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Article History

Accepted: 13 April 2025

First Online: 23 June 2025

Declarations

:

: This work was sponsored by Pfizer.

: J.P., M.B.R., L.W., R.C., and E.H. are employees of Pfizer and hold Pfizer stock. L.D.F. is an employee of Pierre Fabre Medicament.

: These studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, particularly those afording greater protection to the safety of trial participants. An institutional review board approved the protocols, and all participants gave written informed consent. This trial was registered on ClinicalTrials.gov: NCT02050815.

: All participants provided written informed consent before undergoing any study procedures.

: Not applicable.

: The analyses in this paper were based on a data cut-off of 07/19/2017. Upon reasonable request and participant to review, Pfizer will provide the data that support the findings of this study. Participant to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related 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 EU or (2) in programs that have been terminated (that is, development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. See for more information. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available, via a secure portal, to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply. To gain access, data requestors must enter into a data access agreement with Pfizer.

: J.P., M.B.R., L.W., R.C., E.H., and L.D.F designed and carried out the research, analyzed the data, and wrote the manuscript.