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Article History

Received: 30 November 2022

Accepted: 5 May 2023

First Online: 11 May 2023

Declarations

:

: The Mayo Clinic Institutional Review Board (IRB-C) approved the parent study (IRB# 16–000417) with all requirements met of research approval (21CFR56.111 and 45CFR46.111). The Mayo Clinic is the coordinating center for this two-center research study and is responsible for the study’s conduct, administration, and coordinating activities. The University of Minnesota IRB’s Human Research Protection Program approved the parent study at that particular site (#1605M88241). IRBs from both sites approved all protocol documents and consent forms. Written informed consent was provided by either the subject or a subject’s legally authorized representative on the IRB-approved consent form document. All research was performed in accordance with human subjects in research guidelines put forth by both Mayo Clinic and the University of Minnesota Human Research Protection Program.

: Not applicable.

: The authors declare that they have no competing interests.