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Theodore H. Wein: Research: Ipsen, AbbVie, Canadian Institutes of Health Research\/Eurospocnet; Consulting, honoraria\/payment and travel support: AbbVie, Ipsen; Advisory Boards: Ipsen; Data Safety Monitoring Board: Pacira Biosciences, PharmaZzz. Monica Verduzco-Gutierrez: Consulting: AbbVie, Ipsen, Merz, Piramal, Revance. Research grants: Ipsen; Data Safety Monitoring Board: Pacira Biosciences. Ziyad Ayyoub: Consulting: honoraria from AbbVie, Ipsen, and Revance Therapeutics, Inc. Simon Page: Employee and shareholder of Ipsen. Sarah Harding: Employee and shareholder of Ipsen. Pascal Maisonobe: Employee of Ipsen. Mathieu Beneteau: Employee of Ipsen. Atul Patel: Consulting: AbbVie, Ipsen, and Revance; Speaker\u2019s Bureau: AbbVie and Ipsen; Research: (to institution) AbbVie, Ipsen, and Pacira; Treasurer (during the study)\/Vice President (at the time of writing) of the American Academy of Physical Medicine and Rehabilitation.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines and International Conference on Harmonisation Good Clinical Practice Guidelines. All patients provided written informed consent. The protocol and informed consent forms were reviewed and approved by the sponsor, the central ethics committee (Advarra), and by the applicable institutional review boards\/ethical committees at participating sites with respect to scientific content and compliance with applicable regulations for research and humans (Table S1).","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}