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Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter. During the first 2 years, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. 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. Therefore, for interpretation of serial PSAs in a man taking Avodart, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA. Most of the 4,844 subjects randomly assigned to receive combination, Avodart, or tamsulosin completed 2 years of double-blind treatment (79%, 80%, and 78%, respectively). 5-mg daily doses of Avodart in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment studies, each with 2-year open-label extensions.

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