No data will be analyzed before the study ended. Access to interim results, including results according to study arm will be limited to the DSMB members and the statistician who prepared the reports only. The DSMB will review study data every 6 months and the DSMB' summary recommendations will be directed to the PI. A summary of the review of reported AEs/SAEs will be sent to the local IRB to ensure that the participating center will be informed of any pertinent safety issues.