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Dworkin RH et al. – In this article, the authors first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. The authors then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors.

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