2.9.2. Statistical tests.
SECONDARY, RECURRENCE
For discrete variables, summary statistics such as the number and proportion of patients in each group will be calculated. For continuous variables, summary statistics such as the number of patients, arithmetic mean (mean), standard deviation, minimum, median, and maximum values will be calculated for each group. The 95% confidence intervals (CIs) will be calculated using the Clopper-Pearson methodAs primary analysis for the primary endpoint, a comparison of the time to resolution of the 5 COVID-19 symptoms will be performed between the ensitrelvir 125 mg group and placebo group using a Peto-Prentice generalized Wilcoxon testThe primary analyses for each of the 2 key secondary endpoints are as follows: for the key secondary endpoint 1, a comparison of the change from baseline on Day 4 in the amount of SARS-CoV-2 viral RNA will be performed between the ensitrelvir 125 mg group and the placebo group using an analysis of covarianceOther analyses for the primary and key secondary endpoints in the population with <72 hours from COVID-19 onset to randomization from the ITT or mITT population are as follows: a comparison of the time to resolution of the 5 COVID-19 symptoms and the time to the first negative SARS-CoV-2 viral titer will be performed between the ensitrelvir 125 mg group and the placebo group using a log-rank testAnalysis of the time to sustained resolution of the 5 COVID-19 symptoms for 48 hours or longer without any recurrence of the 5 COVID-19 symptoms for 2 days (48 hours) or longer after the resolution of the 5 COVID-19 symptoms will be performed using the same analysis as that for the primary endpoint (except for multiplicity adjustment).For the analysis of the time to resolution of the 12 COVID-19 symptoms that persist for ≥24 hours between the ensitrelvir 125 mg and the placebo group, the same analyses as for the primary endpoint will be performed (except for multiplicity adjustment).For analyzing the change from baseline in SARS-CoV-2 viral titer and the amount of viral RNA at each time point, least squares means and difference between the ensitrelvir 125 mg group and the placebo group based on the analysis of covariance model