6. History of clinically significant cardiovascular disease including, but not limited to: 1) Myocardial infarction or unstable angina </=6 months prior to treatment initiation 2) Clinically significant cardiac arrhythmia 3) Deep vein thrombosis, pulmonary embolism, stroke </=6 months prior to treatment initiation 4) Congestive heart failure (New York Heart Association class III-IV) 5) Pericarditis/clinically significant pericardial effusion 6) Myocarditis 7) Endocarditis