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Article History

Received: 10 May 2017

Accepted: 3 January 2018

First Online: 15 January 2018

Ethics approval and consent to participate

: The trial will be carried out in compliance with the protocol, the principles laid down in the Declaration of Helsinki, version as of October 1996, in accordance with the ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP) and relevant BI Standard Operating Procedures. The study protocol has been reviewed and approved by the respective Institutional Review Board / Independent Ethics Committee and competent authority according to national and international regulations.Prior to patient participation in the trial, thorough study information is provided and written informed consent is obtained from each patient (or the patient’s legally accepted representative) according to ICH GCP and to the regulatory and legal requirements of the participating country. The study is registered with(registration number: NCT01243424).

: Not applicable.

: We have read and understood BMC policy on declaration of interests and declare the following interests: Odd Erik Johansen is a clinical program leader employeed by Boehringer Ingelheim, Asker, Norway. Michaela Mattheus is the responsible trial statistician at Boehringer Ingelheim, Ingelheim, Germany. Prof Bernie Zinman, Toronto, Canada and Prof Mark Espeland, Winston-Salem, US, are members of the CAROLINA® executive steering committee and receive consultancy support from Boehringer Ingelheim. Prof. dr. GJ Biessels, neurologist at the University Medical Centre Utrecht receives research support from Boehringer Ingelheim.

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