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David Wendler [53]David S. Wendler [2]
  1.  2
    Christine Grady, Lisa Eckstein, Ben Berkman, Dan Brock, Robert Cook-Deegan, Stephanie M. Fullerton, Hank Greely, Mats G. Hansson, Sara Hull, Scott Kim, Bernie Lo, Rebecca Pentz, Laura Rodriguez, Carol Weil, Benjamin S. Wilfond & David Wendler (2015). Broad Consent for Research With Biological Samples: Workshop Conclusions. American Journal of Bioethics 15 (9):34-42.
    Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...)
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  2.  1
    David Wendler (2013). What Should Be Disclosed to Research Participants? American Journal of Bioethics 13 (12):3-8.
    Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose only the information that is disclosed in the clinical care setting. To resolve this debate, it is important to identify the ethical concerns raised by clinical research and determine (...)
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  3.  3
    Seema K. Shah, David Wendler & Marion Danis (2015). Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic. American Journal of Bioethics 15 (4):11-16.
    The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth (...)
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  4.  16
    David Wendler (2012). A New Justification for Pediatric Research Without the Potential for Clinical Benefit. American Journal of Bioethics 12 (1):23 - 31.
    Pediatric research without the potential for clinical benefit is vital to improving pediatric medical care. This research also raises ethical concern and is regarded by courts and commentators as unethical. While at least 10 justifications have been proposed in response, all have fundamental limitations. This article describes and defends a new justification based on the fact that enrollment in clinical research offers children the opportunity to contribute to a valuable project. Contributing as children to valuable (...)
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  5.  12
    Segun Gbadegesin & David Wendler (2006). Protecting Communities in Health Research From Exploitation. Bioethics 20 (5):248-253.
    Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).
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  6.  22
    David Wendler (2014). Should Protections for Research with Humans Who Cannot Consent Apply to Research with Nonhuman Primates? Theoretical Medicine and Bioethics 35 (2):157-173.
    Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern (...)
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  7.  14
    David Wendler (2009). Must Research Participants Understand Randomization? American Journal of Bioethics 9 (2):3 – 8.
    In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that (...)
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  8.  3
    Annette Rid & David Wendler (2014). Treatment Decision Making for Incapacitated Patients: Is Development and Use of a Patient Preference Predictor Feasible? Journal of Medicine and Philosophy 39 (2):130-152.
    It has recently been proposed to incorporate the use of a “Patient Preference Predictor” (PPP) into the process of making treatment decisions for incapacitated patients. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Including a PPP in the shared decision-making process between clinicians and surrogates has the potential to better realize important ethical goals for making treatment decisions (...)
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  9.  15
    David Wendler (2004). Risk Standards for Pediatric Research: Rethinking the Grimes Ruling. Kennedy Institute of Ethics Journal 14 (2):187-198.
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  10.  15
    David Wendler (2004). Risk Standards for Pediatric Research: Rethinking The. Kennedy Institute of Ethics Journal 14 (2):187-198.
    : In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective (...)
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  11. David Wendler & Seema Shah (2015). Involving Communities in Deciding What Benefits They Receive in Multinational Research. Journal of Medicine and Philosophy 40 (5):584-600.
    There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, (...)
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  12.  28
    Tina Rulli & David Wendler (2015). The Duty to Take Rescue Precautions. Journal of Applied Philosophy 32 (4):n/a-n/a.
    There is much philosophical literature on the duty to rescue. Individuals who encounter and could save, at relatively little cost to themselves, a person at risk of losing life or limb are morally obligated to do so. Yet little has been said about the other side of the issue. There are cases in which the need for rescue could have been reasonably avoided by the rescuee. We argue for a duty to take rescue precautions, providing an account of (...)
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  13.  64
    Annette Rid & David Wendler (2011). A Framework for Risk-Benefit Evaluations in Biomedical Research. Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  14.  18
    David Wendler (2005). Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks. Hastings Center Report 35 (5):37-43.
    : When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than "minimal" risks, according to guidelines accepted around the world. We need a new standard for what "minimal" risks are, howeve--one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.
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  15. James Flory, David Wendler & Ezekiel Emanuel (2008). Empirical Issues in Informed Consent for Research. In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press 645--60.
     
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  16.  77
    Tina Rulli, Ezekiel Emanuel & David Wendler (2012). The Moral Duty to Buy Health Insurance. Journal of the American Medical Association 308 (2):137-138.
    The 2010 Patient Protection and Affordable Care Act was designed to increase health insurance coverage in the United States. Its most controversial feature is the requirement that US residents purchase health insurance. Opponents of the mandate argue that requiring people to contribute to the collective good is inconsistent with respect for individual liberty. Rather than appeal to the collective good, this Viewpoint argues for a duty to buy health insurance based on the moral duty individuals have to reduce (...)
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  17. David Wendler & Emily Abdoler (2011). Does It Matter Whether Investigators Intend to Benefit Research Subjects? Kennedy Institute of Ethics Journal 20 (4):353-370.
    It is widely agreed that clinical research should satisfy a number of ethical requirements. These include requirements to address a valuable question, to select subjects fairly, and to pose appropriate risks. In contrast, there remains considerable debate over the ethical relevance of investigator intentions: Does it matter ethically whether investigators intend to collect generalizable knowledge or to benefit subjects, or both? Some commentators do not mention investigator intentions when evaluating what makes clinical research ethical (Emanuel, Wendler, and Grady 2000). Others (...)
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  18.  17
    David Wendler & Christine Grady (2008). What Should Research Participants Understand to Understand They Are Participants in Research? Bioethics 22 (4):203–208.
    To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...)
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  19.  9
    David Wendler (2002). What Research with Stored Samples Teaches Us About Research with Human Subjects. Bioethics 16 (1):33–54.
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  20.  10
    Franklin G. Miller, John P. Gluck Jr & David Wendler (2008). Debriefing and Accountability in Deceptive Research. Kennedy Institute of Ethics Journal 18 (3):235-251.
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  21.  3
    Ezekiel J. Emanuel, David Wendler & C. Grady (2008). An Ethical Framework for Biomedical Research. In The Oxford Textbook of Clinical Research Ethics. Oxford University Press 123--135.
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  22.  10
    Annette Rid & David Wendler (2010). Can We Improve Treatment Decision-Making for Incapacitated Patients? Hastings Center Report 40 (5):36-45.
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  23.  1
    David Wendler (2013). Broad Versus Blanket Consent for Research with Human Biological Samples. Hastings Center Report 43 (5):3-4.
    The first of two commentaries on "Respecting Donors to Biobank Research," from the January-February 2013 issue. © 2013 by The Hasti.
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  24.  11
    David Wendler & Seema Shah (2003). Should Children Decide Whether They Are Enrolled in Nonbeneficial Research? American Journal of Bioethics 3 (4):1 – 7.
    The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...)
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  25.  17
    Alexander Friedman, Emily Robbins & David Wendler (2012). Which Benefits of Research Participation Count as 'Direct'? Bioethics 26 (2):60-67.
    It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial (...)
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  26.  29
    John Phillips & David Wendler (2014). Which Alternatives Should Investigators Disclose to Research Subjects? American Journal of Bioethics 14 (4):54-55.
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  27.  30
    Tina Rulli & David Wendler (2012). Response to the Requirement to Purchase Health Insurance. Journal of the American Medical Association 308 (16):1629.
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  28. David Wendler (2008). Research with Biological Samples. In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press 290--297.
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  29.  58
    David Wendler (1996). Innateness as an Explanatory Concept. Biology and Philosophy 11 (1):89-116.
    Although many of the issues surrounding innateness have received a good deal of attention lately, the basic concept of token innateness has been largely ignored. In the present paper, I try to correct this imbalance by offering an account of the innateness of token traits. I begin by explaining Stephen Stich's account of token innateness and offering a counterexample to that account. I then clarify why the contemporary biological approaches to innateness will not be able to resolve the problems that (...)
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  30.  8
    Kenji Matsui, Alaa Abou Zeid, Zhang Xinqing, Benjamin Krohmal, Vasantha Muthuswamy, Young Mo Koo, David Wendler, Jesse Chao, Yoshikuni Kita & Reidar Lie (2009). Informed Consent to Future Research on Stored Tissue Samples: The Views of Researchers, Ethics Review Committee Members and Policy Makers in Five Non-Western Countries. Asian Bioethics Review 1 (4):401-416.
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  31.  6
    Seema Shah & David Wendler (2010). Interpretation of the Subjects' Condition Requirement: A Legal Perspective. Journal of Law, Medicine & Ethics 38 (2):365-373.
    The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should (...)
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  32.  2
    Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond & David Wendler (2016). Adolescent Research Participants' Descriptions of Medical Research. Ajob Empirical Bioethics 7 (1):1-7.
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  33.  2
    John Phillips & David Wendler (2015). Clarifying and Defending the Endorsed Life Approach to Surrogate Decision-Making. Journal of Medical Ethics 41 (9):736-738.
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  34.  1
    Marion Danis, David Wendler & Scott Kim (2015). Acceptable Approaches to Enrolling Adults Who Cannot Consent in More Than Minimal Risk Research. American Journal of Bioethics 15 (10):70-71.
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  35.  1
    David Wendler, Christine Pace, Ambrose O. Talisuna, Faustine Maiso, Christine Grady & Ezekiel Emanuel (2005). Research on Stored Biological Samples: The Views of Ugandans. IRB: Ethics & Human Research 27 (2).
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  36.  1
    Lindsay Sabik, Christine A. Pace, Heidi P. Forster-Gertner, David Wendler, Judith D. Bebchuk, Jorge A. Tavel, Laura A. McNay, Jack Killen, Ezekiel J. Emanuel & Christine Grady (2004). Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial. IRB: Ethics & Human Research 27 (5):13-18.
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  37.  1
    David Wendler, Seema Shah, Amy Whittle & Benjamin S. Wilfond (2002). Nonbeneficial Research with Individuals Who Cannot Consent: Is It Ethically Better to Enroll Healthy or Affected Individuals? IRB: Ethics & Human Research 25 (4):1-4.
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  38.  3
    David S. Wendler (2011). Time to Stop Worrying About the Therapeutic Misconception. Journal of Clinical Ethics 23 (3):272-287.
    Work on the therapeutic misconception suggests that investigators should ensure that potential research subjects understand the fundamental differences between clinical research and clinical care. Yet, what potential research subjects should understand depends on their circumstances and the study in question. This analysis implies that researchers and review committees should stop attempting to define, measure, and dispel the therapeutic misconception, and instead should focus on what potential subjects should understand to participate in individual studies.
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  39.  5
    David Wendler (2011). What We Worry About When We Worry About the Ethics of Clinical Research. Theoretical Medicine and Bioethics 32 (3):161-180.
    Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals (...)
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  40.  2
    Franklin G. Miller & David Wendler (forthcoming). Assessing the Ethics of Ethics Research: A Case Study. IRB: Ethics & Human Research.
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  41.  2
    David S. Wendler & Seema Shah (2006). How Can Medical Training and Informed Consent Be Reconciled with Volume-Outcome Data? Journal of Clinical Ethics 17 (2):149.
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  42.  2
    Christine Grady & David Wendler (2013). Making the Transition to a Learning Health Care System. In Mildred Z. Solomon & Ann Bonham (eds.), Ethical Oversight of Learning Health Care Systems. Wiley-Blackwell 32-33.
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  43.  1
    David Wendler (2014). Justice and Nontherapeutic Pediatric Research. American Journal of Bioethics 14 (9):13-15.
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  44.  1
    Christine Pace, Ezekiel J. Emanuel, Theshinee Chuenyam, Chris Duncombe, Judith D. Bebchuk, David Wendler, Jorge A. Tavel, Laura A. McNay, Praphan Phanuphak & Heidi P. Forster (2004). The Quality of Informed Consent in a Clinical Research Study in Thailand. IRB: Ethics & Human Research 27 (1):9-17.
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  45.  4
    David Wendler (2009). Response to Open Peer Commentaries on “Must Research Participants Understand Randomization?”. American Journal of Bioethics 9 (2):W1 – W2.
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  46.  1
    David Wendler & Seema Shah (2003). A Response to Commentators on "Should Children Decide Whether They Are Enrolled in Nonbeneficial Research?". American Journal of Bioethics 3 (4):37-38.
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  47.  1
    Christine Grady, Jennifer Wagman, Robert Ssekubugu, Maria J. Wawer, David Serwadda, Mohammed Kiddugavu, Fred Nalugoda, Ronald H. Gray, David Wendler, Qian Dong, Dennis O. Dixon, Bryan Townsend, Elizabeth Wahl & Ezekiel J. Emanuel (2008). Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai District. IRB: Ethics & Human Research 30 (2):1.
    Controversy persists over the ethics of compensating research participants and providing posttrial benefits to communities in developing countries. Little is known about residents' views on these subjects. In this study, interviews about compensation and posttrial benefits from a hypothetical HIV vaccine trial were conducted in Uganda’s Rakai District. Most respondents said researchers owed the community posttrial benefits and research compensation, but opinions differed as to what these should be. Debates about posttrial benefits and compensation rarely include residents' views like these, (...)
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  48. Rebecca A. Johnson & David Wendler (2015). Challenging the Sanctity of Donorism: Patient Tissue Providers as Payment-Worthy Contributors. Kennedy Institute of Ethics Journal 25 (3):291-333.
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  49. Holly Kantin & David Wendler (2015). Is There a Role for Assent or Dissent in Animal Research? Cambridge Quarterly of Healthcare Ethics 24 (4):459-472.
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  50. Franklin G. Miller & David Wendler (2008). Is It Ethical to Keep Interim Findings of Randomised Controlled Trials Confidential? Journal of Medical Ethics 34 (3):198-201.
    Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that withholding interim findings from (...)
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