Adverse Events in the Safety Population
disability or incapacity, death, birth defect, congenital anomaly
ADVERSE EVENT, ADVERSE EVENT
Safety population was defined as the participants with at least 1 dose of the intervention or placebo drug. Adverse events were included with an onset date on or after the date of first dose and up to and including 28 days following the date of last dose of study medication.A serious adverse event was defined as any adverse event that resulted in death, was immediately life-threatening, led to inpatient hospitalization or prolongation of hospitalization, caused persistent or clinically significant disability or incapacity, or resulted in a congenital anomaly or birth defect.The results of FSH, LH, and E2 levels analysis showed no significant differences between groups after 12 weeks of treatment (eFigure 2 in 