Ethics Approval and Consent to Participate
Each local research team translated and adapted the generic study protocol to the local requirements and submitted it for review to competent local medical ethical review committees. All committees either approved the study or provided a confirmation letter that it was exempt from approval as the study was not considered as medical research. A portfolio of the ethical documentation can be accessed through Deliverable 23 (D9.1, H – Requirement No. 1), which was submitted to the European Commission (Horizon 2020, Grant Agreement 733025). The study participants signed an informed consent form indicating the purpose of the study and the nature, use, and management of their data. The study protocol was published [