Statistical analysis
SECONDARY
All data is to be handled according to standard procedures. Demographic characteristics and study outcomes will be described for each group, using means and standard deviations for continuous outcomes and proportions for categorical data. The comparability of the groups at baseline (T0) will be explored. Differences will be taken into account during further analyses. The pattern of missingness will be checked before the analyses. All measures will be controlled for outliers and checked for normality. Skewed continuous outcomes will be transformed. The level of significance (Primary and secondary outcomes will be compared between the intervention and control groups using 