Ethics approval and consent to participate
-11
The study was performed in accordance with the principles of Good Clinical Practice and 2013 Declaration of Helsinki. The study protocol was approved by the Scientific Council of Almazov National Medical Research Centre on 23.12.2011 (protocol №11), and later the updated version of the protocol was approved in 2018 by the Local Ethics Committee of Almazov National Medical Research Centre (protocol №2018-12-11). All patients signed informed consent before the enrollment in the study.