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Article History

Received: 29 October 2020

Accepted: 6 March 2021

First Online: 6 April 2021

Declarations

:

: The study protocol was submitted to the German Federal Institute for Drugs and Medical Devices (Bundestinstitut für Arzneimittel und Medizinprodukte, BfArM, Germany) and a waiver of authorization was granted; furthermore, the trial was evaluated and approved by the ethical committee of the Faculty of Medicine at Goethe University Frankfurt (Ethik-Kommission des Fachbereichs Medizin der Goethe-Universität Frankfurt am Main, Germany). The study protocol was subsequently submitted to and approved by the French Drug and Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM, France) and Ethical Committee (Comité de protection des personnes, CPP, France). The study protocol is currently under evaluation by National Authority of Medicines and Health Products, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, INFARMED, Portugal) and the National Ethics Committee for Clinical Research (Comissão de Ética para a Investigação Clínica, CEIC, Portugal).Participants will only be included in the study after they and their caregivers give written informed assent/consent.

: Not applicable.

: CL, MS, AM, HM, SB, AD, HCP, MCB, ML, FBB, JS, MS, CE and CMF have no competing interests to declare.GR is cofounder of Neuroelectrics; RS works at Neuroelectrics, a company that designs and produces EEG and tES solutions.