Conflict of Interest Disclosures: Dr Berry reported receiving grants from Clene Nanomedicine during the conduct of the study; personal fees from Alexion, Amylyx, Biogen, Mitsubishi Tanabe Pharma America (MTPA), Mitsubishi Tanabe Pharma Holdings of America (MTPHA), Roon, Regeneron, and Sanofi; and grants from Alexion, Amylyx, MTPA, MTPHA, Biogen, Rapa Therapeutics, BrainStorm Cell Therapeutics, and uniQure outside the submitted work. Dr Maragakis reported receiving grants from National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) and the US Department of Defense (DoD) Amyotrophic Lateral Sclerosis Research Program during the conduct of the study; personal fees from Novartis and Nura Bio; and nonfinancial support from Janssen and Secretome Therapeutics outside the submitted work. Dr Macklin reported receiving grants from Clene Nanomedicine during the conduct of the study; grants from OrphAI Therapeutics, Alector, Biohaven, Calico, Denali, ITB-MED, Lilly, MTPA, PharmAust, Prilenia Therapeutics, Revalesio, Seelos, and UCB/Ra Pharmaceuticals paid to institution; serving on the advisory board of Annexon, BIAL Biotech, Cortexyme, Chase Therapeutics, Enterin, Hillhurst, Merck, nQ Medical, and Partner Therapeutics; serving on the steering committee of Biogen, Stoparkinson, and UCB; and being a member of the data and safety monitoring board (DSMB) of argenx, NeuroSense, Novartis, and Sanofi outside the submitted work. Dr Quintana reported being an employee of Berry Consultants during the conduct of the study. Dr Saville reported being the owner of Adaptix Trials outside the submitted work. Dr Detry reported consulting fees paid to institution from Sean M. Healey and AMG Center for ALS at Mass General during the conduct of the study; and being a director and senior statistical scientist at Berry Consultants. Dr Vestrucci reported consulting fees paid to institution from Sean M. Healey and AMG Center for ALS at Mass General during the conduct of the study; and being a biostatistician at Berry Consultants. Dr Marion reported being an employee of Berry Consultants during the conduct of the study. Dr McGlothlin reported consulting fees paid to institution from Sean M. Healey and AMG Center for ALS at Mass General during the conduct of the study; and being a biostatistician at Berry Consultants. Ms Chase reported receiving grants from UCB, Biohaven, Clene Nanomedicine, and Prilenia Therapeutics during the conduct of the study. Mr Sherman reported receiving grants from Clene Nanomedicine during the conduct of the study; and grants from US Food and Drug Administration, NIH, Biogen, MTPA, Amylyx, and ALS Association outside the submitted work. Dr Shefner reported receiving grants from NINDS, MPTA, Sanofi, Healey Center for ALS, PTC, and NeuroSense; and personal fees from Amylyx, Novartis, PTC, Acurastem, and NeuroSense outside the submitted work. Dr Babu reported receiving institutional consulting fees from OrphAI, Biogen, uniQure, and MarvelBiome; and research funding from Biogen, Novartis, Ionis, and Denali outside the submitted work. Dr Andrews reported receiving grants from Biogen, Cytokinetics, Amylyx, NIH/NINDS, Calico, and Denali paid to institution; grants from Prilenia Therapeutics; personal fees for serving on the DSMB of AL-S Pharma, Sanofi, and Quralis; and serving on the scientific advisory board of NeuroSense and Akava outside the submitted work. Dr Alameda reported receiving a stipend for being a HEALEY ALS Platform Trial principal investigator during the conduct of the study. Dr D. Ho reported receiving research funding from Clene Nanomedicine during the conduct of the study; research funding from Prilenia Therapeutics, Ra Pharmaceuticals, Biohaven, Seelos, Calico, Denali, Biogen, Transposon, Sanofi, Neurodegenerative Alzheimer’s Disease and Amyotrophic Lateral Sclerosis Basket Trial, and Genentech; serving on the advisory board of Biogen and Sanofi; and serving on the independent data monitoring committee of Alexion outside the submitted work. Dr Ajroud-Driss reported receiving grants from Clene Nanomedicine during the conduct of the study; serving on the advisory board of Amylyx; and receiving speaking fees from Biogen outside the submitted work. Dr Heitzman reported receiving grants from Neurologix Foundation, AbbVie, AbbVie/Calico, Anelexis, Amylyx, Biohaven, Cytokinetics, Denali, Immunovant Sciences GmbH, Abcuro, MTPA, Prilenia Therapeutics, Ra Pharmaceuticals, and Seelos; and personal fees from Amylyx outside the submitted work. Dr Shroff reported receiving speaking fees from UCB, Alnylam, and AstraZeneca; and speaking fees and serving on the advisory board of argenx outside the submitted work. Dr Simmons reported receiving grants from Mass General during the conduct of the study; personal fees from Biogen, Clene Nanomedicine, Corcept, Columbia University, Amylyx, and Insmed; and grants from Sanofi outside the submitted work. Dr Miller reported receiving consulting fees from Ionis Pharmaceuticals, Biogen, Bioio, and Arbor Biotechnologies; licensing agreements from Ionis Pharmaceuticals and C2N; and honorarium from Denali outside the submitted work. Dr Weiss reported being an advisory board member of Biogen, Cytokinetics, MTPA, Amylyx, and Sanofi; and receiving personal fees for being a member of a DSMB outside the submitted work. Dr Goutman reported receiving grants from Healey Center at Mass General paid to institution during the conduct of the study. Dr Foster reported receiving grants from Sean M. Healey and AMG Center for ALS during the conduct of the study. Dr Vu reported receiving reimbursement for trial activities from University of South Florida Department of Neurology during the conduct of the study. Dr Ilieva reported receiving a Trial Capacity Award from The ALS Association and expanded access protocol infrastructure support from TechVsALS. Dr Arcila-Londono reported receiving grants to institution and the research team from Mass General for HEALEY ALS Platform Trial–related activities during the conduct of the study; and being an ALS Association Clinical Trials grant recipient (4 years) outside the submitted work. Dr Jackson reported receiving grants from Mass General during the conduct of the study. Dr Ladha reported receiving personal fees from Amylyx, Biogen, Genentech, and Sanofi outside the submitted work. Dr Heiman-Patterson reported receiving compensation from Healey Center during the conduct of the study; personal fees from the medical advisory board of MTPA, Amylyx, and Novartis; grants from MTPA, Amylyx, ALS Association Enhancement of Clinical Research, Muscular Dystrophy Association, Samus, Alexion, and UCB; and personal fees from p-value group, Projects in Knowledge, and Vindico outside the submitted work. Dr Peltier reported receiving grants from Healey Center at the University of Massachusetts during the conduct of the study. Dr Elliott reported receiving grants from Clene Nanomedicine during the conduct of the study; and grants from Denali, Calico, AbbVie, Seelos, Prilenia Therapeutics, Biohaven, UCB, MediciNova, and The ALS Association outside the submitted work. Dr Bedlack reported receiving grants and personal fees from Clene Nanomedicine during the conduct of the study. Dr Walk reported receiving personal fees from MTPA, Amylyx, and Clene Nanomedicine outside the submitted work. Dr McIlduff reported a master site clinical trial agreement from Sean M. Healey and AMG Center for ALS at Mass General during the conduct of the study. Dr Johnson reported receiving grants from Mass General during the conduct of the study; and personal fees from the argenx speaker’s bureau outside the submitted work. Dr Goyal reported receiving grants from Clene Nanomedicine during the conduct of the study; grants from Abcuro, Amylyx, Annexon, Calico, Cytokinetics, Fulcrum, Janssen, Kezar, MediciNova, MTPA, PepGen, PTC, Roche, Sanofi, and Transposon outside the submitted work; and being on the speaker’s bureau of argenx and CSL Behring. Dr Benatar reported receiving per patient reimbursement from Mass General during the conduct of the study; and consulting fees from Prilenia Therapeutics, Alector, Biogen, Novartis, Bristol Myers Squibb, Woolsey, Eli Lilly, uniQure, and Arrowhead outside the submitted work. Dr Shah reported receiving grants from Abcuro, Muscular Dystrophy Association, and argenx outside the submitted work. Dr Beydoun reported receiving grants from University of Southern California during the conduct of the study; grants from Abcuro, Janssen, Sanofi, and Regeneron; and personal fees from UCB, Alexion, argenx, Takeda, AstraZeneca, and CSL Behring outside the submitted work. Dr Wymer reported receiving grants from MTPA outside the submitted work. Mr Rynders reported being an employee of Clene Nanomedicine during the conduct of the study. Mr Jacob Evan reported being an employee of Clene Nanomedicine during the conduct of the study. Mr Jeremy Evan reported being an employee of Clene Nanomedicine during the conduct of the study. Dr K. Ho reported being an employee of Clene Nanomedicine during the conduct of the study; being a scientific advisor to FamilieSCN2A Foundation; and receiving grants from FightMND, National Multiple Sclerosis Society, Michael J. Fox Foundation, National Academy of Medicine, and NIH/NINDS. Dr Glanzman reported being an employee of Clene Nanomedicine during the conduct of the study. Dr Greenberg reported receiving personal fees from Clene Nanomedicine during the conduct of the study; and consulting fees from Alexion, Novartis, EMD Serono, Horizon Therapeutics/Amgen, Genentech/Roche, Signant, IQVIA, Sandoz, Sanofi/Genzyme, TG Therapeutics, Cycle Pharma, Arialys, Clene Nanomedicine, Syneos, and PRIME Education; grant funding from NIH, Anokion, and Regeneron; serving as an unpaid member of the board of the Siegel Rare Neuroimmune Association; having equity in Clene Nanomedicine and GenrAb; and receiving royalties from UpToDate. Mr Hotchkin reported being an employee of Clene Nanomedicine during the conduct of the study. Dr Paganoni reported receiving grants from Amylyx, Eledon, Alector, Seelos, Calico, Denali, NIH, CDC, and DoD; institutional consulting agreements from Amylyx, Revalesio, Bristol Myers Squibb, Eikonizo, Clene Nanomedicine, Sola, PharmAust, and Prilenia Therapeutics; personal fees from Arrowhead, Cytokinetics, Merck, Biogen, and Johnson & Johnson; and speaking fees from PeerView, Medscape, and i3 Health outside the submitted work. Dr Cudkowicz reported receiving grants from Clene Nanomedicine during the conduct of the study. No other disclosures were reported.
