No history of atrial fibrillation or myocardial infarctionXx_NEWLINE_xXPatients with a history of the following within =< 12 months of study entry are not eligible:\r\n* Arterial thromboembolic events\r\n* Unstable angina\r\n* Myocardial InfarctionXx_NEWLINE_xXNo angina or myocardial infarction within 182 days of registration; in view of potential cardiac risk with lenalidomide, patients with stable angina will be excludedXx_NEWLINE_xXNo clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollmentXx_NEWLINE_xXMyocardial infarction within the past 6 monthsXx_NEWLINE_xXPatients must not have a myocardial infarction within 6 months prior to registrationXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 12 months prior to day 1Xx_NEWLINE_xXPatients with myocardial infarction or unstable angina < 6 months prior to starting study drugXx_NEWLINE_xXHistory of myocardial infarction within 6 months.Xx_NEWLINE_xXUnstable angina or myocardial infarction.Xx_NEWLINE_xXHistory of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac or vascular surgery within 6 months prior to day 1 of study treatmentXx_NEWLINE_xXSevere arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusionXx_NEWLINE_xXUnstable angina pectoris </=6 months prior to enrollmentXx_NEWLINE_xXAcute myocardial infarction </=6 months prior to enrollmentXx_NEWLINE_xXHistory of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks.Xx_NEWLINE_xXPatients with a history of known coronary artery disease or a myocardial infarction within 12 months prior to pre-registrationXx_NEWLINE_xXMust not have a history of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QT prolongationXx_NEWLINE_xXMyocardial infarction of unstable angina within 6 months prior to the planned start date of study drug.Xx_NEWLINE_xXMyocardial infarction or unstable angina pectoris within 6 months prior to randomization.Xx_NEWLINE_xXSevere/unstable angina pectoris, or myocardial infarction within 6 months prior to study entryXx_NEWLINE_xXMyocardial infarction within 6 months prior to study entry,Xx_NEWLINE_xXUnstable angina within 6 months prior to study entry,Xx_NEWLINE_xXMyocardial infarction within the last 6 monthsXx_NEWLINE_xXAcute myocardial infarction ?6 months prior to Day 1Xx_NEWLINE_xXAny comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.Xx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months of the first date of treatment on this study.Xx_NEWLINE_xXHistory of cerebral vascular accident, unstable angina, myocardial infarction, or ventricular arrhythmia within the last 6 monthsXx_NEWLINE_xXAny history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years.Xx_NEWLINE_xXMyocardial infarction within the previous 6 months before planned first dose of study drugXx_NEWLINE_xXMyocardial infarction within 6 months of study doseXx_NEWLINE_xXAcute myocardial infarction or angina pectoris.Xx_NEWLINE_xX12. Subjects with any other concurrent, uncontrolled illness, including known psychiatric or substance abuse disorders which may interfere with the ability of the subject to cooperate and participate in the trial. Other examples of such conditions would include unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA) within 6 months of study entry.Xx_NEWLINE_xXSubjects with myocardial infarction (heart attack) within 1 yearXx_NEWLINE_xXUnstable angina pectoris or myocardial infarction ? 3 months prior to starting treatment in the study.Xx_NEWLINE_xXHistory of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry;Xx_NEWLINE_xXNo uncontrolled arrhythmia; no myocardial infarction in the last 6 monthsXx_NEWLINE_xXHaving known myocardial infarction or unstable angina within 6 months before first ZW25 dosingXx_NEWLINE_xXMyocardial infarction within 6 months prior to initiation of screeningXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months of registrationXx_NEWLINE_xXOther serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 monthsXx_NEWLINE_xXAny history of myocardial infarction in the past 12 monthsXx_NEWLINE_xXMyocardial infarction and/or new ST elevationXx_NEWLINE_xXIschemic cardiac event including myocardial infarction within 3 months prior to first doseXx_NEWLINE_xXMyocardial infarction,Xx_NEWLINE_xXMyocardial infarction within 6 months prior to screening, or pericardial effusion,Xx_NEWLINE_xXHave a recent history of myocardial infarction (within the past 2 months)Xx_NEWLINE_xXMyocardial infarction within 6 months of course 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participateXx_NEWLINE_xXischemic peripheral vascular disease, myocardial infarction within the past 6 months,Xx_NEWLINE_xXHistory of myocardial infarction within the last 6 months.Xx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to day 1Xx_NEWLINE_xXHistory of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stent placement within 6 months prior to study drug dosingXx_NEWLINE_xXSevere uncontrolled cardiac disease within 6 months of study entry, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).Xx_NEWLINE_xXMyocardial infarction in the previous 12 weeks (from the start of treatment)Xx_NEWLINE_xXHas a history of myocardial infarction or unstable angina within 6 months before enrollmentXx_NEWLINE_xXHistory of myocardial infarction within 6 months of the randomizationXx_NEWLINE_xXHistory of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollmentXx_NEWLINE_xXSignificant cardiac disease such as recent myocardial infarctionXx_NEWLINE_xXPatients with a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months)Xx_NEWLINE_xXHistory of arterial thromboembolic event in past 6 months (including cerebrovascular accident [CVA], myocardial infarction [MI])Xx_NEWLINE_xXPatients with unstable angina and/or myocardial infarction within 6 months prior to screeningXx_NEWLINE_xXThe patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiencyXx_NEWLINE_xXPatients within 6 months of myocardial infarction (MI) and stroke will be excludedXx_NEWLINE_xXMyocardial infarction (MI) within 6 months of Screening Visit.Xx_NEWLINE_xXMyocardial infarction within the 6 months prior to study drug administrationXx_NEWLINE_xXSevere/unstable angina within the 6 months prior to study drug administrationXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to first study treatmentXx_NEWLINE_xXHistory of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medicationsXx_NEWLINE_xXHas history of myocardial infarction within the past 6 months.Xx_NEWLINE_xXMyocardial infarction or cerebrovascular accident (CVA) within 6 months.Xx_NEWLINE_xXArterial or venous thrombi (including stroke), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting.Xx_NEWLINE_xXPatient has any unstable or uncontrolled medical condition that would make it potentially unsafe to undergo TURBT including a previous stroke or myocardial infarction within 6 monthsXx_NEWLINE_xXMyocardial infarction within 3 months of registration.Xx_NEWLINE_xXPatients with a history of myocardial infarction within the last 6 months or unstable / uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmiasXx_NEWLINE_xXIschemic cardiac event including myocardial infarction within 3 months prior to first dose;Xx_NEWLINE_xXSignificant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 monthsXx_NEWLINE_xXMyocardial infarction within 6 months of starting study drugXx_NEWLINE_xXEvidence of ischemia or myocardial infarction within the past 6 months, or any significant abnormality on ECG.Xx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration.Xx_NEWLINE_xXHistory of cerebrovascular accident (CVA), myocardial infarction or unstable angina within the previous 6 months before starting therapy.Xx_NEWLINE_xXInpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 monthsXx_NEWLINE_xXMyocardial infarction within 6 monthsXx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to registrationXx_NEWLINE_xXHistory of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.Xx_NEWLINE_xXPatients with history of myocardial infarction within 6 monthsXx_NEWLINE_xXNo stroke, myocardial infarction, or major surgery within 3 months of starting on therapyXx_NEWLINE_xXHistory of an ischemic cardiac event including myocardial infarction within 3 months of study entryXx_NEWLINE_xXMyocardial infarction within 6 months of study entryXx_NEWLINE_xXUnstable angina or a history of myocardial ischemia within prior 6 monthsXx_NEWLINE_xXNo cerebrovascular accident (CVA) within 6 months, no myocardial infarction (MI) within 6 monthsXx_NEWLINE_xXmCRPC EXPANSION COHORT: Any of the following within 6 months before the first dose of study treatment:\r\n* Unstable angina pectoris\r\n* Stroke (including TIA, or other ischemic event)\r\n* Myocardial infarctionXx_NEWLINE_xXNo evidence of a history of a stroke or myocardial infarction within the last 6 months prior to study enrollmentXx_NEWLINE_xXNo uncontrolled arrhythmia; no myocardial infarction in the last 6 monthsXx_NEWLINE_xXActive ischemic heart disease or history of myocardial infarction within six months.Xx_NEWLINE_xXUnstable angina pectoris or acute myocardial infarction =< 3 months prior to starting study drugXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 3 months prior to cycle 1, day 1Xx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months of enrollmentXx_NEWLINE_xXSignificant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 monthsXx_NEWLINE_xXArterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study entryXx_NEWLINE_xXUnstable angina pectoris or acute myocardial infarction =< 3 months prior to starting study drugXx_NEWLINE_xXHistory of myocardial infarction or cerebrovascular accident within 6 months of enrollment dateXx_NEWLINE_xXMyocardial infarction within 6 months of study entryXx_NEWLINE_xXMyocardial infarction less than 6 months before study enrollmentXx_NEWLINE_xXMyocardial infarction within the past 12 months, or stable or unstable anginaXx_NEWLINE_xXHistory of myocardial infarction or severe unstable anginaXx_NEWLINE_xXMyocardial infarction or cardiac surgery within 6 months prior to enrollmentXx_NEWLINE_xXmyocardial infarction in the previous six monthsXx_NEWLINE_xXMyocardial infarction within 1 year of study entry; subjects with a history of myocardial infarction between 6 and 12 months prior to study entry who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participateXx_NEWLINE_xXAny history of peripheral vascular infarction, including visceral infarctionXx_NEWLINE_xXPatients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment.Xx_NEWLINE_xXMyocardial infarction (MI) within 3 months. • Presence of active, uncontrolled infection. • Known central nervous system illness (e.g., Alzheimer's disease).Xx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXHistory of cardiac infarction within the past 12 months prior to the start of study treatmentXx_NEWLINE_xXHistory of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 monthsXx_NEWLINE_xXSubjects that have had a myocardial infarction within the last 6 monthsXx_NEWLINE_xXPatients with a history of myocardial infarction that is < 3 months prior to registrationXx_NEWLINE_xXNo cerebrovascular accident (CVA) within 6 months, no recent myocardial infarction (MI) within 6 monthsXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to study enrollmentXx_NEWLINE_xXPatients with a history of myocardial infarction that is < 3 months prior to registrationXx_NEWLINE_xXTransmural myocardial infarction within the last 6 monthsXx_NEWLINE_xXPatients experiencing a cardiac events (acute coronary syndrome, myocardial infarction, or ischemia) within the 3 months prior to accrualXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within the past 12 monthsXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to day 1Xx_NEWLINE_xXPrior myocardial infarction within one year of study entryXx_NEWLINE_xXSubject has a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months)Xx_NEWLINE_xXHave active angina pectoris or recent myocardial infarction (within 6 months).Xx_NEWLINE_xXHistory of myocardial infarction within 6 monthsXx_NEWLINE_xXPatients with a myocardial infarction or unstable angina within 6 months of study entryXx_NEWLINE_xXMyocardial infarction < 6 months prior to screeningXx_NEWLINE_xXKnown history of Torsade de Pointes, unstable cardiac arrhythmia or proarrhythmic conditions, or a history of recent myocardial infarction within 90 days of study entry.Xx_NEWLINE_xXPatients with a history of myocardial infarction or stroke within the last 6 monthsXx_NEWLINE_xXUnstable angina or a history of myocardial ischemia within prior 6 monthsXx_NEWLINE_xXHistory of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the investigator, increases the risk of ventricular arrhythmiaXx_NEWLINE_xXPatients with clinically significant cardiovascular disease: History of CVA (cerebrovascular accident) within 6 months, myocardial infarction or unstable angina within 6 months, unstable angina pectorisXx_NEWLINE_xXHistory of any one or more of the following cardiovascular conditions within the past 6 months: \r\n* Cardiac angioplasty or stenting \r\n* Myocardial infarction \r\n* Unstable angina \r\n* Coronary artery bypass graft surgery \r\n* Symptomatic peripheral vascular diseaseXx_NEWLINE_xXPatients with clinically significant cardiovascular disease: history of cerebrovascular accident (CVA) within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectorisXx_NEWLINE_xXHistory of cerebral vascular accident (CVA), myocardial infarction or unstable angina within the previous six months before starting therapyXx_NEWLINE_xXDocumented myocardial infarction within six months of enrollment.Xx_NEWLINE_xXDocumented cerebral infarction within past 12 monthsXx_NEWLINE_xXMyocardial infarction or uncontrolled angina within 6 monthsXx_NEWLINE_xXMyocardial infarction (MI) within 6 months prior to the first dose of study drug;Xx_NEWLINE_xXUnstable angina within 6 months prior to first dose;Xx_NEWLINE_xXCurrent or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participationXx_NEWLINE_xXAcute myocardial infarction or unstable angina pectoris < 6 months prior to ScreeningXx_NEWLINE_xXHistory of a stroke, myocardial infarction, or unstable angina in the previous 6 monthsXx_NEWLINE_xXSignificant cardiac disease such as recent myocardial infarctionXx_NEWLINE_xXHistory of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment;Xx_NEWLINE_xXMyocardial infarction (MI) within past 6 months before randomizationXx_NEWLINE_xXHistory of myocardial infarction within 6 months of study entry.Xx_NEWLINE_xXMyocardial infarction within 6 months prior to study entryXx_NEWLINE_xXUnstable angina within 6 months prior to study entryXx_NEWLINE_xXHas a medical history of myocardial infarction or unstable anginaXx_NEWLINE_xXHistory of myocardial infarction, acute coronary syndromes or coronary angioplasty/stenting/bypass grafting within the past 6 months.Xx_NEWLINE_xXActive ischemic heart disease or history of myocardial infarction within six months.Xx_NEWLINE_xXA history of events such as myocardial infarction, cerebrovascular accident or acute hepatitis within 3 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.Xx_NEWLINE_xXHistory of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgeryXx_NEWLINE_xXHistory of myocardial infarction within 6 months or unstable angina within the past 6 months.Xx_NEWLINE_xXUnstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entryXx_NEWLINE_xXPatients with documented myocardial infarction within six months of protocol entryXx_NEWLINE_xXMyocardial infarction (MI) within the last 3 monthsXx_NEWLINE_xXRecent (within twelve months) myocardial infarction.Xx_NEWLINE_xXHistory of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 monthsXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Myocardial infarction within the last 3 monthsXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Myocardial infarction within the last 3 monthsXx_NEWLINE_xXEvidence of a history of a stroke or myocardial infarction within the last 6 months prior to study enrollmentXx_NEWLINE_xXHistory of cerebrovascular accident, myocardial infarction or unstable angina within the previous 6 months before starting therapyXx_NEWLINE_xXPatients with a history of myocardial infarction that is < 3 months prior to registrationXx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollmentXx_NEWLINE_xXMyocardial infarction within 3 months of study initiationXx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft, coronary angioplasty, or stenting) < 6 months prior to screeningXx_NEWLINE_xXHistory of myocardial infarction within 6 months of enrollment.Xx_NEWLINE_xXTransmural myocardial infarction within 3 months prior to step 1 registrationXx_NEWLINE_xXMyocardial infarction or unstable angina less than 6 months before registrationXx_NEWLINE_xXHistory of myocardial infarctionXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to Day 1Xx_NEWLINE_xXAny active angina or any unstable angina pectoris or myocardial infarction within one year of study entryXx_NEWLINE_xXSubjects with a history of myocardial infarction or uncontrolled cardiac dysfunction\n             during the previous 6 monthsXx_NEWLINE_xXImpaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Acute myocardial infarction or angina pectoris =< 6 months prior to starting study drugXx_NEWLINE_xXMust not have a history of myocardial infarction, severe or unstable angina, or peripheral vascular diseaseXx_NEWLINE_xXAcute myocardial infarction =< 12 months prior to starting drugXx_NEWLINE_xXClinically significant cardiomyopathy or cardiac complications, including recent myocardial infarction or cerebrovascular accident within one year, and/or unstable or uncontrolled anginaXx_NEWLINE_xXMyocardial infarction or unstable angina < 6 months prior to registrationXx_NEWLINE_xXPatients with a known history of myocardial infarction or cerebrovascular accident are not eligibleXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to study enrollmentXx_NEWLINE_xXSubjects with a history of myocardial infarction within the last 6 months of screening.Xx_NEWLINE_xXPatients with a history of myocardial infarction within the 6 months prior to screeningXx_NEWLINE_xXPatient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomizationXx_NEWLINE_xXUnstable angina and/or myocardial infarction within 6 months prior to screeningXx_NEWLINE_xXSubject has a high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.Xx_NEWLINE_xXHistory of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral arterial vascular diseaseXx_NEWLINE_xXSymptomatic ischemia or myocardial infarction within the previous 6 moXx_NEWLINE_xXHistory of myocardial infarction (within 12 months) or unstable angina (within 6 months) prior to study enrolment.Xx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXPatients who have had a myocardial infarction within 6 months (24 weeks) prior to registration are not eligibleXx_NEWLINE_xXHistory of cerebrovascular or myocardial ischemia within 6 months of initiationXx_NEWLINE_xXPatients are excluded if they have a history of myocardial infarction or unstable angina within 6 months prior to randomizationXx_NEWLINE_xXTransmural myocardial infarction within the last 6 monthsXx_NEWLINE_xXmyocardial infarction within 6 months prior to randomization;Xx_NEWLINE_xXNo myocardial infarction < 6 monthsXx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXHistory of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months.Xx_NEWLINE_xXHistory of myocardial infarction within 6 months.Xx_NEWLINE_xXHave active angina pectoris, stroke or recent myocardial infarction (within 6 months).Xx_NEWLINE_xXArterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) < 6 months prior to enrollmentXx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXHistory of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months;Xx_NEWLINE_xXAcute myocardial infarction or angina pectoris ? 6 months prior to starting study drugXx_NEWLINE_xXHistory of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entryXx_NEWLINE_xXTransmural myocardial infarction within the last 6 monthsXx_NEWLINE_xXUnstable angina pectoris or myocardial infarction ? 3 months prior to starting CC-122.Xx_NEWLINE_xXSignificant cardiac dysfunction; myocardial infarction within 12 months; unstable, poorly controlled angina pectoris.Xx_NEWLINE_xXDocumented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomizationXx_NEWLINE_xXMyocardial infarction within the last 3 monthsXx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screeningXx_NEWLINE_xXUnstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.Xx_NEWLINE_xXUnstable angina or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollmentXx_NEWLINE_xXUnstable angina within the last 6 months prior to registrationXx_NEWLINE_xXTransmural myocardial infarction within the last 6 months prior to registrationXx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months prior to registration.Xx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment.Xx_NEWLINE_xXHistory or evidence of cardiovascular risk including any of the following -- History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment. Additional Exclusion Criteria for Part EXx_NEWLINE_xXPatients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligibleXx_NEWLINE_xXDiagnosis of unstable angina or myocardial infarction within 6 months of study entryXx_NEWLINE_xXPatients with a history of myocardial infarction, unstable angina, or cerebrovascular accident < 6 months prior to registrationXx_NEWLINE_xXPatients with a history of stroke, myocardial infarction, or unstable angina within 6 months prior to registration are not eligibleXx_NEWLINE_xXHistory of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery =< 6 months prior to registrationXx_NEWLINE_xXHistory of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollmentXx_NEWLINE_xXAcute myocardial infarction or unstable angina pectoris < 6 months prior to ScreeningXx_NEWLINE_xXHistory of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, and/or stenting up to 12 weeks before Cycle 1, DayXx_NEWLINE_xXHistory of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery =< 12 months prior to randomizationXx_NEWLINE_xXSubjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months..Xx_NEWLINE_xXMyocardial infarction within 6 months before the Day 1 visit.Xx_NEWLINE_xXThe participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of randomization.Xx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months prior to Day 1 of the study.Xx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to screeningXx_NEWLINE_xXUnstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 6 months prior to randomizationXx_NEWLINE_xXMyocardial infarction or cerebrovascular accident within 6 months prior to study registrationXx_NEWLINE_xXPatients with any of the following risk factors should have a baseline cardiac function assessment:\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study\r\n* A NYHA classification of II controlled with treatment\r\n* Prior history of impaired cardiac functionXx_NEWLINE_xXMyocardial infarction within 6 months of cycle one, day one (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participateXx_NEWLINE_xXMyocardial infarction within 6 months before C1D1.Xx_NEWLINE_xXHistory of cerebrovascular accident (CVA), myocardial infarction or unstable angina within the previous 6 months before starting therapyXx_NEWLINE_xXDocumented myocardial infarction <6 months from study entryXx_NEWLINE_xXHistory of acute coronary syndromes (specifically, myocardial infarction and unstable angina), severe/unstable angina, coronary angioplasty, or stenting within 6 months prior to the initiation of therapy on this protocolXx_NEWLINE_xXAcute myocardial infarctionXx_NEWLINE_xXMyocardial infarction (MI) within 6 months prior to the first dose of brigatinibXx_NEWLINE_xXUnstable angina within 6 months prior to first doseXx_NEWLINE_xXSubjects with a history of myocardial infarction within the last 6 months.Xx_NEWLINE_xXNo known contraindications to anti-angiogenics such as severe coronary artery disease, recent myocardial infarction or stroke within 6 months, bleeding peptic ulcer or varices within last 3 months, and any other major illness that may jeopardize study treatment or follow upXx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXHistory of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 monthsXx_NEWLINE_xXMyocardial infarction within 6 months of registrationXx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months prior to the first dose of study drug.Xx_NEWLINE_xXRecent history of myocardial infarct (less than 3 months) or history of active angina or arrhythmiaXx_NEWLINE_xXHistory of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entryXx_NEWLINE_xXPatients within three months of a myocardial infarctionXx_NEWLINE_xXMyocardial infarction in the previous 12 weeks (from the start of treatment)Xx_NEWLINE_xXPART B: Any history of myocardial infarction or embolic/occlusive cerebro-vascular accident (stroke)Xx_NEWLINE_xXSubjects with a history of myocardial infarction within the last 6 months of screening.Xx_NEWLINE_xXMyocardial infarction in the previous 12 weeks (from the start of treatment)Xx_NEWLINE_xXHistory of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drugXx_NEWLINE_xXPatients with a history of myocardial infarction that is < 3 months prior to registrationXx_NEWLINE_xXHistory of a myocardial infarction within 6 monthsXx_NEWLINE_xXPatients with a history of the following within =< 12 months of study entry are not eligible:\r\n* Arterial thromboembolic events\r\n* Unstable angina\r\n* Myocardial InfarctionXx_NEWLINE_xXMyocardial infarction within the past 6 months before the first dose of study drugXx_NEWLINE_xXHistory of arterial/myocardial diseaseXx_NEWLINE_xXHistory of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or coronary artery stenting within the past 6 monthsXx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to study enrollmentXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to study DayXx_NEWLINE_xXHistory or clinical signs of myocardial infarction within 1 year prior to study entryXx_NEWLINE_xXPatient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXHistory of myocardial infarction within 12 months prior to day 1 or clinically significant coronary diseaseXx_NEWLINE_xXNone of the following conditions within 6 months prior to enrollment: myocardial infarction, stroke or symptomatic peripheral vascular diseaseXx_NEWLINE_xXNone of the following conditions within 6 months prior to enrollment: myocardial infarction, stroke or symptomatic peripheral vascular diseaseXx_NEWLINE_xXHistory of any one or more of the following conditions within 6 months of registration:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* PneumonitisXx_NEWLINE_xXEjection fraction (EF) of < 40%, myocardial infarction (MI) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ECG evidence of acute ischemia.Xx_NEWLINE_xXHistory of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular diseaseXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to day 1Xx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to day -3Xx_NEWLINE_xXHistory of documented myocardial infarction or cerebrovascular accidentXx_NEWLINE_xXHistory of myocardial infarction within 6 months of enrollmentXx_NEWLINE_xXHistory of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery by-pass graft surgery\r\n* Symptomatic peripheral vascular diseaseXx_NEWLINE_xXPatients with myocardial infarction or unstable angina =< 6 months prior to starting study drugXx_NEWLINE_xXMyocardial infarction within 12 months prior to starting studyXx_NEWLINE_xXMyocardial infarction within four months prior to enrollmentXx_NEWLINE_xXMyocardial infarction within 6 months of treatmentXx_NEWLINE_xXPatients with myocardial infarction or unstable angina =< 6 months prior to registrationXx_NEWLINE_xXPatients with clinically significant cardiovascular disease: history of cerebrovascular accident (CVA) within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectorisXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 12 months prior to day 1Xx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to day 1Xx_NEWLINE_xXKnown myocardial infarction, severe/unstable angina, percutaneous transluminal coronary angioplasty/stenting (PTCA), or coronary artery bypass graft (CABG) within 6 month of the first dose of the study treatmentXx_NEWLINE_xXAcute myocardial infarction ?6 months prior to study participationXx_NEWLINE_xXPatients who have the following risk factors are considered to be at increased risk for cardiac toxicities; these patients should have increased monitoring:\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)Xx_NEWLINE_xXMyocardial infarction within 3 months prior to starting treatmentXx_NEWLINE_xXNo evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina; patients who are over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemiaXx_NEWLINE_xXSubject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug.Xx_NEWLINE_xXMyocardial infarction, uncontrolled angina, uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 VisitXx_NEWLINE_xXUnstable angina pectoris or myocardial infarction less than 6 months prior to starting either study drugXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to enrollment.Xx_NEWLINE_xXPatients with a history of known coronary artery disease or a myocardial infarction within the last 12 monthsXx_NEWLINE_xXSubject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug.Xx_NEWLINE_xXMyocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, within 6 months prior to the first dose of study drugXx_NEWLINE_xXSubject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the first dose of study drug.Xx_NEWLINE_xXUnstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatmentXx_NEWLINE_xXMyocardial infarction or uncontrolled angina within 3 months;Xx_NEWLINE_xXEchocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)Xx_NEWLINE_xXHistory of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 monthsXx_NEWLINE_xXAcute myocardial infarction (AMI) or unstable angina pectoris < 3 months prior to study entryXx_NEWLINE_xXPatients with a history of myocardial infarction that is < 3 months prior to registrationXx_NEWLINE_xXMyocardial infarction in the previous 12 weeks (from the start of treatment)Xx_NEWLINE_xXDocumented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollmentXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to Day 1Xx_NEWLINE_xXMyocardial infarction within the past 6 months, unstable and/or symptomatic arrhythmia, or evidence of ischemia on ECG.Xx_NEWLINE_xXHistory of myocardial infarction or stroke within the last 6 months, or history of uncontrolled cardiovascular or cerebrovascular disease; a 12-lead electrocardiogram (ECG) will be performed during the screening periodXx_NEWLINE_xXHigh cardiovascular risk, including but not limited to, recent coronary stenting or myocardial infarction in the past yearXx_NEWLINE_xXHistory of myocardial infarction within 6 monthsXx_NEWLINE_xXHemodynamically unstable patients (not in cardiogenic shock or having an acute myocardial infarction [MI])Xx_NEWLINE_xXActive coronary artery disease, unstable or newly diagnosed angina or myocardial infarction less than 6 months prior to first study drug administrationXx_NEWLINE_xXHas a medical history of myocardial infarction or unstable angina.Xx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to first study treatmentXx_NEWLINE_xXunstable angina or myocardial infarction within 6 months of enrollment.Xx_NEWLINE_xXPast history of myocardial infarction in the prior 12 monthsXx_NEWLINE_xXUnstable angina pectoris or myocardial infarction ? 6 months prior to starting CCXx_NEWLINE_xXPatients with myocardial infarction or unstable angina =< 6 months prior to starting study drugXx_NEWLINE_xXAcute myocardial infarction or angina pectoris ? 6 months prior to starting study drugXx_NEWLINE_xXMyocardial infarction ? 6 months prior to enrolment.Xx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to the first dose of study-drug treatment in Cycle 1Xx_NEWLINE_xXMyocardial infarction, unstable angina, coronary artery bypass graft, coronary artery angioplasty or stent placement within 12 months before scheduled dosing day 1;Xx_NEWLINE_xXRecent history of myocardial infarction (MI) or symptomatic coronary artery disease within the preceding 6 monthsXx_NEWLINE_xXThromboembolic events, stroke, or ST-elevated myocardial infarction within 7 days of surgery.Xx_NEWLINE_xXPatients with myocardial infarction or unstable angina ? 6 months prior to starting study drug.Xx_NEWLINE_xXMyocardial infarction <6 months from study entryXx_NEWLINE_xXMyocardial infarction or unstable angina < 6 months prior to enrollmentXx_NEWLINE_xXHistory of unstable angina or myocardial infarction within 12 months prior to Day 1 or ischemic heart disease.Xx_NEWLINE_xXHistory of myocardial infarction within the last 6 monthsXx_NEWLINE_xXActive coronary artery disease, defined as myocardial infarction, unstable angina, coronary bypass graft, or stenting within 6 months prior to study entryXx_NEWLINE_xXA history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to randomizationXx_NEWLINE_xXHistory of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting [CABG], coronary angioplasty, or stenting) < 6 months prior to screeningXx_NEWLINE_xXMyocardial infarction within 6 months prior to screening;Xx_NEWLINE_xXA history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to randomizationXx_NEWLINE_xXMyocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drugXx_NEWLINE_xXRecent acute coronary syndrome (ACS)/acute myocardial infarction (AMI) – defined as within 24 weeks prior to screeningXx_NEWLINE_xXMyocardial infarction within 6 months of cycle 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participateXx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history of unstable anginaXx_NEWLINE_xXMyocardial infarction (MI) within 6 months prior to first study drug administrationXx_NEWLINE_xXHistory of myocardial infarction or cerebrovascular accident within 6 months of enrollment date.Xx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months of enrollmentXx_NEWLINE_xXUnstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac diseaseXx_NEWLINE_xXUnstable angina or myocardial infarction within 6 months prior to first doseXx_NEWLINE_xXAcute myocardial infarction ? 3 months prior to starting study drugXx_NEWLINE_xXA history (within 6 months prior to first dose of study treatment) of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplastyXx_NEWLINE_xXHistory of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months.Xx_NEWLINE_xXMyocardial infarction (MI) within 6 months prior to first study drug administrationXx_NEWLINE_xXThromboembolic or myocardial infarction event within 6 monthsXx_NEWLINE_xXMyocardial infarction within 6 months of Screening visit;Xx_NEWLINE_xXHave active angina pectoris, stroke or recent myocardial infarction (within 6 months).Xx_NEWLINE_xXHistory of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.Xx_NEWLINE_xXTransmural myocardial infarction or unstable angina within 3 months prior to study registrationXx_NEWLINE_xXHistory of myocardial infarction within 6 months of Cycle 1, Day 1Xx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to screeningXx_NEWLINE_xXHistory of myocardial infarction or uncontrolled angina within 12 months prior to administration of study drugXx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months prior to the first administration of study drug;Xx_NEWLINE_xXUnstable angina or myocardial infarction within 6 months of enrolment,Xx_NEWLINE_xXAcute myocardial infarction or angina pectoris ? 3 months prior to starting study drugXx_NEWLINE_xXHistory of myocardial infarction within 6 months before Cycle 1, Day 1, or history of unstable anginaXx_NEWLINE_xXCHF, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, myocardial infarction within 6mXx_NEWLINE_xXCHF, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, and myocardial infarction within 6mXx_NEWLINE_xXMyocardial infarction or unstable angina within 6 months of day 1 prior to registrationXx_NEWLINE_xXSubject has had an acute myocardial infarction (AMI)Xx_NEWLINE_xXSignificant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,Xx_NEWLINE_xXHistory of a stroke, myocardial infarction, or unstable angina in the previous 6 monthsXx_NEWLINE_xXMyocardial infarction within one year prior to study entry.Xx_NEWLINE_xXCardiomyopathy or a myocardial infarction within the past 8 months.Xx_NEWLINE_xXSignificant cardiovascular disease, such as cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable anginaXx_NEWLINE_xXClinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study startXx_NEWLINE_xXSubject has history of severe/unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to the first dose of study drug.Xx_NEWLINE_xXMyocardial infarction (MI) within the prior 3 monthsXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 6 months prior to day 1Xx_NEWLINE_xXHistory of myocardial infarction within 6 months prior to first dose of study drugXx_NEWLINE_xXAny history of myocardial infarction in the past 12 monthsXx_NEWLINE_xXA myocardial infarction within 6 months prior to study entry;Xx_NEWLINE_xXNo unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmiaXx_NEWLINE_xXMyocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectivelyXx_NEWLINE_xXMyocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 monthsXx_NEWLINE_xXPatients with documented myocardial infarction within six months of protocol entryXx_NEWLINE_xXMyocardial infarction 6 months prior to screeningXx_NEWLINE_xXAcute myocardial infarction within 6 months before starting study drug.Xx_NEWLINE_xXTransmural myocardial infarction within the last 6 months prior to registrationXx_NEWLINE_xXActive myocardial ischemia (acute ST elevation or non ST elevation myocardial infarction [MI])Xx_NEWLINE_xXHistory of unstable angina or myocardial infarction in the last weekXx_NEWLINE_xXPatients with history of acute myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 12 monthsXx_NEWLINE_xXAcute coronary (e.g. myocardial infarction) or vascular event within the last year as well as uncontrolled coronary heart disease (e.g. progressive angina)Xx_NEWLINE_xXPatients with a history of myocardial infarction or ischemic heart disease within the past six monthsXx_NEWLINE_xXHistory of unstable angina or myocardial infarction 1 month prior to study enrollmentXx_NEWLINE_xXHistory of myocardial infarction or unstable angina within 12 months prior to day 1Xx_NEWLINE_xXMyocardial Infarction (MI) within 3 monthsXx_NEWLINE_xXHistory of coronary artery disease (angina or myocardial infarction)Xx_NEWLINE_xXHistory of myocardial infarction or ischemic heart disease within the past six monthsXx_NEWLINE_xXNo unstable angina, regular use of nitroglycerin for exertional angina, or myocardial infarction (MI) within the last 12 monthsXx_NEWLINE_xXPatients with a history of myocardial infarction or ischemic heart disease within the past six monthsXx_NEWLINE_xXUnstable cardiac disease or myocardial infarction within 6 months prior to study entryXx_NEWLINE_xXRecent myocardial infarctionXx_NEWLINE_xXHistory of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;Xx_NEWLINE_xXNo clinical history of acute myocardial infarction within six months of registrationXx_NEWLINE_xXHistory of an ischemic cardiac event including myocardial infarction within 3 months of study entryXx_NEWLINE_xXUnstable cardiac disease or myocardial infarction within 6 months prior to study entryXx_NEWLINE_xXHistory of unstable angina or myocardial infarction 1 month prior to study enrollmentXx_NEWLINE_xXHistory of unstable angina or myocardial infarction 1 month prior to study enrollmentXx_NEWLINE_xXmyocardial infarction (within the last 3 months)Xx_NEWLINE_xXPatients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)Xx_NEWLINE_xXPatients with myocardial infarction or unstable angina < 6 months prior to starting studyXx_NEWLINE_xXSignificant cardiac conditions (myocardial infarction [heart attack], unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia within 6 monthsXx_NEWLINE_xXMedically eligible to use nicotine replacement therapy (patient currently hospitalized with acute myocardial infarction/ST elevation myocardial infarction [STEMI], unstable angina, uncontrolled arrhythmia, stroke, peripheral arterial disease vascular surgery will not be eligible for inclusion)Xx_NEWLINE_xXIndividuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 yearsXx_NEWLINE_xXHistory of coronary heart disease (history of myocardial infarction or symptoms of angina), diabetes, stroke, orthopedic conditions which limit mobilityXx_NEWLINE_xXMyocardial infarction (MI) in the last 6 monthsXx_NEWLINE_xXMyocardial infarctionXx_NEWLINE_xXSubjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical controlXx_NEWLINE_xXSubjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical controlXx_NEWLINE_xXHospitalization in the past 2 months for any cardiovascular disease, including but not limited to:\r\n* Angina\r\n* Myocardial infarction\r\n* Peripheral vascular disease\r\n* StrokeXx_NEWLINE_xXHistory of significant tachyarrhythmia, severe angina, or myocardial ischemiaXx_NEWLINE_xXRecent myocardial infarctionXx_NEWLINE_xXHistory of myocardial infarction within 6 months of the enrollmentXx_NEWLINE_xXSignificant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 monthsXx_NEWLINE_xXAcute myocardial infarction within 28 daysXx_NEWLINE_xXPrevious history of angina pectoris or acute myocardial infarction (MI) within 6 monthsXx_NEWLINE_xXHas history of myocardial infarction within the past 6 monthsXx_NEWLINE_xXSubjects must not have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months of the first dose of investigational agent.Xx_NEWLINE_xXMyocardial infarction within 3 months prior to C1D1.Xx_NEWLINE_xXSevere uncontrolled cardiac disease within 6 months of study entry, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).Xx_NEWLINE_xXPatients with a history of myocardial infarction are eligible if the event occurred > 6 months prior to entryXx_NEWLINE_xXHistory of prior myocardial infarction or arrhythmiaXx_NEWLINE_xXHistory or clinical signs of myocardial infarction within 1 year of study entryXx_NEWLINE_xXThe patient has had a myocardial infarction in the previous 12 weeks. (Prior to study entry, electrocardiogram [ECG] abnormalities at screening must be documented by the investigator as not medically relevant.)Xx_NEWLINE_xXSignificant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months.Xx_NEWLINE_xXThe participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.Xx_NEWLINE_xXThe participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.Xx_NEWLINE_xXHistory of thrombotic or hemorrhagic stroke or myocardial infarction within 6 monthsXx_NEWLINE_xXAcute myocardial infarction within 6 months before starting study drug.Xx_NEWLINE_xXMyocardial infarction within the last 6 monthsXx_NEWLINE_xXSevere/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction.Xx_NEWLINE_xXMyocardial infarction within the last 6 monthsXx_NEWLINE_xXPatients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitisXx_NEWLINE_xX