Clinical trials referenced in this document:
Received: 11 October 2021
Accepted: 14 February 2022
First Online: 12 March 2022
: The institutional review board/research ethics board (IRB/REB) at each participating center approved the study protocol and provided a waiver of informed consent for the chart reviews at the four historical control sites (Loyola University Chicago Health Sciences Division Institutional Review Board for the Protection of Human Subjects; Kaiser Permanente of the Mid-Atlantic States Institutional Review Board; Mayo Clinic Institutional Review Board Office for Human Research Protection; Mayo Clinic Institutional Review Board). All RBX2660-treated participants provided written informed consent. An independent medical monitor provided safety oversight. All methods were carried out in accordance with relevant guidelines and regulations.
: Not applicable.
: ED, DG, GH, CL, and RO serve on the Rebiotix Physician Advisory Board and DG is Medical Director for Rebiotix, Inc. SK and HD received research support and consulting fees from Rebiotix, Inc. KB, AH, and SM are employees of Rebiotix, Inc. SJ and DY declare that they have no competing interests.