Statistical analysis
Statistical analysis was based on all valid data of randomized participants according to per-protocol analysis. For all variables, normality was evaluated by qqplot and the Shapiro-Wilk test. Descriptive analysis used frequencies and percentages (categorical variables), means and standard deviation (symmetric distributed continuous variables), and median and interquartile range (skewed continuous variables). Parametric Student’s t test was used to evaluate the difference between means, and a nonparametric Mann-Whitney U test was used to evaluate the difference between medians. The chi-square test was employed to assess the association between categorical variables. The mixed effects models evaluated the impact of the intervention over time on the primary outcome, HbAStatistical analyses were performed using the R 4.1.3 statistical package (R Core Team (2022). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL 