Funding

This study was funded by Pfizer Inc. The sponsor, Pfizer Inc, was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript for publication. Medical writing and editorial support provided by Nucleus Global were funded by Pfizer Inc.

Conflict of interest

R.S. reports professional services for AbbVie, Acrotech, Amgen, Arena, Arcutis, Aksebio, AstraZeneca, Ascend, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus BioSciences, Cutanea, Connect, Demira, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, MedImmune, Merck, MSD, Novartis, Oncobiologics, Pfizer, Regeneron, Reistone, Roche, Sanofi, Samson Clinical, SUN Pharma, and UCB. N.M. reports professional services for AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Concert Pharmaceuticals, Eli Lilly, La Roche-Posay, and Pfizer. D.M., D.W., E.H.L., and R.W. are employees of or hold stock or stock options in Pfizer Inc. B.K. has received honoraria and/or consultation fees from AbbVie, AltruBio, Almirall, AnaptysBio, Arena Pharmaceuticals, Bioniz Therapeutics, Bristol Meyers Squibb, Concert Pharmaceuticals Inc, Equillium, Horizon Therapeutics, Eli Lilly and Company, Incyte, Janssen Pharmaceuticals, LEO Pharma, Otsuka/Visterra Inc, Pfizer Inc, Regeneron, Sanofi Genzyme, TWi Biotechnology Inc, and Viela Bio. He has previously served on speaker bureaus for AbbVie, Incyte, Eli Lilly, Pfizer, Regeneron, and Sanofi Genzyme.

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 deidentified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.

Ethics approval

This study was approved by the institutional review boards or ethics committees of the participating institutions. The study was conducted in accordance with the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), ICH Guideline for Good Clinical Practice, and the Declaration of Helsinki.

Consent to participate

Written informed consent was obtained from each patient, parent, or the patient’s legal representative.

Consent to publish

Not applicable.

Code availability

Not applicable.

Author contributions

E.H.L. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors read and approved the final manuscript. Conceptualization: D.M., D.W., E.H.L., R.W. Data curation: R.S., N.M., D.M., D.W., E.H.L, R.W., B.K. Writing—original draft: E.H.L. Writing—review and editing: R.S., N.M., D.M., D.W., E.H.L., R.W., B.K. Formal analysis: D.W.