Adherence to ethical norms
ICH
COMPLICATIONS
The research corresponds to international principles and standards of biomedical ethics: International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organization of Medical Sciences, Rules of ethical principles for scientific medical research with human participants”, approved by the Declaration of Helsinki (1964-2013), ICH GCP principles (1996), Council Directive 609 (of 24.11.1986), the Convention on Human Rights of the Council of Europe.Only patients who signed a voluntary informed consent form to participate in this study were enrolled. The participants received complete answers to all the raised questions. The focus was on interpreting treatment methods, their advantages and disadvantages, consequences, potential complications, etc. The patients were aware that they had the right to withdraw at any stage of the study. The patient was provided with copy of a signed informed consent form to participate in the study. The Ethical Committee of the Medical University Pleven, Bulgaria reviewed and approved the study design (protocol 117-a dated 12/16/2016).