Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines; for step initial registration, the appropriate consent form is the step consent form Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step consent form STEP CROSSOVER REGISTRATION (OPTIONAL): Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step consent form Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines REGISTRATION STEP -RANDOMIZATION: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines Subjects must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines Patients must be informed of investigational nature of this study and must be willing to give written informed consent in accordance with institutional and federal guidelines. Patients must be able to comply with the requirements and assessments of the study protocol Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines; patient must sign an informed consent document indicating that they understand the purpose of and procedures required for the study, and are willing to participate in and comply with the guidelines of the study All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient DONOR: The donor must have been informed of the investigational nature of this study and have signed a consent form in accordance with federal guidelines and the guidelines of the participating institution All patients must be informed of the investigational nature of this study and must sign and\\ give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines Sign (or their legally-acceptable representatives must sign) an informed consent document in accordance with institutional and federal guidelines indicating that they understand the investigational nature of and procedures required for the study, including biomarkers, and are willing to participate in and comply with the guidelines of the study Consent: all patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines The recipient and/or the recipient's legal guardian must have been informed of the investigational nature of this study and have signed a consent form which is in accordance with Federal guidelines DONOR: The donor, or legal guardian, must have been informed of the investigational nature of this study and have signed a consent form in accordance with Federal Guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligible All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines All patients must demonstrate the ability to understand the investigational nature of this study and must sign a written informed consent document in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal regulations All patients must be informed of the investigational nature of the study and standard alternative therapies; all patients must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent for aim study activities in accordance with institutional and federal guidelines Subjects must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance within institutional and Food and Drug Administration (FDA) guidelines Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines