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The study was conducted in accordance with principles of good clinical practice and the Declaration of Helsinki, and received ethics approval in the United Kingdom from the Multicentre Research Ethics Committee for Scotland A, in New Zealand from the Multi-region Ethics Committee and from local research ethics committees applicable to each participating centre.
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The clinical protocol, consent forms, CRFs, and other supporting documents were approved prior to initiation of the study by the ethics committees and applicable scientific review boards at the University of Maryland School of Medicine, and the committees overseeing each site and their collaborating partners from other institutions.
The name of the ethics committee: not applicable.
The president, following prior countersignature of the prime minister, appoints and recalls diplomatic representatives of the Republic of Croatia, at the proposal of the Government and upon receiving the opinion of an applicable committee of the parliament.
An approval from an ethics committee was not applicable because the data are anonymous.
The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice Guidelines, ethical committee approval and applicable local laws and regulations.
It is to be noted that this study did not involve any experimental research on humans or animals, hence an approval from an ethics committee was not applicable in this regard.
Written consent for the trial was given by all applicable ethics committees.
Additional file 1: List of participating study sites and applicable ethics committees.
Ethics approval was provided by the ethics review boards of the coordinating investigators (co-authors FB and JG) in France and Germany (Comité de Protection des Personnes, AP-HP St-Antoine Hospital, Paris and the ethics committee of Regensburg University, respectively) and by all applicable local ethics committees.
This retrospective study was initiated by the Nordic Headache Innovators (NHI) network and was approved by the Regional Committee for Ethics in Medical Research in Norway, the Norwegian Data Inspectorate and the Regional Ethics committee in Stockholm, Sweden when applicable.
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