Statistical analysis
SECONDARY
Baseline categorical variables are described as absolute and relative
frequencies, while baseline quantitative variables are expressed as the mean and
SD or median and interquartile range (IQR). Subjects were analyzed according to
their randomization group, regardless of the treatment they received. Data
distribution was evaluated using graphical analysis and the Shapiro‒Wilk test.
Paired Student’s t test was used to compare the primary outcome between the two
interventions and perform sensitivity analysis. The Friedman test was used to
compare the 5 time points. For the secondary outcomes, categorical outcomes were
assessed using McNemar’s test, symmetrical continuous outcomes were evaluated
using paired Student’s t test, and continuous asymmetrical outcomes were
assessed using Wilcoxon’s signed-rank test. Analyses were performed using R
software,