Page-Wilson, Gabrielle
Oak, Bhagyashree
Silber, Abigail
Meyer, James
O’Hara, Matthew
Geer, Eliza B.
Funding for this research was provided by:
Strongbridge Biopharma plc, a wholly owned subsidiary of Xeris BioPharma Holdings Inc.
NIH/NCI Cancer Center Support Grant (P30 CA008748)
Article History
Accepted: 27 November 2023
First Online: 8 January 2024
Declarations
:
: Funding for this study was provided by Strongbridge Biopharma plc, a wholly-owned subsidiary of Xeris Biopharma Holdings, Inc. Gabrielle Page-Wilson, MD and Eliza B. Geer, MD were contracted by Strongbridge Biopharma, a wholly owned subsidiary of Xeris Biopharma Holdings, Inc. to provide expert guidance for this study. Bhagyashree Oak, PhD, Abigail Silber, MPH, and Mathew O’Hara, MBA are employees of Trinity Life Sciences, which was commissioned by Strongbridge Biopharma, a wholly owned subsidiary of Xeris Biopharma Holdings, Inc. to conduct the current study. James Meyer, MBA, PharmD is an employee and shareholder of Xeris Pharmaceuticals, Inc. This research was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748.
: This was an observational study conducted in accordance with the 1964 Declaration of Helsinki and its later amendments. As this was not a randomized clinical trial, the study was not registered as such. The ADVARRA Institutional Review Board (Columbia, MD; ExternalRef removed) has granted the study exemption from IRB oversight using the Department of Health and Human Services regulations found at 45 CFR 46.104(d)(2). The IRB also completed the necessary additional limited review considerations as set forth under the Revised Common Rule, 45 CFR 46.104(d).
: Informed consent was obtained from all participants included in the study during the screening process and this was required to successfully enroll into the study. Participants were able to exit the study at any time or refuse to answer any questions.