12. Cardiovascular disease with clinical significance, including but not limited to CVA(cerebral vascular accident) or TIA（transient ischemic attack） (≤ 6 months before admission), myocardial infarction (≤ 6 months before enrollment), unstable angina, New York Heart Association classification ≥ Class II Congestive heart failure, need to be treated during the study and may interfere with the study of treatment, or drug can not control the serious arrhythmia;