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In studies with healthy volunteers of single doses up to 800 mgadverse reactions were similar to those seen at lower doses but incidence rates and severities were increased.
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The effectiveness of VIAGRA was evaluated in most studies using several assessment instrumentsThe primary measure in the principal studies was a sexual function questionnairethe International Index of Erectile FunctionIIEFadministered during a 4-week treatment-free run-in periodat baselineat follow-up visitsand at the end of double-blindplacebo-controlledat-home treatmentTwo of the questions from the IIEF served as primary study endpointscategorical responses were elicited to questions about1the ability to achieve erections sufficient for sexual intercourse and2the maintenance of erections after penetrationThe patient addressed both questions at the final visit for the last 4 weeks of the studyThe possible categorical responses to these questions were0no attempted intercourse1never or almost never2a few times3sometimes4most timesand5almost always or alwaysAlso collected as part of the IIEF was information about other aspects of sexual functionincluding information on erectile functionorgasmdesiresatisfaction with intercourseand overall sexual satisfactionSexual function data were also recorded by patients in a daily diaryIn additionpatients were asked a global efficacy question and an optional partner questionnaire was administered.
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