I think you have the wring end of the stick - the way I see it the Problem is mainly the FDA. Just looking at the both this Universe and the Parallel Universe makes me believe that the book 1001 Ways to Slow the Foreigners Down is open at Chapter 1.
Chapter 1 includes a section Principles of Population Design with subsections on Design Criteria and Recruitment Difficulty, Real World Irrelevance, Promotion of Slavish Attachment to Parametric Statistics, …
I think you have the wring end of the stick - the way I see it...
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