YOu have discounted the fact that the FDA in this case isn't looking at Safety as RLF-100 has 20 years of testing proving safety. Hence the trial data statistically was narrowed to eliminate this because this is a treatment with a proven track record for safety.
The only concern here is if the drug treatment works better than Placebo and to what statistical % benefit does it work. So a smaller trial group is all that is needed.
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