Results for 'First-in-human'

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  1.  18
    Uncertain Translation, Uncertain Benefit and Uncertain Risk: Ethical Challenges Facing First-in-Human Trials of Induced Pluripotent Stem (Ips) Cells.Ronald K. F. Fung & Ian H. Kerridge - 2013 - Bioethics 27 (2):89-96.
    The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human (...)
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  2.  21
    Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury.Frederic Bretzner, Frederic Gilbert, Françoise Baylis & Robert M. Brownstone - 2011 - Cell Stem Cell 8 (5):468-475.
    Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, (...)
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  3.  6
    First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine & Ethics 37 (1):38-50.
    The 21st-century translational science campaign could lead to an increase in first-in-human trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: the requirement for adequate preclinical research; study design safeguards; and choice of subject population. I also examine specific ethical considerations relevant to the three subject populations involved (...)
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  4.  6
    Nanomedicine First-in-Human Research: Challenges for Informed Consent.Nancy M. P. King - 2012 - Journal of Law, Medicine & Ethics 40 (4):823-830.
    Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.
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  5.  2
    Which Patient Groups Should Be Asked to Participate in First-in-Human Trials of Stem-Cell-Based Therapies?Kristina Hug & Göran Hermerén - 2012 - Journal of Clinical Ethics 23 (3):256-271.
    The aims of this article are to consider whether there are medical and societal differences among diseases regarding which patient groups should be asked to participate in first-in-human trials of stem-cell-based therapies; any differences in the light of values generally endorsed by different types of ethical theories, since the question in the title of this article is value laden, and its answer depends on which values one wants to promote and protect, and how they are ranked in importance; whether (...)
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  6.  52
    Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy.Audrey R. Chapman & Courtney C. Scala - 2012 - Kennedy Institute of Ethics Journal 22 (3):243-261.
    The transition of novel and potentially promising medical therapies into their initial human clinical trials can engender conflicting pressures. On the one side, because Phase I trials raise greater ethical and human protection challenges than later stage clinical trials, there is a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials, especially if the FIH trial involves significant risks. (...)
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  7.  5
    Efficacy Testing as a Primary Purpose of Phase 1 Clinical Trials: Is It Applicable to First-in-Human Bionics and Optogenetics Trials?Frederic Gilbert, Alexander R. Harris & Robert M. I. Kapsa - 2012 - AJOB Neuroscience 3 (2):20-22.
    In her article, Pascale Hess raises the issue of whether her proposed model may be extrapolated and applied to clinical research fields other than stem cell-based interventions in the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s model suggests prioritizing efficacy over safety in phase 1 trials involving irreversible interventions in the brain, when clinical criteria meet the appropriate population suffering from “degenerative brain diseases” (Hess 2012). Although there is a need to reconsider the traditional phase 1 model, especially with respect (...)
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  8.  2
    Launching Invasive, First-in-Human Trials Against Parkinson’s Disease: Ethical Considerations.Jonathan Kimmelman, Alex John London, Bernard Ravina, Tim Ramsay, Mark Bernstein, Alan Fine, Frank W. Stahnisch & Marina Elena Emborg - unknown
    The decision to initiate invasive, first-in-human trials involving Parkinson’s disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable riskbenefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence is through the application of stringent evidentiary standards for preclinical studies. We (...)
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  9.  12
    Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine & Ethics 40 (4):802-808.
    Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
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  10.  4
    Finite Subjects in the Ethics: Spinoza on Indexical Knowledge, the First Person and the Individuality of Human Minds.Ursula Renz - 2013 - Renz, Ursula . Finite Subjects in the Ethics: Spinoza on Indexical Knowledge, the First Person and the Individuality of Human Minds. Oxford: Oxford University Press.
    This chapter suggests a new interpretation of Spinoza’s concept of mind claiming that the goal of the equation of the human mind with the idea of the body is not to solve the mind-body problem, but rather to show how we can, within the framework of Spinoza’s rationalism, conceive of finite minds as irreducibly distinguishable individuals. To support this view, the chapter discusses the passage from E2p11 to E2p13 against the background of three preliminaries, i.e. the notion of a union (...)
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  11.  32
    The Quest to Improve the Human Condition: The First 1 500 Articles Published in Journal of Business Ethics. [REVIEW]Denis Collins - 2000 - Journal of Business Ethics 26 (1):1 - 73.
    In 1999, the Journal of Business Ethics published its 1 500th article. This article commemorates the journal's quest "to improve the human condition" (Michalos, 1988, p. 1) with a summary and assessment of the first eighteen volumes. The first part provides an overview of JBE, highlighting the journal's growth, types of methodologies published, and the breadth of the field. The second part provides a detailed account of the quantitative research findings. Major research topics include (1) prevalence of ethical behavior, (2) (...)
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  12.  15
    Formal Criteria for the Concept of Human Flourishing: The First Step in Defending Flourishing as an Ideal Aim of Education.Lynne S. Wolbert, Doret J. De Ruyter & Anders Schinkel - 2015 - Ethics and Education 10 (1):118-129.
    Human flourishing is the topic of an increasing number of books and articles in educational philosophy. Flourishing should be regarded as an ideal aim of education. If this is defended, the first step should be to elucidate what is meant by flourishing, and what exactly the concept entails. Listing formal criteria can facilitate reflection on the ideal of flourishing as an aim of education. We took Aristotelian eudaimonia as a prototype to construct two criteria for the concept of human flourishing: (...)
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  13. Human Agency in the Twenty-First Century: The Views of P. S. Davies, R. Niebuhr, and A. N. Whitehead.William J. Meyer - 2017 - International Journal for Philosophy of Religion 82 (2):119-134.
    With neuroscience and psychology making significant advances in contemporary brain research, fundamental questions concerning the nature of human life and activity will become evermore critical as we proceed further into the twenty-first century. Put simply, are we creatures who exercise some genuine degree of freedom and agency in the world or are we creatures whose actions are largely if not wholly determined by biological, neurological, and psychological factors far below the radar of our conscious awareness? This article explores this important (...)
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  14.  21
    Myths of First Cause and Asymmetries in Human Evolution.Marian Annett - 2003 - Behavioral and Brain Sciences 26 (2):208-209.
    The causes of asymmetries for handedness and cerebral speech are of scientific interest, but is it sensible to try to determine which of these came first? I argue that (1) first causes belong to mythology, not science; (2) much of the cited evidence is weak; and (3) the treatment of individual differences is inadequate in comparison with the right shift theory.
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  15.  18
    Right-Handedness May Have Come First: Evidence From Studies in Human Infants and Nonhuman Primates.Daniela Corbetta - 2003 - Behavioral and Brain Sciences 26 (2):217-218.
    Recent studies with human infants and nonhuman primates reveal that posture interacts with the expression and stability of handedness. Converging results demonstrate that quadrupedal locomotion hinders the expression of handedness, whereas bipedal posture enhances preferred hand use. From an evolutionary perspective, these findings suggest that right-handedness may have emerged first, following the adoption of bipedal locomotion, with speech emerging later.
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  16.  10
    Human-Nonhuman Animal Relationships in Australia: An Overview of Results From the First National Survey and Follow-Up Case Studies 2000-2004.A. S. Franklin - 2007 - Society and Animals 15 (1):7-27.
    This paper provides an overview of results from an Australian Research Council-funded project "Sentiments and Risks: The Changing Nature of Human-Animal Relations in Australia." The data discussed come from a survey of 2000 representative Australians at the capital city, state, and rural regional level. It provides both a snapshot of the state of involvement of Australians with nonhuman animals and their views on critical issues: ethics, rights, animals as food, risk from animals, native versus introduced animals, hunting, fishing, and companionate (...)
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  17.  59
    “We Can Rebuild Him!”: The Essentialisation of the Human/Cyborg Interface in the Twenty-First Century, or Whatever Happened to The Six Million Dollar Man? [REVIEW]Simon Bacon - 2013 - AI and Society 28 (3):267-276.
    This paper aims to show how recent cinematic representations reveal a far more pessimistic and essentialised vision of Human/Cyborg hybridity in comparison with the more enunciative and optimistic ones seen at the end of the twentieth century. Donna Haraway’s still influential 1985 essay “A Cyborg Manifesto” saw the combination of the organic and the technological as offering new and exciting ways beyond the normalised culturally constructed categories of gender and identity formation. However, more recently critics see her later writings as (...)
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  18.  11
    Review of Gene Transfer and the Ethics of First-in-Human Research[REVIEW]David B. Resnik - 2011 - Studies in Ethics, Law, and Technology 5 (1).
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  19. Review of Gene Transfer and the Ethics of First-in-Human Research. [REVIEW]David Resnik - 2011 - Law and Ethics of Human Rights 5 (1).
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  20.  1
    Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
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  21. First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine and Ethics 37 (1):38-50.
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  22.  2
    Addressing the Ethical Challenges of First in-Human Trials.Audrey R. Chapman - 2011 - Journal of Clinical Research and Bioethics 2 (4).
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  23.  1
    Nanomedicine First-in-Human Research: Challenges for Informed Consent.Nancy M. P. King - 2012 - Journal of Law, Medicine and Ethics 40 (4):823-830.
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  24.  1
    Rethinking Risk Assessment for Emerging Technology First-in-Human Trials.Anna Genske & Sabrina Engel-Glatter - 2016 - Medicine, Health Care and Philosophy 19 (1):125-139.
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  25.  14
    First International Workshop of the Tiss. EU Project: Rights and Entitlements in Human Tissue and Cells.Katharina Beier - 2009 - Ethik in der Medizin 21 (2):153-155.
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  26.  3
    First International Workshop of the Tiss.EU Project: Rights and Entitlements in Human Tissue and Cells. [REVIEW]Dr Katharina Beier - 2009 - Ethik in der Medizin 21 (2):153-155.
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  27. First in, Last Out?: The Evolution of Aphasic Lexical Speech Automatisms to Agrammatism and the Evolution of Human Communication.Chris Code - 2005 - Interaction Studiesinteraction Studies Social Behaviour and Communication in Biological and Artificial Systems 6 (2):311-334.
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  28.  1
    Environmental Security and the Recombinant Human: Sustainability in the Twenty-First Century.M. Redclift - 2001 - Environmental Values 10 (3):289-299.
    Examining the concepts of ' security ' and 'sustainability', as they are employed in contemporary environmental discourses, the paper argues that, although the importance of the environment has been increasingly acknowledged since the 1970s, there has been a failure to incorporate other discourses surrounding 'nature'. The implications of the 'new genetics', prompted by research into recombinant DNA, suggest that future approaches to sustainability need to be more cognisant of changes in 'our' nature, as well as those of 'external' nature, the (...)
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  29. If No Control, Then What? Making Sense of Neural Noise in Human Brain Mapping Experiments Using First-Person Reports.Jean-Philippe Lachaux - 2011 - Journal of Consciousness Studies 18 (2):162-166.
     
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  30.  8
    Twenty-First-Century Journalism Juxtaposes Words with Still Photographs, Graphics, Cartoons, Video, Sound, and Animation in Seamless Presentations Intended to Be Understood as Real. As Images Work with Words and Music in Short-and Long-Form Journalistic Presentations Alongside Advertising and Entertainment Media, Fact and Fantasy Merge, Dancing Together in Human Memory as If All Are Real. These Increasingly Sophisticated Messages, Conveyed by Media of Every Function and Form, Deserve Careful Attention ... [REVIEW]Julianne H. Newton & Rick Williams - 2010 - In Christopher Meyers (ed.), Journalism Ethics: A Philosophical Approach. Oxford University Press. pp. 331.
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  31.  1
    First in, Last Out?: The Evolution of Aphasic Lexical Speech Automatisms to Agrammatism and the Evolution of Human Communication.Chris Code - 2005 - Interaction Studies 6 (2):311-334.
  32. Tom Gundling.First in Line: Tracing Our Ape Ancestry. Xiii + 204 Pp., Apps., Bibl., Index. New Haven, Conn.: Yale University Press, 2005. $25 .Raymond Corbey.The Metaphysics of Apes: Negotiating the Animal–Human Boundary. X + 227 Pp., Illus., Bibl., Index. Cambridge: Cambridge University Press, 2005. $65 ; $23.99. [REVIEW]Marianne Sommer - 2006 - Isis 97 (1):170-172.
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  33.  31
    Human Nature: What We Need to Know About Ourselves in the Twenty-First Century.Mary E. Clark - 1998 - Zygon 33 (4):645-659.
  34. Meditations on First Philosophy in Which the Existence of God and the Distinction of the Human Soul From the Body Are Demonstrated.René Descartes & George Heffernan - 1992
     
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  35.  1
    Independent Development of the Reach and the Grasp in Spontaneous Self-Touching by Human Infants in the First 6 Months.Brittany L. Thomas, Jenni M. Karl & Ian Q. Whishaw - 2015 - Frontiers in Psychology 5.
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  36. Historical Trends and Human Futures 1 Note on the Texts: References to Kant’s Writings Use the Date of a Contemporary Translation Into English, with the Date of First Publication Given in Square Brackets. Page References Use the Standard Prussian Academy Volume and Page Numbers . However, Where a Translation Does Not Include Them, the Page Number of the Translation is Given, with Sufficient Indication of the Location of the Passage to Make It Simple to Find It in Other Editions and Translations . Where Short Titles Are in Conventional Use, I Use Them; Where Translations of Particular Passages Seem to Me Unconvincing I Have Offered My Own Version, and Given the German Text in a Footnote. 1. [REVIEW]Onora O’Neill - 2008 - Studies in History and Philosophy of Science Part A 39 (4):529-534.
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  37. First Steps in an Account of Human Rights.James Griffin - 2001 - European Journal of Philosophy 9 (3):306–327.
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  38.  2
    The Exodus of Health Professionals From Sub-Saharan Africa: Balancing Human Rights and Societal Needs in the Twenty-First Century.Linda Ogilvie, Judy E. Mill, Barbara Astle, Anne Fanning & Mary Opare - 2007 - Nursing Inquiry 14 (2):114-124.
  39. Naturalism in the First Book of Hume's Treatise of Human Nature.D. F. Pears - 1976 - Proceedings of the British Academy 62 62.
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  40.  21
    Alain Badiou. The Theory of the Subject. Translated by Bruno Bosteels (London: Continuum, 2009), Xliv+ 367 Pp.£ 22.99 Cloth. Colette Balmain and Lois Drawmer, Eds. Something Wicked This Way Comes: Essays on Evil and Human Wickedness (Amsterdam: Rodopi, 2009), 209 Pp. E44. 00 Paper. Aurel Braun. Nato–Russia Relations in the Twenty-First Century (London: Routledge. [REVIEW]Katherine C. Jansen, Joanna Drell & Frances Andrews - 2010 - The European Legacy 15 (3):405-407.
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  41.  9
    The Philosophy of Hume, as Contained in Extracts From the First Book and the First and Second Sections of the Third Part of the Second Book of the Treatise of Human Nature.Herbert Austin Aikins & E. Hershey Sneath - 1894 - Philosophical Review 3 (1):118-119.
  42. First Principles of the Metaphysics of Life Charting the Human Condition. Man's Creative Act and the Origin of Rationalities in The Phenomenology of Man and of the Human Condition. II. The Meeting Point Between Occidental and Oriental Philosophies. [REVIEW]A. -T. Tymieniecka - 1986 - Analecta Husserliana 21:3-73.
  43.  9
    David A. Pailin. A Gentle Touch: From a Theology of Handicap to a Theology of Being Human. London. S.P.C.K. 1992 X + 192.Robert L. Fastiggi. The Natural Theology of Yves de Paris. Atlanta Ga. Scholars Press. 1992. Pp 281. $19.95 Pbk.Merold Westphal. Hegel, Freedom and Modernity New York. State University Press of New York. 1992. Pp Xviii + 295.Paul Davies. The Mind of God: The Scientific Basis for a Rational World. New York. Simon and Schuster. Pp 245.Hiroshi Obayashi Ed. Death and Afterlife. New York. Greenwood Press. 1992. Pp Xxii + 209.B. M. Marshall. Theology and Dialogue: Essays in Conversation with George Lindbeck. Notre Dame Ind. University of Notre Dame. 1990. Pp 288. $29.95.Raymond I. Weiss. Maimonides' Ethics: The Encounter of Philosophic and Religious Morality. Chicago. University of Chicago Press. 1991. Pp 224. $23.95.David Ross Scully. Alfred North Whitehead: A First Look. New York. Vantage Press. 1991. Pp 96.Daniel A. Dombrowski. St John of the Cross: An Appreciation. Alb. [REVIEW]Peter Byrne - 1992 - Religious Studies 28 (4):583.
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  44.  15
    Possible Inspiration Offered by the Yin-Yang Theory of The Book of Changes (Yi Jing) Regarding the Course of Human Culture in the Twenty-First Century.Yang Qingzhong - 2008 - Contemporary Chinese Thought 39 (3):23-38.
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  45.  6
    Atomism, Atheism, and the Spontaneous Generation of Human Beings: The Debate Over a Natural Origin of the First Humans in Seventeenth-Century Britain.Matthew R. Goodrum - 2002 - Journal of the History of Ideas 63 (2):207-224.
  46.  2
    Human Cognitive Development in the First Four Years.Kurt W. Fischer - 1982 - Behavioral and Brain Sciences 5 (2):282.
  47.  1
    Human Development and Class Struggle in Venezuela’s Popular Economy: The Paradox of ‘Twenty-First Century Socialism’.Manuel Larrabure - 2013 - Historical Materialism 21 (4):177-200.
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  48.  2
    Human Conception in Vitro: Proceedings of the First Bourn Hall Meeting.G. R. Dunstan - 1984 - Journal of Medical Ethics 10 (2):99-99.
  49. First Steps in an Account of Human Rights.Griffin James - 2001 - European Journal of Philosophy 9 (3):306-327.
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  50. The Philosophy of Hume as Contained in Extracts From the First Book and the First and Second Sections of the Third Part of the Second Book of the Treatise of Human Nature.David Hume - 1893 - Holt.
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