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PostPosted: Wed Feb 22, 2012 5:55 pm 
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Mutant flu: assessing biosecurity risks
Johannes Rath
Nature 482,470(23 February 2012)doi:10.1038/482470bPublished online 22 February 2012


In the ongoing controversy over the mutant H5N1 avian influenza research (Nature 481, 9–10, 2012), we should be wary of reducing biosecurity measures merely to assigning access rights to sensitive information and materials. A national security body made up of military and law-enforcement officials that puts confidentiality stamps on dual-use research is not in the long-term interest of scientific progress.

Biosecurity in research needs to be integrated into a more comprehensive strategy if it is to be effective and avoid harming public-health interests.
http://www.nature.com/nature/journal/v4 ... 2470b.html

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PostPosted: Wed Feb 22, 2012 5:57 pm 
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Mutant flu: preparing for a pandemic
Eric S. Starbuck
Nature 482,470(23 February 2012)doi:10.1038/482470aPublished online 22 February 2012
We at the global humanitarian organization Save the Children agree that controversy over lab-created H5N1 avian influenza virus should not detract from the larger concern of global preparedness for a flu pandemic (Nature 482, 131; 2012).

In a pandemic flu situation, when all countries and responding organizations are stricken, we think it is unrealistic to hope that the most resource-poor communities around the world will receive adequate supplies of vaccine, antivirals or antibiotics. We believe in preparing now so that community leaders, and the organizations working with them, can mitigate the effects of a severe wave of flu in the absence of substantial outside resources.
http://www.nature.com/nature/journal/v4 ... 2470a.html

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PostPosted: Wed Feb 22, 2012 7:09 pm 
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http://www.recombinomics.com/News/02221 ... error.html

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PostPosted: Wed Feb 22, 2012 8:11 pm 
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'Dangerous' bird flu research available to all
023 February 2012

By Paul Jump

Two leading scientific journals are likely to publish in full two controversial papers detailing a new version of the bird flu virus that may be transmissible between humans despite a US federal advisory body warning of its potentially "catastrophic" misuse by "malevolent individuals, organisations or governments".

The news followed recommendations of a panel of experts convened last week by the World Health Organisation.

Controversy has surrounded the two papers, by academics based in the US and the Netherlands, since they were accepted for publication - one in Science and one in Nature - last year. They detail the creation of a new version of the H5N1 influenza virus that is transmissible between ferrets - and possibly humans - unlike strains currently found in nature.

In December, the US National Science Advisory Board for Biosecurity recommended that the papers be published only in redacted form, with access to full versions restricted to legitimate researchers. It said deliberate misuse of the research could have "catastrophic" consequences.

But the WHO panel, which included lead researchers on the two studies as well as other flu experts and senior figures from journals and funders, concluded that the necessary mechanism for restricted dissemination did not exist. It also said research into creating more transmissible forms of flu viruses should continue in order to protect public health.

The WHO panel said the papers should be published in full after a pause to allow "significant public concern" to be assuaged. It also recommended the continuation of a voluntary moratorium on H5N1 research to allow a safety review of labs to be conducted.

Philip Campbell, editor-in-chief of Nature, said he would comply with the WHO's recommendations. Bruce Alberts, editor-in-chief of Science, said the journals would await instruction about when to publish the full manuscript.

But he urged the WHO and governments to work out a mechanism for restricted distribution so that "the next time this kind of thing happens, we have a mechanism already established".

paul.jump@tsleducation.com.

http://www.timeshighereducation.co.uk/s ... 419119&c=1

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PostPosted: Wed Feb 22, 2012 11:55 pm 
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Germ warfare: The creation of a lethal virus sparks a debate pitting science against security


anna mehler paperny

From Thursday's Globe and Mail

Published Wednesday, Feb. 22, 2012 8:12PM EST

Last updated Wednesday, Feb. 22, 2012 9:51PM ESTWhen two groups of scientists on either side of the Atlantic engineered a highly contagious strain of avian flu, their findings were variously hailed as brilliant, groundbreaking – and reckless.

Late last year, researchers in the United States and the Netherlands announced they'd manipulated the H5N1 virus so it could be spread between mammals and through the air. It’s a global first for a virulent virus. And if the dangerous, transmissible mutation were unleashed – by accident or through malice – it could have pandemic consequences.

More related to this story
•Scientists weigh terror threat against public health in publishing dilemma
•Scientific advancement versus protection from bio-terror
•Ottawa ‘muzzling’ scientists, panel tells global research community

At a special meeting in Geneva last week, the World Health Organization recommended that the sensitive research be published, igniting a tussle within the ranks of global leaders on science, health and security: At what point does potentially life-saving data become reckless bait for would-be bioterrorists?

The recommendation to publish flies in the face of pleas for self-censorship from a U.S. government watchdog, the National Science Advisory Board for Biosecurity. The board asked researchers to hold back on releasing crucial “how-to” portions of their work for fear the details would fall into the wrong hands and spark germ warfare on a global scale. Anyone who needs the information for legitimate research, the board reasoned, could make a special request for it.

Not good enough, the WHO committee decided. The new knowledge, every last bit of it, should be freely available. From a public-health perspective, the committee wrote in a statement, full disclosure is the best option.

That conclusion is sending shock waves through the global scientific, epidemiological and counter-terror communities. And it has particular resonance in Canada.

Save the world from pandemic

The scariest thing about infectious-disease research is that the most dangerous disease out there is the one you don’t know about, because it doesn’t exist yet.

Scientists developing new vaccines can barely keep pace with the rate at which virulent viruses morph into something just different enough to evade the latest cutting-edge treatment.

So it’s no surprise that microbiologists and immunology researchers want to get ahead of the game by trying to guess which way a virus will mutate next – and how it will behave once it shape-shifts.

From this perspective, details of the powerful avian flu created in labs at the University of Wisconsin and the Erasmus Medical Centre in Rotterdam are of maximum importance to people in the business of stalking viruses.

Details of a microscopic viral mutation can mean the difference between recognizing a lethal breed of disease and missing its significance altogether, says Gary Kobinger, a University of Manitoba microbiologist and head of vector design and immunotherapy at the National Microbiology Laboratory of the Public Health Agency of Canada.

If scientists on the lookout for new flu mutations find one whose fingerprint matches this one, they’ll respond very differently than they would without that knowledge, Dr. Kobinger says.

The Winnipeg site is home to Canada’s highest-security bio-safety laboratory, where Dr. Kobinger and his colleagues are researching new vaccines and testing virulent diseases. Knowing what human-transmissible H5N1 looks like would make a huge difference for those watching out for new natural mutations of the virus.

“It’s a very important public-health impact,” says Dr. Kobinger. But “we'd need to have the details. If we don't have the mutation, we're back to square one.”

Canada has a lot on the line in this field. Ottawa is spending hundreds of millions of dollars on experiments researching biological and chemical weaponry.

The military’s research and development arm, Defence Research and Development Canada, has its own biological defence program with an annual budget exceeding $8-million. Separate research into chemical, biological, radiological, nuclear and explosive technology has a multi-year budget of $175-million through the end of this year. Between 2002 and 2011 it undertook 152 research projects with a combined budget of $241-million.

These experiments range from developing new vaccines for the world’s most dangerous diseases to coming up with new ways to detect biological weapons and clean contaminated sites.

Meanwhile, the U.S. scientist behind the mutated flu virus has stepped into the fray to defend his work.

“Some people have argued that the risks of such studies – misuse and accidental release, for example – outweigh the benefits. I counter that H5N1 viruses circulating in nature already pose a threat,” University of Wisconsin researcher Yoshihiro Kawaoka wrote in an online commentary at Nature.com. “It would be irresponsible not to study the underlying mechanisms.”

(Dr. Kawaoka himself has been unavailable for interviews.)

Philip Campbell, the editor-in-chief of Nature, welcomed the WHO’s recommendation. “Discussions at the WHO meeting made it clear how ineffective redaction and restricted distribution would be for the Nature paper,” he said in a statement. “It also underlined how beneficial publication of the full paper could be. So that is how we intend to proceed.”

An editorial published Wednesday evening on Nature's website had a similar rationale: Unless there are additional, as-yet undisclosed biosecurity or biosafety risks, it reads, "it is Nature's view that the papers should ultimately be published in full."

It can be tough to argue in favour of secrecy in a world where disclosure is the norm and information is increasingly accessible. But as Peter Singer, director of the Sandra Rotman Centre at Toronto’s University Health Network, observes, “global health and bio-security go hand in hand. You can’t have one without the other – we need a balance.”

Annihilation of the human species

The biosecurity community is flummoxed that anyone would dismiss expert pleas for secrecy surrounding a human-engineered virus that could be the most dangerous breed of flu on earth.

The spectre of a global pandemic spawned by germ warfare is less the stuff of science fiction and more a reality taken seriously by policy-makers, militaries and security experts worldwide.

For most people the quickest mental reference is the anthrax scare of 2001. But the potential for havoc in 2012 is much greater – and the barrier to accomplishing it much lower.

“Capabilities have been evolving remarkably quickly. … And with that comes the capability of either deliberately or unintentionally creating, in this case, a living product that’s of serious concern,” says David Relman, a Stanford University microbiology expert and a voting member of the U.S. National Science Advisory Board for Biosecurity, which recommended holding back key details of the experiments.

It’s called “dual-use” research –knowledge that has the potential to save lives, or end them.

A 2006 paper on globalization and biosecurity from the National Academies Press noted how quickly technology is changing the implications of previously innocuous research.

“As with all scientific revolutions,” the paper reads, “there is a potential dark side to the advancing power and global spread of these and other technologies. … Most experts believe it naive to think that the extraordinary growth in the life sciences and its associated technologies might not similarly be exploited for destructive purposes.”

As far as Dr. Relman is concerned, research as dangerous as these particular H5N1 flu experiments should not have been going on in the first place.

“You need to show how the work will lead to major, major benefits right away,” he said. “If they cannot show an immediate, tangible, real, scientifically supportable benefit, they shouldn’t have done it.”

Those who argue against even attempting such research note that the safest laboratories are far from foolproof. According to a 2009 report from the U.S. government accountability office, some of the country’s most secure labs reported 400 accidents in the preceding decade, caused by both human error and system failure.

(This particular experiment was done in a “bio-safety level 3” lab – the second-highest level of security that exists. The Public Health Agency of Canada stipulated this month that any Canadians wishing to tinker with a human-transmissible bird flu virus must keep it in a bio-safety level 4 lab. Now other countries are considering following suit.)

Lawrence Librach, director of the University of Toronto’s Centre for Bioethics, goes a step further: The scientists in question, well-intentioned as they might have been, abrogated their responsibilities, he contends.

“Although I respect freedom to speak and academic freedom, this is too risky and the scientists have to act responsibly. I do not believe they are acting responsibly.”

Others argue the research is valuable and should be done – but that its findings, and especially detailed instructions on how to replicate it, be kept under wraps.

“We don’t need every Tom, Dick and Harriet to know which mutations will cause an awful pandemic,” Dr. Singer said. “We do need the people developing flu vaccines and flu surveillance to know that.” Hence the proposal for selective release upon request.

Dr. Relman says he has “mixed feelings” about the WHO’s decision to ignore his board’s advice. But more crucially, he thinks they overstepped their turf.

“I don't think they really were in a position to offer that kind of recommendation,” he said. “I would hope that people who have larger decisions to make would turn to a broader representation of the various interested and relevant parties.”

What comes next

The precise fate of the pair of studies into the H5N1 virus is still uncertain.

While Nature magazine has made clear it agrees with, and hopes to follow, the WHO’s recommendation, there is as yet no timeline on publication. Future discussions are in the offing, but timing and scope are still vague.

In the meantime, international consternation has thrust the issue into the limelight. And that’s arguably a good thing.

“The whole notion of dual-use research … has been promoted in a very useful way: Many more people are aware that there is such an issue,” Dr. Relman said. “On the negative side, the tenor of the discussion has sometimes become very polarized and accusatory. And I think that’s unfortunate.”

At the very least, the kerfuffle should force scientists, security experts and policy-makers to come up with a better mechanism to figure out what happens next time.

“If this is leading to an environment where there’s oversight from different backgrounds … I think that’s very positive,” Dr. Kobinger said, adding that he’s optimistic this won’t cast a chill on bolder experimentation.

“At the end of the day we all want better treatment. We all want better drugs. There’s a lot of devastating chronic diseases we don’t have a solution for. The only way to tackle this problem would be research.”

Canada’s lab-safety edict earlier this month is just one example of the fire that has been lit under jurisdictions that simply hadn’t thought of dealing with a situation like this. And Dr. Singer is hopeful Canada will have a significant role to play on the global stage. “Canada can contribute a lot to resolving this in a balanced way,” he said.

Dr. Relman warns that this scenario is guaranteed to occur again.

“Examples like this will absolutely arise again. Possibly with increasing frequency.”
http://www.theglobeandmail.com/news/tec ... clecontent

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PostPosted: Thu Feb 23, 2012 12:02 am 
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niman wrote:
Enlarge this image

Germ warfare: The creation of a lethal virus sparks a debate pitting science against security


At a special meeting in Geneva last week, the World Health Organization recommended that the sensitive research be published, igniting a tussle within the ranks of global leaders on science, health and security: At what point does potentially life-saving data become reckless bait for would-be bioterrorists?

The recommendation to publish flies in the face of pleas for self-censorship from a U.S. government watchdog, the National Science Advisory Board for Biosecurity. The board asked researchers to hold back on releasing crucial “how-to” portions of their work for fear the details would fall into the wrong hands and spark germ warfare on a global scale. Anyone who needs the information for legitimate research, the board reasoned, could make a special request for it.

Not good enough, the WHO committee decided. The new knowledge, every last bit of it, should be freely available. From a public-health perspective, the committee wrote in a statement, full disclosure is the best option.

That conclusion is sending shock waves through the global scientific, epidemiological and counter-terror communities. And it has particular resonance in Canada.

http://www.theglobeandmail.com/news/tec ... clecontent

Media myth on steroids.

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PostPosted: Thu Feb 23, 2012 1:10 am 
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niman wrote:
niman wrote:
Enlarge this image

Germ warfare: The creation of a lethal virus sparks a debate pitting science against security


At a special meeting in Geneva last week, the World Health Organization recommended that the sensitive research be published, igniting a tussle within the ranks of global leaders on science, health and security: At what point does potentially life-saving data become reckless bait for would-be bioterrorists?

The recommendation to publish flies in the face of pleas for self-censorship from a U.S. government watchdog, the National Science Advisory Board for Biosecurity. The board asked researchers to hold back on releasing crucial “how-to” portions of their work for fear the details would fall into the wrong hands and spark germ warfare on a global scale. Anyone who needs the information for legitimate research, the board reasoned, could make a special request for it.

Not good enough, the WHO committee decided. The new knowledge, every last bit of it, should be freely available. From a public-health perspective, the committee wrote in a statement, full disclosure is the best option.

That conclusion is sending shock waves through the global scientific, epidemiological and counter-terror communities. And it has particular resonance in Canada.

http://www.theglobeandmail.com/news/tec ... clecontent

Media myth on steroids.

The above media report fails to mention the PUBLISHED paper by the CDC which provides the details for the creation of a transmissible H5N1, which uses the SAME changes used by Fouchier (HA Q226L and G228G with PB2 E627K), which can be accessed by anyone with an internet connection.

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PostPosted: Thu Feb 23, 2012 1:43 am 
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niman wrote:
niman wrote:
niman wrote:
Enlarge this image

Germ warfare: The creation of a lethal virus sparks a debate pitting science against security


At a special meeting in Geneva last week, the World Health Organization recommended that the sensitive research be published, igniting a tussle within the ranks of global leaders on science, health and security: At what point does potentially life-saving data become reckless bait for would-be bioterrorists?

The recommendation to publish flies in the face of pleas for self-censorship from a U.S. government watchdog, the National Science Advisory Board for Biosecurity. The board asked researchers to hold back on releasing crucial “how-to” portions of their work for fear the details would fall into the wrong hands and spark germ warfare on a global scale. Anyone who needs the information for legitimate research, the board reasoned, could make a special request for it.

Not good enough, the WHO committee decided. The new knowledge, every last bit of it, should be freely available. From a public-health perspective, the committee wrote in a statement, full disclosure is the best option.

That conclusion is sending shock waves through the global scientific, epidemiological and counter-terror communities. And it has particular resonance in Canada.

http://www.theglobeandmail.com/news/tec ... clecontent

Media myth on steroids.

The above media report fails to mention the PUBLISHED paper by the CDC which provides the details for the creation of a transmissible H5N1, which uses the SAME changes used by Fouchier (HA Q226L and G228G with PB2 E627K), which can be accessed by anyone with an internet connection.

http://pdn.sciencedirect.com/science?_o ... 2-main.pdf
Virology. 2012 Jan 5;422(1):105-13. Epub 2011 Nov 5.
In vitro evolution of H5N1 avian influenza virus toward human-type receptor specificity.
Chen LM, Blixt O, Stevens J, Lipatov AS, Davis CT, Collins BE, Cox NJ, Paulson JC, Donis RO.
SourceInfluenza Division, Centers for Disease Control and Prevention, Atlanta, GA 30333, United States.

Abstract
Acquisition of α2-6 sialoside receptor specificity by α2-3 specific highly-pathogenic avian influenza viruses (H5N1) is thought to be a prerequisite for efficient transmission in humans. By in vitro selection for binding α2-6 sialosides, we identified four variant viruses with amino acid substitutions in the hemagglutinin (S227N, D187G, E190G, and Q196R) that revealed modestly increased α2-6 and minimally decreased α2-3 binding by glycan array analysis. However, a mutant virus combining Q196R with mutations from previous pandemic viruses (Q226L and G228S) revealed predominantly α2-6 binding. Unlike the wild type H5N1, this mutant virus was transmitted by direct contact in the ferret model although not by airborne respiratory droplets. However, a reassortant virus with the mutant hemagglutinin, a human N2 neuraminidase and internal genes from an H5N1 virus was partially transmitted via respiratory droplets. The complex changes required for airborne transmissibility in ferrets suggest that extensive evolution is needed for H5N1 transmissibility in humans.

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PostPosted: Thu Feb 23, 2012 2:17 am 
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Flu papers warrant full publication
Nature 482,439(23 February 2012)doi:10.1038/482439aPublished online 22 February 2012



Although more debate is needed, the benefits of publishing sensitive data outweigh the risks that have so far been made public.


“No one should presume to know all the ways in which influenza virus could be misused, and the motivations for doing so, but the consequences could be catastrophic. There are many scenarios to consider, ranging from mad lone scientists, desperate despots and members of millennial doomsday cults to nation states wanting mutually assured destruction options, bioterrorists or a single person's random acts of craziness. These are low-probability events, but they could introduce a new evolutionary H5N1 seed into the environment that seems not to exist in nature. This might not cause a pandemic instantly, but it could start the virus on a new path for pandemic evolution.”

That is the rationale provided by Paul Keim, acting chair of the US National Science Advisory Board for Biosecurity (NSABB), in response to questions posed by Nature (P. S. Keim Nature 482, 156–157; 2012) about the NSABB's recommendation that recent work on the transmissibility in mammals of artificial strains of avian H5N1 influenza virus should not be published in full. The work was conducted in ferrets — generally considered the best animal models for human transmission — and shows that avian H5N1 viruses have a greater potential to evolve into transmissible forms in mammals, including humans, than had been thought. The work is reported in two papers accepted but not yet published in Nature and Science.

Last week, a group of flu and public-health experts gathered at the World Health Organization (WHO) headquarters in Geneva, Switzerland, to discuss the matter (see go.nature.com/uyr1uu). And it was clear at the meeting that the above opening quote expresses the only rationale that attendees had received.

To its credit and that of the US government, the NSABB is the only body in the world set up to review these issues in a systematic fashion. It includes ex-officio representatives of all relevant government departments (including intelligence and security agencies), as well as independent researchers. The NSABB's guidance was an important first step in public consideration of the impacts and potential regulation of such research. The second step was last week's meeting at the WHO — again, like the NSABB, a body empowered only to make recommendations.

Some context is important in considering the issues surrounding publication. In 2003, Nature and many other journals met to establish editorial procedures for considering papers that have public-health and scientific benefits but that might also have biosecurity risks (see Nature 421, 771; 2003). The statement that emerged from that meeting envisaged the possibility that a journal would reject a paper if it was clear that the risks of publication outweighed the benefits. Nature accordingly used independent advisers in considering the submission of the latest paper, and most of the advisers recommended publication in full. This is also the first paper submitted to any Nature journal for which recommendations have been made against publication on biosecurity grounds.

Rather than simply reject the papers, given also the NSABB's opinion, both Nature and Science decided to investigate another option: to publish a redacted version omitting key methods and data. But a condition of such an approach was that a method should exist for distributing a full version to those in need of the results for public-health reasons and those capable of pursuing the science. Both journals accordingly prepared full and redacted versions.



“There is already a substantial immediate risk to humans.”

Those at the WHO meeting, under conditions of strict security, examined both versions of the two papers. It had already been said in blogs and news coverage that, because the methods used are not novel, and because one of the papers had been presented at an open meeting, redaction would be pointless. As one WHO participant said: “It was only when I'd seen both versions that I realized how ineffective redaction would be.” What was also concluded was that a system for distributing the full paper only to selected individuals would be impossible to set up on any relevant timescale.

But what also became clear, partly from unpublished data, was that not only does the mammalian transmissibility threat seem greater than previously thought, but also that current avian viruses have some of the mutations identified in the new work. In other words, there is already a substantial immediate risk to humans. The meeting also concluded that the new data are of value for surveillance, and that the results should be built on to explore the mechanisms underlying transmissibility and the high fatality rate observed in humans infected by H5N1.

Given the inadequacy of redaction, and the immediate risks to global public health, the biosecurity objections expressed above seem too general and hypothetical to justify obstructing publication and further research. Moreover, with regard to the NSABB's recommendations and the recommendations of the WHO meeting (see go.nature.com/ky2skc), neither of the discussions that preceded them were sufficiently inclusive of the security, societal and research interests at stake.

Therefore, further discussion is essential. That must include a review of the safety regimes (lab equipment, buildings and practices) in which future work should be conducted. The two laboratories in which the latest research originated are categorized as 'BSL-3 enhanced' (see Nature 480, 421–422; 2011), a classification that, although rigorous in these cases, is not well defined in general. The Public Health Agency of Canada has deemed the highest level of BSL-4 to be required (see page 447). Safety-standards committees in the United States and Europe are currently assessing required safety levels, and may report within a few weeks.

As was agreed by the journals and the lead authors at the meeting, publication of the papers must wait at least for the outcome of those discussions. There may yet be regulatory or legal obstacles to publication, or biosecurity or biosafety risks sufficient to outweigh the health risks. Otherwise, it is Nature's view that the papers should ultimately be published in full.
http://www.nature.com/nature/journal/v4 ... 2439a.html

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PostPosted: Thu Feb 23, 2012 8:19 am 
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http://www.recombinomics.com/News/02231 ... n_CDC.html

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