id author title date pages extension mime words sentences flesch summary cache txt cord-324181-nyrpg3ud Baker, Jeffrey Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2) 2020-05-19 .txt text/plain 4253 232 47 title: Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2) 19, 20 We report the safety and efficacy results of single oral dose baloxavir treatment in otherwise healthy children 1-<12 years old with acute influenza from miniSTONE-2 (Clinicaltrials.gov identifier: NCT03629184), a phase III, randomized, active controlled trial. This was a global, multicenter, double-blind, randomized, active controlled trial of the safety, pharmacokinetics and efficacy of a single oral dose of baloxavir versus twice-daily (for 5 days) oral oseltamivir, in otherwise healthy children with influenza. Parents completed the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) 22 questionnaire at scheduled visits (day [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] , and responses were used to measure secondary efficacy endpoints including time to alleviation of signs and symptoms (TTASS) of influenza [defined as when a score of 0 (no problem) or 1 (minor problem) was reported for cough and nasal symptoms on the CARIFS questionnaire, return to normal health and activity, and return to afebrile state (tympanic temperature ≤37.2°C), remaining for at least 21.5 hours]. ./cache/cord-324181-nyrpg3ud.txt ./txt/cord-324181-nyrpg3ud.txt