Samples collected in this study were part of clinical trial NCT01999400. The institutional review boards at the University of Michigan (IRBMED) and the Department of Health and Human Services, Food and Drug Administration (Research Involving Human Subjects Committee [RIHSC]), both approved the study protocol (IRB approved on 4 February 2015). All subjects provided written informed consent in order to participate. Informed consent was obtained from individuals prior to the time of sampling.
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