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More patients exposed to dutasteride than placebo experienced impotence, decreased libido, ejaculation disorders, and gynecomastia in the course of the 24-month study. However, most of these effects were transient, and the incidence of new occurrences of each event decreased in the second year. Additionally, discontinuation because of AEs was rare. These results compare favorably with the AE profile of the existing type II 5-alpha-reductase inhibitor, demonstrating that the more pronounced reduction in DHT by the dual inhibitor of 5ARI does not lead to an increase in the number or severity of AEs.
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