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Authors
Leist, Ivo C.
Rivas-Torrubia, María
Alarcón-Riquelme, Marta E.
Barturen, Guillermo
Consortium, PRECISESADS Clinical
Gut, Ivo G.
Rueda, Manuel
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Article History
Received: 28 March 2024
Accepted: 19 November 2024
First Online: 4 December 2024
Declarations
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: The Ethical Review Boards of the 18 participating institutions approved the protocol of the cross-sectional study (see Additional File : Part B for the names of the ethics committees). In addition, the boards of the 6 sites involved approved the inception study protocol. The studies adhered to the standards set by the International Conference on Harmonization and Good Clinical Practice (ICH-GCP), and to the ethical principles that have their origin in the Declaration of Helsinki (2013). All study participants provided written informed consent prior to their enrolment in the PRECISESADS project. The protection of the confidentiality of records that could identify the included subjects is ensured as defined by the EU Directive 2001/20/EC and the applicable national and international requirements relating to data protection in each participating country. The CS study is registered with number NCT02890121, and the inception study with number NCT02890134 in ClinicalTrials.gov.
: Not applicable.
: The authors declare that they have no competing interest.
