Statistical analysis
SECONDARY
The planned enrollment—prespecified in the protocol—was 132 participants (66 per treatment group); this was intended to yield 112 subjects with completed data assuming a 15% drop-out rate. The sample size was chosen to provide 85% power to detect a statistically significant difference between treatment groups at a one-sided alpha level of 0.025, based on effect sizes for CGI-I and IRLS from a previous proof-of-concept study [Efficacy analyses were performed on the ITT population. Multiple imputation was used for the primary endpoint and no imputation was used for the secondary endpoints. Hierarchical testing was employed to account for multiplicity. CGI-I and PGI-I responder rates were compared using a one-sided normal approximation test for comparison of two proportions; mean scores on the IRLS, MOS-II, MOS-I, CGI-I, and IRLS question 7 were compared using a one-sided, two-sample The safety analysis population included all participants who received any dose of study treatment, including participants who underwent titration but failed screening. Participants were analyzed based on actual treatment received. Rates of AEs were compared using one-sided, two-sample The study protocol and statistical analysis plan are available in 