Study design
This open-label, randomised, controlled, parallel-group, non-inferiority trial with two interim analyses and no trial adaptation was conducted within the ground-based emergency medical district of Aachen. All resulting EMS files and hospital information system-based outcome data of admitted patients were analysed within the scope of data quality assurance for outcome measures. Patients admitted to five hospitals (one university hospital and four primary care hospitals) were followed. The latest version of the published study protocol [The data safety monitoring committee reviewed non-blinded safety data. The study director at the University Hospital RWTH Aachen was responsible for study conduction.