Statistical analysis
illness, fever
VIRUS, RECURRENCE, VIRUS INFECTION, INFLUENZA
Safety was analyzed in the safety population (all patients who received ≥1 dose of the study drug). AEs were summarized by age and system organ class/preferred term. Efficacy was analyzed for the intention-to-treat infected population (all patients who received the study drug who had confirmed diagnosis by RT-PCR of influenza virus infection). Median TTIA and TTRF (with 95% confidence intervals [CI]) were estimated by the Kaplan-Meier method. Patients who did not experience illness alleviation or resolution of fever by the last observation time point were censored at the last observation time point. The recurrence of symptoms and fever was analyzed in the subset of patients with confirmed influenza alleviation or resolution of fever, respectively, before day 4 and is summarized by age and virus type/subtype. Data are presented by age group (< 6 years; ≥6 to < 12 years) and influenza virus type/subtype (A(H1N1)pdm09, A(H3N2), or B); presence or absence of PA/I38X-substituted viruses; and presence or absence of co-infection. Analyses were performed using SAS 9.2 and 9.4 (SAS Institute Inc., Cary, NC, USA).