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All information will be stored in anonymous and non-identifiable formats and each of the studies will commence only after obtaining ethical approval from competent ethics committees.
Waiver of the informed consent is a rare occurrence, which must always be provided by the competent ethics committee (EC).
All clinical studies have been approved by the competent ethics committees.
The competent ethics committees of all participating centres approved the protocol, as required by applicable national legislation.
The study protocols were approved by the competent ethics committees (Berlin: EA4/113/07, EA4/029/11; Halle: 2012-95).
The clinical study as well as the translational research project described here were approved by the competent ethics committees.
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The study was approved by the competent local Ethics Committees, and written informed consent was obtained from all individuals.
International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities.
Where required and before the start of the study, notification and/or approval of the protocol was also obtained from the relevant local competent authorities, ethics committees and/or institutional review boards in each country.
It was conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki and was approved by all the concerned Competent Authorities and Ethics Committees.
The study was approved by the institutional review board of each participating centre or the competent authority and ethics committee.
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