Statistical analysis
The null hypothesis was established as the absence of differences in the reduction of viral load after 4 days of starting treatment as compared with baseline (prior to treatment) between the two study groups. The sample size calculation for the primary efficacy endpoint was performed for a two-sided analysis of variance (ANOVA), with fixed effects and two levels in the factor evaluated corresponding to the active treatment or the control group. A type I error was set at a two-sided 0.05 level with a minimal effect with clinical relevance of 2 log 0 reduction in viral copy number as the minimal difference between the on-treatment groups. A moderate effect of 0.25 (Cohen’s The main analysis of the primary efficacy endpoint was measured by the Student’s 