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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. 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. 4 mg/day, n = 1,610) was compared with Avodart alone (n = 1,623) or tamsulosin alone (n = 1,611) in a 4-year multicenter, randomized, double-blind study. Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter. 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. , serious skin reactions, angioedema) to Avodart or other 5α-reductase inhibitors.
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