Sample Size
We conducted sample size calculations starting from previous study of
Sonneveld N. et al 25. To detect a difference of 0.3,
considering 0.8 SD of differences, given a type I error of 0.05% and
80% power, 58 subjects were required for the analysis. To stratify the
response, we divided the population in two group: pediatric and
pre-adult age (PPaa) with < 18 years age and adult population
with >18 years age.