Farutin, Victor
Prod’homme, Thomas
McConnell, Kevin
Washburn, Nathaniel
Halvey, Patrick
Etzel, Carol J.
Guess, Jamey
Duffner, Jay
Getchell, Kristen
Meccariello, Robin
Gutierrez, Bryan
Honan, Christopher
Zhao, Ganlin
Cilfone, Nicholas A.
Gunay, Nur Sibel
Hillson, Jan L.
DeLuca, David S.
Saunders, Katherine C.
Pappas, Dimitrios A.
Greenberg, Jeffrey D.
Kremer, Joel M.
Manning, Anthony M.
Ling, Leona E.
Capila, Ishan http://orcid.org/0000-0002-5036-6778
Article History
Received: 26 June 2019
Accepted: 6 September 2019
First Online: 23 October 2019
Ethics approval and consent to participate
: The Corrona CERTAIN protocol was reviewed and approved by a central IRB, New England Independent Review Board (NEIRB). 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 the Sponsor prior to initiating any study procedures. Further pertinent details are provided in the publication describing CERTAIN study design characteristics [CitationRef removed]. All CERTAIN subjects were required to provide written informed consent prior to participating.
: Not applicable.
: All Momenta-affiliated authors are currently (or were at the time the study was conducted) employees of Momenta Pharmaceuticals Inc. and may own stock and/or stock options in Momenta Pharmaceuticals, Inc. CJE is an employee and shareholder at Corrona, LLC, and also serves on an advisory board for Merck. DAP is an employee at Corrona, LLC, and also an instructor at Novartis. KCS is a former employee and shareholder at Corrona, LLC. JDG is an employee and shareholder at Corrona, LLC, and is a consultant for Genentech, Janssen, Novartis, Eli Lilly, and Pfizer. JMK is an employee and shareholder at Corrona, LLC; consults for AbbVie, Amgen, BMS, Genentech, Lilly, Regeneron, Sanofi, and Pfizer; and has research grants from AbbVie, Genentech, Lilly, Novartis, and Pfizer.