Compliance with ethical standards
This study was conducted in accordance with consensus ethics principles, International Conference on Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, and local laws and regulations. The protocol was approved by the Advarra Institutional Review Board (Pro00055980; approved 4 November 2021). The study was registered on clinicaltrials.gov (NCT05026164; registered 30 August 2021). Written informed consent was obtained from each participant before any study-related procedures were performed.