Document is current

Article History

Received: 5 October 2017

Accepted: 28 February 2018

First Online: 27 March 2018

Ethics approval and consent to participate

: The protocol was approved by the Institutional Review Board at the Indiana University School of Medicine, #1608126693. The principal investigator and the research staff are responsible for conducting the informed consent process with all the study participants. Informed consent will be obtained from the subject or their legally authorized representative as appropriate. Changes to the study protocol and/or the informed consent will be sent to the Institutional Review Board as protocol amendments. All data will be de-identified prior to analysis; only the principal investigator and project manager will be able to access the code to identify the individual. The protocol was registered in ClinicalTrials.gov NCT03095417 on March 23, 2017 (ExternalRef removed) before starting the trial, and trial status will be updated accordingly.

: Not applicable.

: The authors declare that they have no competing interests. The funding agency had no role in the development of the study design, collection, analysis, interpretation of data, manuscript development, or the decision to submit the manuscript for publication.

: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.