9.0 ETHICAL CONSIDERATIONS 9.1 IRB review The study will be conducted in the Montefiore Medical Center, in compliance with Title 21 of the Code of Federal Regulations (CFR), Part 50 (Protection of Human Subjects), and Part 56 (Institutional Review Board) as well as the principles of the Declaration of Helsinki and its amendments. The Montefiore Institutional Review Board (IRB) will review the protocol and informed consent. The study will not be initiated without IRB approval. All subjects will be required to give written informed consent prior to participation in the study. This study will be performed in accordance with Good Clinical Practices (GCP) by qualified Investigators.