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 guidelinesXx_NEWLINE_xXPatients or their legally authorized representative 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; for all patients the appropriate consent form for this registration is the Step 2 ConsentXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll 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 guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients 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.Xx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any study-related procedures in accordance with institutional and federal guidelinesXx_NEWLINE_xXALL PATIENTS: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXREGULATORY 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 guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients 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 guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xX