The DSMB will be scheduled on a regular basis and as often as necessary. Regular reviews will be conducted yearly and focused primarily on safety issues. A designated third party analysis (prepared by a study statistician) will be delivered to the DSMB two weeks prior to any scheduled review. Prior to study initiation, DSMB members will review study protocols, informed consents, Data and Safety Monitoring Plans and other relevant documents as needed (case report forms, manual of procedures, etc.). During the study, DSMB members will review all study protocol amendments.