Articles tagged as "Human rights / ethics / law and intellectual property"

Reproductive rights of women living with HIV

Community attitudes towards childbearing and abortion among HIV-positive women in Nigeria and Zambia.

Kavanaugh ML, Moore AM, Akinyemi O, Adewole I, Dzekedzeke K, Awolude O, Arulogun O. Cult Health Sex. 2013 Feb;15(2):160-74. doi: 10.1080/13691058.2012.745271. Epub 2012 Nov 23

Although stigma towards HIV-positive women for both continuing and terminating a pregnancy has been documented, to date few studies have examined relative stigma towards one outcome versus the other. This study seeks to describe community attitudes towards each of two possible elective outcomes of an HIV-positive woman's pregnancy - induced abortion or birth - to determine which garners more stigma and document characteristics of community members associated with stigmatising attitudes towards each outcome. Data come from community-based interviews with reproductive-aged men and women, 2401 in Zambia and 2452 in Nigeria. Bivariate and multivariate analyses revealed that respondents from both countries overwhelmingly favoured continued childbearing for HIV-positive pregnant women, but support for induced abortion was slightly higher in scenarios in which anti-retroviral therapy (ART) was unavailable. Zambian respondents held more stigmatising attitudes towards abortion for HIV-positive women than did Nigerian respondents. Women held more stigmatising attitudes towards abortion for HIV-positive women than men, particularly in Zambia. From a sexual and reproductive health and rights perspective, efforts to assist HIV-positive women in preventing unintended pregnancy and to support them in their pregnancy decisions when they do become pregnant should be encouraged in order to combat the social stigma documented in this paper.

Abstract access 

Editor’s notes: Women’s rights to make reproductive health choices extend fully to women living with HIV. The World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), and the Office of the High Commissioner on Human Rights (OHCHR) all affirm the reproductive rights of HIV-positive individuals to choose between continuing and terminating a pregnancy, calling for access to safe abortion services in countries where it is legal for individuals who choose the latter option. This study primarily focused on attitudes towards continued childbearing versus induced abortion in two relatively high prevalence countries, in particular in contexts where induced abortion is not generally viewed favorably. However it does reflect the continued interest overall in childbearing regardless of HIV status for many women. Interestingly, the findings also indicated greater favorability towards a continuation of pregnancy for women on ART – perhaps reflecting a growing understanding that effective PMTCT interventions significantly lower the risk of vertical HIV transmission.

Africa
Nigeria, Zambia
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Ethics and equity

NGO-provided free HIV treatment and services in Burkina Faso: scarcity, therapeutic rationality and unfair process

Ridde V, Some PA, Pirkle C. Int J Equity Health. 2012 Mar 6;11:11

Until 2010, Burkina Faso was an exception to the international trend of abolishing user fees for antiretroviral treatment. Patients were still expected to pay 1,500F CFA (2 Euros) per month for antiretroviral treatment. Nevertheless, many non-governmental organizations (NGOs) exempted patients from payment. The objective of this study was to investigate how NGOs selected the beneficiaries of payment exemptions for government-provided antiretroviral treatment and rationed out complementary medical and psychosocial services. For this qualitative study, Ridde and colleagues conducted 13 individual interviews and three focus group discussions (n = 13 persons) with program staff in nine NGOs (4,000 patients), two NGO coordinating structures, and one national program. These encounters were recorded and transcribed, and their content was thematically analysed. The results were presented to the NGOs for feedback. Results indicate that there are no concrete guidelines for identifying patients warranting payment exemptions. Formerly, antiretroviral treatment was scarce in Burkina Faso and the primary criterion for treatment selection was clinical. These results suggest that this scarcity, mediated by an approach the authors call sociotherapeutic rationality (i.e. maximization of clinical success), may have led to inequities in the provision of free antiretroviral treatment. This approach may be detrimental to assuring equity since the most impoverished lack resources to pay for services that maximize clinical success (e.g. viral load) that would increase their chances of being selected for treatment. However, once selected into treatment, attempts were made to ration-out complementary services more equitably. This study demonstrates the risks entailed by medication scarcity, which presents NGOs and health professionals with impossible choices that run counter to the philosophy of equity in access to treatment. Amid growing concerns of an international funding retreat for antiretroviral treatment, it is important to learn from the past in order to better manage the potentially inequitable consequences of antiretroviral treatment scarcity.

For abstract access click here. 

Editor’s note: With donors looking at capping, reducing, or withdrawing their support from HIV treatment programmes, there is concern about the re-emergence of user fees and the inequities that this would introduce. This qualitative study from Burkina Faso of how non-governmental organisations (NGOs) made decisions about who would go first in line for free treatment, before user fees were removed by the President on December 31, 2009, provides sobering food for thought. The previous scarcity led to selection of those most likely to succeed on treatment, with a patient’s capacity to pay for a full clinical workup and their likelihood of adherence being key influencing factors. Those who could not afford a CD4 count or who did not have a companion to support treatment adherence went lower down the list. Those who were the most militant activists went to the top so that NGOs could survive and continue to fight for treatment expansion. Similar triage decisions had to be made for complementary services such as laboratory tests and nutritional support among those who had already qualified to access antiretroviral treatment. The most socially and economically disadvantaged were least likely to overcome barriers to being selected for treatment access, were most likely to present late for treatment, had difficulties with transport costs, and were most likely to be lost to follow-up. The result of efforts to prove that treatment outcomes in resource-poor countries could be as good as in resource-rich ones and that donor investment in antiretroviral treatment was not ‘wasted’ was the introduction of significant inequities. Arguments that user fees can be used to improve sustainability of treatment programmes should be firmly countered with arguments that inequitable allocation of treatment and complementary services will be the result.

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Universal access: paediatric formulations

The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children

Waning B, Diedrichsen E, Jambert E, Barnighausen T, Li Y, Pouw M, Moon S. BMC Pediatr. 2010 Oct 17;10(1):74. [Epub ahead of print]

  Important advances in the development and production of quality-certified paediatric antiretroviral drug formulations have recently been made despite significant market disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV activists, civil society organizations, and international organizations. Research on uptake and dispersion of these improved products across countries and international organizations has not been conducted but is needed to inform next steps towards improving child health. Waning and colleagues used information from the World Health Organization Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification of paediatric formulations and used 7,989 donor-funded, paediatric antiretroviral drugs purchase transactions from 2002-2009 to measure uptake and dispersion of new paediatric antiretroviral drug formulations across countries and programs. Prices for new paediatric antiretroviral drug formulations were compared to alternative dosage forms. Fewer antiretroviral drug options exist for HIV treatment in children than adults. Before 2005, most paediatric antiretroviral drugs were produced by innovator companies in single-component solid and liquid forms. Five 2-in-1 and four 3-in-1 generic paediatric fixed-dose combinations in solid and dispersible forms have been quality-certified since 2005. Most (67%) of these were produced by one quality-certified manufacturer. Uptake of new paediatric fixed-dose combinations outside of UNITAID is low. UNITAID accounted for 97-100% of 2008-2009 market volume. In total, 33 and 34 countries reported solid or dispersible fixed-dose combination purchases in 2008 and 2009, respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported purchase of these fixed-dose combinations in 2008. Prices for paediatric fixed-dose combinations were considerably lower than liquids but higher than half of an adult fixed-dose combination. Paediatric antiretroviral drug markets are more fragile than adult markets. Ensuring a long-term supply of quality, well-adapted antiretroviral drugs for children requires ongoing monitoring and improved understanding of global paediatric markets, including country-based research to explain low uptake of new, improved formulations outside of UNITAID and what can be done to accelerate children's access to HIV care. A close dialogue is needed between clinicians making selection and prescribing decisions, supply chain staff dealing with logistics, donors, international organizations, and pharmaceutical manufacturers to better match country-based demand with global supply and donor policies.

For abstract access click here

Editors’ note: This article is essential reading for everyone committed to Millennium Development Goal 4, a two-thirds reduction in mortality for children under five by 2015 – that has to be all of us. Clearly documented here is the history and current status of paediatric antiretroviral therapy – an estimated 38% of children in need were on antiretroviral therapy in 2008. Roll out started in industrialised countries but new paediatric infections in these countries have dwindled dramatically with the advent of effective prevention of mother-to-child transmission and safe supplies of blood and blood products. Many challenges face this field in low- and middle-income countries where the vast majority of children living with HIV reside – demand, logistics, funding, attitudes, formulation hurdles – all the factors underpinning low product utilization. UNITAID; the Global Fund to fight AIDS, Tuberculosis and Malaria; PEPFAR; the WHO pre-qualification programme; the USA Food and Drug Administration; Médecins sans Frontières; innovator pharmaceutical companies; generic companies – these are some of key players shaping the global paediatric antiretroviral market. Price negotiations need to ensure affordability along with sufficient profit to sustain prices and stabilize the market. Research is urgently needed at country level to understand how to facilitate uptake of new, improved formulations such as dispersible tablets which dissolve in a small amount of water – they are lighter to carry than syrups and suspensions, and as heat stable as solid formulations.


Photo credit: WHO/UNAIDS/Eric Miller

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Injecting Drug Use

Time to act: a call for comprehensive responses to HIV in people who use drugs

Beyrer C, Malinowska-Sempruch K, Kamarulzaman A, Kazatchkine M, Sidibe M, Strathdee SA. Lancet. 2010; 376:551-63.

The published work on HIV in people who use drugs shows that the global burden of HIV infection in this group can be reduced. Concerted action by governments, multilateral organisations, health systems, and individuals could lead to enormous benefits for families, communities, and societies. The authors review the evidence and identify synergies between biomedical science, public health, and human rights. Cost-effective interventions, including needle and syringe exchange programmes, opioid substitution therapy, and expanded access to HIV treatment and care, are supported on public health and human rights grounds; however, only around 10% of people who use drugs worldwide are being reached, and far too many are imprisoned for minor offences or detained without trial. To change this situation will take commitment, advocacy, and political courage to advance the action agenda. Failure to do so will exacerbate the spread of HIV infection, undermine treatment programmes, and continue to expand prison populations with patients in need of care.

For abstract access click here

Editors’ note: This article is a clarion call to action on HIV and drug use. It argues cogently for the evidence-informed, rights-based public health policies that are urgently needed to address continuing HIV transmission among people who inject drugs. Support for the concept of decriminalisation of drug users is found in a panel on the results of Portugal’s pragmatic, humanistic approach – Portugal decriminalised personal consumption and possession for the consumption of drugs in 2000. A second panel highlights the WHO/UNODC/UNAIDS comprehensive approach for HIV prevention, treatment, and care for people who inject drugs. Informative figures show HIV prevalence in people who inject drugs by region and the growth in opium production in Afghanistan from 1980 to 2009. A personal testimonial underscores why compulsory drug detention centres should be closed and replaced by evidence-informed, human-rights-based drug treatment centres. An assessment matrix compares HIV responses to people who inject drugs in China, Malaysia, Russia, Ukraine, Vietnam, and the USA. A further panel lays out clear points of action for each of 6 key stakeholders: governments, ministries of health, donors, providers, researchers, and people who use drugs. If you are short of time, read the panels, figures, and tables of this excellent paper. If you have more time, read the paper – it draws attention to the findings of each of the six overview articles in this Lancet series.

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Universal Access

HIV prevention, treatment, and care services for people who inject drugs: a systematic review of global, regional, and national coverage.

Mathers BM, Degenhardt L, Ali H, Wiessing L, Hickman M, Mattick RP, Myers B, Ambekar A, Strathdee SA; for the 2009 Reference Group to the UN on HIV and Injecting Drug Use. Lancet. 2010; 375:1014-28

Previous reviews have examined the existence of HIV prevention, treatment, and care services for persons who inject drugs worldwide, but they did not quantify the scale of coverage. Mathers and colleagues undertook a systematic review to estimate national, regional, and global coverage of HIV services in people who inject drugs. The authors did a systematic search of peer-reviewed (Medline, BioMed Central), internet, and grey-literature databases for data published in 2004 or later. A multistage process of data requests and verification was undertaken, involving UN agencies and national experts. National data were obtained for the extent of provision of the following core interventions for persons who inject drugs: needle and syringe programmes, opioid substitution therapy and other drug treatment, HIV testing and counselling, antiretroviral therapy, and condom programmes. They calculated national, regional, and global coverage of needle and syringe programmes, opioid substitution therapy, and antiretroviral therapy on the basis of available estimates of persons who inject drugs population sizes. By 2009, needle and syringe programmes had been implemented in 82 countries and opioid substitution therapy in 70 countries; both interventions were available in 66 countries. Regional and national coverage varied substantially. Australasia (202 needle-syringes per individuals who inject drugs per year) had by far the greatest rate of needle-syringe distribution; Latin America and the Caribbean (0.3 needle-syringes per individuals who inject drugs per year), Middle East and north Africa (0.5 needle-syringes per individuals who inject drugs per year), and sub-Saharan Africa (0.1 needle-syringes per individuals who inject drugs per year) had the lowest rates. Opioid substitution therapy  coverage varied from less than or equal to one recipient per 100 persons who inject drugs in central Asia, Latin America, and sub-Saharan Africa, to very high levels in western Europe (61 recipients per 100  individuals who inject drugs). The number of persons who inject drugs receiving antiretroviral therapy varied from less than one per 100 HIV-positive persons who inject drugs (Chile, Kenya, Pakistan, Russia, and Uzbekistan) to more than 100 per 100 HIV-positive persons who inject drugs in six European countries. Worldwide, an estimated  two needle-syringes (range 1-4) were distributed per persons who inject drugs per month, there were eight recipients (6-12) of opioid substitution therapy per 100 persons who inject drugs, and four persons who inject drugs (range 2-18) received  antiretroviral therapy per 100 HIV-positive persons who inject drugs. Worldwide coverage of HIV prevention, treatment, and care services in persons who inject drugs populations is very low. There is an urgent need to improve coverage of these services in this population at higher risk from HIV. 

For full text access click here:

Editor’s note: Although the number of countries with core HIV prevention services (needle-syringe programmes [NSP], opioid substitution therapy [OST], and antiretroviral therapy[ART]) for people who inject drugs is growing, coverage is highly variable and it remains very poor in the majority of countries. Outside of sub-Saharan Africa, one-third of all HIV infections are acquired through injecting with contaminated equipment. Unless there is concerted action to address the risk environments that decrease the likelihood that sterile injecting equipment can be used, HIV transmission through injecting will continue to flourish. Rapid expansion of coverage for the 9 core interventions identified as essential by UNODC, WHO, and UNAIDS is urgently needed. In addition to NSP, OST, and ART, these are voluntary counselling and testing; prevention and treatment of sexually transmitted infections; condom programming for injecting drug users and partners; tailored information, education and communication; vaccination, diagnosis, and treatment of viral hepatitis; and prevention, diagnosis, and treatment of tuberculosis. New interventions are not needed, rather policies to increase implementation of proven HIV programmes clearly are – and that will require that policy-makers recognise that it is high time for rights-based, evidence-informed policies and programming.

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Human Rights

Access to pain treatment as a human right.

Lohman D, Schleifer R, Amon JJ. BMC Med. 2010;8:8.

Almost five decades ago, governments around the world adopted the 1961 Single Convention on Narcotic Drugs which, in addition to addressing the control of illicit narcotics, obligated countries to work towards universal access to the narcotic drugs necessary to alleviate pain and suffering. Yet, despite the existence of inexpensive and effective pain relief medicines, tens of millions of people around the world continue to suffer from moderate to severe pain each year without treatment. Significant barriers to effective pain treatment include: the failure of many governments to put in place functioning drug supply systems; the failure to enact policies on pain treatment and palliative care; poor training of healthcare workers; the existence of unnecessarily restrictive drug control regulations and practices; fear among healthcare workers of legal sanctions for legitimate medical practice; and the inflated cost of pain treatment. These barriers can be understood not only as a failure to provide essential medicines and relieve suffering but also as human rights abuses. According to international human rights law, countries have to provide pain treatment medications as part of their core obligations under the right to health; failure to take reasonable steps to ensure that people who suffer pain have access to adequate pain treatment may result in the violation of the obligation to protect against cruel, inhuman and degrading treatment.

For full text access click here:  http://www.biomedcentral.com/1741-7015/8/8

Editors’ note: Low- and middle-income countries are home to half of all cancer patients and more than 90% of HIV infections, yet they consume only 6% of the morphine used worldwide. Although the International Narcotics Control Board, which monitors the implementation of the UN drug conventions, drew attention in 1995 to the dual drug control obligation to ensure adequate availability of narcotic drugs, including opiates, for medical and scientific purposes, while preventing illicit production, trafficking, and use of such drugs, an estimated 80% of the world’s population has either no access or insufficient access to treatment for moderate to severe pain. Chronic pain, a common symptom of both cancer and HIV disease, has a profound impact on the quality of life, reduces treatment adherence, and influences the course of disease – it is one of the most significant causes of suffering and disability worldwide. Overcoming a vicious cycle of under-treatment requires governments to develop pain management and palliative care policies, reform regulations that impede access, institute health care worker training, and ensure affordability, including through investigating the feasibility of local manufacture.
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Intellectual Property: patent pools

The UNITAID Patent Pool Initiative: Bringing Patents Together for the Common Good.

Bermudez J, 't Hoen E. Open AIDS J. 2010;4:37-40.

Developing and delivering appropriate, affordable, well-adapted medicines for HIV remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of antiretrovirals are not available in paediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking.  UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property rights - a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the intellectual property related to their inventions to the patent pool. Any company that wants to use the intellectual property to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their intellectual property to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all.

For full text access click here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842943/
Editors’ note: UNITAID, launched at the UN General Assembly in September 2006 by Brazil, Chile, France, Norway, and the United Kingdom, is an innovative financing mechanism that has expanded to include more than 29 countries and the Bill and Melinda Gates Foundation. Some are providing multi-year budgetary contributions while others have placed a solidarity tax on airline tickets. A full plane from Paris to New York raises enough money to cover a year of antiretroviral treatment for 60 HIV-positive children. In addition to dedicating at least 85% of its spending on products for low-income countries, UNITAID is committed to a pro-health approach to intellectual property. The concept of patent pools is very timely now. Fixed dose combinations of the new WHO recommended first line of tenofovir, lamivudine, and nevirapine or efavirenz, do not exist or are limited in supply. Affordable second line drugs are urgently needed for patients failing first line therapy and a third of antiretroviral drugs are not available in paediatric formulation. Patent terms are normally 20 years. Patent pools have worked, for example, in agriculture, aeronautics, and information technology when relevant patents for a process are owned by many different entities. They reward pharmaceutical companies for their investment in research and development, give them a reputational boost, reduce transaction costs associated with negotiating individual license and price reductions, and avert the risk of compulsory licensing of their products. Patent pools provide generic companies access to intellectual property more easily and quickly and they ensure faster access to better, more affordable antiretroviral treatment for patients in low-income countries. Under the World Trade Organisation (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), governments can and do override patents to meet public health needs. However, a less complex and more timely process would be a voluntary patent pool. It is time to step up to the plate!
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Human rights

Structural barriers and human rights related to HIV prevention and treatment in Zimbabwe.

Amon JJ, Kasambala T. Glob Public Health. 2009;4:528-45.

There has long been recognition that individual risk factors can only partially explain vulnerability to HIV infection, and that a broader range of socioeconomic, cultural and political factors must be taken into account. More recently this understanding has been applied to addressing obstacles to accessing HIV treatment. Yet, while structural interventions aimed at contextual factors related to HIV prevention and treatment have been shown to be effective, they have not been widely implemented. Using the situation of Zimbabwe as an example, Amon et al present an illustration of how contextual barriers can be understood in human rights terms, and how using a human rights analysis can specifically help define 'structural-rights' interventions and compel their implementation.

Abstract: 1

Editor’s note: In linking human rights obligations and structural-rights interventions, this paper considers four categories of global human rights concerns: the right to earn a livelihood and own property; the right to freedom of expression, assembly, and information; the right to freedom from gender-based and sexual violence; and the right to the progressive realisation of health. Using the situation of Zimbabwe as an illustration, the paper presents a list of structural-rights interventions linked to goals addressing each of these human rights concerns. This analytic framework explicitly links interventions to redress societal inequities, reduce vulnerability to HIV, and expand access to treatment with state obligations under national and international law. It reinforces the role of governments to address structural barriers and human rights abuses as part of their broader mission of public health.  

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Human Rights

Amon JJ, Kasambala T. Structural barriers and human rights related to HIV prevention and treatment in Zimbabwe. Glob Public Health. 2009 Mar 26:1-17. [Epub ahead of print]

There has long been recognition that individual risk factors can only partially explain vulnerability to HIV infection, and that a broader range of socioeconomic, cultural and political factors must be taken into account. More recently this understanding has been applied to addressing obstacles to accessing HIV treatment. Yet, while structural interventions aimed at contextual factors related to HIV prevention and treatment have been shown to be effective, they have not been widely implemented. Using the situation of Zimbabwe as an example, Amon and Kasambala present an illustration of how contextual barriers can be understood in human rights terms, and how using a human rights analysis can specifically help define ‘structural-rights’ interventions and compel their implementation.

Editors’ note: This article, a must-read for all those interested in effective combination prevention, demonstrates how explicitly recognising human rights provides a mechanism to address structural level barriers to HIV prevention and care, reinforcing government and donor agency accountability to redress societal power differentials. In other words, situating concerns about the socioeconomic, cultural, and political barriers to HIV prevention within a context of human rights provides a framework for action founded on the obligations and responsibilities of states. Drawing on the current HIV and human rights crisis in Zimbabwe, specific examples are provided of concrete structural-rights interventions to address the right to earn a livelihood and own property; the right to freedom of expression, assembly, and information; the right to freedom from gender-based and sexual violence; and the right to the progressive realisation of health.

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Policy and law

Cameron E, Burris S, Clayton M. HIV is a virus, not a crime: ten reasons against criminal statutes and criminal prosecutions. J Int AIDS Soc. 2008;11(1):7. [Epub ahead of print]

The widespread phenomenon of enacting HIV-specific laws to criminally punish transmission of, exposure to, or non-disclosure of HIV, is counter-active to good public health conceptions and repugnant to elementary human rights principles. The authors provide ten reasons why criminal laws and criminal prosecutions are bad strategy in the epidemic.

Editors’ note: HIV is a virus not a crime and criminalisation of HIV is hostile to both HIV prevention and treatment. Knowing one’s HIV status and setting out deliberately to infect another person and achieving this aim demonstrates criminal intent warranting prosecution. However, there is no public health justification for invoking criminal law sanctions against those who unknowingly and unintentionally transmit HIV or expose others to it. Such criminalisation discourages HIV testing and counselling, the pathway to treatment access and HIV status-specific prevention; reinforces stigma, enhances fear, and isolates people living with HIV; and undercuts efforts to address the epidemic.


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