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September 8, 1999

Sildenafil for Diabetic Men With Erectile Dysfunction

Author Affiliations

Margaret AWinkerMD, Deputy EditorIndividualAuthorPhil B.FontanarosaMD, Interim CoeditorIndividualAuthor

JAMA. 1999;282(10):939-941. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-10-jbk0908

To the Editor: The clinical trial by Rendell et al1 designed to test whether sildenafil is a safe and effective treatment for ED in men with diabetes used the following inclusion, and by inference, exclusion criteria: "The patients also had to be in a stable relationship with a female partner for at least the previous 6 months [emphasis added]." The inclusion and exclusion criteria of a clinical trial determine not only who has access to a clinical trial, and therefore to a promising new therapy, but the generalizability of the trial's results.2 Therefore, it is essential to consider why the investigators required that the man's partner be female, and not simply male or female.