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Impact of Stratification Imbalance on Probability of Type I Error

Safety and efficacy of a treatment are the most important issues in any clinical trial. Often, other factors such as gender, stage of disease, etc., are taken into account as part of the trial design. If these factors are not incorporated in the protocol at the design stage, their impact on the Type I error rate may mask the findings of the trial by causing a false positive rate different than the nominal α.

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