Mallefet, Pascal
Armogida, Marianna
Doll, Walter J.
Page, Richard C.
Sandefer, Erik P.
Funding for this research was provided by:
GlaxoSmithKline Consumer Healthcare (N/A)
Article History
Received: 4 December 2020
Accepted: 16 January 2022
First Online: 8 February 2022
Declarations
:
: The final study protocol, any amendments, the informed consent, and other information that required pre-approval were reviewed and approved by an institutional review board (Advarra IRB, Columbia, MD, USA) in accordance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Good Clinical Practice (GCP), and applicable country-specific requirements. Written, dated, and signed informed consent was obtained from each participant prior to the performance of any study-specific procedures.
: Subjects have given consent to publish study results for medical journals, meetings, and on the Internet for other researchers to use.
: PM is an employee of GSK Consumer Healthcare and is a stock shareholder in the company. MA is an employee of GSK Consumer Healthcare and is a stock shareholder in the company. WJD is an employee of Scintipharma, which was contracted by and received compensation from GSK Consumer Healthcare to conduct the clinical study. RCP is an employee of Scintipharma, which was contracted by and received compensation from GSK Consumer Healthcare to conduct the clinical study. EPS is an employee of Scintipharma, which was contracted by and received compensation from GSK Consumer Healthcare to conduct the clinical study.