Saxer, Franziska http://orcid.org/0000-0003-4153-6795
Studer, Patrick
Jakob, Marcel
Suhm, Norbert
Rosenthal, Rachel
Dell-Kuster, Salome
Vach, Werner
Bless, Nicolas
Article History
Received: 27 January 2018
Accepted: 27 August 2018
First Online: 21 September 2018
Ethics approval and consent to participate
: The trial was approved by the ethics committee (Ethikkommission beider Basel, EKBB Reference No. 68/11). Since 2014 the ethics committee incorporates several cantons under the name Ethikkommission Nordweistschweiz (EKNZ). The trial followed good clinical practice (GCP) as well as the tenets of the Declaration of Helsinki. Key personnel had appropriate training in GCP. The trial has been registered with ExternalRef removed: NCT01408693 (ExternalRef removed, last accessed January 24th, 2018). The complete protocol is available as additional file.Eligible patients entered the informed consent process. Depending on their cognitive abilities (quantified using a mental status questionnaire), they were individually, or in the presence of a designated proxy, informed about the diagnosis, the proposed treatment and the randomised trial. Patients were only included by the surgeon on call if they consented in writing or – in the case of cognitive impairment – gave their verbal assent with written consent by a designated proxy according to the Swiss civil code (Art. 378) or a legal guardian.
: Not applicable.
: Rachel Rosenthal has been an employee of F. Hoffmann-La Roche Ltd. since May 01, 2014. The present study was designed before Rachel Rosenthal joined F. Hoffmann-La Roche Ltd. and has no connection to her employment by the company. Rachel Rosenthal continues to be affiliated with the University of Basel. The other authors have no conflict of interest to declare.
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