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Article History

Received: 20 February 2020

Accepted: 24 May 2020

First Online: 10 June 2020

Ethics approval and consent to participate

: The local ethics board at the Hospital Privado Universitario (CIEIS) approved the current version (version 1) of the protocol February 11, 2019. The regional ethics board approved the study protocol May 27, 2019.All outpatients will be assessed for inclusion. If none of the pre-allocation exclusion criteria are met, a member of the research team will provide both oral and written information before allocation (). All patients will be given sufficient time to ask questions and to decide whether to participate in the study. Patients are informed of their right to withdraw from the study at any time. A patient who withdraws consent receives standard care. In addition, the patient/participant may be permanently withdrawn at the treating physician’s or the investigator’s discretion at any time if this is considered to be in the patient’s best interest. A record is kept of patients who consented in the pre-enrolment screening but were never enrolled (patient allocation log).

: Neither the current study protocol nor a future publication will contain any individual person’s data in any form.

: CMÖ has worked as a consultant and received speakers’ honoraria from the Baxter Healthcare Corporation. KB is currently pursuing a master thesis project in collaboration with Gambro Lundia AB (part of Baxter Healthcare Corporation).