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The sponsors had no influence on the study design, data collection and analysis, decision to publish or preparation of the manuscript.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Prior to enrolment, the trial was registered in ClinicalTrials.gov (NCT02267057), and was approved by the Norwegian Medicines Agency (EudraCT 2013-002226-23) and the Regional Committee for Medical and Health Research Ethics (REC-West 2013\/1474).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the study. Verbal and written informed consent was obtained in direct conversation with all patients who were deemed to have medical decision-making capacity. If participants did not have the capacity to give consent, the participant\u2019s next of kin or legal guardian provided informed consent in accordance with ethics committee requirements and Norwegian legislation at the time of the study. We expected that patients with Mini-Mental State Examination scores\u2009\u2265\u200916 would be able to give informed consent [], but nevertheless we included the closest relatives of all patients in a discussion about consent and provided written information about the trial to ensure full transparency. To empower those patients with a reduced ability to consent, we attempted to adjust the information procedure to enable them to understand the purpose and implications of study participation. We included a verbal and written statement assuring that their decision to give consent would not affect the quality of the medical care provided to the patient. Even though informed consent had been given, all participants were free to decline drug administration and other procedures at any time during the trial, irrespective of cognitive state.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}