Statistical analysis
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Categorical data are expressed as frequencies and percentages, and continuous data as mean (± standard deviation, SD) or median and interquartile range (IQR) (25th–75th percentile). Analysis was performed in the per-protocol (PP) dataset, that is, all patients who were randomized, received the intervention, and completed the study procedures. A single-factor analysis of variance (ANOVA) was used to compare CVs changes among the three study groups. The Mann–Whitney 