Li, Jerry http://orcid.org/0000-0002-8774-826X
Pithavala, Yazdi K. http://orcid.org/0000-0003-2301-0538
Gong, Jason
LaBadie, Robert R.
Mfopou, Josué Kunjom http://orcid.org/0000-0003-3058-1996
Chen, Joseph http://orcid.org/0000-0002-5998-7765
Funding for this research was provided by:
Pfizer Inc.
Article History
Accepted: 12 April 2021
First Online: 3 May 2021
Declarations
:
: This study was sponsored by Pfizer Inc.
: Jerry Li, Yazdi K. Pithavala, Jason Gong, Robert R. LaBadie, Josué Kunjom Mfopou, and Joseph Chen are employees of Pfizer Inc. and may own stock and/or stock options in Pfizer.
: This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed. Details of the independent ethics committee that approved the protocol are as follows: Comité d’Ethique Hospitalo-Facultaire Erasme-ULB, Route de Lennik 808, Brussels, BE-BRU B-1070, Belgium.
: All participants provided written informed consent before undergoing any study procedures.
: Not applicable.
: Upon request, and subject to certain criteria, conditions, and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and/or European Union or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: Not applicable.
: JL study design, acquisition of data, interpretation of data. YKP study design, acquisition of data, interpretation of data. Jason Gong: study design, acquisition of data, interpretation of data. RRL study design, interpretation of data. JKM principal investigator of study, acquisition of data, interpretation of data. JC study design, acquisition of data, interpretation of data. All authors reviewed and provided intellectual contributions on previous versions of the manuscript, and read and approved the final manuscript.