2.10.2. Analysis method.
miscarriages
ADVERSE EVENTS, SECONDARY, MISCARRIAGES
Analysis of the primary endpoints will be performed on the FAS, with a secondary analysis on the PPS. The proportion of clinical pregnancies and their 2-sided 95% confidence intervals calculated for the low-dose and high-dose groups, respectively, will be compared with a control value of.05 using the binomial test (1-tailed). The significant level for each comparison is set at .0125 and the study drug is considered effective when the Analysis of the secondary endpoints will be performed on the FAS, with a secondary analysis on the PPS. The proportion of chemical pregnancies and their 2-sided 95% confidence intervals are calculated for the low- and high-dose groups, respectively. Missing data are treated as no chemical pregnancies at 2 weeks after ET.Safety analysis will be performed on the safety analysis set. The proportion of adverse events and miscarriages and their 2-sided 95% confidence intervals are calculated for the low- and high-dose groups, respectively.