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Article History

Received: 23 October 2017

Accepted: 26 March 2018

First Online: 5 April 2018

Ethics approval and consent to participate

: The study was approved and financed April 08, 2013 by the Danish Health Authority, approved by the Regional Scientific Ethical Committee October 23, 2013 of Southern Denmark (S-20130022). The original study protocol included IT facilities for direct visual communications between the patients and health professionals as part of the intervention. Due to technical problems this option never worked and was withdrawn and a protocol revision omitting this parts approved by the Danish Health Authority August 20, 2014 and the Regional Scientific Ethical Committee, September 12, 2014. The study was reported to The Danish Data Protection Agency (16/31551–2224).The trial had no separate data and safety monitoring committee; however, adverse events were monitored by the steering committee to ensure safety and non-futility. Due to a miscommunication between the investigators the study was not registered before the onset of data collection. As soon as the misunderstanding was acknowledged a retrospective registration was made on March 27, 2015 with(no. NCT02422849), shortly after the enrolment of the last patient and before any analysis had been performed.

: Not applicable.

: All authors declare that they have no competing interests.

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