Subjects with other uncontrolled medical conditions, e.g. myocardial infarction, cerebrovascular accident, diabetes or hypertension. Patients with arterial thrombotic events, such as cerebrovascular accident or myocardial infarction, within months of enrollment History of myocardial infarction or cerebrovascular accident within months of enrollment date A history of events such as myocardial infarction, cerebrovascular accident or acute hepatitis within months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy. Known history of cerebrovascular accident, myocardial infarction, or intracranial hemorrhage within months of enrollment. History of cerebrovascular accident, myocardial infarction or unstable angina within the previous months before starting therapy Clinically significant cardiomyopathy or cardiac complications, including recent myocardial infarction or cerebrovascular accident within one year, and/or unstable or uncontrolled angina Patients with a known history of myocardial infarction or cerebrovascular accident are not eligible Patients with a history of myocardial infarction, unstable angina, or cerebrovascular accident < months prior to registration Myocardial infarction or cerebrovascular accident within months prior to study registration History of documented myocardial infarction or cerebrovascular accident Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within months prior to the planned first dose of study drug. Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within months prior to the planned first dose of study drug. Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within months prior to the first dose of study drug. History of myocardial infarction or cerebrovascular accident within months of enrollment date. Subject has history of severe/unstable angina, myocardial infarction, or cerebrovascular accident within months prior to the first dose of study drug.