 9. Clinically significant cardiac disease e.g., uncontrolled hypertension blood pressure of 160110 mmHg on medication, any history of myocardial infarction, unstable angina, New York Heart Association NYHA Grade II or greater congestive heart failure see Appendix H, unstable symptomatic arrhythmia requiring medication subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible, or grade II or greater peripheral vascular diseasesee Appendix H. 