Controversy Kicks Up Over A Drug Meant To Prevent Preterm Birth

A large study published in late October found Makena “did not decrease recurrent preterm births.”

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Jill Lehmann Photography/Getty Images

An independent panel of advisers to the Food and Drug Administration recommended last week that a medication to prevent preterm birth be taken off the market because, the advisers decided, the preponderance of evidence suggests it doesn’t work. But some other leading OB-GYNs say they hope the FDA won’t take the panel’s advice this time.

The medication is a synthetic form of the hormone progesterone, brand-named Makena.

“It was a really hard vote” says Dr. Vivian Lewis, professor emerita of obstetrics and gynecology at the University of Rochester Medical Center in New York, and chairperson of the FDA advisory panel. The panel was made up of 16 people, including physicians of several specialties and statisticians.

“It really came down to two camps,” Lewis tells NPR. All agreed the totality of the evidence gathered so far does not support the medication’s effectiveness for its intended use. But some advisers wanted to leave the medication on the market for now, and require additional study, while others thought it should be pulled.

By a slim majority of just two votes the advisory board recommended the drug be taken off the market.

Makena first gained FDA approval for sale in 2011, largely on the basis of findings from a 2003 study sponsored by the National Institutes of Health.

That study involved 463 pregnant women who had previously had a spontaneous preterm delivery and were therefore at increased risk for another preterm delivery. The women were divided into two groups — one that received progesterone, while the other received a placebo.

Women in the progesterone group got weekly injections of the drug starting at 16 to 20 weeks of pregnancy and continuing until 36 weeks of pregnancy. The study found that treatment with progesterone significantly reduced the risk of preterm delivery at less than 37 weeks gestation.

“There was a 66% drop in the rate of recurrent preterm birth among women taking progesterone,” says Dr. Eva Pressman, chair of obstetrics and gynecology at the University of Rochester. “We think that progesterone acts as a uterine muscle relaxant, which seems to decrease the ability of the uterus to contract,” Pressman explains.

With the highly beneficial findings from that study, the medication was fast-tracked through the FDA approval process, with one major caveat: Makena’s manufacturer was required to do a larger follow-up study to confirm the drug’s benefit.

But that’s not how the findings turned out. The follow-up study, published in late October, found Makena “did not decrease recurrent preterm births.”

The FDA’s advisory panel was charged with reviewing all the evidence and determining whether the benefits of the drug outweighed any risks. The agency doesn’t have to follow an advisory panel’s recommendation, but, typically, it does.

Dr. Christopher Zahn, vice president for practice for the American College of Obstetricians and Gynecologists says he thinks taking Makena off the market would be a mistake.

While the second study “was designed to be a confirmatory trial, there are some factors that make it difficult to interpret,” Zahn says. Although it was much larger than the first study, the second one included a far higher percentage of women who were at low risk of preterm delivery.

This makes direct comparisons of conflicting findings from the two studies difficult, Zahn says, and underscores a need for further confirmatory research.

Makena is the only medication currently available to prevent preterm birth, Zahn notes, and is now the standard of care for women at high risk who have a previous preterm birth.

“It’s one thing to have concern raised because of conflicting data,” he says, “but if that particular medication isn’t available, it no longer becomes an option.” Zahn worries that pulling the drug could produce an uptick in premature births, which creates a host of tragic problems for babies.

“It’s well known that infants born prematurely have increased risks of poor outcomes — including death — and that the risk decreases as gestational age increases” says Zahn. After birth, he adds, premature infants can have “breathing or respiratory problems, organ dysfunction, difficulty with vision and hearing and neural developmental delay.”

In response to the advisory panel’s recommendation, ACOG has issued a statement declaring that its current guidance will remain in effect for now. In part, ACOG’s guidance says, “A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 16-24 weeks of gestation to reduce the risk of recurrent spontaneous preterm birth.”

The obstetricians’ group also says it will “monitor this topic, evaluate additional literature and any further analyses as published.”

Pressman says she agrees that more study of the drug’s relative usefulness is “probably needed.” And she notes that the University of Rochester Medical Center, where she works, will not advise discontinuing the medication for women who have already been receiving weekly injections — “because there is some data indicating that withdrawing progesterone and stopping the treatment can increase the risk of preterm birth more than if they hadn’t started in the first place.”

Lewis, too, calls for more research to better understand the conflicting data. Some patients, she says, do need to be treated for this very serious condition and physicians and other providers want to do the best thing for those patients.

But right now, she says, “it’s very difficult to make a choice, based on the evidence that we have.”

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Open Skies, New START Pacts With Russia Face Bleak Outlook

A Russian Tupolev Tu-154 Open Skies Treaty reconnaissance aircraft sits on the runway at Elmendorf Air Force Base in Anchorage, Alaska, in 2004.

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Mark Farmer/AP

The world’s two nuclear superpowers have never unleashed their atomic arsenals against one another, but two longstanding agreements that have helped keep the United States and Russia from doing so now appear to be on the verge of collapse.

On Friday, Russia’s Foreign Ministry announced that strategic (read: nuclear) talks with the U.S. scheduled for this month have been “postponed indefinitely,” according to the Russian Interfax news agency. Those talks had been expected to center on a possible 5-year extension of the 2010 New Start nuclear arms control treaty, which is set to expire 16 days after the next U.S. presidential inauguration.

“The ball is now in the Americans’ court,” Interfax quotes the Russian Foreign Ministry’s Vladimir Leontyev as telling reporters. “We are looking forward to their decision and to them saying who will represent them and when we can resume our discussions on strategic stability issues.”

But the Trump administration shows little inclination to play ball. A senior White House official said in May that President Trump will not make a decision about extending the only remaining major nuclear accord with Russia until next year. The U.S. State Department has been without a top nuclear weapons negotiator since Under Secretary for Arms Control and International Security Andrea Thompson quit in September.

It may already be too late to work out an extension of New START. Russia’s Foreign Ministry contends that with the time that remains before the treaty’s Feb. 5, 2021, expiration, it will be impossible to complete a new document that could extend the arms pact.

There are also growing signs that the Trump administration may be pulling out of the 1992 Open Skies Treaty. That pact, which has been in effect since 2002, allows American and Russian unarmed surveillance aircraft to fly over and photograph one another’s territory, including military installations.

Last week two of the Open Skies pact’s harshest congressional critics, Sens. Ted Cruz, R-Texas, and Tom Cotton, R-Ark., introduced a Senate resolution demanding the U.S. ditch the treaty.

Trump has also reportedly signed a document this year declaring his intention to pull out of the Open Skies treaty. Doing so would require a six-month advance notice to the pact’s 33 other signatories, which in addition to Russia include most NATO allies and Ukraine.

At last week’s Senate confirmation hearing of Deputy Secretary of State John Sullivan, who’s nominated to fill the vacant U.S. ambassador’s post in Moscow, Sen. Ed Markey, D-Mass., suggested it was former National Security Advisor John Bolton who prodded Trump to abjure the overflight arrangement with Moscow.

“I have received information,” Markey told Sullivan, “that before John Bolton resigned, President Trump may have made a decision to exit the Open Skies Treaty.”

Sullivan would neither confirm nor deny such a decision had been made. “I inquired as to whether we had withdrawn from the treaty and was assured we had not,” Sullivan told Markey, adding that if the U.S. were to pull out, “there would need to be substantial evidence to support the national security interests for withdrawal from that treaty.”

Arms control experts say pulling out of the treaty would be a mistake. “It’s really hard to see what we would gain from withdrawing from the treaty,” former U.S. ambassador to Ukraine Steven Pifer tells NPR. “We actually conduct many more flights over Russia than Russia conducts over the United States.”

A compilation done at the end of the Obama administration shows the U.S. flew three times as many surveillance flights over Russia under the treaty as Russia did over the U.S.

“It’s a very useful way for the parties to be on the same page about who has what, where,” says Olga Oliker, Europe program director for the International Crisis Group. And even though both the U.S. and Russia have sophisticated spy satellites, their ability to capture images can be stymied by clouds that surveillance planes can fly under. “It gives you access,” says Oliker, “to things that even if you have a satellite network you might not be able to see.”

Critics say Russia has failed to comply with the treaty by restricting U.S. overflights.

“Perhaps rather than calling this the Open Skies Treaty,” Sen. Cotton said last month at the confirmation hearing of Adm. Charles Richard’s nomination to head the U.S. Strategic Command, “maybe it should be called the Open Skies Over America and the Closed Skies Over Russia Treaty.”

Russia has effectively placed its heavily militarized enclave of Kaliningrad off-limits for American overflights and has likewise placed restrictions over the Russian-occupied territories of South Ossetia and Abkhazia in the Republic of Georgia. The U.S. has in turn curtailed Russian flights over Hawaii and Alaska.

The admiral designated to command U.S. nuclear forces defended the Open Skies Treaty at his confirmation hearing. “We do derive some benefit from it, particularly with our allies,” Richards told the Senate Armed Services Committee. Alluding to Russia’s modernization of its surveillance aircraft and the failure of the U.S. to update its own fleet, he added, “We would need to make the appropriate resource and operational commitments to utilize the full provisions of the treaty if we were to remain.”

Oliker says the U.S. does need to upgrade or replace its surveillance planes. “If it doesn’t, then it really does stop getting any value for the U.S. from the treaty — not because a treaty has no value, but because America’s airplanes don’t work.”

Already this year, the U.S. has withdrawn from the 1987 Intermediate Nuclear Forces treaty, which obliged the U.S. and the Soviet Union to destroy all of their ground-launched ballistic and cruise missiles with flight ranges between 500 and 5,500 kilometers. The Trump administration, like the Obama administration had before, accused Russia of violating that treaty.

Whereas previous administrations have largely sought to sustain arms control agreements, Trump has shown no affinity for international pacts. Having abandoned the Paris Agreement on climate change, the Iran nuclear agreement and the INF treaty, his string of broken legacy accords now appears likely to stretch further.

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Trump Administration Proposes Relaxing Rules On Waste From Coal Plants

Coal ash swirls on the surface of the Dan River following one of the worst coal-ash spills in U.S. history into the river in Danville, Va., in February 2014. The Environmental Protection Agency wants to ease restrictions on coal ash and wastewater from coal plants.

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Gerry Broome/AP

The Environmental Protection Agency has proposed relaxing two Obama-era regulations on waste products from coal-fired power plants, a move environmental groups say would prolong the risk of toxic spills or drinking water contamination.

The agency wants to ease restrictions on coal ash — the solid residue left over from burning coal — and wastewater from coal plants. In the rule changes announced Monday, plants could have up to five more years to close unlined coal ash ponds, which can leak contaminants into surrounding groundwater.

It’s the latest in a series of moves the Trump administration has taken to try and help the country’s ailing coal industry.

“These proposed revisions support the Trump administration’s commitment to responsible, reasonable regulations by taking a commonsense [sic] approach, which also protects public health and the environment,” EPA Administrator Andrew Wheeler said in a statement.

The utility industry lauded the proposed changes.

“The electric power industry is working to close coal ash basins in ways that put safety first, protect the environment, minimize impacts to communities, and manage costs for customers,” said Jim Roewer, executive director of the Utility Solid Waste Activities group, in an email. He also thanks EPA for “recognizing the technical challenges of meeting the deadline,” and praised a measure that would allow for “site-specific deadline extensions.”

Environmentalists said the rules would simply allow utilities to pollute for longer.

“Instead of having a single strong national set of public health protections for this polluting industry, we are going to be left with federal regulations that are riddled with loopholes,” said Tom Cmar, an attorney with the environmental group Earthjustice.

Coal ash is a powdery residue laced with heavy metals like arsenic, lead, and mercury. The rules governing it were spurred by a catastrophic coal ash spill in 2008, in Tennessee, that dumped millions of cubic yards of toxic slurry into nearby rivers.

Under a rule finalized in 2015, all unlined coal ash ponds were to begin closing in 2018, and to close no later than 2023. The Trump administration’s rewrite would allow some of these plants up to five more years to shut down these facilities.

Last year, a report from the Environmental Integrity Project found coal ash pollution was leaking into groundwater at over 200 power plants nationwide. It found over 90% of sites that store coal ash are leaking levels of contamination exceeding EPA health standards.

At one former coal plant near Pittsburgh, arsenic levels in the groundwater are 372 times EPA’s safe drinking water standards, though the report found no evidence that public drinking water supplies had been affected.

The report was based on data made available by the 2015 coal ash rule. The latest rollbacks would leave those reporting requirements in place.

The EPA also announced changes to a 2015 rule overseeing the discharge of coal plant wastewater. That proposal would relax some limits on the amount of pollutants allowed in wastewater, and let more of it be discharged. The EPA says newly developed technologies allow companies to take harmful materials out of the waste stream.

The EPA says the rule change would save $175 million in compliance costs to industry, and that a voluntary inventive program could prevent the discharge of about 105 million pounds of pollutants a year.

At the time it was created, the 2015 wastewater rule was expected to affect about 12% of coal-fired power plants, and keep 1.4 billion pounds of toxic metals and other pollutants out of rivers and streams. It was projected to cost industry $480 million a year, but save the public roughly the same in benefits, including from lowered health costs.

After several legal challenges to the rule, the EPA in 2017 postponed its implementation until 2020.

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Unskilled Jobs Draw Migrants, Changing Face Of Small Towns Across America

Principal T.J. Funderburg welcomes his mostly immigrant students during morning assembly at Cactus Elementary School.

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It is the 8 a.m. assembly at Cactus Elementary School, located on the bleak plains of the Texas panhandle. Kids with colorful backpacks and sleepy eyes sit cross-legged on the gym floor while their principal kick-starts the day: “Good morning, Cactus Elementary!” The students crow in response.

Many of them come from poor villages in faraway lands — Central America, Somalia, Myanmar, Congo, Haiti — and they’re clearly thrilled to be in school.

Principal T.J. Funderburg welcomes them all. “We need a world map to map where everybody comes from,” he intones in the microphone. “But we’re all here.

Over the past year, student enrollment at Cactus Elementary has surged from 300 to 400 children. The majority of new students are from Guatemala. They are part of a historic wave of more than half a million Central American parents and children who crossed the southern border, fleeing violence and poverty and asking for protection. After they were taken into custody and released to await their day in immigration court, many headed to the heartland where unskilled jobs are plentiful.

Cactus, Texas, is one of the places where America’s newest immigrants are coming, and their presence has had a profound effect on the elementary school.

“What we found is the students that come in from Guatemala and Africa, they may have had some education,” Funderburg says. “In Guatemala, they don’t start first grade until 8 or 9 years old. And so we’ve really had to rethink the way that we do everything.”

For instance, they need more English language teachers and they have fewer pop quizzes for the students who need lots of remedial help. The school also simply needs more space.

On Tuesday, voters will decide on a $107 million bond project for Dumas Independent School District, to which Cactus belongs. It includes a brand new elementary school for Cactus, in part, to accommodate all the recent immigrant children. The bond package is expected to pass.

“The elementary school is a center of pride in this community, a kind of jewel,” Funderburg says proudly.

Students at Cactus Texas Elementary gather for morning assembly on Oct. 22.

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John Burnett /NPR

One might expect locals to oppose a tax increase to educate migrant kids born thousands of miles away. After all, this is Donald Trump country — he won Moore County by 75 percent. The president wants fewer low-skilled immigrants like these, whom he says compete with Americans for jobs and drive down wages.

But Trump’s anti-immigrant rhetoric clashes with economic reality out here in the hardworking panhandle.

Most of the 3,200 residents of Cactus work at the massive JBS Cactus Beef Plant, located across the highway from the elementary school. It’s one of the largest meat processing plants in the nation. Cattle trucks arrive all day and all night; refrigerated trailers depart carrying ribeyes, fajitas and hamburger. The 3,000-plus workforce is overwhelmingly immigrant. The town of aging mobile homes even has its own mosque and Halal meat market.

The meatpacker is a magnet for immigrants because of its payscale as well as the language classes, medical benefits and subsidized housing the company offers. And with a turnover rate of 70 percent, they’re always hiring.

JBS also pays application fees for certain employees seeking U.S. citizenship. On this night, a handful of current and former employees have come to the nearby Cactus Nazarene Ministry Center to prep for the naturalization exam.

“Question number nine: George Washington was a general in the Vietnam War,” says a volunteer instructor. “Nope. Which war?” The students rifle their papers for the correct answer.

“The Revolutionary War!”

Workers on the “kill floor” make $15-$20 an hour. The chain moves fast — a single cutter may process 100 carcasses an hour. In a single eight-hour shift, three workers will butcher 2,500 animals.

“It’s hard, and it’s also dangerous,” says Sylvia Hernandez, a U.S. resident from Chihuahua, Mexico, who has worked at JBS for 10 years, and is studying for the citizenship test. “The kill floor is covered with blood, suet, fat, water.”

In 2006, Immigration and Customs Enforcement agents raided the plant, then owned by Swift & Company, and arrested 300 unauthorized workers. The plant, now owned by JBS — the Brazilian multi-national meat processor — says it carefully vets applicants to ensure a legal workforce.

“Historically, first-generation Americans, asylees and refugees have viewed our jobs as unique opportunities to pursue the American dream and provide a better future for their families,” JBS says in an emailed statement.

“If I’m a U.S. citizen and I speak English,” Hernandez continues, “I’m not going to work there. I’ll look for a better opportunity. It’s the people who don’t speak English who go to work at JBS.”

But it’s not just the beef plant that attracts immigrants to Moore County, where Cactus is located.

“There’s lots of work all over, not just in the plant,” says Rodrigo Gallegos, a 20-year JBS employee, “in the feedlots, the ranches, the dairies. There’s all kinds of work for people who don’t have papers, and for people who have papers.”

The unlimited availability of work for non-English speakers who are willing to do hard jobs has changed the character of Moore County, which used to be majority white. Today, it is 80 percent non-white. Bill Knight runs the local Greyhound station and serves as the GOP chairman. While the immigrant workforce is good for selling bus tickets, he says the fact that some foreign-born workers don’t assimilate rubs some old-timers the wrong way.

Moore County Judge Rowdy Rhoades, inside a courtroom, says his county is more multicultural and tolerant than it used to be.

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John Burnett/NPR

“The anglo, let’s say, feels like they’re not welcome in those Spanish stores because [store employees] are accustomed to speaking to the Spanish in Spanish, and not speakin’ to us in English,” Knight says.

But Moore County Judge Rowdy Rhoades says they’ve come a long way from the days when the county seat of Dumas was raw and racist.

“That was our culture,” he says. “I know back in the ’50s, they had a sign that said, ‘Blacks don’t let the sun set on you in Dumas, Texas.’ “

For decades, the huge beef plant has been a magnet for immigrant workers and Rhoades says most folks have adapted to the diverse population that is now a permanent feature of Moore County.

“So our world has turned around,” he says from his office inside the art deco courthouse.

Rhoades compares learning tolerance to putting on weight.

“You know what, it’s kinda like gettin’ fat. You don’t get fat all at once. You put weight on a little at a time. So you adjust, you change your clothes, you go up a size or two. You notice it, but you adapt.”

After all, Judge Rhoades says, if you like steak it’s got to come from somewhere.

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Microsoft Japan Says 4-Day Workweek Boosted Workers’ Productivity By 40%

Microsoft’s division in Japan says it saw productivity grow by 40% after allowing employees to work for four days a week rather than five. In this file photo, a sales clerk speaks with a customer in front of Microsoft Corp.’s display at an electronics store in Tokyo.

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Workers at Microsoft Japan enjoyed an enviable perk this summer: working four days a week, enjoying a three-day weekend — and getting their normal, five-day paycheck. The result, the company says, was a productivity boost of 40%.

Microsoft Japan says it became more efficient in several areas, including lower electricity costs, which fell by 23%. And as its workers took five Fridays off in August, they printed nearly 60 percent fewer pages.

All of the employees who took Fridays off were given special paid leave, the company says. Encouraged by the results, it’s planning to hold a similar trial in the winter.

Because of the shorter workweek, the company also put its meetings on a diet. The standard duration for a meeting was slashed from 60 minutes to 30 — an approach that was adopted for nearly half of all meetings. In a related cut, standard attendance at those sessions was capped at five employees.

In a blog post announcing the plan in July, Microsoft Japan said there was often no reason for meetings to run an hour, or to tie up multiple people from the same team.

Citing the need for a shift in time management, the Microsoft division also urged people to use collaborative chat channels rather than “wasteful” emails and meetings.

The news prompted excitement among many workers in Japan. A sampling of comments from the Asian news site Sora News 24 ranges from “Here’s to hoping my boss reads about this” to “So I guess me feeling like I’m ready to be done for the week by Wednesday is pretty natural.”

Four-day workweeks made headlines around the world in the spring of 2018, when Perpetual Guardian, a New Zealand trust management company, announced a 20% gain in employee productivity, and a 45% increase in employee work-life balance after a trial of paying people their regular salary for working four days. Last October, the company made the policy permanent.

The Microsoft trial roughly doubled Perpetual Guardian’s productivity gain. But for now at least, the company isn’t saying whether it will test the four-day workweek policy in other locations, or consider making it permanent.

Noting that Microsoft Japan’s “Work Life Choice Challenge 2019 Summer” was a pilot project, a Microsoft spokesperson tells NPR via email, “In the spirit of a growth mindset, we are always looking for new ways to innovate and leverage our own technology to improve the experience for our employees around the globe.”

Many employees might be heartened by the prospect of a three-day weekend, but trials like the recent one in Japan are still only drops in a very large bucket of companies and workers worldwide. While employers could now be more likely to experiment by shortening their own workweeks, workplace analyst and author Dan Schawbel says that for the time being, employees are more likely to focus on a more common workplace perk: flexibility.

“Younger people actually choose work flexibility over health care coverage, even though that expense in America is pretty high,” Schawbel says.

In the U.S., Schawbel sees schedule flexibility and a four-day week as two ways for employers to ease what he calls an ongoing burnout crisis.

At the heart of the discussion of workplace burnout and schedule flexibility is technology. The same electronic tools that have made working from home easier than ever, have also made it harder for employees to fully unplug from their jobs when they aren’t in the office.

It’s an area that’s already being explored in Europe, home of some of the world’s strongest work-life balance laws. France has granted employees the right to disconnect from their jobs, limiting email and other communications after hours, for instance.

But there are signs that the shorter workweek may increasingly become a political issue, similar to parental leave and other benefits. In the U.K., the Labor Party recently made the four-day workweek — at no change in pay — one of its central policies.

Backers of such moves point to a general trend toward shorter workweeks. When the Labour embraced the idea, shadow chancellor John McDonnell was quoted by Labour List as saying, “the average full-time working week fell from nearly 65 hours in the 1860s to 43 hours in the 1970s.”

Since the 1970s, the workweek has stopped shrinking despite sharp gains in worker productivity, McDonnell said. And as U.S. economists have noted, compensation has lagged behind productivity in that same period.

In 2017, a U.S. Bureau of Labor Statistics report found that from 1987 to 2015, productivity rose by as much as 5% annually in industry sectors from information to manufacturing and retail — but compensation never grew by more than 2% in each year of that same period.

Faced with decades of stagnant wage growth, it seems that many workers are now seeking more flexibility — and dreaming of a shorter workweek.

But the current enthusiasm for a four-day workweek should not be taken as proof that today’s employees simply want to avoid work altogether. To illustrate that point, Schawbel refers to what he calls “the money question” from an often-cited 2018 survey he conducted with Kronos.

The question was straightforward, as Schawbel recalls: “If your pay is constant, how many days a week do you want to work?”

One of the potential replies to that question was simply, “None.” But only 4 percent of the workers chose that answer. Only slightly more people chose one day, or two.

The biggest portion — 34 percent — said they want a four-day workweek. The current standard five-day week got 28 percent support. And 20 percent said they’d prefer a three-day workweek.

“It’s important,” Schawbel says, “because it shows people want to work.”

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