 2. Patients with clinically significant cardiovascular disease eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina 6 months to enrollment, New York Heart Association NYHA Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade II or greater peripheral vascular disease, and history of cerebrovascular accident CVA within 6 months. 