Institutional Review Board Statement
MAY, -20
The study protocol was approved by the State Medicines Control Agency and Lithuanian Bioethics Committee (protocol code ICO, 16 April 2019, No. P-19-12 and date of approval 31 May 2019), and was registered on ClinicalTrials.gov on 24 July 2019 (No. NCT04030546) and on EudraCT on 27 January 2019 (No. 2019-000661-20).