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Hunink MGM et al. – The optimal study design for the treatment of intermittent claudication involves a randomized controlled trial collecting data on the quality–adjusted life expectancy and additional admission costs for 525 patients per treatment arm. The optimal sample size remained between 400 and 600 patients for a willingness–to–pay threshold between €30,000 and €100,000/quality–adjusted life–years, for even extreme assumptions about the study costs, and for a range of 3 to 7 years that future patients will benefit from the results of the proposed study.

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