy or a rare disease where sample size might be
607 limited, as discussed further below, a somewhat higher p value – if prespecified and
608 appropriately justified – might be acceptable.

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