Was there a question asked to caregivers and clinicians about whether they believed their girl was on drug or placebo?
The diarrhoea and vomiting symptoms would have been a bit of a giveaway you would think.
Because the primary endpoints were subjective ones, and the placebo effect was seemingly showing up in the first two weeks of the trial, care givers and clinicians guessing correctly that their girls were receiving the drug might colour their responses.
what do you think?
this concern would be put to rest if a question was asked to caregivers and clinicians to guess whether each girl was receiving treatment drug or placebo.
If they were asked and if they guessed correctly more often than you would expect by chance, that kind of messes up the whole study.
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