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The Phase III study examined the safety and efficacy of "on-demand" Levitra, Vardenafil treatment in 1267 men suffering from mild-to-severe impotence. Men in the study were randomized to receive up to 20 mg of Levitra, Vardenafil or placebo over a 6-week period. Men were free to take their Levitra without restrictions on food or alcohol consumption and to have sex with their partners at the time of their choosing after each dose.

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