Ankarfeldt, Mikkel Zöllner http://orcid.org/0000-0001-7954-9255
Petersen, Janne
Andersen, Jon Trærup
Fernandes, Maria Fernanda Scantamburlo
Li, Hu
Motsko, Stephen Paul
Fast, Thomas
Jimenez-Solem, Espen
Funding for this research was provided by:
Eli Lily and Company
Article History
Accepted: 22 April 2021
First Online: 18 May 2021
Declarations
:
: This publication is based on a post-authorization safety study (PASS) for duloxetine funded by Eli Lilly and Company, the manufacturer of duloxetine.
: The study was performed by the Copenhagen Phase IV Unit (Phase4CPH) at the Department of Clinical Pharmacology and the Institute of Applied Economics and Health Research Aps (ApHER), and financed by Eli Lilly and Company, the manufacturer of duloxetine. MZA, JP, and EJS have performed other studies regarding antidepressants involving funding from Janssen Pharmaceutical via their employment in Phase4CPH. TF is former employee at ApHER and currently employed by Quantify Research. JTA and TF have no relevant financial activities outside the submitted work. MFSF is a current employee of Eli Lilly and Company. HL and SPM are former employees of Eli Lilly and Company. HL is currently employed by Gilead Science Inc. and SPM is currently employed by Amgen Inc.
: Due to the study’s observational design using Danish registers, no ethics committee approval or consent from subjects were needed.
: Not applicable.
: The Danish national registers are protected by the Danish Act on Processing of Personal Data and can be accessed following an approved application. The researchers do not store any data and cannot hand over data.
: Not applicable.
: All authors have participated sufficiently in the work to take public responsibility for the whole content. MZA, JP, JTA, HL, TF, and EJS contributed to the concept and design of the study. MZA, JP, JTA, HL, SPM, TF, and EJS contributed to the acquisition, analysis, and/or interpretation of data. MZA drafted the manuscript. JP, JTA, HL, SPM, TF, and EJS revised the manuscript. MZA and JP performed the statistical analysis. HL and SPM obtained funding.