Statistical analysis
INFLAMMATION
Baseline characteristics were reported in n (%) for categorical variables and in mean (SD) or median (IQR) for continuous variables. Biomarkers were log-transformed in the following analyses. We calculated mean percentage changes (95% CI) in biomarkers from baseline to week 24 by treatment allocation. Estimations were performed with analysis of covariance adjusted for randomization strata (insulin, metformin, sulfonylurea derivatives, thiazolidinediones, or other treatment-based regimens) and baseline value. Absolute mean changes (95% CI) in hemoglobin and hematocrit over time were assessed with repeated-measures models using a restricted maximum likelihood. The model consists of randomization strata, treatment allocation, visit and treatment-by-visit interaction as fixed effects, and baseline value as a covariate and baseline-by-visit interaction.We calculated Pearson’s correlation coefficients to determine the relationship between markers of inflammation, iron metabolism and erythropoiesis at baseline. We also assessed correlations between changes in these markers by randomized treatment.We considered p-values ≤ 0.05 as statistically significant. All analyses were performed with R Statistical Software version 4.2.1 (R Foundation for Statistical Computing, Vienna, Austria).