Document is current

Article History

Received: 21 August 2022

Accepted: 22 November 2022

First Online: 20 December 2022

Declarations

:

: The University of California San Francisco Institutional Review Board has given ethical approval for the trial and will review the trial annually (21–34725) and has been provided for review (Supplementary material InternalRef removed). Written, informed consent to participate will be obtained from all participants at enrollment into the trial. Patients may also consent to provide their de-identified data for ancillary studies. There is no financial cost to the participants.Study personnel will approach eligible participants. In a private setting, the study team member will explain the study as well as detailed information about what study participation entails. The study team member will clarify that participation in the study is voluntary, that participation may be stopped at any time, and that all collected data will be kept confidential and securely stored. The study team member will ensure comprehension by inviting the participant to ask questions and will provide time to consider participation. When providing consent, both the study team member and participants will sign two copies of the consent document. One copy will be given to the participant and the other will be kept for study reference.

: Written, informed consent to publish de-identified results will be obtained from all participants. A model consent form is provided (Supplementary material InternalRef removed).

: The authors declare that they have no competing interests.