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Article History

Received: 31 January 2020

Revised: 31 January 2020

Accepted: 17 February 2020

First Online: 4 March 2020

Compliance with ethical standards

: This study was carried out in accordance with the Declaration of Helsinki. All participating investigators obtained full board approval for conducting non-interventional research involving human subjects with a limited dataset. Sponsor approval and continuing review were obtained through a central Institutional Review Board (IRB; New England Independent Review Board, NEIRB No. 120160610). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs and documentation of approval was submitted to Corrona, LLC, prior to initiating study procedures. All patients provided written informed consent and authorization prior to participating.

: Leslie R. Harrold is an employee of Corrona, LLC, and a shareholder in Corrona, LLC, and has received grant/research support from Pfizer and consulting fees from AbbVie, Bristol-Myers Squibb, and Roche. Ying Shan and Sabrina Rebello are employees of Corrona, LLC. Neil Kramer has nothing to declare. Evo Alemao, Sean E. Connolly, and Sheila Kelly have stock options/bond holdings in, and are employees of, Bristol-Myers Squibb. Joel Kremer has stock options/bond holdings in, and is an employee of, Corrona, LLC; has received consultancy fees from AbbVie, Amgen, Bristol-Myers Squibb, Genentech, Lilly, Regeneron, Sanofi, and Pfizer; and has received grant/research support from AbbVie, Bristol-Myers Squibb, Genentech, Lilly, Novartis, and Pfizer. Elliot D. Rosenstein has received consultancy fees from Amgen and Bristol-Myers Squibb; has received grant/research support from Myriad Genetics and Novartis; and is on speakers’ bureaus for AbbVie, Amgen, and Bristol-Myers Squibb.