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The relationship between long-term use of Avodart and male breast neoplasia is currently unknown. If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5. 4 mg/day, n = 1,610) was compared with Avodart alone (n = 1,623) or tamsulosin alone (n = 1,611) in a 4-year multicenter, randomized, double-blind study. During the double-blind treatment period, 2,167 male subjects were exposed to Avodart, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter.

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