Analysis contents

List the frequency of cases enrolled, violated and dropped out;List the details of cases of violation, dropout, low compliance, time-window violation, out of protocol drug usage.List the datasets for analysis.Comparability analysis: compare demographic data and other baseline indicators to measure the balance of each group.Effectiveness analysis: FAS and PPS analysis. The study is a multi-center clinical trial, the influence of central effect on efficacy indicators should be considered in the analysis. Measurement data uses covariance analysis which considering the central factor, and count data uses CMH test corrected by the central stratification.Safety analysis: compare the incidence of AE in each group and describe the AE in the trial. Compare the changes of normal/abnormal laboratory indicators before and after the test, and list the details of cases with abnormal/abnormal aggravation before and after the test.Concomitant medication analysis: compare the details of each group and list them down.