Statistical analysis
SE
SECONDARY
Statistical analysis was performed on the full analysis set, which was defined as all randomized patients who received at least 1 dose of study medication (ESK or PBO nasal spray) and 1 dose of oral AD in the treatment phase. Descriptive statistics of actual values and changes from baseline by treatment group were provided for the weighted EQ-5D HSI, the EQ-VAS, and the individual EQ health dimensions at each time point for the double-blind treatment phase. Changes in the HSI and EQ-VAS scores from baseline to Day 28 were analyzed based on a mixed-effect model for repeated measures (MMRM) with treatment, day, country, class of oral AD (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]), and treatment-by-day as factors and baseline values as the covariates.For the individual EQ health dimensions, the ESK + AD and AD + PBO groups were compared using a Cochran-Mantel–Haenszel Chi-square test adjusting for country and class of AD (SNRI or SSRI). Relative risk (RR) and 95% confidence interval (CI) were calculated. The change from baseline to Day 28 in SDS total score and PHQ-9 total score was evaluated using the same MMRM model as described above. Based on the pre-planned hierarchal testing of key secondary endpoints in the study, a serial gatekeeping (fixed sequence) approach was applied to adjust for multiplicity and to control type I error while evaluating changes in SDS total score, and PHQ-9 total score. Means (± standard error [SE]), mean changes (± SE) from baseline, and least squares (LS) mean changes (± SE) from baseline were presented graphically for the double-blind treatment phase for the observed cases and separately for the last observation carried forward (LOCF) evaluations.