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Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo. 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. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. Over 2 years of treatment, drug-related ejaculation disorders occurred more frequently in subjects receiving combination therapy (9%) compared to Avodart (2%) or tamsulosin (3%) as monotherapy. 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.

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