Statistical analyses
GCA
The presented analyses are descriptive. To demonstrate the utility of PRAS in characterizing absolute change in the study samples over time, differences in the distribution of cognitive development categories between treatment groups in the overall population and in the subpopulation younger than 6 years of age were assessed using a post hoc, non-parametric, one-sided Mann–Whitney U-test. No multiplicity adjustments were made; therefore, these results are considered descriptive. Mean GCA scores over time for patients in each cognitive development category are presented graphically.