affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Oregon Health and Science University, Wake Forest University, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Vanderbilt University Medical Center - Vanderbilt Institute for Clinical and Translational Research, affiliation not provided to SSRN, Duke University - Duke Clinical Research Institute, Vanderbilt University and Vanderbilt University - Department of Biomedical Engineering