Randomization and Blinding

Randomization procedures are employed to ensure that study subjects entered into a comparative study are treated in an unbiased way. Blinding (or masking) procedures (e.g. single-blind or doubleblind) further minimize bias by ensuring that outcome judgments are not based on knowledge of the treatment. If the study design is double-blind, it is essential that all personnel who may influence the subject or the conduct of the study are blinded to the identity of the study medication/device assigned to the subject, and therefore do not have access to randomization schedules.

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