Participatory Guarantee Systems: When People Want to Take Part

  Citation: Cuéllar-Padilla, M.; Haro-Pérez, I.; BegiristainZubillaga, M. Participatory Guarantee Systems: When People Want to Take Part. Sustainability 2022, 14, 3325. https://doi.org/10.3390/ su14063325 Academic Editor: Emanuele Radicetti Received: 18 January 2022 Accepted: 7 March 2022 Published: 11 March 2022 Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/). sustainability Article Participatory Guarantee Systems: When People Want to Take Part Mamen Cuéllar-Padilla 1, Isabel Haro-Pérez 1,* and Mirene Begiristain-Zubillaga 2 1Agroecology, Food Sovereignty and Commons Research Group, Sociology Unit, C5 Building, Campus Universitario Rabanales, Cordoba University, 14080 Cordoba, Spain; [email protected] 2Department of Finance Economy II, Faculty of Economics and Business, University of the Basque Country (UPV-EHU), Plaza de Oñati 1, 20018 Donostia-San Sebastián, Spain; [email protected] *Correspondence: isabel.har[email protected] Abstract: Participatory guarantee systems (PGSs) have emerged as a response to exclusion and intermediation processes involving third-party certification, which is currently the only guarantee system recognised by the European Union for organic food. Despite their unofficial recognition, PGSs are developing and generating shared frameworks of action. In this research, through three certification bodies (two public and one private) and eight PGSs in Spain, we investigate the similarities and differences between the procedures and tasks that both systems develop in order to generate trust in the decision-making structures involved and the responsibilities on which they are based. While the overall organisation of the systems is very similar, there are profound differences in their decision-making: their procedures and who participates in them. The differences we highlight lead us to argue that PGSs effectively solve the exclusion problems that third-party certification generates. Specifically, they offer lower costs and more accessible bureaucracy. They also generate and strengthen, through trust-building, the links and processes of local self-management and empowerment. However, developing PGSs demands much time and dedication, and their official regulation is complex, so it is difficult to predict that they will be widely adopted. Keywords: third-party certification; procedures; participatory governance systems; food system democratisation; alternative food networks 1. Introduction In recent years, participatory guarantee systems (PGSs) have been the subject of a growing, although still emerging, scientific output. Various articles have been published analysing them from the perspective of their operating mechanisms [ 1 – 4 ], their strengths and benefits [4–9], and their weaknesses and challenges [1,2,10–13]. Among the operating mechanisms identified are key factors such as peer review visits and collective decision-making by stakeholders for the endorsement of membership of new entrants to the system. Numerous advantages are recognised relative to third-party certification, particularly their lower costs, their simpler administration procedures—which make the mechanisms better adapted to small-scale production— and the aspects of their procedures that generate articulation, empower small producers and strengthen the local social fabric. Two of the weaknesses identified are the complexity of their collective procedures and their diversity and heterogeneity. Another is the difficulty of making members participate in the manner required, as is also the case in other collective initiatives related to alternative agri-food systems [ 14 ]. The literature also often highlights problems such as the reliability of these mechanisms and their lack of profile in many countries. Sustainability 2022,14, 3325. https://doi.org/10.3390/su14063325 https://www.mdpi.com/journal/sustainability Sustainability 2022,14, 3325 2 of 18 This literature also reflects the criticisms directed at third-party certification [4,9,15–18] . One of the widely identified issues is the costs and paperwork associated with this mechanism, which make it difficult for small producers to join. Others are its underlying exam logic (pass or fail), its inefficiency in identifying fraud, the lack of differential treatment between agribusiness and small producers and the intermediation logic reflected in this procedure. The literature on PGSs is also closely linked to that on alternative food networks [ 19 , 20 ] and the political dimension of agroecology [ 21 , 22 ]. The literature also recognises in particular that the movements generated through the PGSs offer still wider benefits. They strengthen both networks and agroecological political coherence and comprise both producers and consumers willing to play a role in revolutionising food systems, aiming to create a future of organic food which is more ambitious than the current organic certification system [23]. In most cases, PGSs are presented as necessary and interesting alternatives to thirdparty certification, proposed as a response to its limits in contexts such as small farm holdings, marginalised territories, situations of food insecurity, and difficulty of access to markets [ 1 , 9 , 11 ]. Since PGSs pre-date third-party certification, however, it is clear they did not arise as an alternative to the latter. While the official regulations which drove third-party certification towards organic production emerged at the end of the 1980s and the early 1990s, the first systematised and internationally recognised PGSs started functioning in the 1970s [24]. One central differentiating element between the two systems is the procedures through which a guarantee is established. These cover the mechanisms, activities and decisionmaking processes that each system advocates in order to generate confidence. The PGS’s participatory is said both to avoid most of the limits and weaknesses of third-party certification and to offer an alternative to farmers at risk of exclusion from the third-party certification system. But what are the procedural differences between third-party certification systems and PGSs? And what does the participation approach imply for farmers and other actors involved in PGSs? Is it just an issue of size or socioeconomic profile, simply farmers preferring one system over another? The aim of this study is to make a rigorous comparison between the procedures developed by third-party certification systems, based on Regulation 834/2007 and the Standard UNE-EN-ISO/IEC 17065, and the mechanisms developed by PGSs based on the experiences of the relevant bodies and people in Spain. We aim to evaluate how both systems build trust (the type and design of procedures) and to discuss a hypothesis that follows from two research questions. The questions are: 1. What are the similarities and differences between the procedures of third-party certification systems and those of PGSs? 2. What requirements should a group of producers be aware of before becoming involved in a PGSs, bearing in mind its participatory approach? The hypothesis is twofold, as follows: (i) The benefits of the alternative to third-party certification offered by PGSs range wider than simply the problems of exclusion created by third-party certification, including particularly to small and medium-sized entities and in contexts of difficult access to markets). (ii) A PGS may offer an alternative proposal, but it calls for specific requirements and procedures from its potential members, so it might not be a valid option for every producer looking for a guarantee system. 2. Context and Methods PGSs have been developing in Spain since 2004 when they emerged in the south following a policy initiative by the Andalusian government [ 25 ]. In 2015, the first meeting of PGSs in Spain was organised, in which 8 PGSs participated. Since then, three more meetings have taken place, as shown in Table 1. Sustainability 2022,14, 3325 3 of 18 Table 1. PGSs meetings in Spain organised since 2015. Year Place PGSs Participating 2015 Valencia A Gavela, Pontevedra//Basherri Sarea, Guipúzcoa Ecollaures, Valencia//EcoRed, Aragón FACPE Ecovalle, Andalucía//Red Agroecológica de Cádiz SPG Xarxa Llauradora +Bo//Vecinos Campesinos, Murcia 2016 Vigo A Gavela, Pontevedra//ASAP Castilla y León Ecollaures, Valencia//EcoRed, Aragón Ecovalle, Granada//Red Agroecológica de Cádiz SAES, Madrid//Vecinos Campesinos, Murcia 2017 Madrid A Gavela, Pontevedra//ASAP Castilla y León Ecollaures, Valencia//Ecomercado de Córdoba Ecored, Aragón//EhKolektiboa, Euskalerria FACPE El Encinar, Andalucía//Mosaics de Vida, Castellón Red Agroecológica de Cádiz//SAES Madrid Vecinos Campesinos, Murcia 2018 Granada Asociación Como de Graná: eSPiGa//Ecollaures, Valencia EhKolektiboa, Euskalerria//El Encinar, FACPE, Granada La Ortiga, FACPE, Sevilla//Mercado da Terra, Lugo Mosaics de Vida, Castellón//Nature et Progrès PGSs team IFOAM//Red Agroecológica de Cádiz SAES Madrid//SPG Alpujarra y Costa granadina Vecinos Campesinos, Murcia Source: Compiled by the authors. The official certification system in Spain does not recognise these initiatives: its guarantees come from private or public bodies that, depending on the region, develop the certification. For example, in Andalusia, a private system was established in 2002. There are currently 11 private certification bodies operating in the whole area, while elsewhere, a public organic certification committee is responsible for building consumer confidence in the organic sector. Two regions are exceptions, where they have established a hybrid system in which both private companies and a public committee can certify. The research for the present paper included the compilation and systematisation of the procedures implemented in Spain by three third-party certification bodies (two public and one private) and 8 PGSs, all of which have been operating for more than five years and have participated in at least one of the meetings organised since 2015 (shown in Table 2). Table 2. Cases included in the research. Type of Guarantee System Code * Nature or Region Year Activity Began Third-party TP1 Public 2008 TP2 Public 2007 TP3 Private. Andalusia and Castile-La Mancha 2002 PGSs PGS1 Region of Valencia 2012 PGS2 Community of Madrid 2014 PGS3 Granada and Almeria 2010 PGS4 Seville and Cadiz 2011 PGS5 Sanlúcar de Barrameda, Cadiz 2012 PGS6 Murcia and Alicante 2011 PGS7 Basque Country 2014 PGS8 Galicia 2011 Source: Compiled by the authors. * A code is assigned to every case studied in order to guarantee confidentiality. Sustainability 2022,14, 3325 4 of 18 For all case studies, we carried out an extensive bibliographic review of existing documentation on the guarantee systems, such as internal regulations, operating manuals and protocols on procedures, documents, and reports. In addition, the websites and blogs of the case studies were reviewed. Key informants in every case study were contacted for access to this documentation. Ongoing communication was established to clarify concepts, documents, formats and structures, and details about procedures not described in the documents. The case study research methodology is qualitative; it involves the investigation of a real-life situation which, because of its critical analysis, can provide enough insight to generate a theoretical sample from which conclusions can be drawn [26]. Its validity does not lie in a probabilistic sample for the generalisation of results but in the development of a theory that can be transferred to other cases. For this reason, some authors prefer to talk about transferability rather than generalisation in qualitative research [ 27 , 28 ]. Case studies allow us to describe the real context, evaluate results, explore situations and even explain some causal relationships that are too complex for research strategies carried out using surveys or experiments. In addition, triangulation—using multiple sources of evidence— was achieved by a review of the relevant scientific literature and by analysis of the actions taken in the meetings mentioned above and during the research process, as shown in Supplementary Materials Table S1. Once an initial review of the different procedures had been completed, we compiled a table of variables using OpenOffice Calc software to facilitate the organisation of all the data, and we encoded the information provided by the case studies, following these variables and using the Atlas.ti 9 software. In the codification process, when inputting the information for the different thirdparty and PGSs procedures, we identified weaknesses and improvements that needed addressing in the original codex table. A group discussion of the exercise, which included members from some of the PGSs studied, resulted in a final table and codex model. Here, the procedures and tasks of the PGSs and third-party certification bodies were entered and organised into three types of procedures and 17 types of tasks (shown in Table 3). Due to a lack of official regulation of PGSs, there is no universal umbrella framework covering all PGSs, so they do not all share the same procedures. A methodological decision was therefore taken to assume that a procedure forms part of the framework of a PGS if it is shared by at least 5 out of the 8 PGSs studied. In contrast, third-party certification bodies do have an umbrella framework that guides the development of their activities. The documents used are the Standard UNE-EN-ISO/IEC 17065, which establishes how third-party certification bodies must work, and the information provided by the certification entities detailed in Supplementary Material Table S1 . In this case, despite our attempts to access this type of documentation from other private certification bodies, only one existing enterprise operating in Andalusia agreed to provide such documents. The other informants said that it could not be provided because it was confidential information about its internal affairs, despite the research group offering to sign a confidentiality contract. However, due to the common official regulation framework, and after the similarities between the three certification bodies results obtained, we can affirm that the data systematized are consistent. In Figure 1, a general schema of the methodological process explained above is presented. The information organised in the above table guided us in our discussions on the main similarities and differences between the confidence-building schema proposed by PGSs and that established by the European regulation, and on the requirements, specific developments and procedures required in both systems. Sustainability 2022,14, 3325 5 of 18 Table 3. Procedures and tasks systematised to organise the information. Procedure Tasks Explanation Entry Procedure Initial Contact and Entry Procedure First steps: a request for admission by the producer; the request and receipt of the documentation required and payment of the fee. Commitment declaration Declaration of commitment signed by the new producer stating that they are familiar with the rules of the system and how to manage the farm/plots/initiative in line with these rules. Self-evaluation Form to be filled in by the new producer, about the project’s management and design. Audit/Initial visit The first visit to the new farm/initiative. A visit checklist is completed during the visit, and a visit report is prepared soon afterwards. Soil, water or plant samples are taken when necessary. Transition period for integration into the PGS The time that must elapse before an entity can use the label varies with the system, from direct entry to 3 years, depending on various factors. Decision and communication of the entry of the applicant When and how the decision is taken on the final acceptance of a new producer. Follow-up and Trust-Building Procedure Audit/Follow-up visit Audits, or follow-up visits to farms every one or two years. A visit checklist is completed during the visit and a visit/inspection report is prepared soon afterwards. Analytics Soil, water or plant samples are taken when suspicion or doubt is raised and when high or medium risk levels are detected. They are also taken randomly. Evaluation of visits Assessment and evaluation of the visit/inspection report. Membership renewal decision Decision taken on the renewal of the authorisation of the use of the label/full membership of the initiative. Improvement recommendations are made in the case of PGSs. When the decision is unfavourable, sanctions are applied. Confirmation of compliance Document valid for one year in which the farmer guarantees compliance with the norms established. Field notebook Document that farmers must fill in detailing all the practices and activities carried out on the farm. Organisation General assemblies Meeting to be attended by all members where the main procedures of the system are discussed and decisions are taken. This is usually annually, twice a year or by request from the different working groups Working groups Spaces for participation and decision-making on sectoral or thematic issues. Their composition and tasks are defined by the general assembly, and outputs are passed on to, and reviewed by, the general assembly. Visiting groups Task associated with participating in the visits carried out on the farms every year: organising and completing the visit, completing the visit checklist and writing the visit report. Fees Annual amount of money producers must pay to take part in the system. Source: Compiled by the authors. Sustainability 2022,14, 3325 6 of 18 Figure 1. Diagram of the methodological procedure followed. 3. Results By identifying the case studies and the variables they incorporate, our results begin to highlight mechanisms shared by all the PGSs analysed (even though each one has been developed by different people in a different context and without an official framework), and other mechanisms implemented only by some of the PGS. One issue highlighted by the study is the difficulty in accessing documentation from private certification bodies, drawing attention to the non-transparency of these entities. The other main results obtained in the research are presented in the following order: a. those related to the design of the general procedure of both PGSs and third-party certification; b. the actors involved in the procedures and tasks of both systems; c. the PGSs’ governance system and the third-party certification system established to organise and execute their respective procedures and tasks. 3.1. The General Design of the Procedures in Both Systems The two guarantee systems both have two main procedures. The first is the building of confidence around a new producer who wants to be part of the guarantee system for the first time. The second is a follow-up and trust-building, i.e., how the system bolsters the guarantee for the producers over time. Every procedure contains several tasks, which may or may not be included in the guarantee systems studied. Table 4shows whether the official certification (known as third-party certification) includes and carries out such tasks and the number of the PGSs analysed that undertake each specific task. In the entry procedure for both guarantee systems, a mechanism is established that allows new producers to make initial contact and request entry. Both systems then follow up with an initial visit and ask the new producer to sign a letter of commitment acknowledging the principles and standards of the guarantee system to be upheld. An important distinction of third-party certification is that it always establishes a self-evaluation document for the person/company to be certified in addition to setting the transition/conversion period, clearly defined by the legislation, which is a period during which the producer is audited and monitored but cannot yet use the accredited quality label. This conversion period may be made shorter than that dictated by the regulations and is fixed by the certification body itself according to its evaluation of the supporting arguments submitted. In contrast, in PGSs, the self-evaluation document is not widely used and nor is the period of transition between the first visit to an initiative and its effective entry. However, this varies between cases. Just over half establish a transition period, while the rest assume that if the initial visit is positive, the producer is now a full member of the PGS. In some cases, this is because, in order to access the initiative, it is necessary to have Sustainability 2022,14, 3325 7 of 18 the official seal (the farmer must already be certified by a third-party entity). In those PGSs that do establish a transition period, it ranges from 6 months to 1 year. Table 4. Tasks carried out by the different guarantee systems studied. Procedure Task Number PGS Third-Party (Yes or No) Entry Procedure Initial Contact and Entry Procedure 8 Yes Commitment declaration 7 Yes Self-evaluation 2 Yes Audit/Initial visit 8 Yes Transition period/PGS integration 4 Yes Decision and communication on the entry of the applicant 8 Yes Follow-up and Trust-Building Procedure Audits/Follow up visits 8 Yes Analytics 5 Yes Visits evaluation 8 Yes Renewal decision 8 Yes Confirmation of compliance 5 Yes Field notebook 0 Yes Source: Compiled by the authors. With regard to the endorsement follow-up, once the producer or farm is registered and authorised in the initiative, both types of scheme (PGSs and third-party certification) establish similar activities in all cases studied: visits to the farms, evaluation of these visits and decision-making about whether or not to renew the guarantee. Both third-party certification and PGSs set regular visits, which are evaluated using a visit checklist, which is considered in detail before a final decision is made on whether to renew the registration. Third-party certification establishes analytics as a regular monitoring mechanism, and this is also the case for most, but not all, PGSs. It is worth noting that PGSs do not require a field record book to be kept (which is called a field notebook in third-party procedures). Another important issue concerns the documents used by each system. The third-party system requires more documentation of different types and the use of a different language than that of PGSs. The third-party certification uses the language of public administration and administrative processes, written by technical staff based on the legal system it operates in. The PGSs’ documents are developed by people on the ground, the producers and, in some cases, the consumers. This results in them being more accessible and understandable to non-technical people. 3.2. Actors Involved in the Procedures and Tasks of Both Systems Although the frameworks presented above for the procedures of both systems are not dissimilar, it is useful to collect and analyze the results of how the process of each activity in each system is developed. This information is shown in the following figures (Figures 2and 3) and in the additional information in Supplementary Materials Tables S2 and S3. It is important to highlight, first, the differences in the dialogue conducted with the person seeking the guarantee. Third-party systems establish technical contact through their offices and websites, while PGSs function through direct contact between the applicant and one or more members of the initiative, in most cases other producers, or through a commission or the general assembly. Some PGSs have established a Sponsor, who is always a producer, to help the new producer throughout the entry procedure. The new producer is, therefore, offered support from another producer in the first months of working with the PGSs. Sustainability 2022,14, 3325 8 of 18 Figure 2. Development of the entry procedure in third-party certification and PGSs. The second key differentiating factor is how they deal with the initial visit. In PGSs, the visit is a peer-review visit carried out by various members of the initiative, with other producers always present and, on occasions, consumers and/or people with a technical background. A minimum of two producers participate in each visit, with at least one from the same sector as the applicant. The only exception to this is when the applicant producer belongs to a sector that is new to the PGS. In all cases studied, the people who participate in the visits are from the same geographical area as the applicant. This is quite different from third-party certification, where the visit is carried out by a single person with a technical background, and this same person usually covers several geographical areas. The third important difference between the two systems is in how the final decision is made on whether or not to accept the new applicant. In PGSs, this decision is taken collectively by members of the initiative. This is a group of individuals, on occasion the general assembly itself, which can be attended by producers who did not participate in the visit and by other members of the initiative such as consumers or technical support personnel. In all cases studied, these are people from the same geographical and social context as the person being evaluated. In the case of third-party certification, this is decided by the appropriate body of the organisation, made up of one or several people who did not take part in the visit, all with a technical background. Many of the differences identified in the entry procedure also apply to the endorsement follow-up and ongoing trust-building procedure, as shown in Figure 3(additional information in Supplementary Materials Table S3). Sustainability 2022,14, 3325 9 of 18 Figure 3. Development of the follow-up and trust-building procedure in third-party certification and PGSs. While in both systems the basic guarantee procedure is built around three events (the visit, the evaluation of the visit, and the decision on whether or not the producer/farm visited receives the endorsement), the two systems carry out these tasks in very different ways. In the case of ongoing visits, the differences are similar to those noted in initial visits. In PGSs, they are undertaken by other producers and, where appropriate, consumers or technical staff from the initiative. Members of the initiative are committed to participating in a minimum number of visits per year, or being a member of the visiting group for a whole year, on a rotation basis. In other words, everyone who is visited will, in turn, carry out visits accompanied by other people since visits are collective in all cases. In contrast, third-party certification systems are restricted by law from acting in an advisory role, and the technical person who carries out the visit does so purely as an auditor. The second screening used by both systems is the evaluation of the visit report. In PGSs, this is also a peer review and includes other producers and consumers or people with a technical background who were not present during the visit. On occasions, the people who did visit the farm, and the producer being assessed, offer relevant explanations and clarifications to those who did not attend. In third-party certification, this second screening may be based on the work of a certification commission, whose membership is not made clear in the documentation that is reviewed and in some cases by a different technical person in the same company. In other words, the screening is completed by one Sustainability 2022,14, 3325 16 of 18 The issue that particularly concerns us is the way in which the European organic regulations seem to discourage and even penalise self-management processes, even though they are in the minority and create high-quality socially innovative processes (which are not openly acknowledged). The lack of support from European public policies towards sustainable agri-food systems is reflected in the lack of policy integration, as identified by many academics (Cf. [46]). However, we also acknowledge the risks of proposing official recognition for, and the instrumentalisation of, systems that require a willingness to actively participate and convictions of a collective nature and seek to build responses through complex local social processes. PGSs represent profoundly democratic food governance systems and are not, therefore, systems applicable to every context or social group; however, much external support is provided, as they would likely lose the collective identity and self-management which they have so far enjoyed, at least in Spain. The results of this study suggest that PGSs are not a response to third-party certification but a social construct with their identity rooted in their internal diversity and which respond to a political vision different from that of third-party systems. While PGSs engage in dialogue with third-party systems, they involve social innovations of such magnitude that they could only really be developed with a grassroots political approach. With this approach, the mechanisms developed, and the underlying rationale behind them would be closely linked. In addition, the lack of wider awareness of PGSs and their position on the fringe of official status leads to unverified statements from stakeholders in the organic sector suggesting that, because they are non-regulated (their heterogeneity of proposals, each one doing what they want to), their trustworthiness is lower. Thus, the PGSs’ starting point is the demand for recognition of their fundamental links with the political dimension of agroecology. For this reason, it may also be inappropriate to use an ‘instruction manual approach’ to establishing PGSs in contexts open to the idea out of necessity—impoverished producers, small farmers, difficulty accessing the market—since the dedication required in terms of both time and convictions may not be feasible. Our analysis leads us to conclude that the governance model of PGSs, unlike thirdparty certification systems, favours collaboration among stakeholders for the construction and development of the system itself and of more solid Alternative Food Networks (AFNs). In this model, all the following factors become relevant: the decentralisation of decision-making, an orientation towards community links, an organisational structure that emphasises participation and commitment, the development of shared interests and responsibilities, the ability to interact with a variety of central stakeholders in the food system (e.g., consumers, technical staff, activist groups and social movements), and communication between them in terms of coordination and trust. Lastly, taking into account the costs of both systems and the service-provision logic of third-party certification, it must be said that the latter favours neither the productive diversity inherent in the agroecological vision nor moves towards economic cooperation. Therefore, the logic which recognises economic interdependence must be emphasised. It is reflected in the conceptualisation of PGSs’ fees, based on mutual care and resilience and on the inclusion of productive projects and the local community, rather than on penalising diversity. Taking into account the evidence presented on the differences and procedural particularities of guarantee systems by third parties and the PGSs, we consider that PGSs can solve some exclusion problems created by third-party certification. Moreover, they generate locally adapted individual and collective processes in each territory. Thus, given their collective and participatory nature, they are not homogenisable, and they are applicable only in certain contexts or productive projects. Sustainability 2022,14, 3325 17 of 18 Supplementary Materials: The following supporting information can be downloaded at: https: //www.mdpi.com/article/10.3390/su14063325/s1, Table S1. Documentation consulted in each case study and communication with key informants; Table S2. Development of tasks in the entry procedure of both guarantee systems, and the agents responsible; Table S3. Development of tasks in the follow-up procedure of both guarantee systems, and the agents responsible Author Contributions: Conceptualization, methodology, and formal analysis M.C.-P. and I.H.-P.; investigation and writing—review and editing, M.C.-P., I.H.-P. and M.B.-Z.; visualisation, project administration, funding acquisition, M.C.-P. and I.H.-P.; supervision M.C.-P. All authors have read and agreed to the published version of the manuscript. Funding: This research was funded by ERDF/Ministry of Science, Innovation and Universities – Spanish Research Agency / Project reference: CSO2017-85660-R. Institutional Review Board Statement: Not applicable. Informed Consent Statement: Informed consent was obtained from all subjects involved in the study. Data Availability Statement: Not applicable. Conflicts of Interest: The authors declare no conflict of interest. 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