The assessment of clinical trials data uses a paradigm (model) developed for analyses in agriculture and genetics,1 where observations unrelated to the main endpoint were uncommon, and the predictive value of the results was implicit. The risks of the treatments and the choice of decision threshold for the particular situation were usually unimportant.
KeywordsMyocardial Infarction Anticoagulant Therapy Decision Threshold Fatal Embolus Fatal Bleeding
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