Frequency and plans for auditing trial conduct {23}
With respect to the non-availability of an external sponsor, it is not planned to engage an external trial auditor, and therefore, the study group is responsible by itself to ensure that all information is credible, i.e. that all scientific data has been generated, collected and processed are methodologically correct. Regular group meetings will be used to monitor the study quality as well as to optimize procedures in case of problems Furthermore, the study group respect laws and regulations.