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Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (B.T.B., K.F.H.)
University Hospital Aarhus, Aarhus, Denmark (U.H., MN)
University of Iceland, Reykjavik, Iceland (K.E.)
Norwegian Institute of Public Health, Oslo and University of Bergen, Bergen, Norway (A.E.)
Norwegian Institute of Public Health, Oslo, Norway (K.F., R.S.)
University of Turku, Turku, Finland, and Karolinska Institutet, Stockholm, Sweden (M.G., H.K., J.R.)
Harvard T.H. Chan School of Public Health, Boston, Massachusetts (S.H.)
National Institute of Health and Welfare, Helsinki, Finland (A.L.)
Karolinska Institutet, Stockholm, Sweden; National Institute of Health and Welfare, Helsinki, Finland; Brigham and Women's Hospital, Boston, Massachusetts (H.M.)
University of Iceland, Reykjavik, Iceland, and University of New South Wales, Sydney, New South Wales, Australia (H.Z.)
Recognition: The authors thank Loreen Straub for her help.
Grant: Thanks to the grant R21HD092879 from the National Institute of Child Health and Human Development Eunice Kennedy Shriver and Söderström König Foundation. Dr. Huybrechts has benefited from a Career Development Grant K01MH099141 from the National Institute of Mental Health. Dr. Bateman has benefited from a career development grant K08HD075831 from the National Institute of Child Health and Human Development Eunice Kennedy Shriver. The Drugs and Pregnancy project was funded by the Finnish Medicines Agency, the National Institute of Health and Welfare and the Social Insurance Institute of Finland.
Disclosures: Dr. Bateman mentions grants awarded by the National Institutes of Health when carrying out the study and grants awarded to his institution (Lilly, GlaxoSmithKline, Baxalta, Pacira and Pfizer) outside the submitted work. Dr. Hernandez-Diaz reports grants from the National Institutes of Health during the study; grants to his Lilly, Pfizer and GlaxoSmithKline establishment outside the submitted work; and be a counselor for the Antipsychotic Pregnancy Registry and Epidemiologist for the North American Antiepileptic Pregnancy Registry, both at Massachusetts General Hospital. Dr. Kieler indicated that her institution received or received funding from several pharmaceutical companies for post-approval safety studies and comparative efficacy studies; the companies, which his establishment assists, do not hold any marketing authorization for any of the drugs studied. Dr. Huybrechts mentions grants made by the National Institute of Mental Health and Eunice Kennedy Shriver to the National Institute of Child Health and Human Development when carrying out the project. 39 study and grants awarded to his institution by Lilly, GlaxoSmithKline, Pfizer and Boehringer Ingelheim. The unnamed authors here have revealed no conflict of interest. Disclosures can also be found at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-0338.
Disclosures of the editors: Christine Laine, MD, MPH, Editor-in-Chief, says his wife holds stock / asset options with targeted diagnoses and therapies. Darren B. Taichman, MD, PhD, editor, says that he has no financial relationship and no interest in disclosing. Cynthia D. Mulrow, MD, MSc, Senior Editor, says she has no relationship or interest in disclosing. Deborah Cotton, MD, MPH, Associate Editor, says she has no financial ties and no interest in disclosing. Jaya K. Rao, MD, MHS, Associate Editor, says she owns stock / stock options at Eli Lilly and Pfizer. Sankey V. Williams, MD, deputy editor, says that he has no financial relationship or any interest in disclosing. Catharine B. Stack, PhD, MS, Associate Editor of Statistics, says she owns shares in Proctor & Gamble, Pfizer and Johnson & Johnson.
Repeatable Research Statement:Study protocol and statistical code: Parts of the study protocol and statistical code may be made available to interested readers; contact Dr. Bateman (e-mail, [email protected]). Dataset: Not available due to data usage agreements.
Corresponding author: Brian T. Bateman, MD, MSc, Brigham Circle, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120; email, [email protected].
Address of the current author: Drs. Bateman and Huybrechts and Ms Mogun: 1 Brigham Circle, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120.
Drs. Heide-Jørgensen and Nørgaard: Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, 8200 Aarhus N, Denmark.
Drs. Einarsdóttir and Zoega: Center for Public Health Sciences, Faculty of Medicine, University of Iceland, Sturlugata 8, 101 Reykjavik, Iceland.
Dr. Engeland: Department of Global Public Health and Primary Care, University of Bergen, Postboks 7804, 5020 Bergen, Norway.
Drs. Furu and Selmer: Chronic Diseases and Aging, Norwegian Institute of Public Health, Marcus Thranes Gate 6, 0473 Oslo, Norway.
Drs. Gissler and Lahesmaa-Korpinen: THL National Institute for Health and Wellbeing, PO Box 30, FI-00271 Helsinki, Finland.
Dr. Hernandez-Diaz: Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115.
Drs. Kieler and Reutfors: Eugeniahemmet T2, Center for Pharmacoepidemiology, Karolinska Universitetssjukhuset Solna, SE-171 76 Stockholm, Sweden.
Author contributions: Design and Design: B.T. Bateman, K. Furu, M. Gissler, S. Hernandez-Diaz, H. Kieler, A.M. Lahesmaa-Korpinen, J. Reutfors, K.F. Huybrechts, H. Zoega.
Analysis and interpretation of the data: BAT Bateman, Heide-Jørgensen U., Engeland A., Hernandez-Diaz S., Kieler H., Mogun H., Nørgaard M., K.F. Huybrechts, H. Zoega.
Article Writing: B.T. Bateman, H. Zoega.
Critical review of the article for important intellectual content: BT Bateman, U. Heide-Jørgensen, K. Einarsdóttir, A. Engeland, K. Furu, M. Gissler, S. Hernandez-Diaz, H. Kieler, AM Lahesmaa -Korpinen, M. Nørgaard, J. Reutfors, R. Selmer, KF Huybrechts, H. Zoega.
Final approval of the article: BT Bateman, U. Heide-Jørgensen, K. Einarsdóttir, A. Engeland, K. Furu, M. Gissler, S. Hernandez-Diaz, H. Kieler, MA Lahesmaa-Korpinen, H Mogun, M. Nørgaard, J. Reutfors, R. Selmer, KF Huybrechts, H. Zoega.
Statistical expertise: U. Heide-Jørgensen, A.M. Lahesmaa-Korpinen.
Obtaining funding: B. T. Bateman, K. Furu, S. Hernandez-Diaz, H. Kieler, K. F. Huybrechts.
Administrative, technical or logistical assistance: B. T. Bateman, S. Hernandez-Diaz, H. Mogun, H. Zoega.
Collection and assembly of data: Bateman B.T., Engeland A., Furu K., Gissler M., Kieler H., Lahesmaa-Korpinen A., Mogun H., Nørgaard M., Zoega H.
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