References
DILI
ADVERSE EVENT, DRUG-INDUCED LIVER INJURY
Study visit timeline. Treatment arm I is the green tea extract only for the duration of the study, arm II is the green tea extract and 5 days of clomiphene citrate, and arm III is the green tea extract and 5 days of letrozole. Day 1 is the start of the subject’s first menstrual cycle after the screening visit. EGCG: Epigallocatechin gallate.Flow chart of study population; EGCG: Epigallocatechin gallate.Demographic characteristics of randomized patients.EGCG: Epigallocatechin gallate; BMI: Body Mass Index.Adverse events reported by participants.EGCG: Epigallocatechin gallate.End-of-study lab results.ALT: alanine transaminase; AST: aspartate aminotransferase; EGCG: Epigallocatechin gallate.Changes in safety labs from the screening to the last study visit.EGCG: Epigallocatechin gallate. Values are shown as n (top), mean ± SD (bottom). * Statistically significant changes (Safety summary of subjects with liver tests meeting predefined limits of change per Hy’s law *.ALT: alanine transaminase; AST: aspartate aminotransferase; EGCG: Epigallocatechin gallate. BILI: Total bilirubin. * Based on the Assessment of Drug-Induced Liver Injury (DILI) per the FDA [