Document is current

Article History

Received: 13 July 2023

Accepted: 15 September 2023

First Online: 14 October 2023

Declarations

:

: Shailja Shah is a consultant for Phathom Pharmaceuticals and RedHill Biopharma. Rena Yadlapati is a consultant for Phathom Pharmaceuticals and Reckitt Benckiser and owns stock in RJS Mediagnostix. Katherine Cappell, Robert Sedgley, and Machaon Bonafede are employees of Veradigm, which received funding from Phathom Pharmaceuticals to conduct this study. Corey Pelletier and Rinu Jacob are employees of Phathom Pharmaceuticals and own stock and stock options in Phathom Pharmaceuticals.

: The linked dataset only contains de-identified data as per the de-identification standard defined in Section §164.514(a) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section §164.514(b) (1) of the HIPAA Privacy Rule. Because this study used only de-identified patient records, it is therefore no longer subject to the HIPAA Privacy Rule and is therefore exempt from institutional review board approval and for obtaining informed consent according to US law. This study was conducted in compliance with the Declaration of Helsinki and used only de-identified data.