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  • Title: Randomization and efficiency in Zelen's single-consent design.
    Author: Matts J, McHugh R.
    Journal: Biometrics; 1987 Dec; 43(4):885-94. PubMed ID: 3427173.
    Abstract:
    The "single-consent design" was devised by Zelen to circumvent the reluctance of some patients and physicians to participate in certain types of randomized clinical trials. Crucial to the validity of Zelen's design is randomized allocation of patients. Randomization theory is therefore the key theoretical base of the approach taken in this paper to an examination of the efficiency of this design.
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