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It has been approved by the Ethics Committee and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"Asit Parikh, Kristin Stephens, Irving Fox, Catherine Milch, Serap Sankoh, Jesse Shick, Mark Patti, and Megan McAuliffe are or were employees of Takeda Pharmaceuticals at the time this study was conducted. Megan McAuliffe owns stock\/stock options of Biogen and was employed by Biogen at the time this manuscript was submitted. Michael H. Lev is a consultant for GE, MedyMatch, D-Pharm and Takeda. Jesse Shick owns shares in Takeda Pharmaceuticals. Joseph R. Berger reports grants and personal fees from Biogen, grants from TEVA, and personal fees from Genentech\/Roche, Genzyme, Millennium\/Takeda, Novartis, Inhibikase, ExcisionBio, Roche, Amgen, AstraZeneca, Alkermes and Bayer. David B. Clifford is supported by National Institutes of Health (NIH) grants NS077384, AI69495, NR012907, NR014449, NR012657 and UL1 TR000448, and by the Alzheimer Association, and has received research support from Eli Lilly, Roche and Janssen. He has provided scientific advisory or consulting to Amgen, Biogen, Dr. Reddy, Inhibikase, Genzyme\/Sanofi, Takeda\/Millennium, EMD Sorono, Roche\/Genentech, Novartis, GSK, BMS, Pfizer, Quintiles, Drinker Biddle and Reath (PML Consortium Scientific Advisory Board), Shire, and Wave. As a member of the PML IAC, Eugene Major served as an unpaid advisor until he left US government service in 2014. James Provenzale has no disclosures relevant to the content of this manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Prior to study enrolment, informed consent regarding a potential risk of PML associated with administration of the study drug was obtained. 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