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Article History

Received: 26 April 2018

Accepted: 23 October 2018

First Online: 21 November 2018

Ethics approval and consent to participate

: The study protocol was in first instance approved by the Verona Hospital Ethical Review board (study protocol AUT-SFK001, CE1419), and subsequently by following Ethical Review Committees of each recruiting site:All adult subjects participating in this project gave their written consent (or the consent for their chidren) to donate biological samples and clinical and demographic information to participate in this study; assent to participate to this study from the children was obtained whenever obtainable. A multidisciplinary Scientific and Ethical Committee of the Fondazione SmithKline, “Area Ricerca Autismo”, i) created the protocol; ii) ensured that the use of the samples and clinical database was consistent with what consented by the research participants; iii) ensured that research was conducted with sound methodology and by accredited institutions.

: Not applicable.

: PM is an employee of UCB Pharma (Belgium); ER is an employee of Takeda (USA); TKT is an employee of F. Hoffman-La Roche Ltd. (Switzerland); PR is an employee of ViiV Healthcare. PM, ED, LDR and ER were employees of GSK (Italy) during the design and launch of the clinical study. ED has received research support from Roche in the period 2016–2018. AZ has served on the advisory boards of Shire, EcuPharma and Angelini and on data safety monitoring boards of Otsuka and Lundbeck; he has received research support from Shire, Vifor, Roche, Lundbeck, Jannssen.

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