Descriptive statistics will be computed for all study variables. Continuous variables will be described with measures of central tendency (mean, median) and dispersion (range, standard deviation). Categorical variables will be summarized as frequencies and percentages. Comparisons between categorical variables will be compared with the chi-square test; continuous variables will be compared with Student’s t test or non-parametric equivalents. Paired continuous data will be assessed with a paired t test or Wilcoxon signed rank test, depending on distribution. Paired categorical data will be assessed with McNemar’s test. For the longitudinal data, a mixed-model repeated measures analysis will be used to examine the between subject factors and the within subject factor of time (baseline, visit 1, visit 2, etc.), as well as their interaction, on the outcome variables of interest. Post hoc tests with corrections for multiple comparisons will be run to determine where significance lies. P values < 0.05 will be considered statically significant.

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