In 1992, Hansson et al1 proposed a novel design, the prospective randomized open trial with blinded end-point assessments. The lack of blinding of investigators and patients simplified the conduct of the trial, which would become more similar to routine medical practice than the blinded design. The use of blinding for the adjudication of outcomes would preserve the benefits of a fully blinded trial. A number of trials have used this design to evaluate antihypertensive agents and more recently antidiabetic agents.2- 4 These trials were thought to produce valid and, perhaps, more generalizable results.
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