Updates are available Correction dated 2021-08-18

Article History

Accepted: 30 March 2021

First Online: 5 May 2021

Change Date: 18 August 2021

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40257-021-00634-3

Declarations

:

: This study was sponsored by Pfizer Inc.

: Jonathan I. Silverberg has served as an investigator for Celgene, Eli Lilly, F. Hoffmann-LaRoche, Menlo Therapeutics, Realm Therapeutics, Regeneron, and Sanofi; as a consultant for Pfizer Inc., AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Glenmark, Incyte, Kiniksa, LEO Pharma, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron, and Sanofi; and as a speaker for Regeneron and Sanofi. Jacob P. Thyssen is an advisor/investigator or speaker for Pfizer, AbbVie, Eli Lilly, LEO Pharma, Regeneron, and Sanofi-Genzyme. Eric L. Simpson is a consultant for Pfizer, AbbVie, Celgene, Eli Lilly, Galderma, GlaxoSmithKline, Menlo Therapeutics, LEO Pharma, and Regeneron and a principal investigator for AbbVie, GlaxoSmithKline, LEO Pharma, Novartis, Regeneron, Tioga Pharmaceuticals, and Vanda Pharmaceuticals. Gil Yosipovitch has been a consultant and advisor for Bellus, Pfizer, Eli Lilly, Galderma, LEO Pharma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Novartis, Sanofi-Regeneron, and Trevi Therapeutics, and a principal investigator for Pfizer, Galderma, Kiniksa Pharmaceuticals, LEO Pharma, Sanofi-Regeneron, Novartis, and Sun Pharmaceutical Industries. Sonja Ständer is a consultant and/member of advisory boards for Pfizer Inc., Almirall, Bayer, Beiersdorf, Bellus Health, Bionorica, Cara Therapeutics, Celgene, Clexio, DS Biopharma, Galderma, Menlo Therapeutics, Novartis, Nuformix, Perrigo, Sanofi, Sienna Biopharmaceutical, Trevi Therapeutics, and Vifor Pharma; has received research grants from the German Research Foundation (DFG), the European Academy of Dermatology and Venereology (EADV), Almirall, Beiersdorf, Galderma, LEO Pharma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Novartis, Sanofi, and Trevi Therapeutics; and has been an investigator for Dermasence, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Novartis, Sanofi, Trevi Therapeutics, and Vanda Pharmaceuticals. Hernan Valdez, Ricardo Rojo, Pinaki Biswas, Daniela E. Myers, Claire Feeney, and Marco DiBonaventura are employees and shareholders of Pfizer Inc.

: The institutional review board at each study site approved the study protocol and written informed consent was provided by parents/legal guardians. The study was conducted in accordance with the protocol, local legal and regulatory requirements, and the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, International Conference on Harmonisation Guideline for Good Clinical Practice, and the Declaration of Helsinki.

: Written informed consent was provided by the participants of all studies.

: 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 USA and/or the European Union 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.

: All authors contributed to the design of the study; participated in the acquisition, analysis, and/or interpretation of data; reviewed and critically revised the report for important intellectual content; and gave final approval of the version that was submitted.