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Authors
Hudesman, David P.
Chakravarty, Soumya D.
Emond, Bruno
Ellis, Lorie A.
Lefebvre, Patrick
Sadik, Kay
Scher, Jose U.
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Funding
Funding for this research was provided by:
Janssen Scientific Affairs, LLC (NA)
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Article History
Received: 7 August 2019
Accepted: 16 January 2020
First Online: 2 April 2020
Ethics approval and consent to participate
: As this was an analysis of claims data, IRB approval was not required. Per Title 45 of CFR, Part 46.101(b) (4) (ExternalRef removed), the administrative claims data analysis of our study is exempt from the IRB review for two reasons: (1) it is a retrospective analysis of existing data (hence no patient intervention or interaction), (2) no patient-identifiable information is included in the claims dataset.
: Not applicable.
: BE and PL are employees of Analysis Group, Inc., a consulting company which provided paid consulting services to Janssen Scientific Affairs, LLC for the conduct of this study. SDC, LAE, and KS are employees of Janssen Scientific Affairs, LLC and shareholders of Johnson & Johnson, of which Janssen Scientific Affairs, LLC is a wholly-owned subsidiary. DPH reports the following affiliations: Janssen (consulting), Takeda (consulting), AbbVie (consulting), Salix (consulting), and Pfizer (consulting and research support). JUS reports the following affiliations: Janssen (consulting), UCB (consulting), Novartis (consulting and research support), Amgen (consulting and research support [via NIH Target]), and Pfizer (research support).
