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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. 14) for tamsulosin, with a mean difference between combination and Avodart of 1. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. 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.

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