Patients who can provide informed consent Patients must provide written consent Patients must provide written informed consent prior to any study procedures Patients must provide written informed consent. Patients must provide informed consent Patients must provide written informed consent Patients must provide written informed consent. Patients must provide written informed consent prior to any screening procedures Patients must provide informed written consent Patients must provide written informed consent Patients must provide informed written consent Patients must provide written informed consent Patients must provide written informed consent Patients must provide written informed consent For Phase I and II: Patients must provide written informed consent. Patients must provide written consent Patients must provide written informed consent. Patients must provide informed written consent Patients must provide written informed consent prior to any screening procedures Patients must provide written informed consent. Patients must provide written informed consent prior to any screening procedures Patients must provide written informed consent Patients must provide written informed consent Patients must provide informed consent Patients must provide written informed consent prior to any registration on study Patients must provide informed written consent Patients who provide written informed consent for participation in this trial Patients must provide written informed consent Patients must provide informed consent Patients must provide written informed consent. Provide written informed consent prior to any study procedures. Provide written informed consent prior to any screening procedures Provide written informed consent prior to any screening procedures Patients must provide written informed consent Patients must provide written informed consent prior to any screening procedures Provide written informed consent prior to screening Patients must provide written informed consent prior to any screening procedures Patients must provide written informed consent to participate in the study Patients can provide informed consent Patients must provide written informed consent Patients must provide informed written consent Patients must provide written informed consent