Ethics approval and consent to participate
The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation Good Clinical Practice. The protocol and patients’ informed consent received institutional review board/independent ethics committee approval prior to initiation of the study, and all patients provided informed consent prior to enrollment. The AVERT-2 study was governed by both a central institutional review board (IRB; the New England IRB) as well as local and university-based IRBs if required at individual sites. Approval numbers per site were not provided and are not available.