Dunbar, Richard L. https://orcid.org/0000-0002-7059-4794
Gaudet, Daniel
Davidson, Michael
Rensfeldt, Martin
Yang, Hong
Nilsson, Catarina
Kvarnström, Mats
Oscarsson, Jan
Article History
Received: 23 May 2019
Accepted: 21 May 2020
First Online: 30 May 2020
Ethics approval and consent to participate
: The clinical study protocol was reviewed and approved by the institutional review board or independent ethics committee for each of six study centers in the USA and Canada. The study was conducted in compliance with the ethical principles in the Declaration of Helsinki and applicable amendments, and the International Conference on Harmonisation Good Clinical Practice Guidelines. All participants provided written, informed consent.
: Not applicable.
: MD was the Founder and Chief Medical Officer of Omthera (manufacturer of Epanova), prior to its acquisition by AstraZeneca. RLD was employed by ICON Clinical Services during the bulk of the manuscript preparation, and is currently an employee and stock shareholder of Amarin Pharma, Inc. RLD has received grant support from Omthera and AstraZeneca. DG has received grant support from AstraZeneca and GlaxoSmithKline. JO and CN are employees of AstraZeneca. MK and HY were employees of AstraZeneca when the study was conducted.