The most important consideration in the choice of study design and endpoint is that these two features match and represent the objective and the perspective of the trial as closely as possible. The mechanism may also be helpful, but arguments based on the mechanism, structure or levels of the variables, or based on practical considerations, such as (statistical) efficiency, must always be secondary considerations.
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http://dx.doi.org/10.1016/j.jclinepi.2007.10.001 | DOI Listing |
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