“you will know when your daughter is on the drug because of the diarrhoea”.
My point is that it is not about the effects and consequences/benefits/drawbacks etc, etc of the diarrhoea.
It is all about the diarrhoea being a possible indirect 'signifier' of a patient being on the drug or not. The quoted statement (above) suggests that it was being used as such in communication between families and thus be regarded as an unblinding factor.
All that accepted, how would the FDA assess this? (Bearing in mind, the value of the statistical data gathered from both arms is dependent on the integrity of the trial blinding).
Share Price, page-3038
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