As I added, it is not about the effect, it is about the possibility of 'unblinding' (by implication). Blinding is an integral part of this type of trial (placebo comparitive). If it is considered that this has been compromised the overall results could be invalidated.
The question is - will the FDA look into this possibility, and if so what will be the decision? Pretty bold just to say "they won't".
[80% of Trof patients reported diarrhoea against 20% of placebo patients. Would the presence of diarrhoea lead a parent/care giver to lean heavily towards the child being on the active arm? (That is, if increased diarrhoea rates became common knowledge between trial parcipitants). Further (if so) would the FDA then consider this to constitute virtual unblinding of the trial?]
I dunno. I hope not, but without further objective discussion, I would not totally discount the possibility.
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