Ethics
HPE
POLAND
The study was conducted in accordance with the Declaration of Helsinki, all applicable local and state regulations, and International Council for Harmonisation guidelines. The protocol, amendments to the protocol, and the informed consent form were reviewed and approved by institutional review boards at each study site prior to initiation of the study. Ethical approval for the eight study sites in Poland was provided by the Bioethics Committee at the Medical University in Lublin, Lublin, Poland. For the two study sites in the Russian Federation, ethical approval was provided by the Ethics Committee at State Budgetary Educational Institution of Higher Professional Education (SBEI HPE), Ryazan State Medical University named after academician I.P. Pavlov, Ministry of Public Health of the Russian Federation, Ryazan, Russian Federation or the Ethics Committee at SBEI HPE, Saint-Petersburg State Pediatric Medical University, Ministry of Healthcare of the Russian Federation, St Petersburg, Russian Federation.Informed consent was obtained from all participants, and a written consent form was signed by the participant and/or their legal representative in their native language prior to study participation. A Data Safety Monitoring Board (DSMB) provided oversight.