Confidentiality {27}
The collection, transfer, storage and evaluation of personal data within this clinical trial is carried out in accordance with the applicable legal regulations (e.g. EU General Data Protection Regulation, EU reg. 2016/679 GDPR). Data collected during this clinical trial will be recorded on electronic data carriers, treated in strict confidence and only passed on to the sponsor of the trial for scientific evaluation and the assessment of AEs and the responsible supervisory authorities, the ethics commissions and the European database to verify the proper conduct of the trial and to evaluate trial results and AEs. To the extent necessary for the review of the clinical trial, authorised representatives of the sponsor (monitoring and auditing) and/or the regulatory authority, who are bound to secrecy, may inspect the personal data available at the trial site.