key: cord-0073088-mpr3l0jm authors: Grynchak, Alla A.; Tavolzhanska, Yuliia S.; Grynchak, Serhii V.; Smorodynskyi, Viktor S.; Latysh, Kateryna V. title: Convention for the Protection of Human Rights and Fundamental Freedoms as a Constitutional Instrument of European Public Order date: 2022-01-07 journal: Public Organiz Rev DOI: 10.1007/s11115-021-00583-9 sha: f224a6c57a56481a805ad2fb90da452996483b06 doc_id: 73088 cord_uid: mpr3l0jm Convention for the Protection of Human Rights and Fundamental Freedoms simultaneously complements the content of European public order, introducing human rights as a new component and providing two powerful mechanisms for implementing and guaranteeing this order, namely the Convention and a judicial body - the ECtHR. The results obtained allow us to formulate new concepts of unification of terms and approaches to the public order in Europe, which will integrate this region even more into the common legal space and provide the protection of human rights and freedoms at a new, higher level. When the common legal system of the newly established European Union (EU) was formed in the 1950s, it brought to the forefront the question of creating an act that would unify the disparate approaches to the notion of public order as the basis of the social order of states and legal families. The main role was played by the EU constituent acts, which created the basis for the coexistence of the peoples of a united Europe. However, one special sphere still required additional, more specialized regulation, which would include its specific object -namely, human rights (Ovcharenko et al., 2020) . This mission was realized by another European organization -the Council of Europe (CoE). They adopted the fundamental act in this area -the Convention for the Protection of Human Rights and Fundamental Freedoms, 1950 (hereinafter -ECHR, the Convention) . Like the Universal Declaration of Human Rights of 1948, adopted at the universal level within the UN, the analyzed European document has become a truly effective tool, which today significantly and directly affects the wide range of relations of almost five dozen European countries, and indirectly -much more (Vapniarchuk et al., 2019) . However, it was only the beginning of its path, which, in our opinion, was ended after the adoption of 16 additional Protocols to the Convention the last one has not entered into force yet -author's note, including the provision on inclusion EU to the system of the States Parties to the Convention. Today, we can consider the ECHR as a full catalog of fundamental human rights, with its further extension by adding new rights. Further closer implementation of the provisions of the Convention was its recognition as a part of the national systems of many European countries. The question arises: can the Convention be a certain constitutional instrument of European public order? To answer this question, we need to undertake an analysis of the components of this statement. If this formula contains common denominators, the above thesis that the ECHR is a constitutional instrument of European public order will prove true. So, one can say that we deal with a new document, which influences European public order by dictating rules in the sphere of human rights. The research analysis on the subject has shown that different authors unveiled numerous facets of the ECHR, which influenced the inside systems of the States Parties. This involves the following: the influence of the interpretation of the Convention on an unlimited number of persons and related responsibilities of states (Arnardóttir, 2017) ; the study of the relationship and influence of European public order on the creation of a common European legal policy (Kessedjian, 2007) ; conducting a scientific discussion on the hundredth mention of the notion of "European public order" in the decisions of the ECtHR (Dzehtsiarou, 2016) ; conferences covering the application (export) of the ECHR's public order outside Europe, namely the Convention as the applicable law in peacekeeping missions (Exporting the ECHR public policy outside Europe, 2020). This brief analysis only partly shows the variety of the Convention possibilities and breaks new grounds for research. We used such methods during the research: theoretical (analysis; synthesis; concretization; generalization; method of analogies); empirical (the study of other countries' experience, court systems, and regulations); historical development. The main method of this research is the method of analysis of regulations based on the Convention for the Protection of Human Rights and Fundamental Freedoms, 1950 , and case-law of the European Court of Human Rights, which has become an important factor in implementing the idea of the ECHR's importance as a new, additional foundation of European public order (Tsypko et al., 2019) . The authors analyzed the introduction of the Convention in the domestic legislation by the method of analogies, namely the study of the process of origin and supplement of the legal systems of European countries with new content of fundamental norms of public order. Having studied the experience of the Council of Europe and its member states, we can summarize that the Convention for the Protection of Human Rights and Fundamental Freedoms is a part of the domestic law of the State Parties. In the biggest part of European countries, norms of the Convention are recognized as being directly applicable in the domestic legal system. The exceptions are the United Kingdom and Ireland. The importance of constitutional provisions complicates the question of the priority of conventional norms over national ones (Breuer, 2017) . Therefore, when applying the Convention and the decisions of the ECtHR, it is not least important for national legislatures and courts to understand the concept of general principles of law, legal standards in the field of human rights protection. A common understanding of the essence and concept of the ECHR guarantees the same approaches to create national concepts of public order, which, at the present stage of social development, undoubtedly includes the notion of "fundamental human and civil rights and freedoms." The Convention has a fundamental significance since it guarantees a certain level of the legal basis for the states' existence at the level of constitutional laws. And at the present stage, we can say that the Convention already acts as a constitutional instrument of European public order. This statement is proved by the decisions of the ECtHR, which indicate that the Convention plays a role of a "constitutional instrument of European public order" in the sphere of human rights (Guide on Article 15 of the Convention, 2020). In the case G.I.E.M. S.R.L. and others v. Italy, the ECtHR took things a step further and stated in the para. 79: "The time of constitutional parochialism in Europe is over. In the age of multilevel constitutionalism, the Convention is a 'constitutional instrument of European public order.' … prevails over the constitutional provisions and interests of the Contracting Parties … and in all other member States of the Council of Europe." It continues (para. 93) that "the Constitutional Court must pay attention to the to the value of the Convention as a constitutional instrument of European public order and the unique authoritative role of the Court in the legal landscape of Europe" (G.I.E.M. S.R.L. and others v. Italy, 2018). In another judgment, the ECtHR compared the power of the Convention and international obligations of the state, figuring out in the hierarchy of these acts. In the case Avotiņš v. Latvia, it was mentioned (para. 103), that "a State will be fully responsible under the Convention for all acts falling outside its strict international legal obligations, particularly where it has exercised State discretion … In such cases, the interest of international cooperation would outweigh the role of the Convention as a 'constitutional instrument of European public order' in the field of human rights" (Avotiņš v. Latvia, 2016) . The ECtHR also emphasized in the case Hutchinson v. The United Kingdom (para. 45) that the domestic authorities must respect the "final word" of the ECHR judicial body, which is entrusted with the uniform maintenance of the "constitutional instrument of European public order," when the domestic level of human rights protection is lower than that of the Court (Hutchinson v. The United Kingdom, 2017). Accordingly, the Court highlighted few important points again, which have to be applied to all member States of the Council of Europe, their administrative and judicial authorities: a) the ECHR became a certain constitutional instrument; it already exists and is not denied; b) it is an instrument of European public order; c) the ECtHR guards and examines at various levels the relationship between the new concept "ECHR as constitutional instrument" and national law, as well as its competition with rules of international law. The relationship between the ECHR and the domestic law can be regarded within implementing the Convention's provisions and specifically its influence on national law through, in a broad sense, adapting existing norms and controlling over new ones until their adoption in compliance with the Convention's provisions. It is important to understand that the Convention does not contain rules on its textual reproduction in national legal systems. Therefore, the authors speak about different models of implementation of the Convention's provisions in the national legislation of European countries. Now we can talk about two of them. The first model is transformational. It is followed, in particular, by Germany. Another is the reception model. The latter is recognized, in particular, by France, the Czech Republic, Slovakia, Romania, and Poland. However, in the legal systems of these countries, the Convention, having priority over national laws, still gives way to the legal force of the national Constitution. Amendments to national legislation and law enforcement practices to bring them into line with the Convention are, in fact, improvements by human rights mechanisms. Examples include (European Convention on Human Rights. A living instrument. (2020)): Cyprus abolished the criminal prosecution for homosexual relations between consenting adults; Denmark abolished the obligatory membership of a union; France recognized the equality of succession rights between legitimate children and children born out of wedlock; Switzerland legitimated wiretapping. The Convention's impact on national law lies in its provisions that are a source of law even in the countries of the classical Romano-Germanic legal family, including Ukraine, which relatively recently ratified the ECHR as a precondition for accession to the Council of Europe and recognized the Convention and the case-law of the Court as a source of law (On Ratification of the Convention for the Protection of Human Rights and Fundamental Freedoms, 1997, Article 17 of the Law of Ukraine On the Implementation of Decisions and Application of the Case Law of the European Court of Human Rights (2006)). The authors agree with O.V. Butkevich that the development of modern international legal practice moves toward recognizing the ECHR and its decisions as a source of national law. In the legal practice of many states, the decisions of judicial agencies a particular country is a member of are included in the list of sources of the national legal system. At the same time, domestic law enforcement agencies extremely rarely pay due attention to the general standards, principles, frameworks of human rights protection contained in such decisions (Butkevich, 2017) . Indeed, the problem resides rather in the actual application of the Convention's provisions or the ECtHR case-law than their recognition as a source of law (although this is certainly important). Any problem can be prevented. Ukraine's lack of understanding is evidenced by the fact that the country is among the top three "leaders" in the number of appeals to the ECtHR. The specific number of complaints from Ukrainians concerns non-compliance with court decisions (Konstantinova, 2020) . In this part, we should mention the ECtHR decision in Burmych v. Ukraine (on prolonged non-enforcement of decisions of Ukrainian courts), by which the Court referred more than 12,000 cases to the Committee of Ministers of the Council of Europe. The ECtHR reasoned this by the fact that Ukraine has done nothing to solve the problem since the pilot decision in the case of Yuriy Ivanov (no. 40450/04, 15 October 2009). The number of complaints to the ECtHR has only increased (Protsenko, 2017; Case of Burmich and Others v. Ukraine, 2017). It is important to understand the Convention and its implementation mechanisms are so significant now that the ECHR indirectly affects the legal reality of even non-European states. In particular, the European Convention became an example for developing of the American Convention on Human Rights and the African Charter on Human and Peoples' Rights. The place of the norm in the hierarchy depends on the authority, which has issued it. The ECHR is undoubtedly a fundamental international treaty, which importance and impact on the whole continent are no longer in doubt. This is the reason the researchers believe its provisions take precedence over all internal acts. At the same time, European countries have differently resolved the question about the place of the Convention in the system of national legal sources The Netherlands recognized norms of the Convention higher than constitutional ones, while Austria equalized them (Kostyuchenko et al., 2019) . In most European countries, the norms of the Convention prevail over national norms but are not higher than the constitutional ones (in particular, Belgium, Spain, Portugal, France, Switzerland). Norms of the Convention are on a level with national norms in such countries as the United Kingdom, Italy, Germany, and Turkey. In Germany, although the conventional norms are equated with national, the former ones are the mandatory standard of interpretation of the rights enshrined in the national Constitution (Breuer, 2017) . Article 9 of the Constitution of Ukraine states international treaties in force, approved by the Verkhovna Rada of Ukraine as binding, are a part of the national legislation of Ukraine (Constitution of Ukraine, 1996) . Under the preamble of the Law of Ukraine On the Implementation of Decisions and Application of the Case Law of the European Court of Human Rights, this law regulates the relations arising from both the state's obligations to comply with the Court's decisions in the cases versus Ukraine and the need to eliminate the reasons for Ukraine to violate the Convention's provisions (On the implementation of decisions and application of the case law of the European Court of Human Rights, 2006) . Article 17 of this law states that courts apply the Convention and the case law of the ECtHR as a source of law (On the implementation of decisions and application of the case law of the European Court of Human Rights, 2006) . Thus, the Convention is a part of the national legislation and a source of law in Ukraine, together with the case law of the ECtHR on its application. Since the Convention does not provide for any exact approach to use its norms, volumes of the introduction of the Convention into effect through national law are completely different in various countries in Europe (Drzemczewski, 1983) . In most European countries, the norms of the Convention apply "directly" and take precedence over domestic norms. It is enshrined in national laws that the ECHR and the case law of the ECtHR are the sources of law that have direct application. In particular, in Belgium, France, the Netherlands, and Switzerland, the Convention's provisions that are not incorporated into the legislation of these States directly affect national law and take precedence over non-compliant provisions of national law. The direct effect of the ECHR provisions is not new for EU member states. Approaches to the direct effect of EU acts, which are an inevitable component of EU membership, have played an independent role in this. The direct effect of the ECHR is "obvious" to European countries. The subject of the ECHR regulation is the protection of the fundamental rights and freedoms of the individual, which implies in itself the direct effect of the Convention's provisions. Indeed, the guarantee of the rights provided for in the Convention is quite real without any further action by the authorities of the States Parties. Thus, these rights can be considered as directly applicable. Two fundamental provisions determine the primacy of the norms of the European Convention over the provisions of national law that contradict it. The first one states the rights and freedoms protected by the Convention are fundamental. Secondly, the Preamble to the European Convention emphasizes one of the main objectives of the Council of Europe is achieving unity between the Member States, and the European Court as a monitoring mechanism directs its activities to achieve the above objective. The recent history of the European continent has shown that a human has remained the highest value of the modern world despite changes in politics, state, forms of government, economic development, etc. Therefore, there can be no dependence of the fundamental principle of protection of human rights and freedoms on the current political situation in the country (Case of Loizidou v. Turkey, 1995 The legal category of "public order" is quite common in the context of national and international law of many countries. In the broadest sense, it means public relations that are imperative and determine the foundations of the social order of a state. Mentions and definitions of public order can be found in the legislation of Ukraine Nowadays, public order (as well as its definition as "ordre public" in France, "öffentliche Ordnung" in Germany, "offentlig orden" in the Netherlands, "ordine publico" in Italy, "ordino publico" in Spain, etc.) is a necessary component of the legal order of any state. However, the problem is that the legislation of states uses such phrases as "good customs," "public safety," "foundations of social order," "legal foundations" instead of a clear definition of this notion and its essence. Such phrases are rather vague, predominantly of moral and political connotation, and subjective in their perception. Therefore, the administrative and judicial authorities can hardly use them objectively and accurately in real law enforcement situations. The authors believe the study of V. Kisil (2001) represents a thorough analysis of the notion of public order through the prism of private international law. European scholars have also paid attention to this research subject. In particular, K. Kessedjian (2007) revealed whether the public order of member states could prevent the formation of European law and order. Lavenex and Wagner (2007) and A. Orakhelashvili (2003) note that the ECHR is considered to embody elements of European public order and analyze them in the context of the international public order. Thus, we can conclude that "public order" belongs to the category of domestic law by its origin. European public order may be a separate notion. At the same time, the issue of European public order is seen as a traditional perception and an institution of private international law (Pillet, 1890; Mayer, 1994) . The analysis of public order often takes place simultaneously from the standpoint of law of the Council of Europe and the EU (Picheral, 1999) . According to Mr. Dzehtsiarou, the European public order is a set of common norms and principles for the European space, which, given their fundamental nature, form the basis of European society (Dzehtsiarou, 2015) . Therefore, there are two main trends: the first presupposes to approach this issue only in terms of EU law, limiting to its member states. In our opinion, the best is the approach that considers this issue from the standpoint of the CoE law. This second approach is more vital given the following facts: a) More member states (47 in the CoE versus 27 in the EU), and therefore a wider coverage of European countries and their citizens on a geographical rather than a political basis; b) Adoption of the ECHR within the Council of Europe and its binding nature for all member states of the Council of Europe, which resulted in a single joint act governing "public relations that are imperative and determine the foundations of social order"; c) Recognition of the EU as a party to the ECHR at the level of individual states. In addition, aspects of public order are guaranteed through the enshrinement of common European standards on a wide range of human rights and freedoms in the legal acts of the Council of Europe. Ensuring the unity of approaches across the continent has undoubtedly influenced developing a common European public order. Logical questions arise -what place does the ECHR take in the system of European public order? Is it mandatory for the whole European continent and even more? In their research, almost all scholars note the binding nature of the Convention, which is guaranteed by close integration into the structure of the Council of Europe and represents an extremely effective mechanism for institutional implementation and protection of the Convention's provisions. This refers to the well-known European Court of Human Rights. The binding nature of the Convention and the practice of its application by the ECtHR follows from the international obligations undertaken by States in ratifying the ECHR and its Protocols. European countries recognize the conventional provisions and the Court's decisions as sources of law, consideration of which is obligatory in law enforcement. This approach is probably common to all member states of the CoE, with certain features of their historical and legal culture. The ECHR inevitably affects the public policy of states that have ratified its provisions. At the same time, the citizens of the member states of the Council of Europe are confident they will be protected by the provisions of this Convention regardless of the state. This means the requirements for the national legislation of all member states under the Convention's provisions are the same regardless of the legal system and legal family. And these requirements are namely the protection of human rights and fundamental freedoms. Nowadays, any civilized country or scholar does not dispute the binding nature of the Convention, given its nature and significance, the universality of norms for human rights protection, and the establishment of the public order system. The priority of its provisions is recognized by the national governments of many States parties to the Convention. On the European continent, the exception is the Republic of Belarus and the Russian Federation, which defend the idea that the Constitution and national legislation take precedence over the international one (Telekhov, 2021 , The law to themselves, 2020 . This approach is unique, but it confirms the imperial ambitions of the Russian Federation and its disrespect for the citizens to some extent, depriving them of the right to protection and denying European public order in the context of fundamental rights and freedoms. The formation of the European legal space has a characteristic feature -its basic and substantive core are humanitarian and legal norms, while the Statute of the Council of Europe and the ECHR -its organizational and legal framework and system-forming acts. It is now safe to say that European relations have marked a fundamentally new approach to assessing the "human dimension" at the regional level as a decisive factor in determining the deep meaning, the essence of integration and cooperation in Europe. The European Convention is distinctive as it aims to establish certain international norms that the states must observe in their relations with citizens who are under their jurisdiction. The European Convention attempts to organize the legal community around the values enshrined in this conventional document, and thus it organizes a genuine public order common to European democracies. The report by the International Law Commission, "Fragmentation of international law: difficulties arising from the diversification and expansion of international law" (2006) mentions the conception of erga omnes obligation is characterized by "legal indivisibility" of the content of the obligation, unlike jus coges, which typical aspect is the importance of interest protected by norms. It means that this norm provides obligations, which simultaneously have obligatory power for every person in relation to all others. International legal obligations erga omnes partes exist within some groups of states, aiming to protect their collective interests. In this regard, any state of the collective legal regime can hold accountable (Lauterpacht, 1950) . The Convention introduces collective guarantees of human rights (preamble). Any State Parties to the Convention may call on compliance with the Convention, regardless of whether it is a victim of the offending State. The ECtHR plays a key role in the provision of collective interests, which administrates both interstate and individual complaints. This is the revolutionary nature of the Convention. The Convention not only proclaims rights but also creates an effective mechanism for their protection by establishing an equal opportunity for both the individual and the state to appeal violations of the Convention (Lyubchenko, 2018). It is worth noting that Hersch Lauterpacht (Lauterpacht, 1950) emphasized the need for international recognition and protection of human rights in his scientific heritage. His ideas formed the basis of the first draft of the International Bill (Universal Declaration) of Rights and later the European Convention. Individual statements concerning public health issues are examples of applications toward security support of European public order. During the Covid-19 pandemic, the latter is especially true. Thus, as of April 8, 2021, the ECHR held to vaccinate children, having formulated the general European consensus on this issue (Case of Vavřička and others v. The Czech Republic, 2021) . The court referred to social solidarity as the basis for making vaccination against diseases well-known to medical science compulsory. The Court also has noted the recent change in the policy of European states, aimed to establish stricter control over the vaccination due to a decrease in voluntary vaccination and, as a consequence, a decrease in herd immunity. Obviously, the Court's legal reasoning reflects the collective interest in protecting European public order. Among the interstate disputes, the decisions on which promote European public order, we should mention cases related to armed conflicts (Case of Cyprus v. Turkey, 2001; Case of Cyprus v. Turkey, 2014, etc) . The literature highlights that ECHR is an agreement for human rights, which binds the states over erga omnes partes obligation and individuals over direct rights (Šturma, 2020) . The last one was proved by the practice of ECtHR, and also by the fact of the use of these decisions even by the sates that weren't party to the exact case. This fact imposes on states an additional obligation to analyze the relevant decisions and translate them for the study by national law enforcement agencies and citizens. It will increase the level of their legal education and opportunities to protect their rights. We believe erga omnes partes binds the parties to the Convention not only to comply with its provisions but also actively conduct law-making aimed at adopting new legislation based on the Convention and the ECtHR decisions. Erga omnes partes also represents the obligation for constant review of existing legislation to eliminate inconsistencies. Over the years, the ECtHR has undergone a period of transformation and maturation, additional protocols filled in "gaps" that were not taken into account at the time of adoption. At the same time, the case law of the ECtHR also responds to changes in the life of the European community, showing the adaptation of its decisions to new challenges. Moreover, the ECtHR itself calls the Convention a living instrument, noting that "the Court's dynamic and modern interpretation of the Convention gives it strength and makes it extremely relevant. By its case-law the Court has extended the rights set out in the Convention so that its provisions apply today to situations that were totally unforeseeable and unimaginable at the time it was first adopted, including issues related to new technologies, bioethics or the environment" (European Convention on Human Rights. Live instrument, 2020) . Clear examples of living interpretation are heightened standards for protection against torture. Over the years of application of Art. 3 of the Convention, the ECtHR lowered the severity for consequences of torture while leaving the upper limits of such an act unchanged (Tavolzhanska et al., 2020) . The CoE also drew an analogy with living beings, noting that "the Convention is a living instrument that has repeatedly demonstrated its ability to adapt to new challenges over human rights in such areas as respect for privacy, protection of personal data, and biomedicine. This adaptability will play a key role in helping the continent to meet new human rights challenges" (70 years of the European Convention on Human Rights, 2020). Initially, the doctrine of a "living instrument" was developed by the members of the European Commission of Human Rights (hereinafter -the Commission). The Commission was studying the factual circumstances of the case Tyrer v. the United Kingdom (1978) . The ECtHR used a new approach developed by the Commission to interpret the Convention practically regarding the corporal punishment of an underage. Until this case hearing, the "vast majority" of member states of the CoE had not imposed corporal punishment through legal proceedings. Moreover, "some of them have never applied corporal punishment in modern times," since it no longer conforms to the principles and values of European society. The Court referred to the development of generally recognized standards of the penitentiary policy of the member states of the CoE, having indicated on an objective need to take these changes into account. Additional protocols to the ECHR also point to its "living" nature, supplementing it with new content and rights under the extension of the generally recognized catalog of human rights (especially the prohibition of the death penalty in the twentieth century). These protocols also supplement the Convention with judicial reforms, given the recent revolutionary development of society and relations. For example, the reduction of application deadlines from 6 to 4 months corresponds to the modern fast pace of society. However, there is a deeper sense: the earlier the case is considered, the sooner thousands of other similar situations can be prevented. As of April 15, 2021, Italy has ratified Protocol No. 15, which means that it will enter into force on August 1, 2021. On February 1, 2022, the deadlines one can appeal to the ECtHR against a final national decision will be reduced from six to four months. The adoption of Protocol No. 16, which gave the ECtHR the right to provide advisory opinions on the interpretation and application of the Convention's provisions, also supports living interpretation. The further development of European law and the formation of a single European legal space requires the de facto recognition at the level of national public orders that the ECHR is a constitutional instrument of European public order. This will start the process of approximation of national public orders to each other. The ultimate goal of this should be to forum such constitutional norms that would have the same meaning in any national order in Europe. The key for the development of national legal doctrines and legislation may become a new understanding of the Convention as a constitutional instrument of European public order, which opens new horizons for theoretical research and practical training of judicial and administrative branches of government. Constitutional and legal research plays a crucial role here, which should consider the European trends and the emergence of a document, almost equal in force with the basic law. Moreover, law theorists should add a new complete international document to the list of the sources of national public order. Its interpretation is annually amplified by the decisions of an international judicial body. We can say that we deal with a new universal source of law, which has already gone beyond the geographical boundaries of its action and annually introduces new legal categories that may, on the one hand, indirectly limit the sovereignty of the state, but on the other hand, provide additional protection and guarantees to a wider circle of persons. The only significant remark is that the extension of such a catalog of rights and the addition of new concepts can significantly complicate the understanding of these rights, as well as reduce business and other activity for fear of violating any probable rules, knowledge of which is not always available due to their extended catalog. The results obtained can be used in the educational process by students and teaching staff, further scientific studies, and new theoretical developments, especially to amplify the term "public order" and form its unique regional understanding. This article may also entail reviewing the content of the notion of public order defined in national acts. In this process, there is an important aspect of the fundamental, constitutional nature of ECHR, revealed in the case law of the ECtHR. At the same time, the results obtained may be useful for working lawyers to deeper understand the Convention and fundamental human rights and apply the approach of universalization to the application of the ECHR in an unlimited circle of public relations. Data Availability Data will be available on request. The authors declare they have no financial and competing interests. Ethical Approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. 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