Statistical methods
SECONDARY
The analyses performed on primary, secondary and exploratory endpoints were pre-specified in the protocol. Paired two-tailed Wilcoxon tests and two-tailed Mann–Whitney tests were used to analyze non-parametric outcomes within and between groups, respectively. When more than two groups were compared, the Kruskal–Wallis test was used. Data are presented as median (IQR), median (range) or mean ± s.d. as indicated in each respective figure legend. The Kaplan–Meier estimator was used to assess the magnitude of the difference between the survival curves, and the log-rank test was used to compare time to loss of virologic control during ATI between groups. For correlations, Spearman’s correlation coefficient was used. We used the full analysis set, comprising all individuals receiving at least one dose of active treatment with assessable data, for the efficacy analyses and all enrolled individuals for the safety analyses. We used Stata version 17.0 and Prism version 7.0 software for statistical analyses.