BAT: Latent Covid-19 Vaccine Ready for Human Trials

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British American Tobacco (BAT) said on Friday is ready to test its potential Covid-19 vaccine using proteins from tobacco leaves on humans, after it generated a positive immune response in pre-clinical trials, reports Reuters.

Once it gets approval from the U.S. Food and Drug administration (FDA) for the vaccine, the company plans to start testing on humans.

In April BAT announced it was developing a Covid-19 vaccine from tobacco leaves and could produce 1 million to 3 million doses per week if it got the support of government agencies and the right manufacturers.

Multiple companies from a variety of sectors have been racing to develop a vaccine for Covid-19, with some of the vaccines already in human trials. Experts have suggested that a Covid-19 vaccine could take 12-18 months to develop.

On Friday, BAT said it had submitted a pre-investigative new drug application to the FDA and that the agency had acknowledged the submission. BAT said it was also talking with other government agencies around the world about the vaccine.

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New York’s Ban on Flavored Vapor Products Begins May 18

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Sales of flavored vapor products come to close in the U.S. state of New York at retail stores beginning Monday May 18. Monday also brings a close to the sale of all tobacco products at pharmacies.

“Healthcare-related entities should not be in the business of selling tobacco, the leading cause of preventable death in New York State,” wrote Gov. Andrew Cuomo in a press release. “Ending the sale of tobacco and e-cigarette products in pharmacies will help reduce the availability, visibility and social acceptability of tobacco use, especially to youth.”

The measure also makes it illegal to sell electronic nicotine delivery systems (ENDS) online, by phone and by mail order.

New York became the first state in the country to ban flavored electronic cigarettes in September of last year. Cuomo announced the decision as part of a series of efforts to combat the increase in young people using vape products. Cuomo said in a statement that it was “undeniable” that flavors like bubblegum and cotton candy are deliberately designed to target youths.

 

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Los Angeles Vape Shops Challenging Flavor Ban

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A new Los Angeles County ordinance that prevents the sale of flavored tobacco products is being challenged in court by vape shop owners.

On May 4, CA Smoke & Vape Association and Ace Smoke Shop filed a federal lawsuit against the rule that also requires businesses to obtain two additional licenses and imposes new tobacco product standards according to legalnewsline.com, the “great majority” of vapor products and devices will be prohibited, the lawsuit says. It complains that products containing THC are exempted, even though it is “the primary source linked to the outbreak” of recent illnesses, the lawsuit states.

“Similarly, the ordinance makes no distinction between the black-market vaping products at the center of that outbreak and the FDA-regulated products produced by legitimate manufacturers,” the lawsuit states. “Instead, the ordinance implements a blanket prohibition on the sale of flavored tobacco products to all persons, threatening to destroy an entire industry and the livelihoods of Los Angeles County residents.”

The plaintiffs in U.S. District Court for the Central District of California case number 2:20-cv-04065 are represented by Jawlakian Law Group.

 

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India’s Vapor Ban’s Unintended Consequences

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A small but burgeoning product category was blighted when India prohibited the import, production, advertising and sale of vapor products in late 2019. The nationwide ban came after several states and union territories had implemented similar restrictions on electronic nicotine-delivery systems (ENDS) in previous years.

“This was the culmination of a five-year effort to ban e-cigarettes, which began in 2014 when the central government set up three panels to advise on the way forward,” explains Samrat Chowdhery, founder and director of the Association of Vapers India (AVI). “The way these committees were constituted—staffed with anti-tobacco harm reduction [THR] tobacco control experts and government officials—the outcomes were pre-decided and all three recommended a ban.”

Since then, the government had been turning on the screws. Opposition by consumers and later the vapor industry delayed the process but failed to prevent Parliamentary action. “Because of this uncertainty from the start, the e-cigarette market in India grew haphazardly without the involvement of major industry players and much below its potential,” laments Chowdhery.

Reliable data on India’s fragmented vapor market at the time of the ban are hard to obtain. Euromonitor reckons that around 0.6 percent of Indians used ENDS in 2018—a figure Chowdhery calls “conservative”—up from the 0.2 percent the World Health Organization (WHO) estimated for 2016–2017.

With online platforms being the key purchasing channels, according to Euromonitor, the Indian vapor industry comprised mainly small businesses—retailers, wholesalers, e-liquid manufacturers and a few vape shops, according to Chowdhery. “Devices were not made in India, relying solely on imports from China,” he says. “Still, the outlook for the market was good, slated to grow at 60 percent per year until 2022, following Euromonitor’s India report.”

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U.S. Fourth Circuit Denies PMTA Appeal

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The Fourth Circuit on Monday dismissed an appeal from various vaping groups challenging a compliance deadline for vapor products. The decision states that January directives from the U.S. Food and Drug Administration (FDA) have rendered the appeal moot.

In a per curiam opinion, the appellate judges held that guidance issued by the FDA in January moots the vape groups’ appeal because that guidance supersedes older directives from August 2017 at issue in the appeal and leaves “no possible meaningful relief” that the court could grant, according to law360.com.

“Any ruling by this court as to the procedural or substantive reasonableness of the August 2017 guidance would amount to nothing more than an advisory opinion,” the court said.

The appeal stems from a Maryland district court ruling that ordered the agency to set a May 2020 deadline for premarket tobacco product applications (PMTA) on smokeless tobacco products. The FDA, along with various health and anti-vaping groups, had argued that the January guidance restricting the sale of flavored, cartridge-based vapes rendered moot the vape groups’ appeal.

“Because the enforcement timetable for e-cigarettes set out in the January 2020 guidance is independent of the district court’s order, an order by this court reversing the district court would have no effect on FDA’s enforcement of the statute and regulations against e-cigarette manufacturers,” the agency had previously said.

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Juul Moving to D.C.

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Juul Labs is moving its headquarters from San Francisco to Washington, D.C.

The company has faced much regulatory backlash in the past years as they have been accused of marketing to youth and faced many lawsuits. Moving headquarters to Washington will put the company closer to regulators and distance it from “Silicon Valley’s growth-at-all-costs culture,” according to people familiar with the matter.

The move follows other restructuring efforts, such as cutting the workforce, closing some U.S. offices, and scaling back in Europe and Asia.

Juul Labs will remain a large presence in San Francisco, where the company will continue product and software development.

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Struggling for Survival

Photo: VPZ
The vapor industry is suffering serious hardships due to closures caused by Covid-19.

By Timothy S. Donahue

Several countries have considered vape shops essential businesses during the coronavirus pandemic. Countries such as Spain, France and New Zealand have allowed e-cigarette users to continue to have access to nicotine without returning to combustible cigarettes. In many countries such as the U.K. and the U.S., however, vape shops have been forced to close and many business owners say they may never be able to recover.

In the U.K., VPZ, the country’s largest vapor retailer, vowed to keep its shops open. On March 20, the company urged British leaders to follow the lead of other European countries and allow all 155 VPZ stores across the U.K. to be added to the list of essential businesses. That request was denied. On March 23, VPZ announced it would be closing all its locations. In an email, Doug Mutter, director of compliance and manufacturing for VPZ, said the company was disappointed with the lack of explanation from the government concerning the status of vapor retailers.

Doug Mutter | Photo: VPZ

“Other European nations had recognized the work vaping specialists do in reducing the stress on health services and [have] kept the local stores open,” he said. “We had expected this to be the case and had begun investing in new processes in order to manage our business in such an environment. However, without sufficient clarification and in the interest of keeping our staff and customers safe, we have made the decision to close all 155 stores … for the next three weeks.”

James Jarvis

James Jarvis owns four shops in the U.S. state of Ohio. Jarvis also heads the Ohio Vapor Trade Association (OHVTA), an industry advocacy group. He closed his Vapor Station locations in Clintonville, Columbus, Gahanna and Hilliard on March 23. He said that while the governor of Ohio has shown great empathy to Ohioans regarding the coronavirus, the OHVTA knew it needed to recommend that its members make consumers aware that a stay-at-home order or shutdown would be likely at some point, and all shop owners needed to inform customers.

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Experts: Call for Vape Bans Made Covid-19 Worse

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Anti-vaping activist groups continue to use the coronavirus crisis to advance their goal of restricting — or even completely banning — the use of vapor products. They argue that vapers are at higher risk of harm from COVID-19.

However, the available evidence indicates the opposite: If they had worked to convince more smokers to switch to e-cigarettes, there might be fewer coronavirus-related deaths today, according to a story on insidesources.com.

That’s the view of Dr. Michael Siegel, professor of community health sciences at the Boston University School of Public Health.

“It’s absolutely true that if more public health activists had embraced e-cigarettes instead of opposing them and more smokers had been encouraged to switch, there would be less mortality from COVID-19 today,” Siegel told InsideSources. An estimated 2.5 million smokers have given up traditional cigarettes for vaping and other similar technologies.

Siegel has spent much of his career working to reduce smoking and is no friend of Big Tobacco. At the same time, he embraces the “mitigation over prohibition” model for reducing tobacco use. Anti-tobacco prohibitionists — hoping to get every smoker to “just say no” — are fighting an unwinnable battle, Siegel said, according to the story.

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Nicotine Patches Tested on Coronavirus Patients

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French researchers are planning to test nicotine patches on coronavirus patients and frontline workers following a study suggesting smokers are less likely to catch the virus according to The Guardian.

The Paris-based study suggests that something in tobacco helps prevent smokers from contracting the virus, but researchers say they are not encouraging people to take up smoking; cigarette smoke causes damage to the lungs, which can cause individuals who have contracted Covid-19 to suffer more severe symptoms.

Jean-Pierre Changeux, a renowned French neurobiologist, suggested nicotine may stop the virus from reaching cells in the body. Nicotine may also lessen the overreaction of the immune system that has been seen in the most severe Covid-19 cases.

The results coincide with a Chinese study showing that only 12.6 percent of 1,000 infected individuals were smokers whereas the national smoking rate is around 28 percent. In Paris, 8.5 percent of 11,000 Covid-19 patients were smokers while the total number of smokers in France is about 25.4 percent.

“Our cross-sectional study strongly suggests that those who smoke every day are much less likely to develop a symptomatic or severe infection with Sars-CoV-2 compared with the general population,” the report authors wrote. “The effect is significant. It divides the risk by five for ambulatory patients and by four for those admitted to hospital. We rarely see this in medicine.”

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FDA Warns CBD Companies Over Illegal Claims

The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act. This action is part of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.

“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy.

“CBD has not been shown to treat opioid addiction. opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”

The two warning letters were issued to Biota Biosciences of Washington state and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire.

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Opinion: Four-Month FDA Extension Not Sufficient

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Consumers are staying home and spending less as COVID-19 and social distancing mandates sweep across the globe. The extreme, necessary steps to control the spread of the virus have already taken an economic toll, and there certainly will be a long-term impact on individual businesses and workers. One industry, in particular, will likely fail without swift federal action: e-cigarettes, according to Michelle Minton with the Competitive Enterprise Institute.

Cigarettes may prove “pandemic-proof.” Since they are often sold at outlets deemed “essential” under the current lockdown, cigarettes continue to be available and big tobacco companies have so far remained financially unscathed. But the same is not true for their lower-risk competitors. Vape shops, which sell vapor products, like e-cigarettes, have not been universally recognized as essential businesses, so they have been forced to close.

To maximize ways to fight the virus, many states have pressed pause on certain rules and regulations (leading many to wonder if they were #NeverNeeded in the first place.) For example, Vermont Governor Phil Scott signed an order lifting the state ban on home alcohol delivery. This was a pragmatic move, as Reason’s Guy Bentley aptly put it. Vermont lawmakers understand that people still want to imbibe, and at-home delivery discourages unnecessary booze runs.

Yet that pragmatism hasn’t been extended to e-cigarettes, and Governor Scott’s online e-cigarette sales ban enacted last year remains in place. As a result, some adults now find themselves cut off from the products they rely on to stay smoke-free. Without swift federal action, they may be cut off permanently as vape shops go belly up, and many people will revert to smoking.

The last year has already been difficult for those who sell and enjoy vapor products. Even as the evidence that e-cigarettes are relatively harmless for adults and highly effective for smoking cessation has become clearer, calls to ban or restrict e-cigarettes have only grown louder. Groups that oppose nicotine use, no matter how safe, ramped up attacks, spending millions to promote the idea that e-cigarettes are no different than cigarettes and to foment panic over the non-existent “epidemic” of youth vaping.

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Figr Introduced in British Columbia

Pyxus International’s wholly owned indirect subsidiary Figr Brands has introduced its legal recreational cannabis products into British Columbia, Canada, marking Figr’s first western provincial entry in its planned expansion across the country.

Figr’s cannabis products, including the brand’s two newest strains, are now available for purchase through BC Cannabis.

“Figr’s entrance into British Columbia is an exciting step for Figr as the company continues to expand across Canada,” said Pieter Sikkel, Pyxus president and CEO. “We are proud of Figr’s dedication and commitment to providing Canadians new and continued access to high-quality, fully traceable cannabis products, particularly as Canada navigates the unprecedented challenges of the Covid-19 crisis. Cannabis is considered an essential business in British Columbia, and Figr is committed to meeting the demand of consumers while protecting the health and well-being of its employees.”

Within the last nine months, Figr has expanded into three new markets across Canada as well as introduced its initial suite of Figr 2.0 products. Figr’s products are now available in five Canadian provinces through retail locations and online stores, including Prince Edward Island, Nova Scotia, New Brunswick, Ontario and British Columbia.

All of Figr’s cannabis products are tracked from seed-to-sale by SENTRI, Pyxus’ proprietary track-and-trace platform.

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Study: States With Legal THC had Fewer EVALI Cases

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States with laws legalizing recreational marijuana had fewer cases of e-cigarette/vaping-related lung injury (EVALI) than states without such policies in 2019, researchers reported.

In states that had legalized recreational marijuana, the EVALI case rate averaged 1.7 per million population (95% CI 0.3-3.1), far lower than states where it’s legal only for medical purposes (8.8 per million, 95% CI 5.1-12.5) or completely illegal (8.1 per million, 95% CI 4.1-12.0), reported Alex Hollingsworth, PhD, of Indiana University in Bloomington, and colleagues, according to an article on medpagetoday.com.

Moreover, the number of cases was significantly lower in states with legal recreational marijuana compared to those where it was not after adjusting for vaping rates (difference 7.2 cases per million, 95% CI -11.8 to -2.6, P=0.003), they wrote in a JAMA Network Open research letter, according to the story.

“It appears states that have legal access to marijuana have lower rates of EVALI cases, which is consistent with the hypothesis that people have demand for marijuana products, and in states where they don’t have access to them in this regulatory fashion, they end up purchasing them elsewhere,” Hollingsworth told MedPage Today.

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Avail Donates More Than 5,000 Masks to Medical Efforts

James Xu

Avail Vapor has donated more than 5,000 masks to the Virginia Department of Emergency Management to help medical professionals on the front lines of the coronavirus battle protect themselves.

The idea came to light a few months ago when Avail employees heard about the shortage of masks in China when Covid-19 initially struck. Avail works closely with many Chinese suppliers, and Avail employees wanted to support these suppliers in their time of need.

Employees from around the U.S. gathered masks to donate; as a result, Avail shipped thousands of masks to its overseas partners. Now that the United States is experiencing a shortage in masks, those same Chinese colleagues have returned the generosity and shipped thousands of masks to Avail headquarters for employees and health care workers.

“To be successful, our business has always been highly collaborative with global partners,” said James Xu, CEO and chairman of Avail, and a Chinese American. “To see our employees proactively answer a need for their Chinese counterparts was special. Now we are so grateful to our Chinese friends for helping us defend our citizens in this pandemic.”

In addition, Avail has implemented new programs to help its customers during this unprecedented time. Since March 18, 2020, Avail customers who are burdened with a financial impact from Covid-19, as well as those in the medical community or who are first responders, have been eligible for a one-time purchase of select e-liquids for a penny ($0.01 transactional fee plus applicable taxes). Avail is also offering call-ahead and curbside pickup at all retail locations, as the health, safety and well-being of its staff and customers is paramount.

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RELX Sends Relief Supplies to International Customers

Courtesy: RELX

RELX Technology announced the extension of the RELX “For You With Care” project to support its international partners during the COVID-19 crisis. RELX will initially send 78,200 masks and over 515 gallons of hand sanitizer to its global distributors, partners and store owners.

The supplies will be sent to countries in Asia, Europe, Canada and South America. RELX will continue to follow the developments of COVID-19 globally and will send essential supplies to its partners and employees that are in need.

“RELX is wholly committed to supporting the well-being of our employees, partners, and store owners during the COVID-19 pandemic. As a global startup, we are doing what we can to help our global community. We hope our modest donation will help them during these trying times,” said RELX founder and CEO Kate Wang.

In lateJanuary, RELX kicked off the RELX For You With Care Project by donating RMB 1million to the Institute of Psychology, China Academy of Science through theShanghai Soong Ching Ling Foundation to support a training program designed toprovide mental health support services.

Courtesy: RELX
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U.S. House Subcommittee Asks FDA to Ban Vapor

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In what turned out not to be an April Fool’s Day joke, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter urging the U.S. Food and Drug Administration (FDA) to use its authority to clear the market of e-cigarettes for the duration of the coronavirus pandemic and use all available tools to encourage Americans to stop smoking and vaping.

Earlier this week, FDA asked a federal court to delay by four months its order requiring e-cigarette manufacturers to submit applications to remain on the market by May 12, 2020, according to a statement from, according to a statement for the House Committee on Oversight and Reform. 

The Subcommittee did not oppose this request, but instead asked FDA to take the following steps for the duration of the coronavirus crisis: 

(1)  use all available tools to encourage Americans to stop smoking combustible cigarettes and using e-cigarettes;|
(2)  suspend all approvals of Premarket Tobacco Product Applications; and
(3)  commit to immediately clearing the market of all e-cigarettes by prioritizing enforcement against them.

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Breaking: U.S. FDA to Announce Sept. 9 PMTA Deadline

While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.

Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.

The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.

For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.

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U.K. vapor industry asks government to keep vape shops open

March 20, 2020

The U.K. vapor industry is urging the government to keep vape stores open across the country, rather than forcing them to close as part of any intensification of its coronavirus containment strategy. Closing vapes stores, the industry argues, would be a potentially counterproductive move that could place further strain on the already overstretched National Health Service.

In an open letter to Nadhim Zahawi, Parliamentary Under-Secretary of State at the Department for Business, Energy and Industrial Strategy, the U.K. Vaping Industry Association (UKVIA), the largest trade body representing the vaping sector in the U.K., calls for vape shops in cities, towns and rural areas to stay open and be exempt from any government lockdown.

In the letter the UKVIA cites the experience of Italy, the country in Europe hit hardest by coronavirus so far and where the government reversed its decision to close vape stores as part of its containment program.

The letter to the British Minister reads: “We recognize and support the government’s intensified containment plan for the virus but would urge you and your colleagues to look at the example of Italy.

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Vape shop inspections suspended by US FDA due to COVID-19 concerns

March 23, 2020

The U.S. Food and Drug Administration (FDA) has ended activities such as domestic compliance checks and vape shop inspections, the health regulator said, as its staff switch to teleworking amid the fast-spreading coronavirus outbreak.

The health regulator has been scaling back domestic and foreign inspections in the wake of the outbreak, which has infected more than 227,700 people across 175 countries, based on a Reuters tally, according to a story on Reuters.com.

In the United States, the virus has infected over 10,000 people and caused 150 deaths, according to the U.S. Centers for disease Control and Prevention.

The FDA has already temporarily deferred all domestic routine surveillance facility inspections and postponed most foreign inspections through April.

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Largest vape shop chain in Britain remains open during COVID-19 crisis

March 23, 2020

Britain’s largest vaping chain has vowed to keep its shops open amid the coronavirus crisis to stop ex-smokers turning back to cigarettes and is urging the Government not to close vape retailers in a lockdown.

VPZ, which has 155 outlets across the UK, said Britain must follow the lead of countries such as Italy and Spain by ensuring that vaping stores join the list of essential shops allowed to stay open in the event of a total lockdown, according to a story in the dailymail.

The Edinburgh-based group said ex-smokers could be put at significant risk of complications with Covid-19 if they end up relapsing on cigarettes because they are unable to buy vaping products.

This could put the NHS under unnecessary extra strain, VPZ said.

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