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1.
BMC Complement Altern Med ; 19(1): 93, 2019 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-31039772

RESUMO

BACKGROUND: Complementary and alternative medicine (CAM) is a rather novel issue within public healthcare and health policy-making. CAM use in Europe is widespread, patient-initiated, and patient-evaluated, and the regulation across countries has been evaluated as disharmonized. CAM users are left in an uncertain position, and patient safety may be threatened. How "risk" is understood by individuals in health policy-making and clinical encounters involving the use of CAM has not yet been much debated. The aim of this article is to explore and discuss the existence and possible consequences of differing risk understandings among stakeholders maneuvering in the complex landscape of CAM practice and CAM regulation contextualized by European public healthcare systems. METHODS: Qualitative data were derived from two studies on CAM in European healthcare contexts. Findings from the EU project CAMbrella on legislation and regulation of CAM were mixed with data from an interview study exploring risk understandings, communication, and decision-making among Scandinavian CAM users and their doctors. In a secondary content analysis, we constructed the case Sara as a typology to demonstrate important findings with regard to risk understandings and patient safety involving European citizens' use of CAM in differing contexts. RESULTS: By combining and comparing individual and structural perspectives on risk and CAM use, we revealed underexplored gaps in risk understandings among individuals involved in European CAM regulation and legislation, and between CAM users and their medical doctors. This may cause health risks and uncertainties associated with CAM use and regulation. It may also negatively influence doctor-CAM user communication and CAM users' trust in and use of public healthcare. CONCLUSION: Acknowledging implications of stakeholders' differing risk understandings related to CAM use and regulation may positively influence patient safety in European healthcare. Definitions of the concept of risk should include the factors uncertainty and subjectivity to grasp the full picture of possible risks associated with the use of CAM. To transform the findings of this study into practical settings, we introduce sets of questions relevant to operationalize the important question "What is risk?" in health policy-making, clinical encounters and risk research involving European patients' use of CAM.


Assuntos
Terapias Complementares , Conhecimentos, Atitudes e Prática em Saúde , Política de Saúde , Qualidade da Assistência à Saúde , Terapias Complementares/legislação & jurisprudência , Terapias Complementares/psicologia , Terapias Complementares/normas , Europa (Continente) , Humanos , Formulação de Políticas , Risco
3.
Med Law Rev ; 27(2): 189-214, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29955872

RESUMO

This article explores the ambiguities of the legal system that, in France, regulates 'alternative healing', and determines the boundaries of legitimate medical care. While the law suggests that the delivery of therapeutic care should be the monopoly of biomedically-trained professionals, alternative healers operate very widely, and very openly, in France. They practice, however, on the verge of (il)legality, often organising their activities, individually and collectively, so as to limit the likelihood of state intervention. This creates a high degree of precarity for both practitioners and, crucially, for patients. Efforts to change the system are being deployed, but while healers themselves have increasingly organised to seek recognition by the state, alternative healing occupies an uncertain policy space: they are not fully constituted as a social and policy matter by the state, and occupy a liminal position between medicine and spirituality that "unsettles" republican ideals of scientific rationality, and of secularism. This article explores some of those tensions, at the crossroad between law, science, and medicine. It reflects on why tensions seem to persist around the regulatory questions at stake, and suggests that ways forward may depend on moving away from science as a sole arbiter in drawing boundaries of legitimate and illegitimate care in regulation.


Assuntos
Terapias Complementares/legislação & jurisprudência , Assistência à Saúde/legislação & jurisprudência , França , Política de Saúde/legislação & jurisprudência , Humanos , Jurisprudência , Religião e Medicina , Ciência/legislação & jurisprudência
4.
Complement Ther Med ; 37: 6-12, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29609938

RESUMO

OBJECTIVES: This study aims to provide an empirical examination of how complementary medicine practice in Australia is actually regulated under the current national registration model. METHODS: Data was obtained from Australian Health Practitioner Regulation Agency (AHPRA) Annual Reports for the years 2011/12-2014/15 and supplemented by the Chinese Medical Registration Board of Victoria (CMRBV) Annual Reports in 2011/12 for Chinese Medicine complaints. The data analysed includes complaint statistics, stage of closure of complaints and the outcome of complaints concerning Chinese medicine, chiropractic and osteopathy under the National Law. RESULTS: During 2014-2015 the number of complaints per 100 registrants for was highest for the medical board (4.4), while much lower for the chiropractic (1.5), osteopath (0.7) and Chinese medicine (0.5) boards. For conventional boards, 58% of complaints were closed at the assessment stage, while 57%, 29% and 16% of complaints to the osteopath, Chinese medicine and chiropractic boards respectively were closed at the assessment stage. The decision to suspend or cancel registration of health professionals was 17% from the Chinese medicine board, 14% from the Osteopathy Board, 1.5% from the chiropractor board and 0.6% from the medical board. CONCLUSION: It appears that complementary medicine practitioner regulation works at least as well as conventional regulation, and at most complementary medicine boards take a stricter interpretation of misconduct though more research would need to be undertaken to state this definitively. Our findings indicate that the public are using the statutory complaint mechanisms available to them with respect to the three CM groups.


Assuntos
Acreditação/legislação & jurisprudência , Terapias Complementares/legislação & jurisprudência , Pessoal de Saúde/legislação & jurisprudência , Austrália , Terapias Complementares/organização & administração , Pessoal de Saúde/organização & administração , Humanos
5.
Int J Pharm Pract ; 26(6): 485-493, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29349921

RESUMO

OBJECTIVES: To examine community pharmacists' perspectives on CMs regulation in New Zealand, where proposals for CMs regulations had recently been suspended and where, currently, CMs are only weakly regulated. METHODS: Qualitative, in-depth, semi-structured interviews with New Zealand practising community pharmacists are identified through purposive and convenience sampling. Data were analysed using a general inductive approach. KEY FINDINGS: Participants held mixed views regarding harmonisation of CMs regulations across Australia and NZ; some supported an NZ national regulatory framework for CMs, based on the Australian system. Participants recognised the current CMs regulatory framework in NZ as inadequate, that regulation was required to some extent, and that mandatory regulation was not necessarily required. A key reason given in support of CMs regulations was the need for greater assurances around quality of CMs. Participants also supported a regulatory framework that incorporated assessment of the safety of CMs, but were less convinced of the need for, or feasibility of, requiring evidence of efficacy from clinical trials. Participants believed that regulation of CMs practitioners, such as herbalists, and CMs retailers was important, although there were mixed views as to whether regulation should be statutory or whether self-regulation would be adequate. CONCLUSIONS: On the basis of these findings, pharmacists would be expected to welcome proposals for national regulations for CMs in NZ: such regulations should address concerns regarding product quality, inappropriate health claims and supporting evidence, and therefore should support pharmacists in meeting their obligations under the NZ Pharmacy Council's Code of Ethics.


Assuntos
Atitude do Pessoal de Saúde , Serviços Comunitários de Farmácia/organização & administração , Terapias Complementares/legislação & jurisprudência , Farmacêuticos/estatística & dados numéricos , Adulto , Idoso , Austrália , Terapias Complementares/efeitos adversos , Feminino , Pessoal de Saúde/legislação & jurisprudência , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Papel Profissional , Adulto Jovem
6.
BMC Complement Altern Med ; 18(1): 11, 2018 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-29321023

RESUMO

BACKGROUND: Many European citizens are seeking complementary and alternative medicine (CAM). These treatments are regulated very differently in the EU/EFTA countries. This may demonstrate differences in how risk associated with the use of CAM is perceived. Since most CAM treatments are practiced fairly similarly across Europe, differing risk understandings may influence patient safety for European CAM users. The overall aim of this article is thus to contribute to an overview and awareness of possible differing risk understandings in the field of CAM at a policymaking/structural level in Europe. METHODS: The study is a re-analysis of data collected in the CAMbrella EU FP7 document and interview study on the regulation of CAM in 39 European countries. The 12 CAM modalities included in the CAMbrella study were ranked with regard to assumed risk potential depending on the number of countries limiting its practice to regulated professions. The 39 countries were ranked according to how many of the included CAM modalities they limit to be practiced by regulated professions. RESULTS: Twelve of 39 countries generally understand the included CAM treatments to represent "high risk", 20 countries "low risk", while the remaining 7 countries understand CAM treatments as carrying "very little or no risk". The CAM modalities seen as carrying a risk high enough to warrant professional regulation in the highest number of countries are chiropractic, acupuncture, massage, homeopathy and osteopathy. The countries understanding most of the CAM modalities in the study as potentially high-risk treatments are with two exceptions (Portugal and Belgium) all concentrated in the southeastern region of Europe. CONCLUSION: The variation in regulation of CAM may represent a substantial lack of common risk understandings between health policymakers in Europe. We think the discrepancies in regulation are to a considerable degree also based on factors unrelated to patient risk. We argue that it is important for patient safety that policy makers across Europe address this confusing situation. This could be done by applying the WHO patient safety definitions and EU's policy to facilitate access to "safe and high-quality healthcare", and regulate CAM accordingly.


Assuntos
Terapias Complementares , Pessoal de Saúde , Segurança do Paciente , Terapias Complementares/legislação & jurisprudência , Terapias Complementares/organização & administração , Terapias Complementares/normas , Europa (Continente) , Pessoal de Saúde/legislação & jurisprudência , Pessoal de Saúde/normas , Pessoal de Saúde/estatística & dados numéricos , Humanos , Segurança do Paciente/legislação & jurisprudência , Segurança do Paciente/normas , Risco
7.
Surgeon ; 16(5): 271-277, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29305045

RESUMO

Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific approach to the practice of medicine. Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care. CAM may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Despite these drawbacks, patients continue to use CAM due to media promotion of CAM therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Given the increasing demand for CAM, many medical institutions now offer CAM services. Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti-vaccination views. These controversies demonstrate the non-evidence-based philosophies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries.


Assuntos
Terapias Complementares/normas , Medicina Baseada em Evidências/normas , Medicina Integrativa/normas , Terapias Complementares/legislação & jurisprudência , Medicina Baseada em Evidências/legislação & jurisprudência , Humanos , Medicina Integrativa/legislação & jurisprudência , Estados Unidos
8.
J Altern Complement Med ; 24(4): 307-313, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29359948

RESUMO

The World Health Organization (WHO) has called for the increased statutory regulation of traditional and complementary medicine practitioners and practices, currently implemented in about half of nations surveyed. According to recent WHO data, however, the absence of policy guidelines in this area represents a significant barrier to implementation of such professional regulations. This commentary reviews several key challenges that distinguish the statutory regulation of traditional medicine practitioners and practices from biomedical professional regulation, providing a foundation for the development of policy making parameters in this area. Foremost in this regard are the ongoing impacts of the European colonial encounter, which reinforce biomedicine's disproportionate political dominance across the globe despite traditional medicine's ongoing widespread use (particularly in the global South). In this light, the authors discuss the conceptual and historical underpinnings of contemporary professional regulatory structures, the tensions between institutional and informal traditional medicine training pathways, and the policy challenges presented by the prospect of standardizing internally diverse indigenous healing approaches. Epistemic and evidentiary tensions, as well as the policy complexities surrounding the intersection of cultural and clinical considerations, present additional challenges to regulators. Conceptualizing professional regulation as an intellectual property claim under the law, the authors further consider what it means to protect traditional knowledge and prevent misappropriation in this context. Overall, the authors propose that innovative professional regulatory approaches are needed in this area to address safety, quality of care, and accessibility as key public interest concerns, while prioritizing the redress of historical inequities, protection of diverse indigenous knowledges, and delivery of care to underserved populations.


Assuntos
Terapias Complementares , Pessoal de Saúde , Medicina Tradicional/normas , Guias de Prática Clínica como Assunto , Terapias Complementares/legislação & jurisprudência , Terapias Complementares/normas , Pessoal de Saúde/legislação & jurisprudência , Pessoal de Saúde/normas , Humanos , Organização Mundial da Saúde
9.
Med Leg J ; 86(1): 23-31, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28967838

RESUMO

The development of statutory regulation of healthcare professionals first emerged in the 15th century in the UK. However, it was not until the 20th century that statutory regulation of complementary therapies emerged with the Osteopath and Chiropractors Acts. However, during that period, acupuncture failed to gain statutory regulation but was rather subject to the equivalent of trading standards. This review explores the background to this failure and the present need for statutory regulation. It draws comparisons with the need for regulation of hijama, another invasive therapy, for which there is at present no regulation. The benefits of the negative licensing model developed in Australia are considered.


Assuntos
Terapia por Acupuntura/tendências , Terapias Complementares/legislação & jurisprudência , Segurança do Paciente/legislação & jurisprudência , Austrália , Certificação/legislação & jurisprudência , Pessoal de Saúde/legislação & jurisprudência , Humanos
10.
Soc Sci Med ; 190: 190-198, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28865255

RESUMO

Cannabis is an increasingly sought-after remedy for US children with intractable (biomedically uncontrollable) epilepsy. However, like other complementary-alternative medicine (CAM) modalities, and particularly as a federally illegal, stigmatized substance, it is unsanctioned by mainstream medicine. Parents are largely on their own when it comes to learning about, procuring, dispensing, and monitoring treatments. Exploring how they manage is crucial to better assist them. Moreover, it can illuminate how 'research' done on the ground by laypeople variously disrupts and reinforces lay-expert and science-non-science divides. To those ends, in 2016, 25 Southern California parents who used, had used, or sought to use cannabis pediatrically for epilepsy/seizures were interviewed regarding their evidentiary standards, research methods, and aims when trying the drug. Parents generally described their work as experimentation; they saw their efforts as adhering to authorized scientific practices and standards, and as contributing to the authorized medical cannabis knowledge base. Findings subverted assumptions, based on an outdated stereotype of CAM, that cannabis-using parents do not believe in biomedicine. Indeed, parents' desire for their children's biomedical demarginalization, combined with biomedical dependency and a high caregiver burden, fueled a collaborative stance. Implications for understanding the boundaries of science are explored, as are norms for parent agency as ill children's care managers, radicalization among people affected by contested illnesses, and the future of 'medical marijuana.'


Assuntos
Cannabis , Epilepsia Resistente a Medicamentos/tratamento farmacológico , Pais/psicologia , Pediatria , Adolescente , Adulto , California , Criança , Pré-Escolar , Terapias Complementares/legislação & jurisprudência , Terapias Complementares/métodos , Terapias Complementares/normas , Feminino , Humanos , Jurisprudência , Masculino , Pessoa de Meia-Idade , Pediatria/métodos , Recursos Humanos
11.
Intern Med J ; 47(9): 992-998, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28891185

RESUMO

Many patients use complementary medicine (CM) products, such as vitamins, minerals and herbs as part of self-care without professional advice or disclosure to their doctors. While use of CM products is gaining awareness by the medical community and there is mounting evidence for their safety, efficacy and cost-effectiveness, there is also the potential for adverse events from inappropriate use and/or withdrawal, as well as interactions with other medicines. Due to the unique and complex properties of many CM products, research evidence is specific to individual preparations and this can lead to confusion when assessing label claims and interpreting the results of clinical trials and systematic reviews. While the Australian regulatory environment for CM products is the same as for prescription medicines and is based on risk, there is a great need for consumers and clinicians to have access to easily understood, evidence-based information to facilitate informed decision-making.


Assuntos
Terapias Complementares/normas , Medicina Baseada em Evidências/normas , Preparações de Plantas/normas , Austrália , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , Terapias Complementares/legislação & jurisprudência , Medicina Baseada em Evidências/legislação & jurisprudência , Humanos
12.
Pediatrics ; 140(3)2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28847978

RESUMO

The American Academy of Pediatrics is dedicated to optimizing the well-being of children and advancing family-centered health care. Related to this mission, the American Academy of Pediatrics recognizes the increasing use of complementary and integrative therapies for children and the subsequent need to provide reliable information and high-quality clinical resources to support pediatricians. This Clinical Report serves as an update to the original 2008 statement on complementary medicine. The range of complementary therapies is both extensive and diverse. Therefore, in-depth discussion of each therapy or product is beyond the scope of this report. Instead, our intentions are to define terms; describe epidemiology of use; outline common types of complementary therapies; review medicolegal, ethical, and research implications; review education and training for select providers of complementary therapies; provide educational resources; and suggest communication strategies for discussing complementary therapies with patients and families.


Assuntos
Medicina Integrativa , Pediatria , Atitude do Pessoal de Saúde , Pesquisa Biomédica , Criança , Terapias Complementares/educação , Terapias Complementares/ética , Terapias Complementares/legislação & jurisprudência , Terapias Complementares/estatística & dados numéricos , Suplementos Nutricionais/normas , Humanos , Cobertura do Seguro , Medicina Integrativa/educação , Medicina Integrativa/ética , Medicina Integrativa/legislação & jurisprudência , Medicina Integrativa/estatística & dados numéricos , Licenciamento , Educação de Pacientes como Assunto , Pediatria/estatística & dados numéricos , Percepção , Papel do Médico , Relações Médico-Paciente , Estados Unidos
13.
Clin Transl Sci ; 10(2): 84-92, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-28121072

RESUMO

US Food and Drug Administration (FDA)-approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA-approved companion or complementary diagnostic status.


Assuntos
Terapias Complementares/legislação & jurisprudência , Técnicas e Procedimentos Diagnósticos , Neoplasias/tratamento farmacológico , Medicina de Precisão/métodos , United States Food and Drug Administration/legislação & jurisprudência , Biomarcadores/análise , Técnicas e Procedimentos Diagnósticos/economia , Acesso aos Serviços de Saúde , Humanos , Reembolso de Seguro de Saúde , Terapia de Alvo Molecular/métodos , Medicina de Precisão/economia , Qualidade de Vida , Estados Unidos
14.
Pan Afr Med J ; 28: 232, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29629018

RESUMO

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.


Assuntos
Medicina Tradicional Africana/normas , Fitoterapia/normas , Preparações de Plantas/uso terapêutico , Terapias Complementares/legislação & jurisprudência , Medicina Herbária/legislação & jurisprudência , Humanos , Quênia , Legislação de Medicamentos , Preparações de Plantas/normas , Plantas Medicinais/química
15.
Cad. naturol. terap. complem ; 6(11): 93-100, 2017.
Artigo em Português | MOSAICO - Saúde integrativa | ID: biblio-876124

RESUMO

O presente Código de Ética Profissional se aplica a todo bacharel em Naturologia atuante no Brasil e tem como objetivo apresentar os princípios éticos norteadores, além de direitos e deveres no exercício de sua profissão.(AU)


Assuntos
Humanos , Terapias Complementares/ética , Brasil , Códigos de Ética , Terapias Complementares/legislação & jurisprudência
16.
Forsch Komplementmed ; 23(3): 179-80, 2016.
Artigo em Alemão | MEDLINE | ID: mdl-27404103

RESUMO

Jeder Vertragsarzt ist schon konfrontiert worden mit der Diskrepanz zwischen leitliniengerechter Behandlung und Ausschlüssen in der Gesetzlichen Krankenversicherung (GKV). Um der wirtschaftlichen Gefahr durch Regresse, Honorarkürzungen und Plausibilitätsprüfungen zu entgehen, haben die Regeln der GKV Vorrang. Droht dann aber bei Abweichung von Leitlinien die zivilrechtliche oder gar strafrechtliche Haftung? Immer wieder fragen sich Ärzte, wie verbindlich Leitlinien sind und wie weit sie die Therapiefreiheit einschränken können.


Assuntos
Terapias Complementares/legislação & jurisprudência , Medicina Baseada em Evidências/legislação & jurisprudência , Programas Nacionais de Saúde/legislação & jurisprudência , Naturopatia , Atitude do Pessoal de Saúde , Terapia Combinada , Alemanha , Humanos , Guias de Prática Clínica como Assunto
19.
Soc Sci Med ; 155: 73-81, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26990177

RESUMO

This paper examines the extent to which the position of the medical profession and the state towards complementary and alternative medicine (CAM) practitioners has changed since the late 1990s, taking Portugal as a case study. Using Light's concept of countervailing powers, we consider the alliances, interests, rhetoric and degrees of control between these three actors over time, focussing particularly on the extent to which CAM practitioners have acted as a countervailing force in their relationship with the medical profession and the state. It also brings to the fore the position of supra-state agencies concerning CAM regulation. A critical discourse analysis was conducted on data derived from a systematic search of information dating from the late 1990s up to 2015. Our analysis suggests that CAM has emerged as an active player and a countervailing power in that it has had significant influence on the process of state policy-making. The medical profession, in turn, has moved from rejecting to 'incorporating' CAM, while the state has acted as a 'broker', trying to accommodate the demands and preferences of both actors while simultaneously demonstrating its power and autonomy in shaping health policy. In sum, the history of countermoves of CAM, the medical profession and the state in recasting power relations regarding CAM regulation in Portugal has highlighted the explanatory value of Light's countervailing power theory and the need to move away from a professional dominance and corporatist approach, in which CAM has simply been seen as subjugated to the power of the medical profession and the state.


Assuntos
Terapias Complementares , Terapias Complementares/legislação & jurisprudência , Política de Saúde , Humanos , Portugal , Autonomia Profissional
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