Document is current

Article History

Received: 6 April 2021

Accepted: 20 August 2021

First Online: 28 August 2021

Declarations

:

: Informed consent will be obtained from all subjects participating in this study. Ethical approval was approved by the Colorado Multiple Institutional Review Board (COMIRB; #16-2308). All research procedures will be performed in a confidential setting, and all documents generated by this study, including consent, will be stored in a locked filing cabinet in the locked office of the PI. Electronic data will be de-identified with the exception of a correlational spreadsheet including demographic information and study IDs for scheduling and safety contact purposes. This, and all other research data, will be stored on a password protected network drive and backed-up on the hard-drive of the PI. Identifying information will not be shared outside of the research team or regulatory bodies (e.g., IRB). Subjects have the right to request their personal health information as well as the results of the different research measures from the investigator, although they will be notified that these do not have any clinical value.

: By providing consent, subjects acknowledge the use of their information and publish study-related documents as outlined in the consent form.

: There are no disclosures related to financial or alternative competing interests within this clinical trial.