Grouped subjects according to the randomised treatment. The intent-to-treat (ITT) analysis
Grouped subjects according to the randomised treatment. The intent-to-treat (ITT) analysis set included all subjects who were randomly assigned to receive double-blinded study drug and was used for the subgroup analyses.Randomisation and blindingEfficacy and subgroup analysisOn Day 1, eligible subjects were randomly assigned to receive either inosine pranobex or placebo in a 1:1 allocation ratio with no stratification. The active drug and matching placebo tablets were provided in identical cartons that were identified with a kit number, such that all study site staff and subjects remained blinded throughout the study. Only personnel with access to the interactive web response system and clinical supplies were unblinded and had access to the treatment assignments; all other parties involved in the study were fully blinded.InterventionInosine pranobex or placebo 500-mg tablets were selfadministered by the subjects for 7 days (2 tablets orally 3 times daily). The first dose was taken immediately after randomisation at the study site, and the remaining doses were to be self-administered at home. Doses were taken approximately 8 h apart but consistent with the subject’s lifestyle, ie, scheduling of dosing did not disturb the subject’s usual sleep patterns. The subjects were provided with kits containing (randomised) medication sufficient for 1 subject for 7 days of treatment. Subjects were instructed to consume no more than 42 tablets for the specified duration and were required to return the excess study drug tablets at the end-of-treatment (EOT) visit. Adherence to study drug administration was good and was monitored as part of the study.ProceduresThe primary efficacy endpoint was the time to resolution of all influenza-like symptoms present at baseline to none (ie, a score of 0, defined as the complete PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/27362935 absence of symptoms, on the influenza-like symptoms assessment scale [details provided in Nutlin (3a) site Additional file 1]). The secondary endpoints included time to resolution of respiratory symptoms (cough, sore throat, and nasal obstruction); time to absence of fever (oral temperature of 37.5 for at least 2 consecutive readings that were at least 12 h apart); time to resumption of normal activity (ie, score of 0 on daily activities assessment scale); and frequency of viral respiratory infection complications, defined as hospitalisation, death due to ILI or complications of ILI, or requirement of antibiotic treatment for secondary bacterial infection. A subgroup analysis was conducted for time to resolution of all influenza-like symptoms present at baseline to none in subjects with clinically diagnosed ILI. This was conducted in subjects less than 50 years of age and subjects at least 50 years of age without related ongoing disease (related ongoing disease was any medical condition with the preferred terms of asthma, bronchitis, chronic bronchitis, or chemical bronchitis that was ongoing at the start of the study). In addition, an analysis was conducted in subjects less than 50 years of age who were non-obese (BMI <30 kg/m2) or obese (BMI 30 kg/m2). An additional analysis was conducted for time to resolution of all influenza-like symptoms to mild or none for subjects less than 50 years of age.Safety analysisSafety was evaluated during the study through analysis of adverse events (AEs), vital signs, and physical examinations.Bioethical issuesThe total study duration was 21 days (? days) for each subject and consisted of a 7-day dosing period (Day 1 to.
