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Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
CONSORT-diagram. Patients enrolled to cohort-1 (prior to the trial amendment) are depicted in blue, patients enrolled in cohort-2 (after the trial amendment) are depicted in orange.