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Re: HyGro post# 534605

Thursday, 11/17/2022 9:53:22 PM

Thursday, November 17, 2022 9:53:22 PM

Post# of 700215
note sure what to make of this from the SAP

A crossover option was included in the Trial design on demand of patients and investigators, and was
necessary to enable recruitment and retention of patients when the Trial began 13 years ago in
2007.



werent we told this was required by the FDA?

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