Data analysis
SECONDARY
Statistical analyses will be performed with SAS v9.4, and R v4.1. All primary statistical analyses will be conducted on the miTT population. A p-value < 0.05 will be considered statistically significant for the primary and secondary endpoints.Patient characteristics will be described for all demographic and clinical data recorded at inclusion in the overall population, miTT population and according to group. Qualitative variables will be described with absolute numbers and percentages. Continuous variables will be reported using mean, standard deviation (SD), median, quartile 1-quartile 3 (q1-q3), min-max.The comparison of average total sleep time for primary endpoint will be performed with Z-test. Comparisons for secondary endpoints will be carried out using Student’s t-test, Wilcoxon rank-sum test, analysis of variance (ANOVA), and Kruskall-Wallis test, as appropriate. The association of qualitative variables will be carried out using chi-square or Fisher’s exact tests, as appropriate.