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Thus, the mg dose may provide some additional benefit beyond that achieved with the mg dose and may be the most appropriate choice for initiation of therapy in many men. Except for the global efficacy assessment questions, all assessment tools are validated, and a higher score indicates better outcome. In this study, analyses were conducted on data from the intent-to-treat population for each study, which was defined as men who took at least one dose of study medication and who provided sufficient efficacy data for at least one efficacy analysis. During the DBPC phase of each trial, patients in each treatment group received an average of seven or eight doses per month. In both trials, most AEs were mild or moderate in severity. For the mg fixed-dose regimen relative to the flexible-dose regimen, there was a similar increase from baseline in the percentage of EHS 4 erections and EHS 3 or 4 erections, a similar improvement from baseline in IIEF scores, a greater improvement from baseline in SEAR scores and SEX-Q scores, and a higher EDITS Index; approximately one-third more men in the mg fixed-dose vs the flexible-dose regimen were satisfied with their sildenafil treatment. Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction. Early sildenafil dose optimization and personalized instruction improves the frequency, flexibility, and success of sexual intercourse in men with erectile dysfunction.

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