Statistical analysis
In Study 1, all statistical analyses were performed using SAS Version 9.4 (SAS Institute, Inc., Cary, NC, USA). Based on clinical experience, in Study 1, a sample size of up to 260 patients was to be enrolled to enable the assessment of safety and PK parameters. In Study 2, a sample size of 180 patients was to be randomized to offer approximately 97% power to detect a positive dose-response relationship. However, considering the early termination of the study, statistical analysis was not performed as planned. Therefore, the data are presented descriptively.All analyses were presented by dose groups and the combined age strata. In the final analysis, placebo data from the dose groups and/or age strata (being summarized) were pooled to form a larger comparative group. Regarding the efficacy analyses, the population was based on the intent-to-treat infected (ITT-i) analysis set that included all enrolled patients who had received at least one dose of the study drug, and were centrally confirmed PCR positive for RSV RNA. The mean RSV RNA logThe time to non-detectability was assessed using the Kaplan-Meier analysis. Those patients who did not reach an undetectable viral load at the last observable assessment were censored. Kaplan-Meier plots were provided by the treatment group and the dose cohort within the lumicitabine group.