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Therefore, Avodart may cause fetal harm when administered to a pregnant woman. 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). When including the open-label extensions, 1,009 male subjects were exposed to Avodart for 3 years and 812 were exposed for 4 years. 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. Avodart is contraindicated for use in women of childbearing potential and during pregnancy.

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