I think the FDA will approve this drug, even if the study has these problems affecting its validity. They are honestly not the most honest organisation. You guys raise some good ethical points.
I had a look at the differences in the study and there was a prevalence of vomiting and diarrhea in both groups, however, a lot more prevalent in the group taking the drug, especially diarrhea.
The thing is the results show statistically significant "differences" FROM placebo.
The organisers of the study know who are placebo and who are controlled. Since there are statistically significant "differences", and from what I understand very very strong differences, and the prevalence of both those side effects in placebo and controlled, it would be enough to be a valid study. The participants in the placebo group that experienced diarrhea and vomiting did not give the same rating as the controlled group, otherwise, we wouldn't get these results.
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