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Article History

Accepted: 23 April 2021

First Online: 10 May 2021

Declarations

:

: The present study is part of the REproduction Gestation And Reproduction (REGARDS) research programme funded by the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) [French National Agency for the Safety of Medicines and Health Products]. This programme aims to improve drug monitoring in pregnant women, in France. Allocation of funding did not impact the study design and conduct, data collection, management, analysis and interpretation or the preparation, review and approval of the manuscript. This publication represents the views of the authors and does not necessarily represent the opinion of the French Medicines Agency.

: Mélanie Araujo, Clémentine Vabre, Justine Benevent, Agnès Sommet, Christine Damase-Michel, Caroline Hurault-Delarue and Isabelle Lacroix have no conflicts of interest that are directly relevant to the content of this article.

: The EFEMERIS cohort was approved by the French Data Protection Agency on 7 April, 2005 (authorisation number 05-1140). This study was performed on anonymised patient data.

: The women included in EFEMERIS were informed of their inclusion and of the potential use of their anonymised data for research purposes. They can oppose the use of their data at any time.

: The women included in EFEMERIS know that their gathered and anonymised data can be used for medical research purposes and can thus be published.

: Because of the nature of this research, participants of this study did not agree for their data to be shared publicly, thus supporting data are not available.

: Not applicable.

: Study design: MA, CH-D, IL. Data acquisition, analysis or interpretation: MA, CV, CH-D, IL. Drafting of the manuscript: MA, CH-D, IL. Critical review of the manuscript for significant intellectual content: MA, CV, CH-D, AS, CD-M, JB, IL. All authors had full access to all study data and are responsible for the integrity of the data and the accuracy of the data analysis. All authors have read and approved the final version.