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The study will be conducted according to common guidelines for clinical trials (Declaration of Helsinki ICH-GCP, Version Seoul 2008, cf. ), including certification by an external audit according to ICH-GCP at the Institute for Medical Informatics, Biometrics and Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany.
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The study was carried out in accordance with the international standards for clinical trials, the declaration of Helsinki and the Good Clinical Practice Regulations.
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This trial followed the Declaration of Helsinki Good Clinical Practice guidelines (ICH-GCP) for trial conduct and included an external audit.
The trial complies with the Declaration of Helsinki and the trial has been approved by the Regional Ethics Committee of Southern Denmark (S-20110084).
The linked trials comply with the Declaration of Helsinki and Good Clinical Practice.
Conduct of the study adhered to standards of data collection for clinical trials, according to the Declaration of Helsinki.
Conduct of the study was in line with the standards of data collection for clinical trials, according to the Declaration of Helsinki.
All trials complied with the Declaration of Helsinki and were approved by the locally appointed ethics committee of each participating centre.
The study was conducted in accordance with the regulations governing clinical trials such as the Declaration of Helsinki and was approved by the Hospitals' Ethics Committees.
Patient's management was performed in accordance with the local standard practice and the study was conducted in accordance with the regulations governing clinical trials, such as the Declaration of Helsinki as amended in Edinburgh (2000).
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