Deviations from the initial study protocol
RECRUITMENT
We initially started our study in December 2019. Due to the COVID-19 pandemic and related restrictions imposed by the German authorities also on clinical research, we had to discontinue all our activities (e.g. recruitment, inclusion of participants, the follow-up clinic) on March 20, 2020. Consequently, we needed to restart the RCT, since the duration of the interruption was not foreseeable at this time. Intensive discussions among the study team and with the funding agency led to a reduction of planned participants to 40. We chose this number primarily for economic reasons, as limited duration of the project and limited budget did not allow a further extension to achieve a number of 100 participants. We were able to resume activities on June 15, 2020.