Composition of the data monitoring committee, its role and reporting structure {21a}
No data monitoring committee is set up for this trial. The data monitoring is done by the primary investigator and is independent of the sponsors. In Denmark, only trials approved by the Danish Medicines Agency, to investigate new drugs or changes in drugs, are mandatory to be monitored by The Regional GCP units (Good-Clinical-Pratice Units) in accordance with Danish legislation. This current trial on exercise does not involve any change in the patient's pharmacological treatment.