Abstract
It is widely recognized that, for all of their virtues, randomized trials cannot be relied on to provide answers to all of our questions regarding the impact of medical interventions [1,2]. For example, the nature and duration of a protocol for administering a given treatment may differ between the setting of the trial and that of medical practice more generally. Also, it is possible that in some regards, patients who fall outside a trial's eligibility criteria may be atypical in their response to the treatment.
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