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Article History

Accepted: 15 September 2022

First Online: 10 November 2022

Declarations

:

: All authors have participated sufficiently in the work to take public responsibility for the whole content. MZA, JP, JTA, MFSF, HL, TF, and EJS contributed with the concept and design of the study. MZA, JP, JTA, MFSF, HL, SPM, TF, and EJS contributed with the acquisition, analysis and/or interpretation of data. MZA drafted the manuscript. JP, JTA, MFSF, HL, SPM, TF, and EJS revised the manuscript. MZA, and JP performed the statistical analysis. MFSF, HL, and SPM obtained funding. All authors read and approved the final version.

: This publication, including the open access fee, is funded by Eli Lilly and Company, the manufacturer of duloxetine.

: The researchers do not store any data and cannot hand over data. Data are available by applying to the relevant authorities in Sweden and Denmark.

: Not applicable.

: 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, the manufacturer of duloxetine. MZA, JP, and EJS have conducted other studies regarding antidepressants, involving funding from Janssen Pharmaceutical via Phase4CPH. JTA and TF have no relevant financial activities outside the submitted work. TF is a former employee of ApHER and is currently employed by Quantify Research. 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.

: The present study is based on a safety study regarding duloxetine and pregnancy outcomes, with the protocol and the full study report available via the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP, EUPAS20253).

: The study was approved in Sweden by the Swedish Regional Ethics Review Board in Gothenburg (ref: 1040-17 and T782-18) and the Swedish National Board of Health and Welfare (ref: 30714/2017), and in Denmark by the Data Protection Agency (j.nr. VD-2018-371, I-Suite nr. 6621). No approval from the Danish Research Ethics Committees for the Capital Region was needed as only national registers were used. Data were gathered and analyzed at Statistics Denmark. The article does not contain clinical studies or patient data.

: Not applicable.

: Not applicable.