Page-Wilson, Gabrielle
Oak, Bhagyashree
Silber, Abigail
Okeyo, Janetricks
Ortiz, Nancy
O’Hara, Matthew
Moloney, Stephen
Geer, Eliza B.
Funding for this research was provided by:
Strongbridge Biopharma plc, a wholly-owned subsidiary of Xeris Biopharma Holdings, Inc.
Article History
Accepted: 30 March 2023
First Online: 19 April 2023
Declarations
:
: 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.
: Study participants consented to the publication of their data anonymously on an aggregate basis.