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Murrell is an investigator, advisory board member for Argenx, Principia Biopharma, Regeneron Pharmaceuticals Inc., Roche; investigator for AstraZeneca; co-creator of BPDAI; creator of ABQOL. Pascal Joly is a consultant for Amgen, Argenx, AstraZeneca, Innovaderm, Principia Biopharma, Roche, Sanofi-Regeneron Pharmaceuticals Inc., Thermo Fisher Scientific. Victoria P. Werth is a consultant for AbbVie, Argenx, AstraZeneca, Janssen, Kyowa Hakko Kirin, Eli Lilly, Principia Biopharma, Regeneron Pharmaceuticals Inc., Roche-Genentech; reports grants from Argenx, Roche-Genentech, Sanofi-Regeneron Pharmaceuticals Inc., Syntimmune; co-creator of BPDAI. Hideyuki Ujiie is a consultant for Argenx, Ishin Pharma. Margitta Worm reports consultancy for AbbVie, Aimmune Therapeutics, ALK-Abell\u00f3, Amgen, AstraZeneca, Boehringer Ingelheim, DBV Technologies, Kymab, LEO Pharma, Lilly, GSK, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi-Aventis. Aaron R. Mangold reports consultancy for Argenx, Boehringer Ingelheim, Bristol Myers Squibb, Clarivate, Eli Lilly, Incyte, Janssen, Kyowa Kirin, Momenta, Pfizer, PHELEC, Regeneron Pharmaceuticals Inc., Soligenix; grants from AbbVie, Akari Therapeutics, Argenx, Corbus, Eli Lilly, Elorac, Incyte, Janssen, Kyowa Kirin, Merck, Miragen, Novartis, Palvella, Pfizer, Priovant Therapeutics, Regeneron Pharmaceuticals Inc., Soligenix, Sun Pharma, UCB; patents for Methods and Materials for Assessing and Treating Cutaneous Squamous Cell Carcinoma (provisional 63-423254), Use of oral JAKi in Lichen Planus (provisional 63\/453,065), Topical Ruxolitinib in Lichen Planus (WO2022072814A1). Elena Avetisova, Jennifer Maloney, and Arsalan Shabbir are employees and shareholders of Regeneron Pharmaceuticals Inc. Elizabeth Laws and Ariane Dubost-Brama are Sanofi employees and may hold stock and\/or stock options in the company. Eric Mortensen was an employee and shareholder of Regeneron Pharmaceuticals Inc. during the development of this manuscript, and currently is an employee at AstraZeneca.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This clinical trial will be conducted in accordance with the ethical principles originating in the Declaration of Helsinki, and consistent with the International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP), the Japanese GCP, and applicable regulatory requirements. All participants must sign an informed consent form prior to their participation in the study, reviewed and approved by the institutional review board (IRB) and the ethics committee (EC). Any suspected unexpected serious adverse reaction during the study will be reported to the health authorities, EC, IRB, and participating investigators. Final study results will be published on a public clinical trial website according to applicable local guidelines and regulations. The safety profile of dupilumab has been well established in several clinical trials across multiple indications; however, the LIBERTY-BP ADEPT study is the first primary clinical trial to be conducted in elderly patients with a severe, potentially life-threatening disease. Therefore, an additional independent data monitoring committee, composed of members who are independent from the sponsor and the study investigators, will monitor the safety of dupilumab in patients by performing formal reviews of accumulated safety data that will be blinded by treatment group.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}