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Prostate 28 , 251265 (1996)

With respect to the applicant's assertion that TERLIVAZ offers a treatment option for a patient population unresponsive to currently available treatments because among patients in the CONFIRM trial, patients that had failed prior therapy with available options achieved a statistically significant improvement in renal function with TERLIVAZ, we note that the applicant provided evidence from data on file for the clinical study report of the CONFIRM trial