Shire’s ADHD amphetamine wins British backing






LONDON (Reuters) – Shire‘s hyperactivity treatment Vyvanse will be available in Europe within months after Britain’s drugs regulator backed the amphetamine-based stimulant used to treat millions of U.S. students.


The drug, lisdexamfetamine dimesylate, has a slow-release action that activates the amphetamine ingredient over the course of a day, helping levels of alertness and concentration in children with ADHD (attention deficit hyperactivity disorder).






It was assessed under the European Union‘s decentralized approvals procedure, led by Britain’s medicines watchdog. The application was supported by two European studies and clinical data from the United States.


Seven other EU countries – Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden – participated, and they have agreed product labels. They will now issue their own national approvals, a process that takes up to three months, Shire said.


Chief executive Angus Russell said: “As all ADHD patients are different and will vary in their responses to the available treatments, we believe introducing Elvanse will provide physicians with a broader range of options to help patients with ADHD manage their individual needs effectively”.


Shire has established a leading position in treating hyperactivity in the United States with its stimulants Adderall XR and Vyvanse. The latter saw sales rise 24 percent to $ 247 million in the three months to September.


Shore Capital analyst Brian White said while he had modest sales expectations in the short term for the drug in Europe, where it will be the first amphetamine to be approved for ADHD, the decision was significant because the condition was becoming better known in Europe.


“Shire has been very successful in the U.S. with its ADHD franchise and one would expect them to use that experience to do a similar job in Europe, although that will take a lot longer just given the much lower awareness,” he said.


“They have another product coming along later (Intuniv) which is a non-stimulant, and that could be more appropriate for the European market than a stimulant.”


Vyvanse, which Shire said was the top-selling branded prescribed ADHD medicine in the United States, has been indicated in Europe for ADHD in children aged six years and over when treatment with methylphenidate, better known as Ritalin, was not successful.


(Editing by Dan Lalor)


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First of eight funerals begins at Newtown church


NEWTOWN, Conn. (AP) — Family members have gathered for the first of eight funerals for school shooting victims to be held at a Catholic church in Newtown, Conn.


A motorcade of dozens of vehicles led by police motorcycles accompanied the family of 6-year-old James Mattioli to St. Rose of Lima on Tuesday. His funeral comes a day after two other 6-year-old boys were laid in the first of a long, almost unbearable procession of funerals.


Margarita Rosniak and her 10-year-old daughter, Charlotte, watched from the sidewalk as people entered the church. They had traveled from California for a Christmas vacation in New York and came to Newtown to join the residents in their grief.


Clutching her daughter close, Margarita Rosniak spoke of sympathizing with the parents. Her daughter says she plans to do a school project on the massacre. She asks, "What was the point of it? They're just little kids."


Gunman Adam Lanza shot his mother Friday, then headed to Sandy Hook Elementary where he killed 20 children and six adults, and himself.


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Iran media: Son of ex-president released on bail






TEHRAN, Iran (AP) — Iranian media say the son of influential former President Akbar Hashemi Rafsanjani has been released on bail.


Several papers, including the pro-reform Etemad daily, say Mahdi Hashemi was released late Sunday and immediately went to his father’s home.






Authorities arrested the younger Hashemi in late September, a day after he returned to Iran from Britain.


He is held on charges of fomenting unrest in the aftermath of Iran’s disputed 2009 presidential election that brought President Mahmoud Ahmadinejad a second term in office. Hashemi also faced corruption charges.


His arrest came days after his sister, Faezeh, was taken into custody to serve a six-month sentence on charges of making propaganda against Iran’s ruling system.


Since Rafsanjani backed Ahmadinejad’s reformist challenger in 2009, his family has come under pressure from hardliners.


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RIM begins BlackBerry 10 tests with business, government clients






TORONTO (Reuters) – Research In Motion Ltd said on Monday that it had begun a “beta testing” program that allows 120 companies and government departments to try out its new BlackBerry 10 smartphones before their global launch on January 30.


The Canadian company, which is trying to reverse a sharp decline in market share for the BlackBerry, said the program would enable so-called enterprise customers in business and government to size up the BB10.






Features of the BB10 include the ability to separate personal and business information so that the user can store both without compromising security.


RIM has struggled in recent years to hold on to its base of enterprise customers, which typically pay a higher subscription fee than consumers, as their employees push to use devices such as Apple Inc’s iPhone for business as well as personal communications.


“This is a crucial step for us in getting our large enterprise customers ready to support BlackBerry 10 at the point of launch date, as opposed to post-launch date,” Bryan Lee, senior director for enterprise accounts, said in a phone interview.


RIM is providing the software and handsets at no charge, and the companies do not have to buy anything once the trial is finished.


The company plans to release its quarterly results on Thursday, and analysts expect it to report its third straight loss as it struggles to sell its older devices.


RIM made its name selling mobile email devices to bankers, lawyers and other professionals before expanding to sell phones to consumers.


The company said the BB10 testers were from financial, insurance, healthcare, manufacturing, media, and distribution industries and include 64 Fortune 500 companies, as well as government departments.


Lee would not identify any of the entities, beyond Integris Health and the U.S. Immigration and Customs Enforcement agency, which have both said they are testing the new devices.


The customers have installed test versions of RIM’s new server software, which manages iPhones and devices using Google Inc’s Android software as well as BlackBerrys, and will each receive two preproduction BlackBerry 10 handsets later this week.


RIM shares were down 2.1 percent at C$ 13.59 in morning Toronto Stock Exchange trading.


The stock has rallied from September’s multiyear lows around C$ 6.50 on a wave of optimism over the new devices, but the share price is still far below mid-2008 highs of around C$ 150.


(Reporting by Alastair Sharp; Editing by Lisa Von Ahn)


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Beck looks for new connection with ‘Song Reader’






NASHVILLE, Tenn. (AP) — Beck Hansen wants you to think about the way music has changed over the last century and what that means about how human beings engage each other these days.


Laboring over the intricate and ornate details of his new “Song Reader” sheet music project, he was struck by how social music used to be — something we’ve lost in the age of ear buds.






“You watch an old film and see how people would dance together in the ’20s, ’30s and ’40s. You’d go out and people would switch partners and it was a way of social interaction,” Hansen said. “It’s something that was part of what brought people together. Playing music in the home is another aspect of that that’s been lost. Again, I’m not on a campaign to get people to take up songs and play music in their home or anything. But it is interesting to me, the loss of that, what it means.”


Beck hopes the “Song Reader” inspires some of us to pick up instruments and limber our vocal cords. It includes 20 songs annotated on sheet music that’s been decorated in the style popular in the early 20th century when the songwriting industry was a thriving enterprise with billions of songs sold.


The 42-year-old singer notes in the book’s preface that Bing Crosby’s “Sweet Leilani” sold an estimated 54 million copies in 1937, meaning about 40 percent or more of the U.S. population was engaged in learning how to play that song. They were touching it directly, speeding it up, slowing it down, changing the lyrics and creating something new.


“There’s popular bands now that people know the words to their songs and can sing along, but there’s something about playing a song for yourself or for your friends and family that allows you to inhabit the song and by some sort of osmosis it becomes part of who you are in a way,” he said. “So when I think of my great-grandparents’ generations, music defined their lives in a different way than it does now.”


Beck proposed the idea to McSweeney’s Dave Eggers in 2004 and it soon blossomed into something more ambitious as the artist wrapped his mind around the challenge of not just writing a song, but presenting it in a classic way that also engages fans who might not be able to read music or play their own instruments.


They quickly agreed it would make no money, but it seemed like an idea worth exploring.


“And it seemed like only Beck would have thought of it,” Eggers said in an email to the Associated Press. “It’s a very generous project, in that he wrote a bunch of songs and just gives them to the world to interpret. That’s a very expansive kind of generosity and inclusiveness that we’re happy to be part of. On a formal level, we love projects like this, that are unprecedented, and that result in a beautiful object full of great art and great writing. And it all started with Beck. It’s a testament to his groundbreaking approach to everything he does.”


Beck hopes fans will record their own versions and upload them to the Internet so those songs grow into something more universal.


As for his own recorded music, that’s a little more complicated.


Beck’s not sure where he’s headed at the moment. He recorded an album in 2008, but set it aside to work with Charlotte Gainsbourg on “IRM,” which he wrote and produced. He’s also been writing songs for soundtracks and special projects and producing artists like Thurston Moore, Stephen Malkmus and Dwight Yoakam. All that has left him feeling creatively satisfied, but he does acknowledge it’s been a while since he released 2008′s Danger Mouse-produced “Modern Guilt.”


He says in many ways he’s reached a crossroads he’s not yet sure how to navigate.


“This last year I’ve been thinking about whether I’d finish those songs (from 2008), whether they’re relevant or worthy of releasing. I know that doesn’t sound very definitive,” he said, laughing, “but that’s the kind of place I’m in — in this kind of limbo — and, um, yeah.”


The “Song Reader” spurred Beck to think about his own work in a new light as well. Spending six months finishing off the project after working on it sporadically over the years, he was struck by how much craft went into the creation of each song and how quickly music can come into existence today.


“There is so much music out there, to me,” he said. “I don’t know if it’s just where I am in my own music making or if it’s a product of the amount of music out there, but I feel like a piece of music does have to have a certain validity to be put out there and to ask people to listen. … I feel like it’s impossible for everyone to keep up, you know, so I guess I’ve been feeling like maybe there’s something to picking what you’re going to put out, about being more particular about what you put out.”


___


Online:


http://beck.com


___


Follow AP Music Writer Chris Talbott: http://twitter.com/Chris_Talbott.


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Pediatricians call to keep thimerosal in vaccines






(Reuters Health) – A mercury-containing preservative rarely used in the United States should not be banned as an ingredient in vaccines, U.S. pediatricians said Monday, in a move that may be controversial.


In its statement, the American Academy of Pediatrics (AAP) endorsed calls from a World Health Organization (WHO) committee that the preservative, thimerosal, should not be considered a hazardous source of mercury that could be banned by the United Nations.






The AAP in 1999 asked for its removal from vaccines in the United States because of a concern that youngsters receiving multiple shots containing thimerosal might get too much mercury – and develop autism or other neurodevelopmental problems, despite the lack of hard evidence at the time.


“It was absolutely a matter of precaution because of the absence of more information,” said Dr. Louis Cooper, from Columbia University in New York, who was on the organization’s board of directors at the time.


“Subsequently an awful lot of effort has been put into trying to sort out whether thimerosal causes any harm to kids, and the bottom line is basically, it doesn’t look as if it does,” he said.


In a 2004 safety review, for example, the independent U.S. Institute of Medicine concluded there was no evidence thimerosal-containing vaccines could cause autism. A study by the Centers for Disease Control and Prevention came to the same conclusion in 2010.


With the exception of some types of flu shots, the compound is not used in vaccines in the United States, which are distributed in single-dose vials.


And nobody is arguing that should change, according to Dr. Walter Orenstein, a member of the AAP Committee on Infectious Diseases and a researcher at the Emory Vaccine Center in Atlanta.


But in countries with fewer resources – where many children still die of vaccine-preventable diseases – it is cheaper and easier to use multi-dose vials of vaccines against diphtheria and tetanus, for example.


Thimerosal prevents the rest of a multi-dose vial from getting contaminated with bacteria or fungi each time a dose is used.


Researchers estimated it could cost anywhere from two to five times as much to manufacture vaccines for developing countries without thimerosal, and both transporting vaccines and keeping them refrigerated would also be much harder.


“We’re having a hard time completing the task of getting every kid immunized now. That would add a tremendous burden,” Cooper said, adding that more children would probably die as a result.


Children who can now be protected from these life-threatening diseases could become vulnerable, Orenstein told Reuters Health.


The new statement is published in the AAP’s journal Pediatrics.


Thimerosal contains a type of mercury called ethyl mercury. Toxic effects have been tied to its cousin, methyl mercury, which stays in the body for much longer.


Earlier this year, the WHO said replacing thimerosal with an alternative preservative could affect vaccine safety and might cause some vaccines to become unavailable.


Mercury, however, is still on the list of global health hazards to be banned in a draft treaty from the United Nations Environment Program – which would mean a ban on thimerosal.


Reducing mercury exposure “is a wonderful thing,” Orenstein said.


However, “We need this exception because thimerosal is so vital for protecting children.”


For the Pediatrics document, please see: bit.ly/cxXOG


(Editing by Christine Soares, Nick Zieminski)


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Funerals begin for Newtown victims


NEWTOWN, Connecticut (Reuters) - Mourners in Newtown, Connecticut, headed for the first two of 20 funerals of schoolchildren massacred in their classroom as the rest of the nation anxiously sent children back to school on Monday with tightened security.


Within hours of the school day starting, lockdowns were declared in nearby Connecticut and New York towns. In New Jersey, one high school's morning announcements included an added warning not to let strangers into the building.


Newtown's schools remained closed on Monday, the first academic day since the 20-year-old gunman claimed 28 lives, including his mother's and his own.


Tiny caskets marked the first wave of funerals for the 20 children and six adults killed in the shooting rampage at Sandy Hook Elementary School on Friday. Noah Pozner and Jack Pinto, both 6 years old, will be laid to rest on Monday afternoon.


Their funerals come a day after President Barack Obama visited Newtown to comfort the families. Obama's remarks were heralded on Monday morning by relatives of teacher Victoria Soto, 27, who was killed as she tried to protect her first-grade students.


"He really made us feel like she really was a hero and that everyone should know it," her brother, Carlos Soto, told CBS "This Morning."


All the dead children were 6 or 7 years old. The school principal of Sandy Hook Elementary, the school psychologist and four teachers were also gunned down.


Noah was the youngest victim of rampage and his twin sister, Arielle, escaped unhurt. The family's rabbi has said he encouraged Noah's mother to focus on her other four children amid the grief.


Jack was a wrestler who loved sports. The New York Giants receiver Victor Cruz played Sunday's football game with the boy's name written all over his cleats and gloves.


At Sunday night's memorial, Obama offered words of hope and promises of action to stop future tragedies.


"We bear responsibility for every child ... This is our first task, caring for our children. It's our first job. If we don't get that right, we don't get anything right," he said.


The president kept his emotions in tighter check than he did on Friday, when he cried openly while addressing the shooting. But tears ran freely among mourners in the packed high school auditorium, who wailed when he read the names of the adults and children killed.


Schools remained closed in Newtown as faculty members met to decide when they would open again. To keep children occupied on a drizzling Monday, youth sports groups set up an indoor field day with athletics, board games and arts and crafts. By early morning, more than 100 children joined in the activities.


The community will have to make a decision about what to do with the bullet-ridden Sandy Hook Elementary School, whose students will for now attend classes in an empty school in a neighboring town.


"I think we have to go back into that building at some point. That's how you heal. It doesn't have to be immediately but I sure wouldn't want to give up on it," said local resident Tim Northrop.


A more detailed picture of Adam Lanza's stunning attack emerged on Sunday.


After killing his mother, Nancy Lanza, at home, Adam Lanza shot his way into the school. He had attended Sandy Hook as a child, according to former classmates.


Police said Lanza was armed with hundreds of bullets in high-capacity magazines of about 30 rounds each for the Bushmaster AR 15 rifle and two handguns he carried into the school, and had a fourth weapon, a shotgun, in his car outside. He killed himself in the school.


In Washington, a pro-gun lawmaker called on Congress and the gun industry to come together on a "sensible, reasonable approach" to curbing high-powered, assault weapons like those used in Newtown.


"Never before have we seen our babies slaughtered. This never happened in America, that I can recall, ever seeing this kind of carnage," said Senator Joe Manchin, a West Virginia Democrat who has earned top marks from the gun industry. "This has changed where we go from here."


(Additional reporting by Jeff Mason, Edith Honan, Martinne Geller, David Ingram, Colleen Jenkins and Chris Francescani; Susan Heavey and Doina Chiacu in Washington; Writing by Barbara Goldberg; Editing by Mohammad Zargham and Doina Chiacu)



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Leaked BlackBerry Handset Appears to Emulate iPhone’s Design






Photos of RIM’s first handset that will run BlackBerry 10 — the company’s next operating system, which is scheduled for release in early 2013 — landed on a Vietnamese forum this week. If the 18 photos of the device on tinhte.vn are to be believed, the L-Series, codenamed BlackBerry London, looks quite similar to Apple‘s iPhone 5.


The BlackBerry-branded device in the photos has a rectangular touchscreen with a black bezel along the top and bottom of it, a la the iPhone 5. Watch the video above to learn more. In the photos, the device is powered off, so we don’t get a peek at the OS, but you can see BlackBerry 10 running on a different touchscreen device, in the slideshow below.






[More from Mashable: Dropbox for iOS Gets a New Coat of Paint]


RIM is scheduled to launch BlackBerry 10 and two new smartphones Jan. 30.


BlackBerry 10 Lock Screen


You unlock a BlackBerry 10 device by swiping up from the bottom of the screen.


[More from Mashable: Apple Names Its Best iPhone and iPad Apps of 2012]


Click here to view this gallery.


Photo via tinhte.vn


This story originally published on Mashable here.


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Sundance film “End of Love” finds distributor






LOS ANGELES (TheWrap.com) – Gravitas Ventures and Variance Films have acquired all North American rights to writer-director Mark Webber‘s drama “The End of Love,” the companies announced on Thursday.


The father-son drama, which debuted at this year’s Sundance Film Festival, stars Webber alongside Shannyn Sossamon (pictured), and Webber’s real-life son Isaac Love, and features appearances by Michael Cera, Jason Ritter, and Amanda Seyfried.






The film tells the story of struggling actor Mark (Webber), who is forced to grapple with his inability to grow up when the mother of his two-year-old son Isaac suddenly dies. As he kindles a relationship with a young single mother, Mark begins to realize that he can no longer remain in denial about the real-life consequences his choices have on Isaac.


Gravitas Ventures will debut the film across all major video on demand (VOD) platforms on January 21, 2013 with a theatrical release from Variance Films beginning March 1 2013 in select markets.


“Propelled by the authenticity and intimacy of the performances, our acquisition team was unanimous that ‘The End of Love’ was one of the strongest films not only of Sundance, but of all of the films we saw last year,” said Nolan Gallagher, founder and CEO of Gravitas Ventures.


“I’m thrilled that ‘The End of Love’ has found a home with Gravitas and Variance,” said Webber. “In the rapidly changing landscape of how films are seen, these two companies are at the forefront of embracing that change.”


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Child deaths and bitter cold in Syrian refugee camps






ZAATARI, Jordan (Reuters) – One-year-old Ali Ghazawi, born with a heart defect, faced a battle for survival even before his family fled Syria‘s civil war. It was a struggle he lost two weeks ago in the bitter winter cold of a tented refugee camp in north Jordan.


Ali died two days after undergoing a heart operation in Zaatari camp, which houses at least 32,000 refugees who escaped fierce bombardment in Syria’s rebellious southern province of Deraa, cradle of the uprising against President Bashar al-Assad.






“I covered my son with two blankets, but he was not warming up, and he turned blue before he passed away in my hands,” said his sobbing 22-year-old mother, alone with a three-year-old daughter after she left her husband in Deraa and crossed the border in November.


Ali was the fourth baby to die in three weeks in the windswept camp. United Nations aid workers say none of the deaths were the direct result of conditions in Zaatari, yet they highlight the challenge facing relief agencies scrambling to provide basic shelter for half a million refugees in the region.


“These deaths are a result of cumulative factors, some related to shortage in needs and natural causes. But on top of that, the reality that conditions are harsh cannot be ignored,” said Saba Mobaslat, program director at Save the Children.


Jordan, Lebanon and Turkey each host more than 130,000 registered refugees, and relief workers predict the numbers will only increase as violence escalates around the capital Damascus.


Mirroring Syria’s youthful population, almost 65 percent of Jordan’s camp residents are newborns and young children.


“Every night we are getting children as young as four days old, six days old, one week, two weeks old, and it’s a real struggle to try to make sure that everyone survives,” said Andrew Harper, Jordan head of the United Nations High Commissioner for Refugees (UNHCR).


“Women are giving birth on the border, and people are coming across pregnant. It’s a situation where we just need to redouble efforts, particularly as we move into winter, because you have hundreds of pregnant women who cross the border,” Harper said.


Families often send the most vulnerable to safety, he added, so alongside the very young in Zaatari are many older refugees. “Last night we had a couple who were 97 years old,” he said.


“CHILDREN’S CAMP”


Along the main road in the middle of the camp’s muddy and gravel streets, children of all ages race around the makeshift market place that sprang up after the camp opened in July.


Many families join in, out of enterprise or necessity, selling everything from hot falafel to household goods, old clothing and fresh vegetables.


“It’s a children’s camp. You walk into it and there are children everywhere. It’s in your face. The male adults are staying behind, and a woman comes with 10 children without her bread earner,” Mobaslat added.


In one of several UNICEF-run playgrounds, among seesaws, swings and volunteers giving music lessons, the scars of war are fresh in the minds of most children.


“I long for my home, and I hope Bashar falls to get back to my home. It’s much better than here, where we are humiliated,” said Mohammad Ghazawi, 12, who came to play after a break from selling cheap cigarettes.


Their elders complain that two thin blankets per refugee distributed in recent weeks were not enough to warm them in tents that let in rain water despite zinc reinforcements and waterproof layers that have helped insulate them.


“Kids are dying from cold and lack of blankets. My kids shiver at night, and one has constant diarrhea,” said Mohammad Samara, 46, who fled heavy shelling in the southern Syrian town of Busr al-Sham in October with his wife and four children.


Carsten Hansen, country director for the Norwegian Refugee Council (NRC), which has set up a heated tent that receives families on arrival, says much progress has been made to help distribute aid.


“Everybody is trying to mobilize resources … in order to react to bigger numbers and a huge influx,” Hansen said, adding that 6,000 gas heaters had been airlifted to Jordan to help heat the tent camp.


FROM CRISIS TO DISASTER?


Harper said UNHCR was working to prevent “this humanitarian crisis becoming a major disaster”. But he said that while aid teams were racing to improve conditions at Zaatari, there were 100,000 other registered refugees living outside the camp and probably another 100,000 unregistered, whose living conditions were not improving.


In Lebanon, too, host to 154,000 refugees, many face a bleak winter, and aid workers expect their numbers to more than double by the middle of next year.


In the Bekaa Valley town of Bar Elias, a woman from the northern Syria province of Idlib says her home for the last year has been a wooden shack with only plastic sheeting to protect from the rain. Plastic bags are stuffed into the roof as extra insurance against leaks. “There is no water, no electricity, no school for my kids,” she said in a croaky voice.


“My husband is sick. The situation is very bad.”


Mads Almaas, NRC country director in Lebanon, said many more may flee Syria over the winter to escape worsening conditions there, putting even greater strain on relief efforts.


“The violence will not only continue but also get worse. And even in the increasingly likely event of the fall of Assad, we don’t think the violence will end,” he said.


Almaas said the United Nations would launch a regional response plan on Wednesday anticipating a total of 300,000 registered refugees in Lebanon by mid-2013. “At first we thought it was too high. Now we are concerned it is too low,” he said.


In Turkey, which hosts 136,000 refugees, camps for the most part have facilities such as portable electric heaters, and refugees receive three hot meals a day from the Red Crescent. But temperatures can plunge below freezing in the rugged terrain along the 900 kilometer (560 mile) border with Syria during the winter months, and rain can be torrential and cause flooding.


Overcrowding remains a concern, with extended families cramped in single tents and ever more refugees arriving as fighting across the border drags on.


Across the region, aid workers fear an explosion in violence could leave them seriously overstretched.


“Right now funds are sufficient. What is a challenge is if we get any shocks, something like 5,000-10,000 refugees arriving (in Lebanon) in a matter of hours,” Almaas said.


If fighting swept through the center of Damascus, thousands of Syrians could flee to the Lebanese border in a matter of hours. “For that, we are not prepared as the NRC. I also question the international community’s capacity.”


(Additional reporting by Oliver Holmes in Beirut and Nick Tattersall in Ankara; Editing by Dominic Evans and Will Waterman)


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