Funding

This study was funded by Pfizer and Eli Lilly and Company. The journal’s Rapid Service fee was funded by Pfizer and Eli Lilly and Company.

Medical Writing/Editorial Assistance

Medical writing support was provided by Matt Soulsby, PhD, CMPP, of Engage Scientific Solutions and funded by Pfizer and Eli Lilly and Company.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Author Contributions

All authors contributed to the (1) conception/design of the study and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be submitted. Gianluca Bonfanti and Roger Edwards were also involved in analysis of data.

Disclosures

Thomas J. Schnitzer reports clinical research study support from Pfizer, Lilly, Regeneron, Galapagos, Taiwan Liposome Corporation, and Anika Therapeutics and has served as a consultant or on an advisory board for Pfizer, Eli Lilly and Company, Glaxo-Smith Kline, AstraZeneca, Noven, Galapagos, and Merck. Gianluca Bonfanti is an employee of Engineering Ingegneria Informatica, a paid sub-contractor to Health Services Consulting Corporation in conjunction with this study and development of this manuscript. Joanna Atkinson is a full-time employee of Pfizer, LTD. Sean Donevan is a full-time employee of, and owns stock/options in, Pfizer Inc. Lars Viktrup is a full-time employee of, and owns stock/options in, Eli Lilly and Company. Joana Barroso has received research support from Grünenthal. Ed Whalen is a full-time employee of, and owns stock/options in, Pfizer Inc. Roger A. Edwards is an owner of Health Services Consulting Corporation, a paid consultant by Pfizer in connection with this study and development of the manuscript.

Compliance with Ethics Guidelines

The studies included in this analysis were approved by an institutional review board or independent ethics committee at each study center. All patients provided written informed consent before participating. The studies were conducted in compliance with the Declaration of Helsinki and all International Conference on Harmonization Good Clinical Practice guidelines. Please see the primary study publications for more detail.

Data Availability

Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.