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AI in Non-Mfg Areas : Although this warning letter was in a drug manufacturing context, the logic applies to any regulated activity where AI is used clinical trials, labeling, pharmacovigilance, etc

Shin MK, Kim MK, Bae YS, Jo I, Lee SJ, Chung CP, et al

Cell Rep (2019) 29(9):273144.e4

McGuire, found that oral semaglutide reduced major adverse cardiovascular events (MACE) to 3.1 events per 100 person-years, compared to 3.7 events in the placebo group a 14% reduction (HR 0.86) over a median follow-up of 49.5 months