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PlentyParanoid

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PlentyParanoid

Re: frrol post# 225552

Sunday, 04/22/2018 8:25:30 AM

Sunday, April 22, 2018 8:25:30 AM

Post# of 403074
Yes, planned as being pre-specified regarding its statistical power and hence its timing plus being spelled out in the trial protocol i.e. communicated to FDA. Any other kind would very likely prevent the use of p2b trial in application support beyond safety evaluation.
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