Effect size calculation
The efficacy variables used in this analysis were the change from baseline of the following scores: SKAMP-C, SKAMP-A, SKAMP-D, PERMP-A, and PERMP-C. These variables were analyzed using a linear mixed model repeated-measures analysis. The model included terms for treatment, time, predose, treatment-by-time interaction, predose-by-time interaction, study center, subject age, and subject sex. The random effects were specified using the repeated statement to account for serial within-subject correlation. A significance level The effect size was estimated for each variable and for each measurement using Cohen's 