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Patient disposition, randomized controlled trial.
Patient disposition, open-label study.
Patient Demographics and Baseline Clinical Characteristics for the Randomized Controlled Trial and Open-Label Study
↵a 2 mg for children aged 6–11 y, 3 mg for adolescents aged 12–17 y.
↵b 1 mg for children aged 6–11 y, 2 mg for adolescents aged 12–17 y.
↵c n = 301.
↵d n = 302.
↵e T scores standardized for age and gender, mean = 50, SD = 10.
↵f n = 159.
↵g not assessed.
Change From Baseline to Week 12 for Primary and Key Secondary Efficacy Measures
↵c P value adjusted for 2 comparisons.
↵d The CGI-I involves an evaluation with respect to baseline, and the value is therefore presented as an absolute value rather than as the least squares mean change from the baseline value.
AEs Reported by ≥2% of Patients in Either Eszopiclone Group During the Double-Blind Period (Safety Population)
↵c AEs that were more frequent in the eszopiclone group than in the placebo group by at least 1%.
AEs Reported by ≥2% of Patients During the Open-Label Study
↵b C-SSRS interviews identified suicidal ideation in one additional patient.
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