Please keep in mind phII was stat sig when combining both treatment arms prior to discovering the errors. Not saying FDA would take this into consideration, however, any no -governmental idiot would realize the 1mg arm was only tainted with placebo.
I would also suggest that those who are unfamiliar with statistics, or need a refresher, use wiki and look up the definitions of statistical significance and the rejection of the null hypothesis. No need to go into the math. It will help to understand what we are looking at.
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