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Michael H. Pillinger declares investigator-initiated research grants paid to institution from Hikma Pharmaceuticals; consulting fees from Sobi, Amgen, Federation Bio, Scilex and Fortress Biotech; and participation on a data safety monitoring board for Horizon Therapeutics. Abiola Oladapo and Nana Kragh are employees of Sobi. Nana Kragh may hold stock\/stock options in Sobi. Charis Yousefian and Dani Brooks declare consulting fees to Endpoint Outcomes from Sobi. Current affiliation of Charis Yousefian is Vector Psychometric Group, LLC, Chapel Hill, NC, USA; current affiliation of Dani Brooks is Boston Medical Center, Boston, MA, USA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study received approval from the Western International Review Board-Copernicus Group Institutional Review Board (IRB Protocol #20215052). 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