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HyGro

10/10/22 1:51 PM

#520708 RE: pgsd #520572

It is supportive of adaptive trials -- NWBO was NOT an adaptive trial. It wasn't prospectively designed as one, didn't set up scenarios for trial changes, did not have an interim review to determine changes in the trial, otherwise never met any of the adaptive trial design criteria.

Post hoc trial manipulations are by NO means an adaptive trial.