 - Significant co-morbid condition or disease which in the judgment of the investigator would place the patient at undue risk or interfere with the study e.g. cardiac disease such as acute coronary syndrome or unstable angina within 6 months, New York Heart Association NYHA class 2 or greater congestive heart failure CHF, uncontrolled hypertension, arrhythmia requiring medication or mechanical control, chronic obstructive pulmonary disease COPD, cirrhotic liver disease, or other conditions 