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Ethical issues were considered and authorisation for the study was granted by the appropriate authorities.
The appropriate authorisation for the study was obtained from the individual consultants in the Hospitals audited.
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These personnel will submit the administrative authorisations for the study, handle regulatory affairs, provide ethics committee contact and response, take up safety monitoring and pharmacovigilance responsibilities of the sponsor, as well as provide logistic coordination and a contact point for all the 22 participating hospitals.
KN provided clinical authorisation and support for the study.
JR provided clinical authorisation and support for the study.
The outcome was defined as a successful EU marketing authorisation within the study period (April 2000-October 2006).
Authorisation from the Norwegian Medicines Agency (Statens Legemiddelverk, SLV) was granted (Ref. no. 07/12515-8) for the study.
Surprisingly however, before we could complete the analysis of this study, the MCA issued a Marketing Authorisation for the phenothrin mousse.
Rivaroxaban and dabigatran were granted marketing authorisation for the prevention of stroke and systemic embolism in patients with AF during the study period but neither was reimbursable for this indication by the Social Insurance Institution of Finland.
Marketing authorisation for the use of BoNT-A in this context was ensured for each participating country prior to the start of the study.
The study was approved by the Ethics committee of the Hospital District of Southwest Finland and the investigators also received authorisation for the use of data from the Ministry of Social Affairs and Health.
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