I don't see it as likely that there will be any carry over of the type I penalty to stage 2 if they manage to change the dose to 2mg/kg. However, I do see a type I penalty for stage 1 for requesting an interim analysis to be performed to look at the efficacy of the stage 1 dosages. Ultimately it will be up to the FDA whether one gets applied or not, it's not always straightforward to determine.
Ann: iPPS SIGNIFICANT OA PAIN REDUCTION AT 12 MONTHS, page-138
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