- Included were subjects who completed Pfizer study A1481082 or A1481123 without a major
protocol violation and with all treatment-related adverse events resolved prior to
crossover into the open-label study.
- For subjects receiving hormone replacement therapy and/or selective serotonin reuptake
inhibitor treatment, dosage of these must be stable at the start of this extension
study and remain stable throughout.
- Subjects should continue to maintain a stable sexual relationship throughout the
study.
- Excluded were subjects who experienced either treatment-related serious adverse events
or significant treatment-related laboratory abnormalities in the previous study, and
subjects who misused study medication and/or failed to adequately account for study
medication in the previous study, or who were non-compliant with visits.
- Also excluded were subjects who were currently prescribed and/or taking nitrates or
nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational
or aerosols).