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FDA bans personal genetic test kit

Written By Unknown on Rabu, 27 November 2013 | 23.58

26 November 2013 Last updated at 07:04 ET

The US Food and Drug Administration has imposed a ban on a company offering personal genetic screening to the general public.

Google-backed 23andme has been ordered to "immediately discontinue" selling its saliva-collection tests after failing to provide information to back its marketing claims.

The tests aims to show how personal genetic codes may affect future health.

The company said it would address concerns.

The start-up has been operating since 2006 and was co-founded by Anne Wojcicki, the wife of Google co-founder Sergey Brin.

For $99 (£61), users receive a kit allowing them to take sample of saliva. This is sent to the company and in return users receive a readout of their genetic code.

The website promises reports on 254 health conditions and traits as well as offering to help people trace their genealogy.

Under FDA rules, the company must provide proof about how accurate its detection methods are as well as supplying the error rates from its personal genome service (PGS).

In a public letter the FDA said that 23andme had not supplied this information, despite increasing its marketing campaign and the scope of its tests.

"FDA is concerned about the public health consequences of inaccurate results from the PGS device - the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work," said Alberto Gutierrez, director of the FDA's centre for devices and radiological health, in a letter to the company.

"Patients relying on such tests may begin to self-manage their treatment through dose changes or even abandon certain therapies depending on the outcome of the assessment," he added.

Build-a-baby

Despite hundreds of emails and 14 face-to-face meetings with 23andme, little evidence had been provided, the agency added.

The company said: "We recognise that we have not met the FDA's expectations regarding timeline and communication regarding our submission.

"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

The Center for Genetics and Society said it welcomed the FDA's stance.

"Our society regulates medical products to protect public health. Without strong public oversight, we're back to the era of snake oil," said executive director Marcy Darnovsky.

"The public agency charged with protecting public health has finally lost patience with a private company that seems to think it doesn't have to play by the rules," she added.

It is not the first time the company has hit the headlines. A "build-a-baby" patent, which offered to show perspective parents what traits a future baby may have, was criticised by the Genetics and Society organisation.

The company described the system as an enjoyable way for parents to "dip their toes into genetics".

There are an increasing number of companies offering low-cost home genetic testing - but some medical experts have raised questions about the accuracy of the tests, and asked what benefit they offer to consumers.


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Blackberry shakes up top management

25 November 2013 Last updated at 22:50 ET

Struggling smartphone maker Blackberry has shaken up its top management as part of its continuing reorganisation.

The firm's chief financial officer, Brian Bidulka, will be replaced by James Yersh who has previously served as controller and head of compliance.

The chief marketing officer and chief operating officer will leave the firm with no replacements announced.

This comes just weeks after the firm appointed a new interim chief executive as it shelved a plan to sell itself.

Blackberry named John Chen as the interim chief executive officer as it announced it had abandoned a planned sale to its biggest shareholder, Fairfax Financial Holdings.

The management changes are the first major move made by Mr Chen.

'Working more closely'

Blackberry once dominated the smartphone market, but has seen its fortunes dwindle in recent years,

It has been hurt by the success and popularity of smartphones launched by rivals such as Apple and Samsung. Its attempts to boost its market share have not yielded the desired results.

In September, it reported a net loss of $965m (£597m) for the second quarter, blaming poor sales of its new smartphone, the Z10.

The firm has also announced a plan to cut 4,500 jobs, or 40% of its workforce, to reverse the giant losses.

Mr Chen said the management changes were aimed at refining the company's strategy "to ensure we deliver the best devices, mobile security and device management".

"I look forward to working more directly with the talented teams of engineers, and the sales and marketing teams around the world to facilitate the BlackBerry turnaround and to drive innovation," he added.


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YouTube toughens comment checks

27 November 2013 Last updated at 10:54 ET By Leo Kelion Technology reporter

Google has acted to tackle abuses of YouTube's comments system that were made possible by it tying the posts to its Google+ social network.

The firm said it had taken steps to improve recognition of "bad links" and detection of Ascii art - drawings created out of punctuation and other characters.

The inclusion of web addresses and art in YouTube posts only became possible after the switchover.

Using Google+ has proved controversial.

An online petition has raised more than 216,000 signatures calling for the comments section to return to its original form.

It objects to the fact that tying YouTube to Google+ makes it harder to stay anonymous since members of the social network are supposed to provide their real first and last names.

That change was intended to combat spam, which the US firm said had "plagued" YouTube for years.

However, some users have complained that by allowing links and art in comments Google had instead exacerbated the problem.

Security blogger Graham Cluley wrote that by allowing links the firm had made it "easier than ever for spammers, make-money-fast-scammers and malware-spreaders to get airtime".

Meanwhile, the Ars Technica news site reported on the rise of what it called "comment pornographers" - people who post pictures of genitalia made out of dots, dashes and other symbols.

One of YouTube's most popular members, Swedish video game commentator Felix Kjellberg, had been one of those who had temporarily blocked comments on new videos as a consequence.

"Front page/top comments are filled with links to virus sites, advertisers, self-advertisers, spam, [and] copy-and-paste pics," the clip-maker known as PewDiePie wrote.

Google said it had now changed the way long comments were displayed, making it harder to show drawings, and promised to offer video creators more control over their viewers' posts.

"Bulk moderation has been a long standing creator request and we'll be releasing tools for that soon," it said. "At the same time, we're also working on improving comment ranking and moderation of old-style comments."

One company watcher said it was important for the firm to ensure the switchover was a success.

"There is the rationale that it will help drive the adoption of Google+, which I think it is fair to say has struggled against competing social networks," said Richard Broughton from the consultants IHS Screen Digest.

"It will also help with the monetisation of YouTube over the coming years.

"Having information about the people who are consuming the videos - thanks to them being linked to a Google+ account - provides an awful lot of information, which is of use to advertisers.

"But making this scale of change to a network that has more than one billion regular users worldwide will inevitably offend or annoy some of them."


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Qualcomm faces China antitrust probe

25 November 2013 Last updated at 20:58 ET

China has launched an antitrust probe against one of the world's biggest chipmakers, the US firm Qualcomm.

Qualcomm said the probe involved China's anti-monopoly law, but added that regulators told it the "substance of the investigation is confidential".

The firm said that it was "not aware or any charge" by the regulators that it had broken the law.

China has increased scrutiny of business practices that lead to higher prices for consumers.

In August, Chinese regulators levied a record fine of 670m yuan ($109m; £71m) on six foreign producers of baby milk formula for price-fixing.

China's National Development and Reform Commission, the body which is probing Qualcomm, also launched a pricing investigation into the pharmaceutical industry earlier this year.

4G launch
Continue reading the main story

You're getting ready to have this battle over 4G royalties and now you have this antitrust investigation"

End Quote Cody Acree Williams Financial

The investigation against Qualcomm also comes at a time when China is gearing for the launch of 4G Long Term Evolution (LTE) Networks.

The country will start commercial 4G mobile communications services on 18 December.

China Mobile, the country's biggest mobile operator with over 700 million users, will be the first one to offer the services to its subscribers.

That will be followed by China Unicom and China Telecom, the country's other two major carriers.

The US firm is a key player in the area and some analysts suggested the probe against it may be an attempt to help domestic players in China.

"We suspect this investigation is related to the forthcoming launch of TD-LTE by China Mobile... and the negotiations on chip pricing and license pricing between Qualcomm and Chinese-based handset [manufacturers] that are likely occurring right now," said Travis McCourt an analyst with Raymond James & Associates.

Cody Acree, an analyst with Williams Financial, added: "You're getting ready to have this battle over 4G royalties and now you have this antitrust investigation".

"It may well be that this reform commission is beginning to throw up reasons and excuses for why China doesn't pay royalties on 4G."


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Microsoft Xbox One bans swear words

26 November 2013 Last updated at 07:57 ET

Users of Microsoft's Xbox One console caught swearing in video clips are having their accounts suspended.

Files containing "excessive profanity" will be taken down and their owners will have access to some features on Xbox Live removed.

Microsoft said all files uploaded to its Upload Studio were monitored for violations of its code of conduct.

The review process was to help maintain a clean, safe and fun environment for all users, the company said.

Direct peer-to-peer communications such as Skype chats and calls are not monitored by the Xbox Live enforcement team, according to Microsoft.

Xbox Live, which allows users to upload media files, including videos they have made, and take part in multiplayer games, was available on previous Microsoft consoles, but the company says the new Xbox One console has a more sophisticated system of enforcement.

"As a result, if someone misbehaves on the service, we may only suspend some of their privileges," said a Microsoft spokesperson.

The XBox One was launched in the UK and 12 other countries on 22 November.

Rumours of account suspensions first surfaced on gaming forums, with one user noticing they could not upload videos after previously posting one containing a "bad word."

Ban or suspend

Responses to the action taken by Microsoft were varied.

"I question the validity of this, but the average gamer is 32. I don't mind hearing someone saying it. Free speech," said one member.

Another thought some moderation was necessary: "Game uploads get sent to everyone. You see them when you browse a game etc. There has to be some control and moderation. Your private conversations are not censored or moderated. Only what you share with the public which includes little kids."

Keza MacDonald, UK games editor at IGN.com, said new features on the latest consoles presented challenges for companies.

"What's happening with the new generation of gaming consoles is that they are increasingly incorporating social network-like features - there's a lot more sharing and communication between players, which means more potential for abuse of the terms of service.

"Both Xbox One and PlayStation 4 have robust parental controls, but those don't apply to content or video that players are uploading and sharing themselves.

"For this reason both Microsoft and Sony are strongly enforcing the terms of service... which is especially important when these consoles are in people's living rooms," she said.

Users of rival console, Sony's PlayStation 4, may also experience a ban if they fail to adhere to the program's terms of service.

Twitch allows gamers to "broadcast, play and chat" using a live streaming service but after reports of people using the feature to show sexual content the company announced that any streams not about gaming or games would be moderated and turned off.

"Twitch has a very strict terms of service policy. We are very vigilant about removing content that breaks the TOS guidelines and depending on the severity of the violation we will either ban or suspend accounts," the company said in a statement given to the website Kotaku.

The service is already very popular via other platforms but the PlayStation 4 is the first console to integrate the Twitch broadcasting feature.

The PlayStation 4 goes on sale in the UK on 29 November.


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Net names .bike and .guru available

26 November 2013 Last updated at 09:03 ET

Nine new web address suffixes, including .bike, .clothing, .singles and .guru, have been made available as the net names system undergoes a radical shake-up.

The new names, formally known as generic top level domains (gTLDs) are currently open only to those with registered trademarks.

They will be open to the general public at the end of January 2014.

New names are expected to be released at a rate of about 10 a week.

Continue reading the main story
  • .guru
  • .ventures
  • .camera
  • .clothing
  • .lighting
  • .singles
  • .voyage
  • .holdings
  • .equipment

Last month four new domains were launched: شبكة, the Arabic word for "web"; 游戏, the Chinese word for "game"; and the Russian words for "online" and "web site", онлайн and сайт.

Approximately 1,400 new gTLDs are expected to come online in the next few years.

The Internet Corporation for Assigned Names and Numbers (Icann) believes that the new set of names will transform the way business is done online.

"From fashion brands and dating agencies, to spiritual healers and cycle advocates, the launch of these new domains mean consumers can easily find specific content within each extension, while businesses will benefit from a stronger and more relevant online proposition," said Jan Corstens, project director of Icann's Trademark Clearinghouse.

Icann has invited companies to submit applications for names they would like to register.

Firms have come forward to request almost 2,000 new names including the likes of .porn, .ninja, and .ferrari. The BBC has expressed an interest in .bbc.

As well as domain names set aside for brands there will be around 700 more generic names, such as .shop, .hotel and .site.

But not everyone thinks that the shake-up is necessary. The Coalition Against Domain Name Abuse estimates that companies will need to spend thousands of pounds to ensure their brands are not hijacked by others.


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Sony files patent for 'SmartWig'

27 November 2013 Last updated at 02:42 ET

Sony has filed a patent application for "SmartWig", as firms jostle for the lead in the wearable technology sector.

It says the SmartWig can be worn "in addition to natural hair", and will be able to process data and communicate wirelessly with other external devices.

According to the filing, the SmartWig can help navigate roads and collect information such as blood pressure.

Google and Samsung are among the firms that have launched products in wearable technology - seen as a key growth area.

"Wearable gadgets are definitely going to be one of the big areas of growth over the next two years," Andrew Milroy, an analyst with consulting firm Frost & Sullivan, told the BBC.

"And Sony - which is trying to regain some of the sheen it has lost in recent years - clearly understands that and wants to play a major role in the sector."

'Very popular'
Continue reading the main story

The usage of a wig has several advantages that, compared to known wearable computing devices, include a significantly increased user comfort"

End Quote Sony patent filing

The Japanese firm said the wig could be made from horse hair, human hair, wool, feathers, yak hair, buffalo hair or any kind of synthetic material.

At the same time, the communication interface and sensors placed in the wig are at least partly covered by parts of the wig in order to be hidden from sight during use.

It said that as a result, the device has the potential to become "very popular" as it could be used as a "technically intelligent item and fashion item at the same time".

"The usage of a wig has several advantages that, compared to known wearable computing devices, include a significantly increased user comfort and an improved handling of the wearable computing device."

Potential uses

Sony listed various potential uses of the SmartWig in its filing, including helping blind people navigate roads.

It said that a small video camera or a sensor on the wig could help to provide the position and the location of the wearer.

A remote user can then use the images provided and send vibration commands through the network and navigate the wig user manually to a desired destination.

"Although navigation systems based on vibration motors have been widely introduced, a navigation system integrated into a wig... is so far not known," the firm said.

A further potential improvement of the wig may use ultrasound waves to detect objects around a user.

Sony said the gaming industry or "any type of virtual reality appliance" could also be an "interesting field" of use for the device, though it did not provide any details.

It could also have uses in the healthcare sector, as a combination of sensors can help collect information such as temperature, pulse and blood pressure of the wearer.

"The system can detect these kinds of data naturally and transmit them to the server computer," it said.

The device can also be used during presentations where a wearer can "move to the next presentation slide or back to the preceding presentation slide by simply raising his/her eyebrows".

A Sony spokesperson told the BBC that the firm had not decided on any plans for commercial production of the SmartWig yet.


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NSA 'plan to shame web-porn users'

27 November 2013 Last updated at 08:26 ET

The US authorities have studied online sexual activity and suggested exposing porn site visits as a way to discredit people who spread radical views, the Huffington Post news site has reported.

It published a document, leaked by former National Security Agency contractor Edward Snowden, identifying two Muslims said to be vulnerable to accusations of "online promiscuity".

An official said this was unsurprising.

But campaign group Privacy International called it "frightening".

"Without discussing specific individuals, it should not be surprising that the US government uses all of the lawful tools at our disposal to impede the efforts of valid terrorist targets who seek to harm the nation and radicalise others to violence," Shawn Turner, director of public affairs for National Intelligence, told the Huffington Post.

Continue reading the main story

Microsoft is considering rolling out new encryption initiatives, according to a report in the Washington Post.

It says Microsoft is concerned about a programme called Muscular alleged to involve the NSA and GCHQ working together to intercept data from the private cables connecting companies' computer servers.

Google and Yahoo have already announced similar moves.

By digitally scrambling the information, the companies would make it harder for the agencies to make sense of intercepted files, potentially making the cyber-spies more reliant on formal requests.

However, both the NSA and GCHQ are also known to be working on counter-encryption efforts.

A spokeswoman for Microsoft was unable to comment at this time.

Privacy International said: "This is not the first time we've seen States use intimate and private information of an individual who holds views the government doesn't agree with, and exploit this information to undermine an individual's message."

The report came shortly after a group of United Nations experts adopted a "right to privacy" resolution.

The UN's Human Rights Committee said it was "deeply concerned at the negative impact" the interception of data "including extraterritorial surveillance" could have "`in particular when carried out on a mass scale".

The resolution will be passed by the UN's General Assembly before the end of the year, but is largely symbolic since it is not legally binding.

'Sexually explicit'

The latest of Mr Snowden's leaked document is dated October 2012 and says it was distributed by the office of the director of the NSA to other US government officials.

It names six Muslims whom it describes as "prominent, globally resonating foreign radicalisers" about whom surveillance efforts had revealed potential "vulnerabilities that can be exploited".

It says the information is largely based on gathered "Sunni extremist communications", including material sourced by the FBI.

"Some of the vulnerabilities, if exposed, would likely call into question a radicaliser's devotion to the jihadist cause, leading to the degradation or loss of his authority," it says.

One example is evidence of the target "viewing sexually explicit material online or using sexually explicit persuasive language when communicating with inexperienced young girls".

Others include proof of the target:

  • using donations to pay personal expenses
  • charging exorbitant speaking fees
  • using questionable sources and contradictory language in public messages

None of the six individuals who appear in the report are accused of being directly involved in terrorism.

But the document says one of the two said to have been involved in "online promiscuity" had previously been imprisoned for inciting hatred against non-Muslims, and the other had been involved in promoting al-Qaeda propaganda.

Of the four other targets, one is said to be vulnerable to being exposed for being "attracted to fame" and another for having a "glamorous lifestyle".

Privacy International spokesman Mike Rispoli said: What is frightening about the NSA's capabilities are that they collect massive amounts of information on everyone, including your political beliefs, contacts, relationships, and internet histories.

"While these documents suggest this type of personal attacks are targeted in nature, do not forget that the NSA is conducting mass surveillance on the entire world and collecting a vast amount of information on nearly everyone."

A spokeswoman for the NSA's UK equivalent - GCHQ - declined to comment on details of the Huffington Post's report.

But she highlighted the UK government's Counter-Terrorism Strategy, which discusses using the internet to gather evidence against individuals in order to challenge terrorist propaganda.

"All of GCHQ's work is carried out in accordance with a strict legal and policy framework which ensures that its activities are authorised, necessary and proportionate, and that there is rigorous oversight," she added.


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Ex-Nokia employees launch smartphone

27 November 2013 Last updated at 08:38 ET By Dave Lee Technology reporter, BBC News

A team of ex-Nokia employees has released the first handset running on a new smartphone platform.

The Jolla phone - pronounced Yol-la - is powered by open-source operating system Sailfish, but can run most apps designed for Google's Android platform.

The company has paired with a major Finnish network, and hopes to set up a similar deal with a UK operator.

Industry analysts said Jolla faced a challenge in taking on a market dominated by Google and Apple.

Just 450 Jolla phones will be available at launch on Wednesday evening, with the majority going to customers who have pre-ordered the device.

Co-founder Marc Dillon told the BBC the company was in the process of ramping up manufacturing.

He said the phone's ethos was to provide a more "open" approach to how people used their mobiles, a contrast to the relatively closed systems used on the iPhone and, to a lesser extent, Android devices.

"There's different opportunities for people to get apps form different places, different stores," he said.

"We've created a world-class platform. Users will be getting more choice."

Continue reading the main story

This is the 'what might have been' scenario had Nokia not gone down the Microsoft road with Windows Phone"

End Quote Geoff Blaber CCS Insight
Dumped OS

The platform - originally called MeeGo - was developed by Nokia, but dumped in 2011 in favour of the company adopting the Windows Phone system.

Nokia released just one handset running the software, the N9-00.

Antti Saarnio, chairman and co-founder of Jolla, told the BBC in May that MeeGo - now called Sailfish - had not been given enough chance to succeed.

"Everybody felt so strongly that they wanted to continue," he said.

Large parts of the Sailfish code were open-source, which meant anyone could expand and adapt the platform, Mr Dillon said.

"We are ramping up our Jolla community right now.

"There's already a Sailfish website so that developers can come and contribute."

David v Goliath

According to CCS Insight, 81% of smartphones shipped globally from July to September ran Google's Android software. Apple's iOS accounted for 13%.

Smaller players such as Blackberry, Microsoft and Mozilla made up the numbers.

Analyst Geoff Blaber, from CCS, said while it might seem Jolla was taking on an impossibly large challenge by trying to muscle in, its strategy could pay off.

"It's easy to characterise this as David v Goliath," he told the BBC. "But the fact is if Jolla can maintain a competitive cost base, there is already an enthusiast base seeking this product. It could be successful."

But Mr Blaber added the handset was a means to an end, and that Jolla's long-term strategy was to create a operating system it could licence to other manufacturers.

"This is the challenge," he said.

"At the moment we have a situation where Android is utterly dominant. They've got to prove the software is competitive and it works."

Jolla may also be buoyed by support in its home country as a result of Microsoft's planned buy-out of Nokia.

Jolla co-founder Mr Dillion said he was getting "stopped everywhere I go".

"We're not trying to piggy-back, but we have seen a bump," said Mr Dillon. "We've had a lot of support in Finland."

Mr Blaber added: "This is the 'what might have been' scenario had Nokia not gone down the Microsoft road with Windows Phone."

Follow Dave Lee on Twitter @DaveLeeBBC


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Bitcoin currency breaks $1,000 mark

27 November 2013 Last updated at 10:57 ET

The value of a single bitcoin has surpassed $1,000 (£613) for the first time, according to Mt.Gox, one of the virtual currency's major exchanges.

Bitcoin's value has been rising rapidly since a US Senate committee hearing earlier this month.

Confidence grew after the committee described virtual currencies as a "legitimate financial service".

Bitcoin has become popular in part due to it being difficult to trace transactions.

The currency is often linked to illegal activity online.

Customers using the Silk Road - a website selling illegal drugs that was shut down last month - would pay for goods using Bitcoin.

Continue reading the main story

Bitcoin is often referred to as a new kind of currency.

But it may be best to think of its units being virtual tokens rather than physical coins or notes.

However, like all currencies its value is determined by how much people are willing to exchange it for.

To process Bitcoin transactions, a procedure called "mining" must take place, which involves a computer solving a difficult mathematical problem with a 64-digit solution.

For each problem solved, one block of bitcoins is processed. In addition the miner is rewarded with new bitcoins.

This provides an incentive for people to provide computer processing power to solve the problems.

To compensate for the growing power of computer chips, the difficulty of the puzzles is adjusted to ensure a steady stream of about 3,600 new bitcoins a day.

There are currently about 11 million bitcoins in existence.

To receive a bitcoin a user must have a Bitcoin address - a string of 27-34 letters and numbers - which acts as a kind of virtual postbox to and from which the bitcoins are sent.

Since there is no registry of these addresses, people can use them to protect their anonymity when making a transaction.

These addresses are in turn stored in Bitcoin wallets which are used to manage savings.

They operate like privately run bank accounts - with the proviso that if the data is lost, so are the bitcoins owned.

Many worried the crackdown would cause the value to plummet, but instead growing confidence that regulators will not imminently seek to ban the currency has seen its price soar.

Enthusiasts say it is a highly efficient way of handling global money transfers.

"For Bitcoin to go from zero to $1,000 in just five years has been amazing to watch," said Mike Hearn, a Bitcoin developer.

"It's easy to forget that Bitcoin's true value is not in an arbitrary exchange rate, but in its ability to enable new applications and services which aren't possible with today's payment networks."

Senate hearing

The US Senate hearing earlier this month was prompted by the closure of the Silk Road.

Representatives from the Department of Justice and financial regulator the Securities and Exchange Commission were asked to provide their views about virtual currencies to the committee, and submissions have been received from the FBI and the US Federal Reserve.

"Virtual currencies, perhaps most notably Bitcoin, have captured the imagination of some, struck fear among others, and confused the heck out of the rest of us," the chairman of the committee, senator Thomas Carper, said in opening remarks.

The FBI, in a letter to the committee, said that it recognised virtual currencies offered "legitimate financial services" but they could be "exploited by malicious actors".

Mythili Raman, the head of the Justice Department's Criminal Division, told the committee: "We have seen increasing use of such currencies by drug dealers, traffickers of child pornography, and perpetrators of large-scale fraud schemes."


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