212 CHAPTER 3.1 Declarations Authors’ contributions MS, BB, AS, OD, IW, WK, NR, SB, and DOM made substantial contributions to the conception and design of the intervention. EKC, BTGMS, CJAH, KDM, EM, AL, MF, NS, LA made substantial contributions to the design of the intervention. MS and ZS were involved in the creation of software used in the intervention, and EKC, BTGMS, CJAH, KDM, WK, SB, and DOM have drafted the work or substantively revised it. All authors have approved the submitted version and have agreed to be personally accountable for their own contributions. We have not received substantial contributions from non-authors. Competing interests The author(s) declare that they have no competing interests. Data availability statement Data will be deposited in the Bern Open Repository and Information System (BORIS) (www.boris.unibe.ch). BORIS allows searching and is indexed by search engines. All items are stored with a unique Digital Object Identifier (DOI) that can be referenced in respective publication. The whole study database will be in csv format, and will include README files, metadata, information about the performed processing and analytical steps, variable definitions, and references to vocabularies used to help secondary users to understand and reuse the data. Data will only be shared upon request. Data use proposals will be evaluated by the OPERAM publication committee. The data is owned by the sponsor-investigators. In case of data sharing, a data-sharing agreement between the external party and the sponsor-investigator will need to be agreed on and signed. Ethics approval The OPERAM study received ethical approval from the following ethics committees: • Belgium: Comité d’éthique hospitalo-facultaire cliniques universitaires SaintLuc UCL Bruxelles • Ireland: Clinical Research Ethics Committee of the Cork Teaching Hospitals • Netherlands: Medisch Ethische Toetsingscommissie Utrecht • Switzerland: Kantonale Ethikkomission Bern
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