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Article History

Accepted: 2 February 2022

First Online: 29 April 2022

Declarations

:

: This study was sponsored by Merck (CrossRef Funder ID: 10.13039/100009945), as part of an alliance between Merck and Pfizer. Medical writing support was provided by ClinicalThinking and was funded by Merck and Pfizer.

: YV is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA. AMG and PR are employees of Merck Healthcare KGaA, Darmstadt, Germany. MR was an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA at the time of the study, and holds stock in Bristol Myers Squibb. BB and AK are employees of Merck Healthcare KGaA, Darmstadt, Germany and hold stock in Merck. HD was an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA at the time of the study.

: The trial was conducted in accordance with the ethics principles of the Declaration of Helsinki and the International Council on Harmonisation guidelines on Good Clinical Practice. The protocol was approved by the institutional review board or independent ethics committee of each center.

: All legal representatives of patients or patients provided written informed consent before enrollment.

: Not applicable.

: Any requests for data by qualified scientific and medical researchers for legitimate research purposes will be subject to Merck’s Data Sharing Policy. All requests should be submitted in writing to Merck’s data sharing portal (). When Merck has a co-research, co-development, or co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck will endeavor to gain agreement to share data in response to requests.

: Not applicable.

: All authors participated in the interpretation of the study results, and in the drafting, critical revision, and approval of the final version of the manuscript. All authors designed and performed the research and analyzed the data.