Document is current

Article History

Received: 11 October 2022

Accepted: 9 October 2023

First Online: 1 November 2023

Declarations

:

: This retrospective study was performed in accordance with all relevant guidelines and regulations. This study used research identifiable files (RIF) housed on the Centers for Medicare and Medicaid Services (CMS) Chronic Conditions Warehouse Virtual Research Data Center (VRDC). These files were accessed through a secure network connection provided by the CMS VRDC, and this research was conducted using software tools within this secure environment. To avoid disclosure or perceived disclosure of confidential information, the VRDC analysts reviewed and approved all data outputs, confirming that all data were deidentified and ensuring that protected health information (PHI) and/or personally identifiable information (PII) contained in the RIF was protected. The CMS Privacy Board reviewed and approved the research protocol, Data Use Agreement, and other documents used to acquire data used for this study, and they ensured that the research request satisfied the requirements of the Common Rule and the Health Insurance Portability and Accountability Act (HIPAA). Institutional review board (IRB) exemption was approved by Western Institutional Review Board® under 45 CFR § 46.101(b)(4). The informed consent was waived by Western Institutional Review Board® under 45 CFR § 46.101(b)(4). As a claims database study, no patients were enrolled and no human tissue samples were collected or used.

: Not applicable.

: TKM received financial and nonfinancial research support for this manuscript from Insmed Incorporated (Bridgewater, NJ), grants and consulting fees from Insmed Incorporated, speaking and lecture fees from AstraZeneca and Novartis, and consultation or advisory fees from Spero and RedHill Biopharma; PW, MH, and AC are employees and shareholders of Insmed Incorporated.