The role of placebo response in the efficacy outcome assessment in viloxazine extended-release pivotal trials in paediatric subjects with attention-deficit/hyperactivity disorder.

28 The application of band‐pass filters to the mean change of the total Montgomery–Asberg Depression Rating Scale scores in this study increased the separation of active drug from placebo and reversed the direction of the original trial outcome (MMRM; P = .58) by generating a nonsignificant trend in a positive direction ( P = .13 and 0.16).

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As such, Study 812P304 was considered a negative study, given that 600 mg/d viloxazine ER did not reach statistical significance on the predefined primary endpoint.

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