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The two studies included patients at high risk for coronary, peripheral or cerebrovascular events as summarized in Table 1. Recruitment from 730 centres in 40 countries for ONTARGET (n = 25,620) was completed in July 2003, and TRANSCEND (n = 6,000) in May 2004. The study results will be reported in 2008. The difference between our views is that I believe one should separate out considerations of realistic benefits, which aims to assess how much power we expect the trial will achieve (a mathematical criterion), from considerations of the MID, which should be used to help assess whether the inferences from the trial are likely to be useful for clinical decision-making (a value criterion).

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