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When including the open-label extensions, 1,009 male subjects were exposed to Avodart for 3 years and 812 were exposed for 4 years. To interpret an isolated PSA value in a man treated with Avodart for 6 months or more, the PSA value should be doubled for comparison with normal values in untreated men. Avodart Capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5. These data suggest that Avodart arrests the disease process of BPH in men with an enlarged prostate. 01) for tamsulosin, with a mean difference between combination and Avodart of -1. 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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