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Amy Gutierrez is a consultant for Biogen, Novartis, Sanofi Genzyme, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, TG Therapeutics, and Janssen. Lawrence Goldstick has received consulting fees from TGA, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Bristol Myers Squibb, and Sanofi; payment or honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing, or educational events from TGA, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Sanofi, and Bristol Myers Squibb. Ralf Koelbach is an employee of Cytel Inc., Berlin, Germany, funded by EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA. Julie Aldridge is a former employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA. Angela Chandler is a former employee of EMD Serono, Inc., Boston, MA, USA, an affiliate of Merck KGaA. Christina Caon is an employee of EMD Serono, Inc., Boston, MA, USA, an affiliate of Merck KGaA. Joshua Katz served in the scientific advisory board for Genentech, EMD Serono and Novartis, and received speaker fees from Biogen, Genentech, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Novartis, and TG Therapeutics.","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 Good Clinical Practice. A central or local institutional review board (IRB) at each site approved the protocol. The details of IRBs have been included in Supplementary Table\u00a0\n                      \n                      . 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