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Verbal and written information regarding informed consent will be presented to the caregivers and\/or patients. Any modifications to the protocol that may affect the conduct of the study will be presented to the committee. The trial was registered with ClinicaTrials.gov (NCT02797249) prior to the inclusion of the first patient. All important changes to the protocol will be implemented in the trial registration. All participants will provide written informed content, and the ethics committee has approved the procedures. The full protocol will be available freely owing to the open access nature of the publication. The findings of this RCT will be submitted to a peer-reviewed journal. Abstracts will be submitted to relevant national and international conferences. The standards delineated in the guidelines of the Consolidated Standards of Reporting Trials will be followed in this RCT. All investigators will have access to the final trial dataset. We plan to communicate the trial results to the participants, healthcare professionals, policy makers, the funding agencies, the public and other relevant groups via conferences, publications and\/or other data-sharing arrangements.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"608"}}