FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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6 Leaking Tanks Are Wash. Nuke Site's Latest Woe

Federal and state officials say six underground tanks holding a brew of radioactive and toxic waste are leaking at the country's most contaminated nuclear site in south-central Washington, raising concerns about delays for emptying the aging tanks.

The leaking materials at Hanford Nuclear Reservation pose no immediate risk to public safety or the environment because it would take perhaps years for the chemicals to reach groundwater, Washington Gov. Jay Inslee said Friday.

But the news has renewed discussion over delays for emptying the tanks, which were installed decades ago and are long past their intended 20-year life span.

"None of these tanks would be acceptable for use today. They are all beyond their design life. None of them should be in service," said Tom Carpenter of Hanford Challenge, a Hanford watchdog group. "And yet, they're holding two-thirds of the nation's high-level nuclear waste."

Just last week, state officials announced that one of Hanford's 177 tanks was leaking 150 to 300 gallons a year, posing a risk to groundwater and rivers. So far, nearby monitoring wells haven't detected higher radioactivity levels.

Inslee then traveled to Washington, D.C., to discuss the problem with federal officials, learning in meetings Friday that six tanks are leaking.

AP Photo/Shannon Dininny, File

The declining waste levels in the six tanks were missed because only a narrow band of measurements was evaluated, rather than a wider band that would have shown the levels changing over time, Inslee said.

"It's like if you're trying to determine if climate change is happening, only looking at the data for today," he said. "Perhaps human error, the protocol did not call for it. But that's not the most important thing at the moment. The important thing now is to find and address the leakers."

Department of Energy spokeswoman Lindsey Geisler said there was no immediate health risk and that federal officials would work with Washington state to address the matter.

Regardless, Sen. Ron Wyden, the new chairman of the Senate Energy and Natural Resources Committee, will ask the Government Accountability Office to investigate Hanford's tank monitoring and maintenance program, said his spokesman, Tom Towslee.

The federal government built the Hanford facility at the height of World War II as part of the Manhattan Project to build the atomic bomb. The remote site produced plutonium for the bomb dropped on Nagasaki, Japan, and continued supporting the nation's nuclear weapons arsenal for years.

Today, it is the most contaminated nuclear site in the country, still surrounded by sagebrush but with Washington's Tri-Cities of Richland, Kennewick and Pasco several miles downriver.

Several years ago, workers at Hanford completed two of three projects deemed urgent risks to the public and the environment, removing all weapons-grade plutonium from the site and emptying leaky pools that held spent nuclear fuel just 400 yards from the river.

But successes at the site often are overshadowed by delays, budget overruns and technological challenges. Nowhere have those challenges been more apparent than in Hanford's central plateau, home to the site's third most urgent project: emptying the tanks.

Hanford's tanks hold some 53 million gallons of highly radioactive waste — enough to fill dozens of Olympic-size swimming pools — and many of those tanks are known to have leaked in the past. An estimated 1 million gallons of radioactive liquid has already leaked there.

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Britain clings to austerity despite AAA loss

LONDON: British finance minister George Osborne insisted Saturday that he would not abandon his deficit-cutting drive after Moody's stripped the country of its coveted triple-A debt rating.

The opposition lashed Osborne, saying his plan for the economy was shot through, while analysts said that although it was an embarrassment for him, the downgrade would have a limited impact in the markets.

In an expected rebuff to London's hopes that sharp spending cuts would both gradually eliminate the deficit and revive growth, Moody's rating agency cut Britain's grade by one notch to Aa1 on Friday.

Osborne said it was a "loud and clear message that Britain cannot let up in dealing with its debts, dealing with its problems, cannot let up in making sure that Britain can pay its way in the world.

"What is the message from the ratings agency? Britain's got a debt problem. I agree with that. I've been telling the country for years that we've got a debt problem, we've got to deal with it.

"What do they also say? That if we abandon our commitment to deal with that debt problem, then our situation would get very much worse and I'm absolutely clear that we must not do that."

Asked if he had broken his commitment to protecting Britain's credit rating, he said the true test of credibility was whether Britain could borrow money.

"At the moment, we can do that very cheaply with very low interest rates precisely because people have confidence that we have got a plan," he said.

Moody's said government debt was still mounting and that growth was too weak to reverse the trend before 2016.

It described the British economy as constrained both by turgid global growth and the drag from businesses and the government rapidly slashing their debt burdens.

Calling it a "humiliating blow", Labour opposition finance spokesman Ed Balls said Osborne had failed in his chief stated mission of retaining Britain's AAA status.

"The reality is an economy which is not growing, a deficit which is getting bigger, families in real stress and a government which is ploughing on regardless with a plan which is not working," he told BBC television.

"Saying 'the medicine is not working, let's increase the dose of the medicine' -- that is completely crazy economics."

However, Howard Archer, chief UK economist at IHS Global Insight research group, said that the market had been anticipating the downgrade for some time, though Britain's pound sterling currency may be vulnerable.

"It does focus attention on the UK economy's extended and ongoing serious problems," he said.

"The loss of the AAA rating certainly puts pressure on Mr Osborne to come up with more initiatives in the (March 20) budget to try and boost growth.

"While an embarrassment for the government and a cause for piqued pride, we suspect that the loss of the AAA rating will have only a limited negative impact for the UK economy."

Mark Littlewood, director general of the Institute of Economic Affairs free-market think-tank, said: "The damaging impact of ballooning national debt, public spending raging out of control and tax rises should not be underestimated.

"Taking immediate action to tackle the deficit must now be the priority. George Osborne should focus on making sufficient savings in public spending to implement a substantial programme of tax reductions."

Meanwhile Howard Wheeldon, senior strategist at stockbrokers BGC Partners, said the downgrade was not a reason for an economic policy change.

"Any amount of manipulation by attempted false stimulation of the economy in an attempt to create 'artificial' growth would in my view make an already bad deficit problem even worse," he said.

"We have all lived beyond our means for far too long.

"If the UK deficit is to be brought down and the task of reducing the debt mountain begun, Mr Osborne has no option but to stick to his guns.

"We are light years away from returning to growth."

- AFP/fa

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Assembly elections 2013: Meghalaya registers 88% voting, Nagaland 83%

NEW DELHI: Meghalaya recorded 88 per cent polling and Nagaland 83.27 per cent in the assembly elections held on Saturday, which passed off peacefully barring a few minor incidents in Nagaland.

The counting would be held on February 28. Meghalaya recorded a high turnout defying a bandh call by militants in some districts and came close to its last time turnout of 89.04 per cent.

Defying a bandh called by militants in seven districts, 88 per cent of the 15.03 lakh electorate cast their votes to elect 60 members from among 345 candidates in the election to the ninth Meghalaya assembly on Saturday.

State's chief election officer P Naik said voting was more intense in the Khasi Jaintia Hills region despite a 36-hour bandh called from 6pm on Friday by the banned Hynniewtrep National Liberation Council in seven districts.

Nagaland had recorded 86.19 per cent voting in the last assembly polls.

Brisk polling was recorded in Nagaland for 59 out of 60 seats of the state assembly amidst unprecendented security. Polling has been adjourned in Tuensang sadar seat following the sudden death of Congress candidate P Chuba Chang on Friday.

Enthusiasm was noticed among the electorate following calls by Nagaland Baptist Church Council and Election Commission for "one person one vote".

The sources said polling was peaceful across the state barring some skirmishes between party workers and candidates' supporters.

In the bye-elections to six assembly constituencies which were also peaceful, Chalfilh in Mizoram recorded 78 per cent voting, Bhatpar in Uttar Pradesh 50 per cent and Moga in Punjab recorded 70.33 per cent polling, deputy election commissioner Alok Shukla told reporters here.

In the bypolls to three assembly constituencies in West Bengal, Nalhati Birbhum recorded 65 per cent polling, English Bazar in Malda district 75 per cent and Rejinagar in Murshidabad district recorded 72 per cent polling.

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Govs to hear Oregon health care plan

SALEM, Ore. (AP) — Oregon Gov. John Kitzhaber will brief other state leaders this weekend on his plan to lower Medicaid costs, touting an overhaul that President Barack Obama highlighted in his State of the Union address for its potential to lower the deficit even as health care expenses climb.

The Oregon Democrat leaves for Washington, D.C., on Friday to pitch his plan that changes the way doctors and hospitals are paid and improves health care coordination for low income residents so that treatable medical problems don't grow in severity or expense.

Kitzhaber says his goal is to win over a handful of other governors from each party.

"I think the politics have been dialed down a couple of notches, and now people are willing to sit down and talk about how we can solve the problem" of rising health care costs, Kitzhaber told The Associated Press in a recent interview.

Kitzhaber introduced the plan in 2011 in the face of a severe state budget deficit, and he's been talking for two years about expanding the initiative beyond his state. Now, it seems he's found people ready to listen.

Hospital executives from Alabama visited Oregon last month to learn about the effort. And the U.S. Department of Health and Human Services announced Thursday that it's giving Oregon a $45 million grant to help spread the changes beyond the Medicaid population and share information with other states, making it one of only six states to earn a State Innovation Model grant.

Kitzhaber will address his counterparts at a meeting of the National Governors Association. His talk isn't scheduled on the official agenda, but a spokeswoman confirmed that Kitzhaber is expected to present.

"The governors love what they call stealing from one another — taking the good ideas and the successes of their colleagues and trying to figure out how to apply that in their home state," said Matt Salo, director of the National Association of Medicaid Directors.

There's been "huge interest" among other states in Oregon's health overhaul, Salo said, not because the concepts are brand new, but because the state managed to avoid pitfalls that often block health system changes.

Kitzhaber persuaded state lawmakers to redesign the system of delivering and paying for health care under Medicaid, creating incentives for providers to coordinate patient care and prevent avoidable emergency room visits. He has long complained that the current financial incentives encourage volume over quality, driving costs up without making people healthier.

Obama, in his State of the Union address this month, suggested that changes such as Oregon's could be part of a long-term strategy to lower the federal debt by reigning in the growing cost of federally funded health care.

"We'll bring down costs by changing the way our government pays for Medicare, because our medical bills shouldn't be based on the number of tests ordered or days spent in the hospital — they should be based on the quality of care that our seniors receive," Obama said.

The Obama administration has invested in the program, putting up $1.9 billion to keep Oregon's Medicaid program afloat over the next five years while providers make the transition to new business models and incorporate new staff and technology.

In exchange, though, the state has agreed to lower per-capita health care cost inflation by 2 percentage points without affecting quality.

The Medicaid system is unique in each state, and Kitzhaber isn't suggesting that other states should adopt Oregon's specific approach, said Mike Bonetto, Kitzhaber's health care policy adviser. Rather, he wants governors to buy into the broad concept that the delivery system and payment models need to change.

That's not a new theory. But Oregon has shown that under the right circumstances massive changes to deeply entrenched business models can gain wide support.

What Oregon can't yet show is proof the idea is working — that it's lowering costs without squeezing on the quality or availability of care. The state is just finishing compiling baseline data that will be used as a basis of comparison.

One factor driving the Obama administration's interest in Oregon's success is the president's health care overhaul. Under the Affordable Care Act, millions more Americans will join the Medicaid rolls after Jan. 1, and the health care system will have to be able to absorb the influx of patients in a logistically and financially sustainable way.

The federal government will pay 100 percent of the costs for those additional patients in the first three years before scaling back to 90 percent in 2020 and beyond.

"There are a lot of governors who are facing the same challenges we're facing in Oregon," Kitzhaber said. "They recognize that the cost of health care is something they're going to have to get their arms around."

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Oscar Pistorius Granted Bail in Murder Case

Oscar Pistorius was granted bail today in a South African court, meaning he can be released from jail for the six to eight months before his trial for the allegedly premeditated killing of his girlfriend Reeva Steenkamp.

Magistrate Desmond Nair, in reading his lengthy decision, said, "The issue before me is whether this accused, being who is and the assets he has [here], would seek to duck and dive all over the world."
His conclusion:
"I cannot find that he is a flight risk."

Nair said, "The accused has made a case to be released on bail."

The judge also said he had to weigh whether Pistorius would be a danger to others. He noted that Pistorius has been accused of using foul language against people in arguments and once threatened to break someone's legs, but he said that was different from someone with an arrest record of violence.

"I appreciate that a person is dead, but I don't think that is enough," he said.

Nair also said he could not be influenced by the public's "shock and outrage" if Pistorius is released.

The judge's ruling came on the fourth and final day of the bail hearing for Pistorius, the Olympian accused of murdering his girlfriend on Valentine's Day.

Pistorius, who gained global acclaim for racing at the 2012 London Olympics, shot his model-girlfriend through a closed bathroom. He says he killed Reeva Steenkamp accidentally, but prosecutors alleged that he took a moment to put on his prosthetic legs, indicating that he thought out and planned to kill Steenkamp when he shot her three times through the bathroom door.

Alexander Joe/AFP/Getty Images

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Pistorius sobbed today in court. Barry Roux, his defense attorney, said the prosecution misinterpreted the assigning of intent, meaning that the runner's intent to shoot at a supposed intruder in his home cannot be transferred to someone else who was shot -- in this case, Steenkamp.

"He did not want to kill Reeva," Roux told the court.

PHOTOS: Paralympics Champion Charged in Killing

When Magistrate Nair, who overheard the bail hearing, asked Roux what the charges should be if Pistorius intended to kill an intruder, the defense attorney responded that he should be charged with culpable homicide.

Culpable homicide is defined in South Africa as "the unlawful negligent killing of a human being."

Roux also made light of the prosecution's argument that Pistorius is a flight risk, saying that every time the double-amputee goes through airport security, it causes a commotion. He said that Pistorius' legs need constant maintenance and he needs medical attention for his stumps.

The prosecution argued today that the onus was on Pistorius to provide his version of events, and his version was improbable.

Prosecutor Gerrie Nel also spoke of Pistorius' fame and his disability, even relating him to Wikipedia founder Julian Assange, who is now confined to Ecuador's London Embassy, where he has been granted political asylum.
"[Assange's] facial features are as well known as Mr. Pistorius' prostheses," Nel said.

Nel argued that Pistorius' prostheses do not set him apart, stating that it's no different to any other feature, and the court cannot be seen to treat people with disabilities accused of a crime, or famous people accused of crime, any differently.

Pistorius has said that in the early hours of Feb. 14 he was closing his balcony doors when he heard a noise from the bathroom. Fearing an intruder, and without his prosthetic legs on, he grabbed a gun from under his bed and fired through the closed bathroom door, he told the court.

But prosecutors say that's implausible, that the gun's holster was found under the side of the bed where Steenkamp slept, and that Pistorius would have seen she wasn't there. Prosecutors also say the angle at which the shots were fired shows Pistorius was already wearing his prosthetics when he fired.

FULL COVERAGE: Oscar Pistorius Case

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South Africa's Pistorius awarded bail in murder case

PRETORIA (Reuters) - Star South African athlete Oscar Pistorius was awarded bail on Friday after being accused of murdering his girlfriend.

The decision by Magistrate Desmond Nair drew cheers from Pistorius' family and supporters at the Pretoria magistrate's court, although the athlete appeared unmoved as the decision was read out.

The decision followed a week of dramatic testimony about how the athlete shot dead his girlfriend Reeva Steenkamp at his luxury home near Pretoria in the early hours of February 14, Valentine's Day.

Prosecutors said Pistorius, 26, committed premeditated murder when he fired four shots into a locked bathroom door, hitting his girlfriend cowering on the other side. Steenkamp, 29, suffered gunshot wounds to her head, hip and arm.

Pistorius' defense team argued the killing was a tragic mistake, saying the athlete had mistaken Steenkamp for an intruder. They said he was too famous to pose a flight risk and deserved bail to prepare for a case that has drawn worldwide attention.

The full trial is unlikely to start for several months. Olympic and Paralympic star Pistorius, a double amputee who ran races on carbon fiber blades, faces life in prison if convicted of murder.

The shooting and allegations that have emerged at the bail hearing have stunned the millions around the world who saw his track glory as an inspiring tale of triumph over adversity.

(Reporting by Peroshni Govender; writing by David Dolan; Editing by Andrew Roche)

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Volkswagen says net profit up 40% in 2012

FRANKFURT: Volkswagen, Europe's biggest car manufacturer, said on Friday that its net profit zoomed ahead by more the 40 percent last year on higher vehicle sales.

VW said in a statement its net profit soared by 40.9 percent to a record 21.7 billion euros ($28.6 billion) in 2012 as revenues rose by 20.9 percent to 192.7 billion euros and deliveries to customers were up 12.2 percent at 9.276 million vehicles.

Underlying or operating profit rose by 2.1 percent to 11.51 billion euros.

The group said it would propose an increased dividend of 3.50 euros per share for 2012 compared with 3.00 euros per share a year earlier.

Looking ahead, VW said it expected to "outperform the market as a whole in a challenging environment" and deliveries to customers would increase year-on-year.

"However, we are not completely immune to the intense competition and the impact this has on business," it cautioned.

While 2013 sales revenues were expected to exceed the 2012 level, "given the ongoing uncertainty in the economic environment, our goal for operating profit is to match the prior-year level in 2013," VW said.

Despite the car manufacturer's strong 2012 performance, analysts had been expecting an even stronger gain in profits last year.

As a result, VW shares were the biggest losers on the Frankfurt stock exchange in afternoon trading, plummeting 4.26 percent while the overall market was showing a gain of 0.81 percent.

- AFP/de

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Suriyanelli gang-rape case: Victim lodges complaint against Rajya Sabha deputy chairman PJ Kurien

KOTTAYAM: In a new twist to Suriyanelli gang-rape case, the victim on Friday lodged a police complaint insisting that Rajya Sabha deputy chairman PJ Kurien be made an accused.

The complaint lodged at Chingavanam police station also sought that Dharmarajan, an absconding convict who had jumped bail in the case and was arrested recently from Karnataka, and two other people — Unnikrishnan and Jamal, be also arraigned as accused.

According to the complainant, Dharmarajan had told a television channel that he had accompanied Kurien to Kumily rest house in his car on February 19, 1996 where the victim had been sexually exploited.

The victim and her parents had come to the police station to file the complaint.

The assistant sub-inspector accepted the complaint but refused to register the case saying the sub-inspector was not present, the victim's counsel Anila George said.

She said the victim's plea was to make Kurien an accused. So far, there is no police case or FIR against Kurien.

"When his name came up, police went after alibis and they have come to the conclusion that it was not possible for Kurien to be at the Kumily rest house because of the alibis. So he was never made an accused," George claimed.

The counsel said in the light of new amendment to CrPC 166A, when a girl makes a complaint police authorities are bound to register a crime, failing which they are liable to be prosecuted.

Kurien's name figured again in connection with the case recently after the victim wrote to her advocate to explore the possibility of filing a review plea in the Supreme Court, seeking a fresh probe against him. Kurien has maintained he has been cleared of the charges by the apex court.

The case relates to the victim hailing from Suryanelli in Idukki district of Kerala being abducted in January 1996 and transported to various places and sexually exploited by different persons.

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Adults get 11 percent of calories from fast food

ATLANTA (AP) — On an average day, U.S. adults get roughly 11 percent of their calories from fast food, a government study shows.

That's down slightly from the 13 percent reported the last time the government tried to pin down how much of the American diet is coming from fast food. Eating fast food too frequently has been seen as a driver of America's obesity problem.

For the research, about 11,000 adults were asked extensive questions about what they ate and drank over the previous 24 hours to come up with the results.

Among the findings:

— Young adults eat more fast food than their elders; 15 percent of calories for ages 20 to 39 and dropping to 6 percent for those 60 and older.

— Blacks get more of their calories from fast-food, 15 percent compared to 11 percent for whites and Hispanics.

— Young black adults got a whopping 21 percent from the likes of Wendy's, Taco Bell and KFC.

The figures are averages. Included in the calculations are some people who almost never eat fast food, as well as others who eat a lot of it.

The survey covers the years 2007 through 2010 and was released Thursday by the Centers for Disease Control and Prevention. The authors couldn't explain why the proportion of calories from fast food dropped from the 13 percent found in a survey for 2003 through 2006.

One nutrition professor cast doubts on the latest results, saying 11 percent seemed implausibly low. New York University's Marion Nestle said it wouldn't be surprising if some people under-reported their hamburgers, fries and milkshakes since eating too much fast food is increasingly seen as something of a no-no.

"If I were a fast-food company, I'd say 'See, we have nothing to do with obesity! Americans are getting 90 percent of their calories somewhere else!'" she said.

The study didn't include the total number of fast-food calories, just the percentage. Previous government research suggests that the average U.S. adult each day consumes about 270 calories of fast food — the equivalent of a small McDonald's hamburger and a few fries.

The new CDC study found that obese people get about 13 percent of daily calories from fast food, compared with less than 10 percent for skinny and normal-weight people.

There was no difference seen by household income, except for young adults. The poorest — those with an annual household income of less than $30,000 — got 17 percent of their calories from fast food, while the figure was under 14 percent for the most affluent 20- and 30-somethings with a household income of more than $50,000.

That's not surprising since there are disproportionately higher numbers of fast-food restaurants in low-income neighborhoods, Nestle said.

Fast food is accessible and "it's cheap," she said.

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