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Copyright 2008, The Johns Hopkins University and Simon Day. All rights reserved. Use of these materials permitted only in accordance with license rights granted. Materials provided AS IS ; no representations or warranties provided. User assumes all responsibility for use, and all liability related thereto, and must independently review all materials for accuracy and efficacy. May contain materials owned by others. User is responsible for obtaining permissions for use from third parties as work is licensed under a Creative Commons Attribution -NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this Issues, ITT, Post-Hoc, and SubgroupsSimon Day, PhDJohns Hopkins UniversitySection AIntention to Treat4 Intention to Treat The principal is that every patient who is randomized should be included in the analysis Why Ensures a valid analysis; ensures different groups of patients are comparable (because of randomization) Avoids many causes of bias; particularly avoids ambiguous decisions about who to include/who not to include in the analysis5 Intention to Treat Which treatment is better?

5 Intention to Treat Which treatment is better? or . . . Is treatment X better than treatment Y? − “Better” as used in “clinical practice” or “all other things being

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