Pettis, Ronald J.
Woodley, Wendy D.
Ossege, Kevin C.
Blum, Adam
Bolick, Natasha G.
Rini, Christopher J.
Funding for this research was provided by:
BD Biosciences
Article History
Accepted: 20 February 2023
First Online: 13 March 2023
Declarations
:
: Prior to study initiation, Schulman Investigational Review Board/Ethics Committee reviewed and approved the study protocol, the informed consent form and other supporting study documentation which could have potentially impacted subject safety or willingness to participate, including proposed subject reimbursement.Prior to giving informed consent, each subject had the opportunity to review the study procedures, risks, and benefits, and ask any questions regarding the study. Before enrollment, each subject gave informed consent, documented by signing a written form, created and approved in compliance with 21 CFR Part 50.25 and 21 CFR Part 56. Each subject was given a copy of the signed informed consent document.
: Informed consent was obtained from study participants before inclusion in the study.
: R.J.P., W.D.W., N.G.B., and C.J.R. were employees of the study sponsor and funding entity, Becton, Dickinson and Company (BD), when the study was performed and may also be stockholders.