Document is current

Article History

Received: 21 December 2020

Accepted: 7 October 2021

First Online: 2 November 2021

Declarations

:

: All methods were conducted in accordance with the relevant guidelines and regulations including the Declaration of Helsinki and approvals were obtained from the relevant ethics committees across all studies. The OPUS registry protocol (ID: AC-055-503) and informed consent forms were approved by the Quorum Review Institutional Review Board (IRB). The Western IRB (WIRB)-Copernicus Group approved the OrPHeUS chart review protocol (ID: AC-055-510) and waived the requirement for informed consent, to enable inclusion of patients who had died in this retrospective observational study. The EXPOSURE registry protocol (ID: AC-065A401) and informed consent forms were approved by the relevant local ethics committee of each site (Supplementary Table InternalRef removed). Patients in OPUS and EXPOSURE provided informed consent for their protected, anonymised health information to be stored in a computer database and analysed by researchers and healthcare professionals, and for the results of this analysis to be published.

: Not applicable.

: PB was contracted by Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson. RO, HS, MB, and EMD are employees of Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson. GW is an employee of Janssen-Cilag Ltd. AD, AO, and PS are employees of Odysseus Data Services, Inc., a contract research organisation that performed the OMOP CDM ETL work as part of a commercial engagement with Johnson & Johnson.