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Authors
Voss, Erica A. https://orcid.org/0000-0002-0651-0613
Ali, Saberi Rana
Singh, Arun https://orcid.org/0000-0002-9567-6139
Rijnbeek, Peter R.
Schuemie, Martijn J. https://orcid.org/0000-0002-0817-5361
Fife, Daniel
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Article History
Accepted: 29 May 2022
First Online: 9 July 2022
Declarations
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: This study was funded by Janssen Research & Development, LLC.
: Erica A. Voss, Saberi Rana Ali, Arum Singh, and Martijn J. Schuemie are employees of Janssen Research and Development LLC and shareholders of Johnson & Johnson (J&J) stock. Daniel Fife, at the time of this research, was also an employee Janssen Research and Development LLC and shareholder of J&J stock; however, he has since retired. Peter R. Rijnbeek is an employee of an institution that receives/received research grants from Janssen Research and Development LLC. J&J subsidiary companies market both tramadol-containing and codeine-containing products.
: This study utilized data from the CPRD obtained under license from the UK Medicines and Healthcare Products Regulatory Agency. However, the interpretation and conclusions contained in this study are those of the authors alone. The protocol for this study (reference # 20_173) was approved by the Independent Scientific Advisory Committee. This protocol was also submitted to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and was approved (ENCePP reference ID, EUPAS36038) [19]. The New England Institutional Review Board determined that studies conducted in MDCR, MDCD, and OPTUM_DOD were exempt from study-specific institutional review board review, as these studies do not qualify as human subject research.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are available to license from IBM, Optum, and CPRD. Data are available from IBM at , from Optum at , and from CPRD at .
: The protocol and code are publicly available on GitHub ().
: DF was responsible for conceptualization of this work. EAV was responsible for data curation and performing the formal analysis. EAV, SRA, AS, PRR, MJS, and DF contributed to development of the methodology. EAV was the project manager and performed all the programming while SRA, AS, PRR, MJS, and DF supervised the work. EAV generated all images and developed the original draft. EAV, SRA, AS, PRR, MJS, and DF were involved with reviewing and editing the publication. All authors read and approved the final version.
