The Covid argument is not very valid. Did Covid affect treated patients more than placebo patients? If so, why? Does the fact that there was a pandemic change the laws of statistics?
5 patients were randomized but then never did the baseline visit and never took a single day of med or placebo. The other 503 patients comprise the ITT and safety cohort and all took at least 1 day of medication (or placebo) Modified ITT or mITT are the patients who made it through the titration to week 12 and thus have at least one evaluation post treatment (they were done week 12, 24, 36, 48). Some patients dropped out during those 12 weeks and were not evaluated but they still dropped out. See Figure 1 https://pmc.ncbi.nlm.nih.gov/articles/PMC12184016/pdf/main.pdf
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