Ethics

All studies will be approved by the respective local ethics boards and adhere to the Declaration of Helsinki and pertinent legislature. The clinical trial will be conducted according to the pertinent European regulations and clinical on-site monitoring will be conducted to ensure that the rights and well-being of study participants are protected and that investigators comply with the approved protocol. In addition, a within-project ethical advisory board (IEB ) supplemented and supervised by an independent ethical advisor as well as an external Scientific and Ethics Advisory Board (SEAB) and Data and Safety Monitoring Committee (DSMC) have been formed. The latter amongst others reviews any issues concerning the safety of the trial participants

Gain insight into the mechanisms underlying this comorbidity triad with its huge burden for healthcare, economy, and society