Statistical analyses
AIDS
AIDS
Participants’ characteristics by study arm were described and reported as the number of participants with relative frequencies for categorical factors and as the median and interquartile range (IQR) for continuous variables.Repeated measurements of all biomarkers were available at the three fixed time points (T0 = baseline, T6 = 6 months after randomization, and T12 = 12 months after randomization) of the trial overall, and the description was broken down by study arm. Box plots were used to describe the distribution of the raw data at the three time points (the graphs display values below Q1 and Q3 as outliers). We then performed unadjusted and adjusted parametric mixed-linear models with random intercepts and slopes including the main effects (study arm and time) as well as the interaction term. The adjusted model also included the key baseline confounders age, nationality, AIDS, duration of HIV, duration of viral load (VL) suppression, and CD4 count nadir. We fitted separate models for each of the outcome variables in the log scale and estimated at each time point the mean levels and difference by study arm with the corresponding 95% CI using the model predictions.Two symmetric analyses were conducted: the first using as the main outcome the absolute parameters values and the second analysis using the changes from T0 as an alternative outcome. Although the two approaches and the related statistical tests partially overlap statistically, this second analysis allows the estimation of the parameter changes from T1 by study arm. Specific contrasts (i.e., the mean CD4 count difference by study arm at T6) were considered only when there was an overall type 3 significant p-value (<0.05) for the global test for interaction between study arm and time. All participants stayed on the randomization treatment until the end of the study. Although a total of 10 parameters (CD4, CD8, ratio, CD4 TM, CD4 EMRA, CD8 TM, CD8 EMRA, two classes of monocytes, and IL-6) were fitted, these analyses were conceived 