Composition of the data monitoring committee, its role and reporting structure {21a}
An independent local monitor (Tirol Kliniken) will check trial quality repeatedly (at least every 6 months) and check at least 10% of the signed informed consent files (ICF). Complete data of the first five participants will be reviewed, including inclusion and exclusion criteria. The study has a low risk; therefore, there is no need for data safety monitoring board.