Provisions for post-trial care {30}
damages
ADVERSE EVENTS
In any clinical situation, including emergencies, appropriate medical care will be provided. After the study, medical follow-up will be provided for all participants at the study centre or suitable facilities according to the local standard. In case of adverse events (AEs), all necessary medical care will be provided for all participants at the study centre or suitable facilities even after data collection for the research study is completed. On behalf of the sponsor, mandatory subject insurance according to national and EU regulations has been implemented for all trial subjects. This insurance covers all possible damages that the subject suffers directly or indirectly as a result of the investigational medicinal product or interventions in connection with the clinical trial.