Koller, Dora http://orcid.org/0000-0002-0415-0466
Almenara, Susana
Mejía, Gina
Saiz-Rodríguez, Miriam
Zubiaur, Pablo
Román, Manuel
Ochoa, Dolores
Navares-Gómez, Marcos
Santos-Molina, Elena
Pintos-Sánchez, Elena
Abad-Santos, Francisco http://orcid.org/0000-0002-6519-8885
Funding for this research was provided by:
H2020 Marie Skłodowska-Curie Actions (721236)
Consejería de Educación, Juventud y Deporte, Comunidad de Madrid (PEJ-2018-TL/BMD-11080)
Article History
Received: 21 October 2020
Accepted: 7 November 2020
First Online: 5 December 2020
Funding
: The study and DK were financed by the H2020 Marie Sklodowska-Curie Innovative Training Network 721236 grant. MN is co-financed by “Consejería de Educación, Juventud y Deporte” PEJ-2018-TL/BMD-11080 grant from “Comunidad de Madrid” and “Fondo Social Europeo”. No Rapid Service Fee was received by the journal for the publication of this article.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
: Wrote Manuscript: DK, MSR, PZ, SA, FAS; Designed Research: DK, FAS, MSR, GM, MR, DO; Performed Research: DK, MR, GM, FAS, MN; Analysed Data: DK, SA, ESM, EPS.
: This was published previously as a preprint ExternalRef removed.
: FAS and DO have been consultants or investigators in clinical trials sponsored by the following pharmaceutical companies: Abbott, Alter, Aptatargets, Chemo, Cinfa, FAES, Farmalíder, Ferrer, Galenicum, GlaxoSmithKline, Gilead, Italfarmaco, Janssen-Cilag, Kern, Normon, Novartis, Servier, Silverpharma, Teva and Zambon. DK, MSR, PZ, SA, GM, MR, MN, ESM and EPS declare no conflict of interest. DK changed affiliation since the completion of the study to Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.
: The protocol was approved by its research ethics committee (Comité Ético de Investigación Clínica (CEIC) of Hospital de La Princesa, registry number 3411) authorized by the Spanish Drugs Agency and the study was performed under the guidelines of Good Clinical Practice and the Declaration of Helsinki. All subjects signed the informed consent before inclusion and were free to withdraw from the study at any time.
: All data generated or analysed during this study are included in this published article (and its supplementary material files). Clinical trial registry name, URL and registration number: TREATMENT-HV; EUDRA-CT 2018-000744-26; ExternalRef removed.