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of 3 pills a day for a 5-year treatment period. The counts for the boxes could be near the number of subjects randomized if they include the number receiving any of the assigned treatments, or near 0 if they include only the number of subjects perfectly compliant during the 5-year course of treatment. There are no withdrawals (fifth tier of boxes) from trials after randomization under the intention-to-treat analysis construct. The primary analysis in any report should be one in which persons, their outcomes and events, and related followup data are counted to the assigned treatment, regardless of a person’s course of treatment, level of compliance with the assigned treatment, or evaluability. There is no point in randomizing persons to treatment if the assignment is ameliorated or ignored in the analysis. This is not to say that other less stringent analyses should not be performed or reported, but rather that they are not informative in the absence of the primary analysis. Withdrawn or withdrawal in the context of trials is best reserved for use as a technical term in relation to analysis. 6 Its

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