Significant history of cardiovascular disease Uncontrolled or significant cardiovascular disease Significant cardiovascular disease; Significant cardiovascular disease or active pulmonary disease Significant cardiovascular disease Significant cardiovascular disease Any of the following cardiovascular criteria: Significant cardiovascular/cerebrovascular disease within months prior to Day of study drug administration Significant cardiovascular disease Has a history of or current uncontrolled cardiovascular disease History or evidence of cardiovascular risk Significant cardiovascular disease. Significant cardiovascular disease Any significant cardiovascular events within months prior to study entry History of a significant cardiovascular illness Significant active cardiovascular or pulmonary disease including: Significant cardiovascular disease Uncontrolled or significant cardiovascular diseases History or evidence of cardiovascular risk Uncontrolled or significant cardiovascular disease Subjects with significant or uncontrolled cardiovascular disease Significant cardiovascular disease Uncontrolled or significant cardiovascular disease Significant cardiovascular disease or ECG abnormalities. History of uncontrolled cardiovascular disease including Significant known cardiovascular impairment. Uncontrolled or significant cardiovascular disease. Uncontrolled or significant cardiovascular disease Any known uncontrolled cardiovascular disease; Evidence of significant cardiovascular conditions as specified below: Uncontrolled or significant cardiovascular disease History of cardiovascular disease Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including: Patients with a significant cardiovascular disease or condition, including: Patients with a significant cardiovascular disease or condition, including: Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to: Cardiovascular Function: Adequate cardiovascular function in the opinion of the Investigator with no clinically significant uncontrolled cardiovascular disease. Subject has significant cardiovascular disease, including: Uncontrolled cardiovascular history, defined as: Has cardiovascular risk factors History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: Significant cardiovascular disease, such as Predefined cardiovascular disease Acute cardiovascular disease in the previous days Significant cardiovascular disease within months prior to Day of Cycle Has uncontrolled or significant cardiovascular disease Have a significant electrocardiogram finding or cardiovascular disease No known history of cardiovascular disease Significant cardiovascular disease Uncontrolled or significant cardiovascular disease History of cardiovascular illness; Significant cardiovascular disease Uncontrolled or significant cardiovascular disease Significant cardiovascular disease. Significant cardiovascular disease within months of screening. Significant cardiovascular disease within months of screening. Significant cardiovascular disease Uncontrolled or significant cardiovascular disease Significant cardiovascular disease Uncontrolled or significant cardiovascular disease Significant cardiovascular disease. Significant cardiovascular disease Has a history of any of the following cardiovascular conditions within months of randomization: Significant cardiovascular disease Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol. History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease Significant active cardiovascular or pulmonary disease including: Significant cardiovascular or liver disease Significant history of cardiovascular disease History or evidence of cardiovascular risk including any of the following: Significant cardiovascular disease or significant pulmonary disease Significant cardiovascular diseases Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease Serious cardiac or cardiovascular disease or condition Have a history or current evidence of uncontrolled cardiovascular disease. Significant cardiovascular or pulmonary disease Patient has uncontrolled or significant cardiovascular disease, including: Significant cardiovascular disease Significant cardiovascular disease. History or evidence of cardiovascular condition Significant cardiovascular disease Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: Uncontrolled or significant cardiovascular disease, including: A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular or hepatic disease Severe cardiovascular or hepatic disease Significant cardiovascular disease Uncontrolled or significant cardiovascular disease Cardiovascular conditions as defined in the protocol History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease History or current evidence of cardiovascular risk. Patients must not have cardiovascular disease risk factors as defined below: Have significant or active cardiovascular disease Active cardiovascular disease or significant history thereof. Significant cardiovascular disease. DONOR: Significant cardiovascular disease Significant disease or uncontrolled disease, i.e. cardiovascular renal, hepatic, endocrine, metabolic, neurologic; or other significant disease that would limit the patients ability to participate in the study as determined by the investigator or medical monitor. unstable cardiovascular function Uncontrolled or significant cardiovascular disease Uncontrolled or significant cardiovascular disease, including: History (within the last months) of significant cardiovascular disease. Significant or uncontrolled cardiovascular disease Significant cardiovascular disease History of significant cardiovascular disease, defined as: Significant cardiovascular disease History of significant cardiovascular disease will be excluded Significant history of cardiovascular disease Significant cardiovascular disease History or evidence of cardiovascular risk including any of the following: Subject has a significant cardiovascular disease Any of the following cardiovascular conditions: Significant cardiovascular diseases Significant cardiovascular or cerebrovascular disease within months prior to Day of Cycle A history or evidence of cardiovascular risk including any of the following: History of serious cardiovascular disease Significant or uncontrolled cardiovascular disease or bleeding disorder Patients with a significant cardiovascular disease or condition, including: Evidence of uncontrolled cardiovascular conditions A history or evidence of cardiovascular risk including any of the following Patients with a significant cardiovascular disease or condition, including: History or current condition of uncontrolled cardiovascular disease Uncontrolled or significant cardiovascular disease Uncontrolled or significant cardiovascular disease Significant cardiovascular impairment, defined as: Patient has uncontrolled or significant cardiovascular disease, including: Uncontrolled or significant cardiovascular disease Cardiovascular disease Patients with malnutrition, active infection, significant pulmonary disease and cardiovascular disease as determined by the physician as they could impact fatigue Unstable cardiovascular disease in the last months Uncontrolled or significant cardiovascular disease, including any of the following: Significant history of cardiovascular disease Any prior cardiovascular disease Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are ineligible Significant cardiovascular disease Not be undergoing evaluation and workup for active cardiovascular disease; men with treated and stable cardiovascular disease may participate Active, unstable cardiovascular function: Have any of the following cardiovascular conditions: Uncontrolled or significant cardiovascular disease