- History of serious systemic disease, including: myocardial infarction within the last 6 months; uncontrolled hypertension (blood pressure of >160/110 mmHg on medication); unstable angina; New York Heart Association (NYHA) Grade II or greater congestive heart failure; unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); or peripheral vascular disease (Grade II or greater). Prior history of thrombotic events and stroke are also included as exclusion criteria.