Sensitivity analysis
clinician-evaluated, clinician-evaluated RLS, RLS
Next, we ran a post hoc analysis to evaluate if study endpoints were robust to incorporating participant-reported RLS symptoms in the success metric instead of clinician-evaluated RLS symptoms. In place of the clinician-evaluated CGI-I ≤ 5 success criterion, we substituted participant-rated IRLS score ≤ 20 at the end of the step-down (below the threshold for severe RLS). Based on this metric, 60% of participants (12 of 20) were successful and the average successful dose reduction was 26.4 percent. There was considerable agreement between metrics; 16 of 20 participants (80%) would have had the same outcome under both metrics (11 success, 5 fail).