31. Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100 mmHg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including: - myocardial infarction or unstable angina within </=6 months prior to the first study treatment. - New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF). -serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia). - Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior of study enrollment. - Prior history of hypertensive crisis or hypertensive encephalopathy.