Shaefi, Shahzad http://orcid.org/0000-0002-6832-3282
,
Brenner, Samantha K.
Gupta, Shruti
O’Gara, Brian P.
Krajewski, Megan L.
Charytan, David M.
Chaudhry, Sobaata
Mirza, Sara H.
Peev, Vasil
Anderson, Mark
Bansal, Anip
Hayek, Salim S.
Srivastava, Anand
Mathews, Kusum S.
Johns, Tanya S.
Leonberg-Yoo, Amanda
Green, Adam
Arunthamakun, Justin
Wille, Keith M.
Shaukat, Tanveer
Singh, Harkarandeep
Admon, Andrew J.
Semler, Matthew W.
Hernán, Miguel A.
Mueller, Ariel L.
Wang, Wei
Leaf, David E.
Article History
Received: 12 August 2020
Accepted: 4 December 2020
First Online: 2 February 2021
Declarations
:
: This study is unfunded work.
: DEL received research support from BioPorto outside the submitted work. DMC reports grants and personal fees from NovoNordisk, personal fees from PLC medical, grants from Bioporto, personal fees from Fresenius, personal fees from AstraZeneca, grants and personal fees from Jannssen, grants and personal fees from Gilead, and personal fees from Merck, all outside the submitted work. AS reports personal fees from Horizon Therapeutics PLC, AstraZeneca, and CVS Caremark. SG is a scientific coordinator for the ASCEND trial (GlaskoSmithKline), outside the submitted work. KSM reports serving on the BREATHE Trial Steering Committee, funded by Roivant/Kinevant Sciences, outside the submitted work. BOG receives consulting fees from Sedana Medical outside the submitted work. The authors of the writing committee are supported by the following grants from the National Institutes of Health: K08GM134220 and R03AG060179 (SS); R01HL144566 and R01DK125786 (DEL); K23HL130648 (KSM); R37 AI102634 (MAH); F32DC017342 (SG); K23DK120811 (AS); K23HL143053 (MWS).
: The study was approved with a waiver of informed consent by the Institutional Review Board at each participating site.
: Not applicable.
: The authors SS, SKB, and DEL take responsibility for the integrity of the data and the accuracy of the analysis and are willing to submit to external review of the data upon request.
: Analyses were performed using SAS software version 9.4 (SAS Institute), code available upon request.
: SS, SKB, and DEL conceived the study, had full access to the data in the study, and take responsibility for the integrity of the data and accuracy of the analyses. SS, SKB, and DEL wrote the manuscript. WW, ALM, MAH, and DEL performed the statistical analyses. ALM, and DEL designed the figures. SS, SKB, SG, DEL, DMC, SC, SHM, VP, MA, AB, SSH, AS, KSM, TSJ, ALY, AG, JA, KMW, TS, and HS acquired the data. All the authors provided feedback on the protocol and critically revised and approved the final version of the manuscript.
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