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The analysis team was blinded to treatment assignment. The data analyst, who was not involved in the collection of data, entered the data in the database without knowledge of group assignment. A statistician, who was also blinded to group assignment, analyzed and assessed the data. The statistician also verified that the data were randomly assigned prior to analysis. The primary study endpoint was the difference in the proportion of participants who experienced primary sleep apnea syndrome resolution at visit 2 in the tricyclic antidepressant (TCA) arm versus the placebo arm of the study. The primary analysis was intention to treat. A per-protocol analysis was also conducted.
The sample size was chosen to permit a definitive result with over 85% power to reject the null hypothesis of no difference between the proportion of participants who achieved primary sleep apnea syndrome (SAS) resolution at visit 2 in the treated arm versus the placebo arm (H0 = “no difference between the proportions of participants who achieved primary SAS resolution in the treated and placebo arms”). The sample size was determined based on the assumption that the proportion of participants who achieved primary SAS resolution would be lower in the placebo arm than in the TCA arm. The aim was to test the null hypothesis by using the Wilcoxon signed rank sum test. The null hypothesis was rejected if the test statistic was 827ec27edc