Statistical analysis
respiratory viral infections
RSV INFECTION, RESPIRATORY VIRAL INFECTION
Clinical safety and tolerability were assessed on the safety population, comprising all subjects who received ≥1 dose of study drug. Clinical variables were evaluated in the full analysis population, which included all subjects who received a dose of study drug and for whom ≥1 post‐treatment assessment was available. Pharmacokinetic analysis was performed on those subjects in the safety population for whom both pre‐ and post‐dose samples were available.All data are summarized by descriptive statistics with 95% confidence intervals for comparisons. As respiratory viral infections may coexist with potentially pathogenic respiratory bacteria that may affect the severity of RSV infection,In study Part 1, no formal sample size calculation was performed. For Part 2, it was calculated that a sample size of 16 patients in each active treatment group would provide >90% power to detect a 50% reduction (mean ratio of 0.5) in RSV viral load AUC with AK0529 as compared with placebo, using a one‐sided significance level of 0.05, two‐sample equal variance All analyses were performed using SAS® Version 9.3 (SAS Institute Inc., Cary, NC, USA).