© 2014 Giarelli G.
Summary: The problem of integration of alternative and complementary medicine (CAM) with biomedicine in contemporary health care systems has been quite debated during the last few years. We can identify two main models of strategic integration: the market-driven integration typical of the American health care system and the state-driven integration proper of the European, Canadian, and Australian health care systems. Whereas in the first model the medical-industrial complex (health insurances, private health care facilities, pharmaceuticals and health technologies industry) is the leading actor playing a substantive role in a demand-led process of integration where the market rationale is affecting all the other social actors involved (professions, citizens, researchers and the state), in the second case it is the state which plays a fundamental role in advancing the process that some scholars call of ‘mainstreaming’ of alternative medicine, with some contradictions.
In the Italian case, in fact, this role appear somewhat unclear, since it is strongly conditioned by the medical profession and its vested interests: since many years, a bill on regulation of alternative medicines is still on discussion in the Parliamentary Health Commission and its approval appears quite far away. In this national regulatory vacuum, some Regional Health Authorities (Piedmont, Lombardy, Campania, Emilia-Romagna, Umbria and Tuscany) within the National Health Service (NHS) have started taking different measures in order to integrate some non-conventional medicines (in particular, homeopathy, herbal therapy and acupuncture) within their regional health systems, sometimes conflicting with the central government. Finally, the situation appears further complicated by the fact that, even though medical pluralism is not formally implemented in the Italian National Health Service yet, according to more recent surveys a growing number of citizens choose to treat themselves using some kind of non-conventional medicine. On the whole, the Italian case show a high degree of ambivalence between chances of an actual pluralistic integration and risks of co-optation of weakened forms of non-conventional medicines within the formal health care system.
A preliminary problem of definitions
When a certain social phenomenon is variously defined by different scholars and social actors involved in various international contexts, this means that we are in the presence of a complex and ambiguous phenomenon, whose boundaries and contents are probably quite blurred and undefined. It is certainly the case of the object of this paper, whose preliminary problem is how to define it. In fact, the first issue is how we can term what we suppose should be integrated with conventional biomedicine within a health care system: “natural medicines”, “sweet medicines”, “holistic medicines”, “traditional medicines”, “non-scientific medicines”, “complementary and alternative medicines” are the most commonly used definitions we can find. However, each of these labels has got some kind of drawback that makes it inappropriate. “Natural” or “sweet medicines” sounds quite naïve, considering that these definitions imply the absence of any iatrogenic collateral effect compared with biomedical drugs, which is certainly not true, especially for phytotherapy. “Holistic medicines” appears inadequate for two reasons: not all of them are actually holistic (consider the increasingly widespread selling of homeopathic drugs in conventional pharmacies), and at least some recent new branches of biomedicine also aspire to be considered holistic, such as psychosomatic medicine, systemic medicine, bio-psycho-social medicine, and psycho-neuro-endocrine-immunology. “Traditional medicines” is the label used by the World Health Organization (WHO, 2002) in deference to the longstanding traditions where such forms of medicine – as it the case of Ayurveda in India or of Chinese Medicine – represent an integral part of the cultural and medical heritage: but this is not true in the Western context, for example, where biomedicine is the indigenous form of medicine and the term “traditional medicine” is often used interchangeably with it. Moreover, “non-scientific medicines” appears a derogatory expression towards any form of medicine different from biomedicine, ethnocentrically assumed to be the only possible type of scientific medicine. Finally, “Complementary and Alternative Medicine” (CAM) is the locution proposed by the consensus conference held at the Office of Alternative Medicine * of the National Institutes of Health in Bethesda (USA) in 1997 and then adopted by the Cochrane Collaboration: it is currently the most widespread definition, at least in the anglophone countries, and it refers to ‘a broad domain of healing resources that encompass all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period‘ (NIH Panel on Definition and Description, 1997: 50). However, even this descriptive definition cannot be considered satisfactory, since it is implicitly evaluative as it underlies a distinction between those first-choice treatments considered negatively outside mainstream, unsupported by scientific and legal legitimization (alternative), and those second-choice or associated therapies which play just a subordinate role with reference to biomedicine (complementary).
For all the above reasons, at least in the Italian context we prefer to use the expression “Non-Conventional Medicines” (NCM) which was officially adopted by the National Federation of the Provincial Colleges of Physicians and Dentists (FNOMCeO, 2002), and then also approved in the Consensus Document of the Coordination Committee composed by most of the Italian medical associations of non-conventional practitioners in Bologna (Roberti di Sarsina, 2005); but it was also adopted by the European Parliament (Resolution n.75/1997) and by the Council of Europe (Resolution n. 1206/1999). There are at least three epistemological reasons supporting this choice. Firstly, it is as little laden as possible with both positive and negative ideological connotations, and is hence more scientifically neutral. Secondly, it has the merit of marking the conventional nature of official orthodox medicine and its historical path to legitimacy. Thirdly, it defines in a dynamic and relativistic way those medicines different from biomedicine whose identity can at present be defined in opposition to conventional medicine only: but these medicine currently excluded from official healthcare organizations or medical faculties teaching can become fully part of the conventional medicine in the near future. Moreover, we argue that it is necessary to keep the label “non conventional medicines” in plural form, since the polymorphous and different nature of these medicine makes impossible to trace any unity in their nature and identity if not in opposition to conventional orthodox biomedicine.
But non-conventional medicines is not simply a synonymous of integrated medicine. Therefore, a second issue of definition we should consider refers to how we define the process and the outcome of the integration between non-conventional medicines and biomedicine: in fact, two main definitions were developed since the historical conference organized by the Royal College of Physicians and the US NCCAM in London on 23-24 January 2001, which can be considered the official date of birth at the international level of what we are discussing. Two quite significant definitions which were apparently considered as synonymous, but if properly decoded reveal a lot of underlying discrepancies. In fact, on one side, ‘integrated medicine’ is the preferred definition in the UK and Europe, which refers to ‘practicing medicine in a way that selectively incorporates elements of complementary and alternative medicine into comprehensive treatment plans alongside solidly orthodox methods of diagnosis and treatment’ (Rees and Weil, 2001:119). On the other side, “integrative medicine” is, instead, the referred definition mainly in the USA and Australia, ‘its focus being on health and healing rather than disease and treatment. It views patients as whole people with minds and spirits as well as bodies and includes these dimensions into diagnosis and treatment. It also involves patients and doctors working to maintain health by paying attention to lifestyles factors such as diet, exercise, quality of rest and sleep, and the nature of relationship’ (Ibid.).
Evidently, the two definitions are not overlapping, and they have a lot of implications in terms of political, organizational, and epistemological contents. The political issue they imply consists in the type of legitimacy given to non- conventional medicines within the framework of the healthcare system from the widespread starting point of marginality, exclusion and illegitimacy which was dominant until a few years ago in most countries: just a subordinate inclusion within still substantially monopolistic biomedical systems which have become more tolerant or a full recognition on equal and autonomous terms within legitimized comprehensive and integrated systems? The second issue regards the organizational arrangements which translate in operational terms the previous political issue: in fact, the subordinate inclusion is usually operationalized in the healthcare services in terms of the conventional hierarchical medical division of labour, meaning that the non-conventional practitioners are just allowed to work under the wings of the medical profession, more or less what already happened in the past to nursing and other health professions aspiring to full professionalization (the “paramedical” model). On the other side, the full recognition means the establishment of multidisciplinary teams working according to a functional division of labour and horizontal power relationships, as historically it happened to the pharmacists and the dentists (the “allied professions” model). Finally, the third issue refers to the epistemological differences of the respective paradigms on which biomedicine and non-conventional medicine are based: undoubtedly, most of the non-conventional medicines are based on a more holistic and comprehensive paradigm than the Cartesian, mechanistic and reductionist paradigm dualistically separating mind and body on which biomedicine is grounded. It is not simply a matter of scientific versus non scientific knowledge, but of different kinds of science and medicine. Refusing to consider this fundamental epistemic difference threatens to trivialize the process of integration, wasting the chance for a dialogue between different visions and medical cultures which can only benefit the future of healthcare. However, trying to answers all the above three issues brings us well beyond the problem of definitions and therefore we need to address the complex international debate about the different models of integration.
An international overview: two main models of integration
There is at present an abundant international literature on the problem of integration of non-conventional medicines with biomedicine, an issue at the forefront of current thinking about the future organization of healthcare in post-industrial societies. Various classifications of possible modes of implementation of the integration process have been made: “horizontal” vs. “vertical” delivery, “parallel” vs. “team oriented” delivery, from “parallel” to “integrative” healthcare, etc. (Boon and Verhoef, 2004; Hollenberg, 2006; Shuval 2012). However, most of the scholars agree on a dichotomic classification of the modes of integration: it can be defined as “syncretic combination” versus a “selective incorporation”.
The first model consists of a syncretic combination of the most effective elements of both biomedicine and non-conventional medicines on the basis of both scientific evidence and experience-based evidence. It corresponds to what in the USA we have seen it is called “integrative” medicine, but there are some example of this approach in Europe, such as the Birkenholm Centre in Denmark (Launso, 1989) and the Marylebone Health Centre in London (Peters et al., 2002); and in Australia, the Shellharbour Hospital (Templeman and Robinson, 2011). In USA there are already many examples of this kind of approach: both in the hospital setting, such as the integrative, patient-centred clinical practice implemented by the Department of Family Medicine at the University of Michigan (Myklebust et al. 2008), the Health and Healing Clinic at the California Pacific Medical Center (Scherwitz et al. 2003), the North Hawaii Community Hospital (Fass, 2001), the Service for Integrative Medicine of the Memorial Sloan-Kettering Cancer Center (Cassileth et al., 2005), and the Center for Integrative Medicine of the University of Maryland School of Medicine (Berman, 2001); and in the primary care setting, such as the Complementary Health care Plans of the Oregon (Brinkley and Simpson, 2001), the Center for Comprehensive Care of Seattle and the East-West Health Center of Denver (Giarelli, 2005: 114-6), the Multicenter Lifestyle Demonstration Project, better known as Ornish Program (Ornish, 1998), the Akron General Health and Wellness Center at the Summit County of Houston (Jahnke, 2001).
However, the most significant case exemplifying this model is certainly the University of Arizona Center for Integrative Medicine founded and directed by Andrew Weil since the late 1990s. As he himself explains, the philosophy underlying this Center is that,
‘Integrative medicine does try to incorporate the best CAM ideas and practices into comprehensive treatment plans, but it has more important goals than the simple substitution, say, of herbs for pharmaceutical drugs.
Above all, integrative medicine seeks to work with the body’s natural potential for healing. It assumes that the organism has an array of mechanisms to maintain health and promote healing and that the aim of treatment should be to unblock or activate or enhance those mechanisms. In practice, it pays attention not only to the physical bodies of patients but also to their minds and emotions and their spiritual lives. It looks at their total lifestyles in order to suggest changes in routines that might favour healing, and it exhorts physicians to model healthy lifestyles for their patients. It also emphasizes the centrality of the doctor/patient relationship in the healing process’ (Weil, 2003: xiii).
Therefore, according to this model integrative medicine implies a healing orientation that does not simply equal curing, since it emphasizes the centrality of the doctor-patient relationship on the basis of a series of principles elaborated in a working document of the Center (Maizes, Rakel and Niemiec, 2009: 6-8):
• Patient and practitioner are partners in the healing process, and care is based on this continuous healing relationship informed by scientific knowledge and implemented through a partnership that recognizes the uniqueness of each person;
• All factors that influence health, wellness, and disease are taken into consideration, including mind, body, spirit, and community, as well as body;
• Appropriate use of both conventional and alternative methods facilitates the body’s innate healing response by nutrition, activity, mind-body medicine, etc.;
• Effective interventions that are natural and less invasive should be used whenever possible: integrative medicine orders therapies ranking first those that have the greatest potential for benefit with the least potential for harm;
• Good medicine is based on good science, it is inquiry-driven and open to new paradigms: practical and pragmatic research models that evaluate systems of care and investigate the interaction of multiple health influences are needed, considering all the limitations of the conventional randomized control trials (RCTs);
• Ultimately the patient must decide how to proceed with treatment based on values, beliefs, and available evidence: integrative medicine honors the individual’s right to choose a healing path for her/him;
• Alongside the concept of treatment, the broader concepts of health promotion and prevention of illness are paramount, with an emphasis on supporting balance, maintaining health and promoting longevity;
• Practitioners of integrative medicine should exemplify its principles and commit themselves to self-exploration and self-development, pursuing self-reflection as a “heal the healer” approach that is the most effective method of empowering professional to develop an understanding of the self-healing mechanisms.
The actual implementation of all these principles requires a profound change of the conventional clinical work and approach to disease, starting with the anamnesis, the physical examination of the body and the diagnosis, which become part of a more comprehensive ‘integrative assessment’ including, for example, not only patient’s medical history but also one’s family, occupational and social history, lifestyles, stress and coping strategies, and spiritual life (Rakel, 2003: 11-6). Even the conventional individual practitioner become part of a health-oriented multi/interdisciplinary team including different types of specialists delivering both conventional and non conventional therapies. Therefore, it is really a broader paradigm of medicine and a new vision of healthcare what is emerging from this model, even though the question which remains open is to what extent and in which way all the above principles are actually implemented in reality. For example, a study on integrative medicine settings in Canada (Hollenberg, 2007) found that concepts like “collaboration”, “synergism”, “trust”, “respect” and “inter-/transdisciplinary practice” commonly used in these settings were then rarely effectively actualized.
One main problem is that this model was driven, at least initially, by consumer demand and even though is now increasing being accepted by health professionals and institutions, it remains mainly market-driven: in fact, it is directly the patient who selects her/his own providers, and may or may not inform her/his conventional providers of one another. This means that the decision to start and continue an integrative programme is highly subject to market trends and also depends on managerial skills and planning visions: for example, many of the integrative clinics opened during the 1990s closed after two-three years despite high patient demand because of poor financial performance (55%), reprioritized hospital initiatives (40%), lack of community interest (35%), inability to break even (30%), lack of medical staff support (30%), and general cut to considered non-essential programmes (25) (Ananth, 2008). Moreover, another main problem is that this model is increasingly attracting major corporate interests throughout the USA (Collyer, 2004), with a strong risk of corporatisation and commercialisation of the integrative practices: once the medical-industrial complex (health insurances, private health care facilities, pharmaceuticals and health technologies industry) have realized that the costs of non-conventional therapies are generally cheaper than conventional biomedical drugs and surgeries, they have started showing a steadily increasing interest in their development and inclusion within the official health plans.
The second model of integration consists instead in the selective incorporation of exclusively evidence-based non-conventional medicines into conventional biomedicine. Given the steadily extensive public use of non-conventional products and practices – even because in the USA they are not subject to the same strict control and evaluation procedures by the Food and Drug Administration (FDA) followed for biomedical drugs – on one side, and the paucity of knowledge about the safety and efficacy of most non-conventional treatment combined with an often poor communication between patients and physicians about this use on the other side, an actual situation of risk for harm exists from these treatments, as the WHO also suggests (WHO, 2004). Even though many non-conventional practices, such as acupuncture, homeopathy, and meditation, are inherently relatively low-risk treatments, if they are used by unskilled practitioners or in place of more effective treatments, adverse consequences may results.
This is the reason why this approach is mainly oriented towards defining the role of the physician as patient advocacy and protection from harmful practices by facilitating informed choice. Particularly, the framework the physician should follow is the “four P approach”, namely (Chez et al. 1999:34):
• Protect patients against dangerous practices.
• Permit practices that are harmless and may assist in comfort or palliation.
• Promote and use those practices that are proven safe and effective.
• Partner with patients by communicating with them about the use of specific non-conventional therapies and products.
Patients need to be especially cautious about products and practices that can produce direct adverse effects from toxicity or unintended effects from interactions with biomedicine (e.g., herbal remedies and megavitamins supplements), and the conventional physician can help patients distinguish them, and make sure they do not abandon effective care for practices that rely on secret formulas, promise cures for multiple unrelated conditions by slick advertising on internet and mass media. Actually safe and effective non-conventional treatments are considered, according to this approach, only those medicines which have undergone controlled trial demonstrations of the same type utilized by Evidence-Based Medicine (EBM) for biomedicine: by searching the published medical literature, the physician can play a central role in assisting the patient to determine the value of available evidences for non-conventional treatments and their applicability for her/his condition. Finally, the physician has a responsibility to fill the major communication gap with the patient about non-conventional medicines use by asking the patient about her/his use and working with her/him to assure that it be done safely.
In this model of selective incorporation the role of the general practitioner (GP) is thus central as a primary contact practitioner and as filter and gatekeeper, with eventual subsequent referral (or approval of patient’s referral) to other non-conventional providers: and the GP remains also responsible for diagnosis, monitoring and coordination of health care and treatment plans for the patients. Even though this model has received the official support of the National institute of Medicines (Jonas and Levin, 1999), it appears less common and difficult to implement in the privatized and mostly deregulated US health care market; whereas it has found significant diffusion in Europe, especially in Sweden (Sundenberg et al., 2007) and Germany (Linde et al., 1996), and in Canada (Scherwitz et al. 2004) and Australia (Australian Government Department of Health and Aging, 2004), where the state often plays a significant role.
The main problems with this model are the possible loss of essentials features of the non-conventional medicines and the spread of a reductive version of them as a consequence of the selective and evaluative process adopted (Bodeker and Chaudury, 2001); and the kind of power relationships and interprofessional dynamics in terms of equitable/inequitable partnership this model entails between GPs and non-conventional practitioners ((Templeman and Robinson, 2011).
The Italian case: diffusion and regulation of non-conventional medicines
According to the most recent national survey (ISTAT, 2014), 8,2% of the Italian population (4.9 millions people) use non-conventional medicines: by a comparison with the previous surveys of 2000 and 2005, the trend shows a clear sharp decline from 15,5% in 2000 (about 9 millions people) to 13.6% (about 8 millions people) in 2005 to the present value, which is evidently negatively influenced by the rough economic crisis. In fact, the typical Italian user of these kind of medicines has been identified as an adult aged between 35 and 44 years, with a high level of education (post-high school), mainly female, with a middle-high social status and living in the most affluent Northern regions of Italy (Giarelli, 2007: 57-87). The most used NCM in Italy are homeopathy, herbal remedies, acupuncture, anthroposophic medicine and chiropractic.
In term of perceived efficacy, according to the above enquiries most users consider worth these treatments, admitting they have gained amelioration or healing without any side effect. Since the economic burden of these drugs and practices lies almost always completely on the shoulders of the families because the Italian National Health Service in most case does not cover these expenses, this is another important indicator of families’ attitudes towards NCM.
The number of NCM practitioners is on the increase, especially among general practitioners: ‘in Italy today there are almost 3,000 medical doctors using acupuncture, more than 8,00 homeopaths, about 20,000 medical doctors with homeopathic training and approximately 160 medical doctors who have completed the three-years residential course on anthroposophic medicine’ (Roberti di Sarsina and Iseppato, 2009: 1-2). This means that many physicians (and also veterinaries, dentists and pharmacists) have moved from previous position of opposition or silent “wait and watch” to one of interest and, sometimes, of direct practice. Moreover, in Italy we have almost 30 companies producing homeopathic remedies, and the amount of Italian homeopathic market is about € 300 millions per year. Contextually, the concern for an appropriate training for NCM providers and for drugs safety and consumers appropriate information has increased consistently (Cuzzolin and Benoni, 2009).
The last importance actor of the healthcare system beyond patients, practitioners and health care industry, namely the State, appears till recently significantly absent. In fact, in spite of many attempts during the last twenty-five years to pass a law in the Parliament acknowledging and regulating the practice of NCM, no such law has yet been approved. In this situation of legislative gap by the State, however, other public institutions such as the Supreme Court of Justice (Suprema Corte di Cassazione) have taken action by ensuring that the individual is free to choose treatments, and that the medical provider is professionally qualified with regard to the choice of treatment. This situation of “dual freedom” by the individual’s choice of treatment and the physician’s choice of medical approach is consistent with the Italian Constitution, even though the Italian National Health Service (NHS) currently does not provide any cover for NCM. Since the responsibility for healthcare is shared by the State with the twenty Regions – whereas the State sets appropriateness healthcare standards applied throughout the country, named LEA (Livelli Essenziali di Assistenza), the Regions have the responsibility to organize and manage the health care system and facilities, and can add at their own expenses additional LEA. This is the reason why some Regions such as Tuscany and Emilia-Romagna, beyond including a section on NCM within their regional health plans, have also approved regional laws guaranteeing additional LEA regarding the chance of utilization of homeopathy, acupuncture and Traditional Chinese Medicine, phytotherapy, and manual medicines within their own public healthcare services (Tacchino e Tanzi, 2006).
Since the lack of a national law regulating NCM, even other Italian Regions have implemented some kind of measure in this sector. Campania Region (Neaples), e.g., allocated some funds for research and traning on NCM by the Local Health Authorities of the region; in Lombardy Region (Milan), a WHO Collaborating Centre for Traditional Medicine (one out of the five existing in the world) was established in 1997 at the University of Milan with the support of the regional government; and in Piedmont Region (Turin) the first regional reference centre for acupuncture and the scientific coordination for NCM was established in 2008 by Piedmont Region. Even in Emilia-Romagna Region, since 2004 a Regional Observatory for NCM (of which the author is a member) was established and charged with the aim of setting up and promoting scientific research and evaluation programmes of NCM (focusing particularly on homeopathy, acupuncture and phytotherapy) within the regional healthcare services in collaboration with health practitioners, especially physicians. Finally, the Umbria Region defined special tariffs and specific access pathways for physicians practicing NCM, whose training it also regulated.
Some Regions, such as Piedmont, even attempted to supplement lack of national regulation on NCM by the State by approving regional laws recognising new health professional profiles concerning NCM: however, these regional laws were abrogated by the Constitutional Court who established that the regional governments cannot pass laws on the recognition of professionals or establishment of new registers because this matters are reserved to the State.
Even private actors such as medical practitioners have taken action. The Supreme Court of Justice in recent years has ruled repeatedly that it is an abuse of the medical profession for anyone to practice NCM if they have not attained a degree in Medicine, since the practice of medicine (implying diagnosis and treatment prescription) is reserved in Italy to medical doctors only. Given the fact that, e.g., even an homeopathic diagnosis or an acupuncture prescription and practice are considered medical practices, the Court established that, in the interest of public health, all NCM may be practiced by physician only, with all the attainments it implies in terms of State qualifying examination beyond possession of a degree in Medicine, and membership of the Provincial professional registers. This sentences have paved the way to the initiative of the National Federation of Colleges of Doctors and Dentists (FNOMCeO), which in 202 in Terni recognize 9 types of NCMs because of their social relevance: acupuncture, Traditional Chinese Medicine, Ayurvedic Medicine, homeopathy, anthroposophic medicine, homotoxicology, phytotherapy, chiropractic and osteopathy. Moreover, it also issued some guidelines requiring proper training on NMC and introduced an article concerning NCM within the professional code of medicine.
Consequently, the need for a specific training for physicians practicing directly some form of NCM was recognized: and even though a series of flourishing private centres already existed in the sector, in recent years a significant number of Italian public universities (Milan, Florence, Siena, Rome, Catanzaro) started opening new post-graduate courses (especially biennial Masters) to meet the new demand of knowledge by medical doctors and also by other health professionals. More recently, a formal agreement was reached by the State and the Regions in 2013 in order to regulate the minim standards required by both public academic and private accredited courses in terms of hours of teaching and clinical training and of core contents.
Conclusion: an ambivalent integration
An analysis of the above situation described with reference to the Italian context can highlight the fact that, in spite of a greater proximity to the selective incorporation model we introduced, the Italian case shows a great degree of heterogeneity and ambivalence. In fact, even though legally the Italian health care system remains a biomedical exclusively monopolistic system (Stepan, 1983), in practice it can be considered a tolerant system where a certain degree of medical pluralism by both practitioners and patients is admitted.
However, in the near future the evolution of this situation will very much depend from the answers to the three issues we mentioned at the very beginning: namely, firstly, the political issue regarding the type of legitimacy will be given to non-conventional medicines within the framework of the healthcare system in general and of the National Health Service in particular; secondly, the organizational issue concerning the arrangements which will translate in the operational terms of the division of labour the previous political issue; and thirdly, to what extent the epistemological differences of the respective paradigms on which biomedicine and non-conventional medicines are based will actually be taken into account or simply removed or mystified in the implementation of the integration model adopted.
To answer all these questions, undoubtedly, much more field research is requested to deepen all the issues involved. Particularly, a multilayered paradigm will be necessary to examine the micro-social implications at the doctor-patient interaction level, the organizational settings and the division of labour at the meso-social level and the institutional arrangements at the macro-social level of all the three issues raised.
*Since 1998 it was redefined as National Center for Complementary and Alternative Medicine (NCCAM).
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