Cardiovascular Risks as outlined in the protocol. Any of the following cardiovascular criteria: Has a history of or current uncontrolled cardiovascular disease History or evidence of cardiovascular risk History or evidence of cardiovascular risk History of uncontrolled cardiovascular disease including Any known uncontrolled cardiovascular disease; Evidence of significant cardiovascular conditions as specified below: History of cardiovascular disease Cardiovascular disorders Uncontrolled cardiovascular history, defined as: Has cardiovascular risk factors History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: Predefined cardiovascular disease Acute cardiovascular disease in the previous 30 days No known history of cardiovascular disease History of cardiovascular illness; History of specific cardiovascular abnormalities; Has a history of any of the following cardiovascular conditions within 12 months of randomization: History or evidence of cardiovascular risk including any of the following: Serious cardiac or cardiovascular disease or condition Have a history or current evidence of uncontrolled cardiovascular disease. History or evidence of cardiovascular condition History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiovascular conditions as defined in the protocol Evidence of current uncontrolled cardiovascular conditions History or current evidence of cardiovascular risk. Participants with cardiovascular conditions specified in protocols Patients must not have cardiovascular disease risk factors as defined below: Evidence of current uncontrolled cardiovascular conditions within the past 6 months unstable cardiovascular function History of certain cardiovascular conditions within the past 6 months. Prior therapy with known risk for cardiovascular complications. History or evidence of cardiovascular risk including any of the following: Any of the following cardiovascular conditions: A history or evidence of cardiovascular risk including any of the following: A history or evidence of cardiovascular risk- specific criteria have to be met History of serious cardiovascular disease Evidence of uncontrolled cardiovascular conditions A history or evidence of cardiovascular risk including any of the following History or current condition of uncontrolled cardiovascular disease Patients with the following manifestations of cardiovascular disease are excluded: Evidence of current uncontrolled cardiovascular conditions History of certain cardiovascular conditions within the past 6 months. Participants with certain cardiovascular conditions are excluded. Participants with any of the following cardiovascular conditions are excluded: Cardiovascular disease Unstable cardiovascular disease in the last 6 months Any prior cardiovascular disease unstable pulmonary or cardiovascular conditions. Not be undergoing evaluation and workup for active cardiovascular disease; men with treated and stable cardiovascular disease may participate Acute major illness (e.g., unstable cardiovascular condition, etc.) Acute major illness (e.g., unstable cardiovascular condition, etc.) Acute major illness (e.g., infection, unstable cardiovascular condition, etc.) Acute major illness (e.g. unstable cardiovascular condition, etc.) Active, unstable cardiovascular function: Have any of the following cardiovascular conditions: