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Two studies were conducted to assess the efficacy of CIALIS at a given timepoint after dosing, specifically at24 hours and at 36 hours after dosing. Therefore, CIALIS administration with nitrates is contraindicated. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see CONTRAINDICATIONS] .

Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH [see CIALIS 5 mg For Once Daily Use For ED And BPH] . The first study (Study J) randomized 1058 patients to receive either CIALIS 2.5 mg, 5 mg, 10 mg or 20 mg for once daily use or placebo. The second study (Study K) randomized 325 patients to receive either CIALIS 5 mg for once daily use or placebo.

The full study population was 87% White, 2% Black, 11% other races