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An event is included in the database if it meets one or more of the following criteria: –Declaration of a state of emergency or call for international assistance.
The study was conducted according to the Declaration of Helsinki Criteria and to the procedures for compassionate drug administration approved by the Ethic Committees of Carlo Besta Institute (Milan, Italy).
The Doha Declaration clarified the criteria of national emergency to clearly include public health crises [ 6].
The study was approved by the RWTH Aachen University regional research ethics committee (Ref: EK 161/07) and met the Declaration of Helsinki criteria.
The trial was monitored by the Agency for Good Clinical Practice at the University of Copenhagen and the Declaration of Helsinki criteria were followed [ 9].
The local ethical committee approved the study, which was performed according to the Declaration of Helsinki criteria, and all patients provided their written informed consent for participation in the study.
The MIRACLE study will be performed according to the study protocol, as well as the ICH-GCP criteria, the Declaration of Helsinki, EU directives and applicable legal requirements.
23 This declaration is no validity criterion and provides no guarantee that the case definition works according to the intentions.
In cases of multi-author collaborative efforts but not in manuscripts with fewer authors open-ended authorship declaration without instructions on ICMJE criteria elicited responses from authors that were similar to responses when ICMJE criteria were explicitly required.
The study was conducted according to the criteria of the Declaration of Helsinki.
The study was carried out in accordance with the criteria of the Declaration of Helsinki.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com