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Table 2 Identification of spin one of the selected studies

From: Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports

One study that examined the use of esketamine in treatment-resistant depression used a hierarchical testing approach: if the higher of two doses was not positive, according to the protocol the lower dose should not have been tested and reported. It was nevertheless tested and presented in the paper despite a negative result on the 84 mg dose: “… Although esketamine 56 mg/ antidepressant could not be formally tested, the LS means difference was –4.1 [–7.67, –0.49] (nominal 2-sided P value=.027)” and “… Statistical significance was not achieved for the primary endpoint; nevertheless, the treatment effect (Montgomery-Asberg Depression Rating Scale) for both esketamine/antidepressant groups exceeded what has been considered clinically meaningful for approved antidepressants vs placebo [...] This study provides supportive evidence for the safety and efficacy of esketamine nasal spray as a new, rapid-acting antidepressant for patients with treatment- resistant depression.”