Ethics approval and consent to participate
This study was approved by the Local Ethics Committee of the Interregional Clinical Diagnostic Center, Kazan, Russia (Protocol #81 of 04/24/2018). However, there was a change in the list of the study centers after that approval, and the final version of the study protocol was issued on 04/30/2018. The amendment did not deter the enrollment of the patients. All recruited subjects or their legal representatives signed written informed consent. The study methods were performed in accordance with the Declarations of Helsinki.