Ethics approval and consent to participate
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (IRB) at each respective clinical site for studies involving humans. Primary approval was obtained from Western IRB and WCG IRB. Institutional IRB approvals were obtained from the Univ. of Virginia IRB and the Oregon Health & Science University IRB. None of the authors on this study are members of the IRB approval committees. Informed consent was obtained from all subjects involved in the study.