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Authors
Dunlop, Rachael Anne https://orcid.org/0000-0002-7816-3251
Cox, Paul Alan https://orcid.org/0000-0001-6401-2981
Mehta, Paul
Stommel, Elijah W.
Banack, Sandra Anne https://orcid.org/0000-0001-5183-2702
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Funding
Funding for this research was provided by:
Denis and Diane Lyman Foundation, Faulk Foundation
Centers for Disease Control and Prevention
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Article History
Received: 23 June 2025
Accepted: 24 November 2025
First Online: 16 December 2025
Declarations
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: Informed consent was obtained from all individual participants included in the study. Since this study used only de-identified participant data, Advarra IRB (Pro00053269) determined that it “does not meet the DHHS definition of human subjects research under 45 CFR 46 and, therefore, does not require IRB oversight.” Sample collections were overseen by each respective institution (US National ALS Biorepository, CDC, Advarra Institutional Review Board, Pro00053269; Phase IIa clinical trial, NCT03580616, 2018-06-26, Dartmouth IRB D18095; Innovative Research Inc., Novi, MI, Food and Drug Administration (FDA) approval, #3003372368; Precision for Medicine, Norton, MA, CR00425931).
: Informed consent was obtained from all individual participants included in the study.
: The not-for-profit research institute Brain Chemistry Labs has applied for a patent on the use of this biomarker.
