? 2022 Elsevier LtdMignot E, Mayleben D, Fietze I, et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol 2022; 21: 125–39—In this Article, in the Summary, the number of countries in which the trials were done should be 18. In the Outcomes section of Methods, the prespecified efficacy endpoints “change from baseline in subjective WASO and latency to sleep onset (LSO) at months 1 and 3” should be deleted as they are not reported. In the Statistical analysis section of Methods, available data were included in efficacy analyses “according to ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials”. In figure 1A, the right-hand box of the penultimate row should read “1 withdrew for administrative reasons”, and “1 other” should be added underneath. In figure 1B, the centre box of the ninth row should read “2 lost to follow-up”; and in the right-hand box of the penultimate line “4 withdrew consent” should be added underneath. In figures 2 and 3, the number of participants with an assessment at each timepoint has been corrected. In figure 2C, the two-sided p value for daridorexant 25 mg versus placebo at month 1 should be “p=0·0005”. In table 3, the number of hallucinations in the column for Study 2, Daridorexant 25 mg should be “3 (1%)”. In the tenth paragraph of the Results, in the left-hand column, the proportions of participants who had an Insomnia Severity Index score of less than 10 at month 3 should state that they are based on patients who had an assessment at that timepoint. In the twelfth paragraph of Results, the third sentence should be amended to read “..and one participant in the daridorexant 25 mg group in study 1 and three participants in the daridorexant 25 mg group in study 2 reported hallucinations,..”. These corrections have been made to the online version as of April 5, 2022.
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