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Initial nonresponders younger than 65 years were significantly more likely to report successful intercourse at both tadalafil dosages relative to placebo-treated men younger than 65 years. Tadalafil was found to be significantly superior to placebo at both dosages for all primary efficacy end points; specifically, the mean IIEF-EF domain score increased by 4.

Tadalafil also produced significant changes in other end points, including intercourse satisfaction, sexual confidence, and overall satisfaction with sexual life.

This study also investigated serum biomarkers for diabetes hemoglobin A 1 c and inflammation, including C-reactive protein, nitrotyrosine, intracellular adhesion molecule-1, and vascular adhesion molecule-1.

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No significant changes were noted for these serum parameters. Importantly, the frequency of sexual intercourse attempts was not significantly different between the treatment groups throughout the study.

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    These men were treated with 20 mg of tadalafil on demand for 4 weeks, followed by a 4-week washout period; they were subsequently treated with a 12-week, 10- or 20-mg flexible daily dose of tadalafil.

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