Funding for this research was provided by:
Pfizer
Article History
Accepted: 7 September 2022
First Online: 14 September 2022
Declarations
:
: This work was supported by Pfizer Inc.
: All authors are employees of Pfizer Inc and may hold stock or stock options.
: The analyses for this study were conducted retrospectively using deidentified patient data; as such, this study was deemed exempt by the institutional review board and informed consent was not required.
: Not applicable.
: 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 US and/or EU 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.
: No specific custom code was created for the study. We utilized an SAP Business Objects (Desktop Intelligence Version 12.6.2.1782) based application to analyze the study data. For more details, please contact the corresponding author.
: All authors met the below criteria for authorship: Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and, drafting the work or revising it critically for important intellectual content; and, final approval of the version to be published; and, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.