Holland, Diane E.
Vanderboom, Catherine E.
Mandrekar, Jay
Borah, Bijan J.
Dose, Ann Marie
Ingram, Cory J.
Griffin, Joan M.
Funding for this research was provided by:
Foundation for the National Institutes of Health (NIH-NINR R01NR016433)
Article History
Received: 19 May 2020
Accepted: 16 October 2020
First Online: 28 October 2020
Ethics approval and consent to participate
: The Mayo Clinic Institutional Review Board approved the study on October 30, 2017 (No. 17-005188). Additionally, a Data Safety and Monitoring Committee was established and closely monitors the trial for participant safety. Informed consent is obtained from all study participants; however, if a care recipient lacks the cognitive capacity to provide informed consent, the care recipient’s documented legal authorized representative signs the consent form. On the consent form, participants are asked whether they allow their previously collected data to be used should they choose to withdraw from the trial. Participants are also asked permission for the research team to share relevant data with people on the study team and research or regulatory authorities, when relevant. This trial does not involve collecting biological specimens. There is no anticipated harm or compensation for trial participation. There is no provision for post-trial care.
: Not applicable.
: The authors declare that they have no competing interests.