Richardson, David http://orcid.org/0000-0002-6481-8851
Zhan, Lin
Mahtani, Reshma
McRoy, Lynn
Mitra, Debanjali
Reynolds, Maria
Odom, Dawn
Hollis, Kelly
Kaye, James A.
Jones, Cheryl
Hargis, Jeffrey
Funding for this research was provided by:
Pfizer
Article History
Received: 9 October 2020
Accepted: 26 December 2020
First Online: 11 January 2021
Compliance with ethical standards
:
: D. Richardson, K. Hollis, D. Odom, M. Reynolds, and J.A. Kaye are employees of RTI Health Solutions who were paid consultants to Pfizer in connection with development of this manuscript. R. Mahtani, J. Hargis, and C. Jones have received consulting fees from Pfizer Inc. L. Zhan, L. McRoy, and D. Mitra are employees and stockholders of Pfizer Inc.
: The final protocol, any amendments, and informed consent documentation were reviewed and approved by the RTI International’s institutional review board (IRB) and IRBs for each site participating. The study was conducted in accordance with legal and regulatory requirements, as well as with scientific purpose, value, and rigor, and follows generally accepted research practices described in Good Practices for Outcomes Research issued by the International Society for Pharmacoeconomics and Outcomes Research.
: Written informed consent was obtained prior to the subject entering the study (before initiation of study protocol-specified procedures) by study personnel; the nature, purpose, and duration of the study were explained to each subject.