Ethics Statement
The Advarra Institutional Review Board approved this clinical study
(IRB# Pro00048737). The Advarra IRB waived the requirement for signed
informed consent for the research under 45 CFR 46.117(c)(2). The study
team complied with all Advarra IRB policies and procedures, as well as
with all applicable Federal, State, and local laws regarding the
protection of human subjects in research as stated in the approved IRB
(Pro00048737).