All applicable national and European Union (EU) legislation, particularly the General Data Protection Regulation (EU 2016/679)20 for the protection of individuals have been considered in the design of the study-related Information Technology (IT) infrastructure with regard to the confidential processing, collection and access to personal data. The technical deployment of the MyPal platform comprises of local server installations at each of the clinical study sites and one central server installation at the sponsor’s site distinctly defining premises of data accessibility. The data security concept entails regular synchronisation of only anonymised data from local to central database. The apps being installed on mobile devices are protected by confidential credentials and store encrypted data only temporarily locally in case of absent internet connection until they are deleted from the mobile device subsequent to transmission to the respective databases.

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