Thanks for the link, clarified some things that the FDA draft guidance doc left out.
It applies to Phase II exploratory findings sure. But Phase III is confirmatory
https://www.jli.edu.in/blog/clinical-trial-phases/
MSB:
https://clinicaltrials.gov/ct2/show/NCT04371393
Ann: COVID ARDS Trial Topline 60-Day Results, page-573
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