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The NSABP [National Surgical Adjuvant Project for Breast and Bowel Cancers] study of simple mastectomy versus lumpectomy with and without radiation began as a conventionally randomized clinical trial. Accrual rates were unacceptably low. After the protocol was modified to permit prerandomization the accrual rate increased substantially. Because enough patients have been enrolled in this study, this prerandomized trial has begun to yield important results . Presumably as a consequence of the conversion to prerandomization, many thousands of women as a result of this trial will be able to choose, and will be advised by their physicians to select, less disfiguring surgery for early breast cancer. Apparently prerandomization has been successful, not only in generating medical knowledge, but in producing extraordinarily significant human benefits.