Revised Airlie House consensus guidelines for design and implementation of ALS clinical trials.

Amyotrophic Lateral Sclerosis Biomarkers Clinical Trials as Topic Delphi Technique Guidelines as Topic Humans Outcome Assessment, Health Care Patient Selection Research Design Statistics as Topic

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
02 04 2019
Historique:
received: 09 06 2018
accepted: 06 12 2018
pubmed: 10 3 2019
medline: 18 12 2019
entrez: 10 3 2019
Statut: ppublish

Résumé

To revise the 1999 Airlie House consensus guidelines for the design and implementation of preclinical therapeutic studies and clinical trials in amyotrophic lateral sclerosis (ALS). A consensus committee comprising 140 key members of the international ALS community (ALS researchers, clinicians, patient representatives, research funding representatives, industry, and regulatory agencies) addressed 9 areas of need within ALS research: (1) preclinical studies; (2) biological and phenotypic heterogeneity; (3) outcome measures; (4) disease-modifying and symptomatic interventions; (5) recruitment and retention; (6) biomarkers; (7) clinical trial phases; (8) beyond traditional trial designs; and (9) statistical considerations. Assigned to 1 of 8 sections, committee members generated a draft set of guidelines based on a "background" of developing a (pre)clinical question and a "rationale" outlining the evidence and expert opinion. Following a 2-day, face-to-face workshop at the Airlie House Conference Center, a modified Delphi process was used to develop draft consensus research guidelines, which were subsequently reviewed and modified based on comments from the public. Statistical experts drafted a separate document of statistical considerations (section 9). In this report, we summarize 112 guidelines and their associated backgrounds and rationales. The full list of guidelines, the statistical considerations, and a glossary of terms can be found in data available from Dryad (appendices e-3-e-5, doi.org/10.5061/dryad.32q9q5d). The authors prioritized 15 guidelines with the greatest potential to improve ALS clinical research. The revised Airlie House ALS Clinical Trials Consensus Guidelines should serve to improve clinical trial design and accelerate the development of effective treatments for patients with ALS.

Identifiants

DOI: 10.1212/WNL.0000000000007242 PMID: 30850440 PMC: PMC6448453
pubmed: 30850440
pii: WNL.0000000000007242
doi: 10.1212/WNL.0000000000007242
pmc: PMC6448453
doi:

Substances chimiques

Biomarkers 0

Types de publication

Consensus Development Conference Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1610-e1623

Subventions

Organisme : Motor Neurone Disease Association
ID : TURNER/OCT18/989-797
Pays : United Kingdom
Organisme : NINDS NIH HHS
ID : U13 NS093847
Pays : United States

Informations de copyright

Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

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Auteurs

Leonard H van den Berg (LH)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA. L.H.vandenBerg@umcutrecht.nl.

Eric Sorenson (E)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Gary Gronseth (G)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Eric A Macklin (EA)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Jinsy Andrews (J)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Robert H Baloh (RH)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Michael Benatar (M)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

James D Berry (JD)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Adriano Chio (A)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.
ORCID: 0000-0001-9579-5341

Philippe Corcia (P)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Angela Genge (A)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Amelie K Gubitz (AK)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Catherine Lomen-Hoerth (C)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Christopher J McDermott (CJ)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Erik P Pioro (EP)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Jeffrey Rosenfeld (J)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.
ORCID: 0000-0003-4327-7774

Vincenzo Silani (V)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Martin R Turner (MR)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Markus Weber (M)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Benjamin Rix Brooks (BR)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Robert G Miller (RG)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

Hiroshi Mitsumoto (H)

From the Department of Neurology (L.H.v.d.B.), Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands; Department of Neurology (E.S.), Mayo Clinic, Rochester, MN; Department of Neurology (G.G.), University of Kansas Medical Center, Kansas City; Department of Medicine (E.A.M.), Massachusetts General Hospital, Biostatistics Center, Harvard Medical School, Boston; Department of Neurology (J.A., H.M.), Columbia University, Eleanor and Lou Gehrig ALS Center, New York, NY; Department of Neurology (R.H.B.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (M.B.), University of Miami, FL; Neurological Clinical Research Institute (J.D.B.), Massachusetts General Hospital, Boston; Rita Levi Montalcini Department of Neuroscience (A.C.), University of Torino, Italy; Centre Constitutif SLA (P.C.), Université de Tours, France; Department of Neurology (A.G.), Clinical Research Unit, Montreal Neurological Institute, Neurosurgery, McGill University, Montreal, Canada; National Institute of Neurological Disorders and Stroke (A.K.G.), National Institutes of Health, Bethesda, MD; ALS Center (C.L.-H.), University of California San Francisco; Department of Neuroscience (C.J.M.), Sheffield Institute for Translational Neuroscience, University of Sheffield, UK; Department of Neurology (E.P.P.), Section of ALS & Related Disorders, Cleveland Clinic, OH; Department of Neurology (J.R.), The Center for Restorative Neurology, Loma Linda University School of Medicine, CA; Department of Neurology and Laboratory of Neuroscience (V.S.), Istituto Auxologico Italiano, IRCCS, Milan; Department of Pathophysiology and Transplantation (V.S.), "Dino Ferrari" Centre, Università degli Studi di Milano, Milan, Italy; Nuffield Department of Clinical Neurosciences (M.R.T.), University of Oxford, UK; Neuromuscular Diseases Unit/ALS Clinic (M.W.), Kantonsspital St. Gallen, Switzerland; Carolinas Neuromuscular/ALS-MDA Care Center (B.R.B.), Charlotte; Department of Neurology (B.R.B.), Carolinas Medical Center, University of North Carolina School of Medicine, Charlotte; Forbes Norris ALS Treatment and Research Center (R.G.M.), California Pacific Medical Center San Francisco; and Department of Neurosciences (R.G.M.), Stanford University, CA.

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