Bacci, Elizabeth Dansie
Coyne, Karin S.
Poon, Jiat-Ling
Harris, Linda
Boscoe, Audra N.
Funding for this research was provided by:
Alexion Pharmaceuticals (NA)
Article History
Received: 1 February 2019
Accepted: 15 December 2019
First Online: 21 December 2019
Ethics approval and consent to participate
: The studies were conducted in accordance with the Declaration of Helsinki, followed good clinical practice guidelines, and were approved by a local independent ethics committee/institutional review board (Schulman IRB; Reference #201602496). Written informed consent was obtained from all individual participants included in Phase I of the study; electronic informed consent to participate was obtained from all study participants in Phase II.
: Not applicable.
: LH is employed by Alexion Pharmaceuticals Inc. (and may own Alexion stock or stock options). ANB was employed by Alexion Pharmaceuticals Inc. at the time the study was conducted and is currently employed by Agios Pharmaceuticals. JLP was employed by Evidera at the time the study was conducted and is currently employed by and owns stock at Eli Lilly and Company. EDB and KSC are employed by Evidera, a business unit of PPD, which provides consulting and other research services to pharmaceutical, medical device, and related organizations. In their salaried positions, they work with a variety of companies and organizations, and are precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received funding from Alexion Pharmaceuticals Inc., to participate in the study and for the development of this manuscript.