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ClinicalTrials.gov identifier: NCT01949311. The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication. Medical writing and editorial assistance were provided by Carolyn Ellenberger, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals, Inc., according to the Good Publication Practice guideline.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Lisa A. Beck has acted as investigator and\/or consultant for AbbVie, Allakos, Arena Pharmaceuticals, AstraZeneca, BenevolentAI, DermTech, Galderma, Inc., Incyte, Janssen, Kiniksa Pharmaceuticals, LEO Pharma, Lilly, Novartis, Numab Therapeutics, Pfizer, Principia Biopharma, RAPT Therapeutics, Regeneron Pharmaceuticals, Ribon Therapeutics, Sanofi, sanofi-aventis, Stealth BioTherapeutics, and Union Therapeutics; and owns stock in 3M, Gilead, Medtronics, and Moderna. Mette Deleuran has received research support, honoraria for lecturing, and\/or consulting\/advisory board agreements from AbbVie, Arena Pharmaceuticals, Aslan Pharmaceuticals, Eli Lilly, Incyte, La Roche-Posay, LEO Pharma, MSD, Numab Therapeutics, Pierre Fabre, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi. Robert Bissonnette has acted as a consultant for and\/or has received grants\/research support from AbbVie, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aristea Therapeutics, Asana BioSciences, Bellus Health, Bluefin Biomedicine, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, EMD Serono, Evidera, Galderma, GSK, Inmagene Biopharmaceuticals, Incyte, Kiniksa Pharmaceuticals, Kyowa Kirin, LEO Pharma, Novan, Pfizer, Ralexar Therapeutics, RAPT Therapeutics, Regeneron Pharmaceuticals, Inc., Respivant Sciences, Sanofi, Siena Biopharmaceuticals, Target RWE, and Vyne Therapeutics and is a shareholder with Innovaderm Research. Marjolein de Bruin-Weller has acted as a consultant, advisory board member, and\/or speaker for AbbVie, Almirall, Arena Pharmaceuticals, Aslan Pharmaceuticals, Eli Lilly, Galderma, Janssen, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, Inc. Ryszard Galus has acted as principal investigator for Boehringer Ingelheim, Dermira, Galderma, Glenmark, Incyte, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi. Takeshi Nakahara has received speaker fees from Maruho and Sanofi. Seong Jun Seo has acted as speaker, investigator, and consultant for AbbVie, Eli Lilly, LEO Pharma, Sanofi. Faisal Khokhar, Jing Xiao, Noah Levit, and Arsalan Shabbir are employees and shareholders or Regeneron Pharmaceuticals, Inc. Jignesh Vakil, Ainara Rodriguez Marco, John O\u2019Malley are employees of and may hold stock and\/or stock options in Sanofi.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"This study was conducted in accordance with the ethical standards of the responsible committees and the Declaration of Helsinki and with the International Council for Harmonisation guidelines for good clinical practice. The trial was overseen by an independent data and safety monitoring board. The protocol was reviewed and approved by institutional review boards\/ethics committees at all centers.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all patients or their proxies.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., US FDA, European Medicines Agency, Pharmaceuticals and Medical Devices Agency), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to\n                      \n                      .","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"LAB, MD, RB, MdeBW, RG, TN, and SJS acquired data. JX conducted the statistical analyses on the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}