[AndyJackson]

Just in case my sarcasm is missed, the idiocy of the FDA procedure is like this. Let us suppose that kids playing in traffic leads to increased mortality. We randomly select a pool of kids and subject one group to structured play in traffic and one group to structured play on an enclosed playground.

Of course we already know the outcome. It's physics and probability of large numbers.

[Herakles]

Yea, the old saying is “when a freight train at full speed is about to be rammed up your butt and u are tied to the tracks, proper testing to get to the statistics goes out the window”, ie only an idiot would care.