 - History or current evidence of cardiovascular risk including any of the following: current clinically significant uncontrolled arrhythmias, acute coronary syndromes including myocardial infarction and unstable angina, coronary angioplasty, or stenting within 6 months prior to randomization, current Class II congestive heart failure as defined by New York Heart Association NYHA, treatment-refractory hypertension defined as a blood pressure of systolic blood pressure SBP 140 millimeters of mercury mmHg andor diastolic blood pressure DBP 90 mmHg which cannot be controlled by anti-hypertensive therapy, has an intra-cardiac defibrillator or permanent pacemaker and known cardiac metastases. 