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Article History

Received: 24 January 2021

Accepted: 4 May 2021

First Online: 27 May 2021

Declarations

:

: Ethics approval was obtained and participants provided written consent prior to the any study procedures. Ethics committees that approved the study are as follows:• USA: Copernicus Group Independent Review Board (CGIRB), Cary NC (IRB reference number IRB00001313)• UK: REC- London – Riverside, Chelsea & Westminster Hospital, London• Netherlands: Foundation Beoordeling Ethiek Biomedisch Onderzoek (Foundation BEBO), Assen• Denmark: Den Videnskabsetiske Komité for Region Nordjylland, Aalborg Øst• Czech Republic: Eticka Komise Vestra Clinics, Rychnov nad Kněžnou; Etická komise nestátního zdravotnického zařízení CLINTRIAL, s.r.o., Praha

: Not applicable.

: NDP is a consultant to Boehringer Ingelheim. He serves on the DSMB of Abbvie’s M15-566 trial. He is the CEO and co-owner of the Brain Research Center, The Netherlands.JEH reports receipt of personal fees in the past 2 years from AlzeCure, Aptinyx, Astra Zeneca, Athira Therapeutics, Axon Neuroscience, Axovant, Biogen Idec, BlackThornRx, Boehringer Ingelheim, Cerecin, Cognition Therapeutics, Compass Pathways, CRF Health, Curasen, EIP Pharma, Eisai, Eli Lilly, FSV7, G4X Discovery, GfHEU, Heptares, Lundbeck, Lysosome Therapeutics, MyCognition, Neurocentria, Neurocog, Neurodyn Inc, Neurotrack, Novartis, Nutricia, Probiodrug, Regeneron, Rodin Therapeutics, Samumed, Sanofi, Servier, Signant, Syndesi Therapeutics, Takeda, Vivoryon Therapeutics, vTv Therapeutics, and Winterlight Labs. Additionally, he holds stock options in Neurotrack Inc. and is a joint holder of patents with My Cognition Ltd.H-MC has no conflicts to declare. JJA is the founder and CEO and Ms. Kelly Blackburn is an employee of the sponsor of the trial, EIP Pharma Inc.PS reports receipt of fees (to the university) in the past 2 years from Axon Neuroscience, Cognition Therapeutics, EIP Pharma, Green Valley, GemVax, Novartis, Vivoryon (Probiodrug AG), FUJI Film/Toyama, Rodin Therapeutics, and Medavante. He is a paid medical advisor to the Brain Research Center and serves on the supervisory board.