Honestly, I'm a bit confused. Wasn't the trial designed, approved, and run under regulatory guidance to the extent, that data and periodic checks and verifications were made throughout? As it is with interim reviews to assess safety and benefit compared to standard care? Are we saying that in the three years BTW DL and Jama, that the regulators were not involved, as part of a verification process, so as to avoid having to do it as an afterthought long after? The latter seems to be a weapon of mass bureaucratic slow walking if I've understood correctly imo.
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