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Lancet Study Shows Real World Patients Are up to 400% More Likely to Suffer Adverse Events Than Drug Trials Show

by Will Jones
19 July 2021 3:04 PM

Dr Sebastian Rushworth has written today about the serious problem of the underestimation of side-effects in drug trials, which he says should “shake the very foundations of evidence based medicine”.

His article reports on the results of a study recently published in the Lancet Healthy Longevity, funded by the UK Medical Research Council and the Wellcome Trust, which seeks to establish the extent to which drug trials underestimate side-effects by comparing trial data to real world data. The study focuses in particular on blood pressure drugs known as RAAS blockers, which Dr Rushworth explains were chosen because of the number of trials that have been done by different companies. There is no reason the results should not apply equally to other drugs, he says, including Covid vaccines (for which there have been an unprecedented number of adverse event reports despite the trials showing them to be safe).

The results are shocking. The difference was not marginal but out by a factor of three or four.

The real world patients were between 300% and 400% more likely to experience a serious event than the participants in the trials! That is in spite of the fact that the trials, as mentioned above, were using a broader definition of what constituted a serious event. If the trials were representative of reality, then they should have a higher rate of events than is seen in the real world data. Instead they have a rate that is several times lower!

The difference was just as large in trials specifically involving older people, so age differences can’t be the full explanation, he says (though he allows part of it may be that participants in the trials of older people may be healthier and younger than real world patients).

His main explanation, however, is darker. Are the drug companies simply under-reporting adverse events, both in the drug and placebo treatment groups?

The easiest solution, if you want to avoid finding nasty side effects, is to not report them, regardless of which treatment group the participant is in. That will cut down on total adverse events in both groups, which will make any difference between the groups that does exist smaller in absolute terms, and also less likely to reach the level of statistical significance. Voila – the treatment group and the placebo group end up having similar rates of side effects, and the drug company can conclude that the drug is completely safe.

Is that what’s happened here? Are the pharmaceutical companies hiding adverse events? Well, it’s very strange that the real world data shows a rate of serious adverse events that is several times higher than is found in the trials. It’s hard to see how that massive difference could be explained in any other way.

This is a huge problem, he argues, which calls into question the reliability of drug trials for telling us how safe drugs really are.

If the drug trials and the real world data show such wildly different rates of adverse events, then it really begs the question how much we can trust the trials at all. It would be perfectly reasonable in this situation to say that all “evidence” produced by pharmaceutical companies is so suspect that it should be dismissed out of hand, and that only independently funded trials should be used as a basis for medical treatment decisions.

Combined with the routine exclusion of high risk groups from trials, who are both more likely to suffer adverse effects and less likely to get the full benefit, we need to ask how much we really know about the risks and benefits of the drugs and vaccines that we give to people every day.

But what alternative is there, asks Dr Rushworth, when without drugs companies funding trials far fewer would be done at all?

Worth reading in full.

Tags: Big PharmaSide-effectsTrialsVaccines

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52 Comments
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huxleypiggles
huxleypiggles
1 year ago

Cross-bows next on the banning list.

I wonder why?

36
-1
DHJ
DHJ
1 year ago
Reply to  huxleypiggles

Probably based on the false perception that it is a superior weapon compared to the contents of a tool box, kitchen drawer or a vehicle (particularly an incendiary EV). Ever heard of a mass-crossbow shooting?

18
0
soundofreason
soundofreason
1 year ago
Reply to  DHJ

I’ve seen the documentary about the repeater crossbows.

3
0
Mogwai
Mogwai
1 year ago

Another good video to go along with the Andrew Percy one above is this 5min clip of Peter Whittle on GBN yesterday, talking about Islamism and where the continuous appeasement of Muslims has got us to today;

https://www.youtube.com/watch?v=UrpYdj3iRj0&t=297s&ab_channel=TheNewCultureForum

We know that the fear of authorities being labelled as ”Islamophobic” for years has caused huge amounts of suffering, crimes to go unpunished and for these ‘people’ to have gained a lot of power and influence within society as a result, but when we look at the origins of the nonsensical word, ‘Islamophobic’, you can see that this is entirely the point. Would the likes of Muslims Assad and Hussein, for instance, be correctly labelled Islamophobic, or is this just another slur, such as the word ”racist” which only applies to white people, everybody else getting a free pass and protected status within society? Have our authorities in the West already achieved ”dhimmi” status due to their constant appeasement of Muslims over the years, consequently is that what their policies and ‘two-tier’ policing, for example, have made us, the citizens, as a result? If so then it would seem the Muslim Brotherhood have their wish and Sharia already has a foot in the door and there is much evidence all across Europe to support this.

”Given the fact that the term ‘Islamophobia’ was almost certainly invented by the Muslim Brotherhood as an ideological weapon to silence critics, it begs the question of whether we want to continue using their language. While understanding the origins of the phrase is very instructive, it does not change the conceptual problems with the term itself. The main problem is that it fails to distinguish between prejudice and discrimination against Muslims as people, prejudice against Islam, and informed criticism of Islam or Islamism as a set of ideas and practices. Freedom of speech and thought allows anyone to criticise an ideology, but not to discriminate against people on the basis of their religion. A second problem is that ‘Islamophobia’ is often defined as a form of racism directed toward Muslims.

 The issue here is that Muslims are not a racial group, and that people of all ethnicities can be Muslims. A third problem, which was recognised by the editor of the Runnymede report on Islamophobia in 1997, is that the suffix ‘phobia’ implies a delusional or irrational fear that is analogous to a mental illness. Attacking the person in this way, rather than their argument, is a classic ‘ad hominem’ (attacking the person) fallacy. A fourth problem is that we rarely use these phobia terms to protect any other religion. We practically never describe atheists who make jokes about Christianity as ‘Christophobics,’ or describe critics of mindfulnessmeditation as ‘Buddhophobics.’ Both terms have almost never been searched on Google in the past 15 years. One potential solution to these conceptual problems, which was put forward by the UK think-tank Policy Exchange, is to describe the problem as “bias against Muslims,” which acknowledges the existence of real bias against people, while distinguishing it from informed criticism of an ideology. May the debate continue.”

https://europeanacademyofreligionandsociety.com/news/islamophobia-the-origins-of-a-confusing-concept/

Last edited 1 year ago by Mogwai
51
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ellie-em
ellie-em
1 year ago

https://www.telegraph.co.uk/news/2024/02/22/pro-lockdown-mps-cant-deny-the-huge-costs-of-their-actions/
IIRC, the Tories were – and unfortunately, currently remain – ‘in power’ when the atrocious lockdowns were initiated, ably assisted by their BFF sycophants and partners-in-crime on the opposite benches. As such, the Tories have to take the ultimate responsibility for the disastrous impact of their mismanagement.

52
0
huxleypiggles
huxleypiggles
1 year ago
Reply to  ellie-em

“Tories have to take the ultimate responsibility for the disastrous impact of their mismanagement.”

Sadly ellie-em there was no mismanagement. Every action was planned and coordinated.

11
0
soundofreason
soundofreason
1 year ago
Reply to  ellie-em

I agree the Conservatives should be punished for the lockdowns and quite a few other things (have an upvote). However, we must also remember that the Coronavirus Act 2000 which enabled so much of the stupidity was passed without division in the Commons and Lords (ie no Member of either House objected) and it had immediate Consent from the Scottish parliament.

A plague on both your Houses.

11
0
ellie-em
ellie-em
1 year ago
Reply to  soundofreason

Absolutely, every one of the self-serving shysters voted for the Act.

Never forgive, never forget.

8
0
Mogwai
Mogwai
1 year ago

Ooh I don’t know, this is a tough one. Stay or deport the cultural enricher? I don’t think our Geert is afraid of a ridiculous made-up word if it means highlighting the real and present danger these people pose to citizens;

”Dutch politician Geert Wilders has demanded the deportation of an asylum seeker currently standing trial for sexually assaulting four 11-year-old girls at a swimming pool resort in the Netherlands.
A total of 10 young girls and women filed complaints against the 29-year-old Syrian asylum seeker last year after he allegedly targeted and groped female visitors of the Center Parcs resort in Zandvoort.

Hart van Nederland reported how some of the girls had their buttocks groped by the man, while others claimed the migrant had clamped his legs around their waists and pressed his genitals against their hips.
Police attended the facility at the time of the alleged offenses and a full investigation was conducted with CCTV footage showing the man directly heading toward young girls in the swimming pool several times.

The Syrian national, who is still awaiting an asylum decision and fears the court proceedings will impact his application, told the court through an interpreter that he denies the allegations and claims to be homosexual and thus not attracted to women.
His defense counsel has argued there is insufficient evidence for a conviction, and claimed his client had no intention of touching children in an inappropriate manner and any interaction with the minors was not sexually motivated.

He reminded the court that a criminal conviction would likely result in a refusal by the Dutch authorities to grant his client asylum which would have far-reaching consequences for both the defendant and his wife and daughter who are currently residing in Turkey and awaiting the green light to travel to the Netherlands under family reunification laws.”

https://rmx.news/netherlands/netherlands-wilders-calls-for-immediate-deportation-of-syrian-asylum-seeker-accused-of-groping-4-small-girls-in-dutch-swimming-pool-resort/

42
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soundofreason
soundofreason
1 year ago
Reply to  Mogwai

Surely in any decent legal system the consequences of a possible guilty verdict are not relevant to the case. Circumstances could obviously affect sentencing if someone is found guilty – but not so much if they’re found to be a kiddie fiddler. This guy’s defence counsel should have been told off good and proper by the court.

The accused now claims to be homosexual. Presumably not exclusively so, as he wants his wife and child to join him. Perhaps the child was the result of a grudge pregnancy (someone had it in for him)? Anyhow, either way he will be reunited with his wife and child soon – perhaps in Turkey.

Last edited 1 year ago by soundofreason
8
0
Lockdown Sceptic
Lockdown Sceptic
1 year ago

The Countryside Is Not Racist – latest leaflet to print at home and deliver to neighbours or forward to politicians, media, friends online. 

11b-The-Countryside-Is-Not-Racist-MONOCHROME-copy
24
-3
Heretic
Heretic
1 year ago
Reply to  Lockdown Sceptic

Speaking of sheep and being savaged…

Dog owners warned after sheep ‘attacks’ in North Wales | UK News | Sky News

Two XL bully dogs shot dead after killing 22 pregnant sheep – as owner fined | UK News | Sky News
—Despite this attack costing the farmer £14,000, Judge Cohen only fined the dog owner £900. Part of the War on Farmers.

“Even if a dog doesn’t make physical contact, the distress of the chase can also cause sheep to die, miscarry and separate lambs from their mothers. Farm animals are also being chased into danger – drowning in rivers, falling from cliffs and getting their necks trapped in fencing.”

Rebecca Davidson, rural affairs specialist, NFU Mutual

7
0
soundofreason
soundofreason
1 year ago
Reply to  Heretic

Dog owners warned after sheep ‘attacks’ in North Wales

North Wales Police have reported a number of suspected attacks in the past month and are reminding dog owners to keep their pets on a short lead when near livestock.

Wow! I had no idea sheep were so dangerous… Or have I missed something?

Perhaps something was lost in translation?

Seriously: WTF? 22 sheep in lamb killed by dogs. Owner of dogs fined only £900? £40.90 each. £10 a leg.

The £14,000 loss to the farm looks like the deadweight price of 4 lambs according to this site. Typically two lambs per ewe per season. So this season’s loss of lambs and next.

Last edited 1 year ago by soundofreason
4
0
Heretic
Heretic
1 year ago
Reply to  soundofreason

You’re right that the headlines could be misconstrued 🙂 . Thanks for the info about deadweight prices. The important point is that dogs on leads are not necessarily controlled by their owners, and still manage to attack, as in the case of the Cornish parents who took their three kids for a family bike ride along a path. A dog owner allowed his vicious dog on a lead to first attack the 7-year-old boy, knocking him off his bike and biting him through his clothing. Then the dog owner proceeded to calmly continue along the path and allow his vicious dog to attack the boy’s 5-year-old brother, also biting him in the leg. Though the children’s father managed to get the dog owner’s name and address, the arrogant owner said it wasn’t his fault that his dog didn’t like kids on bikes!

The fact is that neither humans nor most animals have any defence against dog attacks. Horses get their skin torn off even by small dogs leaping up to bite them. Here in the UK, people are not allowed to carry any defence against dog attacks, or human attacks. The only thing that will protect people, posties, livestock and wildlife is muzzling all dogs in public, including public transport, as is the law in countries like Austria. And prison terms for anyone whose dog attacks and injures a human or domestic animal.

Royal Mail reports surge in dog attacks on postal workers | ITV News

Last edited 1 year ago by Heretic
1
0
soundofreason
soundofreason
1 year ago
Reply to  Heretic

dogs on leads are not necessarily controlled by their owners

Certainly not two Bully XLs.

0
0
modularist
modularist
1 year ago

“Police stood by as ‘From the river to the sea’ projected onto Parliament, says MP”

‘Speech people hate’ not ‘hate speech’.

30
-2
DHJ
DHJ
1 year ago
Reply to  modularist

Speech some people hate. It’s been used by Jews and Israelis when it suits their own ends. I suspect a vast number of people are indifferent or hadn’t been aware of it prior to late 2023.

25
-10
DHJ
DHJ
1 year ago

If Parliament is in no position to tell Israel where to operate, then they are in no position to allow military and any other support of the Israeli campaign.

20
-13
WyrdWoman
WyrdWoman
1 year ago

Brief comment by Doctors Without Borders on the situation in Gaza: https://www.youtube.com/watch?v=k4JvprvzDgU

6
-4
WyrdWoman
WyrdWoman
1 year ago

Some comprehensive statements at the ICJ public hearing, China and UAE in particular. Here is Saudi Arabia’s representative, His Excellency Ziad Al-Atiyah giving a blistering critique of Israel’s position: https://www.youtube.com/watch?v=kk1USi85c1M

10
-11
john ball
john ball
1 year ago
Reply to  WyrdWoman

China is currently persecuting a million Moslem Uihgurs. Strange there is not the same concern about that.

25
-2
A Y M
A Y M
1 year ago
Reply to  john ball

Whataboutery is the most favoured diversionary tactic of the Zionist supporters, isn’t it?

11
-17
john ball
john ball
1 year ago
Reply to  A Y M

It is indicative of the double standards of those who only seem to protest about the activities of Jews in this case trying to recover the hostages and prevent a repeat of the abhorrent attacks and by comparison ignore Moslems killing Moslems in much greater numbers such as when Saddam slaughtered around 100,000 Kurds or Assad (father of the present president) launched nerve gas attacks killing between 20,000 and 40,000 of his own citizens; or the current civil wars going on in Yemen, Syria and Sudan where ell over a million have been killed.

9
-6
A Y M
A Y M
1 year ago
Reply to  john ball

“Jews in this case trying to recover the hostages and”

By killing them, refusing to negotiate and carpet bombing everything?

”prevent a repeat of the abhorrent attacks “
You mean the ones they knew were coming but let happen and then lied about the circumstances and are using the entire day as cover for ethnic cleansing and murdering tens of thousands.

Yeah I’m being so unfair to Jews.

6
-11
Heretic
Heretic
1 year ago
Reply to  john ball

Assad did not do that. The Globalists hate President Assad and his father for driving the Muslim Brotherhood Terrorists out of Syria, and for protecting Syrian Christians against Muslim and Kurdish attacks.

Unfortunately, the Brotherhood just set up new headquarters in London.

6
0
WyrdWoman
WyrdWoman
1 year ago
Reply to  john ball

Don’t forget to mention the UAE and SA’s abuses of human rights. Right up there with the UK in its treatment of Assange, or supplying weapons to a country being investigated for genocide and another bombing its own civilians in Donetsk, eh?

13
-6
A Y M
A Y M
1 year ago
Reply to  WyrdWoman

China just went sub nuclear by stating that Palestinians have (oh my Lord) the right to defend themselves against Israeli aggression.

Ahh wow!

https://youtu.be/LaCrM0L3YBk?si=HCkV-IR_oFbZfs6W

and from Middle East Eye

Representatives of 52 countries are addressing the ICJ on Israel’s decades-long occupation of Palestinian land.
Beijing’s envoy said there were “various people (who) freed themselves from colonial rule” and they could use “all available means, including armed struggle”.
He described the Palestinian use of armed resistance as legitimate and not an act of terrorism.

“The struggle waged by peoples for their liberation, right to self-determination, including armed struggle against colonialism, occupation, aggression, domination against foreign forces should not be considered terror acts,” Zhang Jun told the court.

In his speech, Jun criticized Israeli policies, characterizing them as “oppression that has severely undermined and impeded the exercises and full realization of the Palestinian people’s right to self-determination”.
The ICJ’s public hearings, which will be held until February 26, come after a UN General Assembly resolution requesting an ICJ advisory opinion.
The number of states participating in the oral proceedings is the highest of any case since the ICJ’s establishment in 1945 and is separate to the more publicized genocide case brought by South Africa. A panel of 15 judges are expected to take about six months to deliberate before issuing an advisory opinion.

This is quite extraordinary: 

This is Ma Xinmin, China’s Foreign Ministry’s legal adviser, speaking on behalf of China, saying at the ICJ today that Israel is a colonizer and that the Palestinians have a right to resistance under international law,…

— Arnaud Bertrand (@RnaudBertrand) 

11
-8
WyrdWoman
WyrdWoman
1 year ago
Reply to  A Y M

Yep, saw that. It was a toss up between posting the China statement or the SA one, I thought the latter was more representative of the simmering rage the rest of the world appear to be feeling at this point!

8
-9
WyrdWoman
WyrdWoman
1 year ago

AnsarAllah hit another British ship: https://www.zerohedge.com/geopolitical/another-uk-ship-fire-yemen-sea-becomes-littered-disabled-tankers

6
-1
WyrdWoman
WyrdWoman
1 year ago

“Ninety-nine million patient records and they concluded that the benefits outweigh the risks!? We respectfully disagree” 

Dr James Lyons-Weiler points out a few more salient facts about this corrupt study:

https://popularrationalism.substack.com/p/on-the-99m-person-study-allegedly?utm_source=profile&utm_medium=reader2

17
-1
Dinger64
Dinger64
1 year ago

“US lands on the moon for the first time in 50 years”

https://www.irishtimes.com/world/us/2024/02/23/us-lands-on-moon-for-first-time-in-more-than-50-years/

14
-5
Dinger64
Dinger64
1 year ago

Its simple to solve this problem!
Israel, Palistine, Russia and Australia are not in Europe! So ban the the lot, sorted!

https://www.newstalk.com/news/inconceivable-for-israel-to-take-part-in-eurovision-as-ebu-reviews-song-1645044

12
0
A Y M
A Y M
1 year ago
Reply to  Dinger64

““I just think if we were to sit down on the night and Israel was to go on, as if nothing is happening, and perform a song that it would be a very, very low point in the history of Eurovision.”

And that is saying something after the last couple of years.

8
-6
WyrdWoman
WyrdWoman
1 year ago
Reply to  A Y M

They could always get those kids on who were singing for genocide a few months back, really tug at the heartstrings (the ones not spattered about the Gazan rubble, that is). That would be a real vote winner, don’t you think?

7
-4
A Y M
A Y M
1 year ago
Reply to  WyrdWoman

I mean if you dropped the subtitles it would win Dix points down the line, cute little kids sweetly singing, what could go wrong?

3
-3
A Y M
A Y M
1 year ago

Not seen anything on the ever declining quality of “News Round-U” articles on

Assange extradition

the further slaughter of civilians by US/UK based pariah state Israel,

the French legislation threatening 15 years in jail for criticising MRNA gene altering shots.

the fierce questioning of Richy Thelema Sunak on GB news

Toby you had better pay more attention to the daily list of Specter/Telegraph/Spiked/Guido Fawkes hasbara on the DS. It’s not useful or challenging to TPTB.

16
-6
modularist
modularist
1 year ago
Reply to  A Y M

I’ve got the popcorn ready for the sh*tfest that will erupt if Shamima Begum wins her appeal.

7
0
A Y M
A Y M
1 year ago
Reply to  modularist

Red meat indeed.

2
-2
ellie-em
ellie-em
1 year ago
Reply to  modularist

Great news, she lost. Cheered me up no end.

14
-1
modularist
modularist
1 year ago
Reply to  ellie-em

That’s nice for you 🙂 I had no emotional reaction myself, though it might have been more entertaining if she’d won and we’d been treated to a spate of frothing articles in Spiked and The Telegraph. Next time, maybe. I’ll have to be content with Cruella for now 🙂

5
-4
A Y M
A Y M
1 year ago
Reply to  A Y M

Russel Brand, in usual style covers the GB news clip and the French legislation here:
https://youtu.be/u0Ha4mv2Pu4?si=fC6uCqzn5EmRb6Nz

10
0
WyrdWoman
WyrdWoman
1 year ago
Reply to  A Y M

Perhaps it should be renamed ‘MSM News Round-Up’, for clarity. It would certainly be more accurate.

16
-5
A Y M
A Y M
1 year ago
Reply to  WyrdWoman

Bingo

6
-5
modularist
modularist
1 year ago
Reply to  WyrdWoman

I joined this site because I valued this section. It instantly went downhill. I apologise for putting a hex on it, and I promise not to renew my subscription.

0
0
A Y M
A Y M
1 year ago
Reply to  modularist

I’d prefer it if you stayed on to comment BTL. But I don’t blame you a bit.

1
-1
modularist
modularist
1 year ago
Reply to  A Y M

Fair enough.My apologies.

0
0
A Y M
A Y M
1 year ago
Reply to  modularist

No apologies! I meant it as a hope you would not leave! There are a minority here it seems that are consistently sceptical on every issue.
I think you are one of those. It would be sad to see another one go.

0
0
A Y M
A Y M
1 year ago

A highly enjoyable video of Killary Clinton getting filibustered for being a war criminal at a “Women’s Cimema for Peace” event (drips in irony).

https://youtu.be/YiSQDhUdvds?si=hOhHGcvHdMpkGQeZ

And Jimmy Dore discussing her murder victim Seth Rich’s coverup…FBI won’t release his laptop information for 66 years…

https://youtu.be/XThp3Rx4HyM?si=rvb6kuLHoTUfwQFG

7
-1
JayBee
JayBee
1 year ago

Gideon Levy, Haaretz:
“Eine Welt, die entschlossen ist, eine Lösung zu finden, muss Israel vor eine klare Wahl stellen: Sanktionen oder ein Ende der Besatzung, Gebiete oder Waffen, Siedlungen oder internationale Unterstützung, ein demokratischer Staat oder ein jüdischer Staat, Apartheid oder ein Ende des Zionismus.”
https://globalbridge.ch/israel-muss-zum-frieden-gezwungen-werden/

5
-4
JayBee
JayBee
1 year ago

Guilt&Responsibility:
The case of Germany and Israel
“There is a thing to say about a nation that erroneously understands guilt as an inherited condition from which it cannot escape and on which it must act more or less indefinitely. Such a nation is trapped in the past—or has been so trapped, or let itself be trapped, or intentionally trapped itself. This opens us to a recognition we must not miss:”
https://www.unz.com/article/guilt-and-responsibility/
Applicable to most other colonial&co history and relationships between nations and people.

5
-4
WyrdWoman
WyrdWoman
1 year ago
Reply to  JayBee

Glenn Greenwald gave very thoughtful coverage to these issues too recently on the back of Israel’s criticism of Brazil, asking the questions – ‘who owns the memory of Nazism in WW2’ and ‘is there anyone with the legitimacy to dictate how the holocaust can be discussed [and] by whom’ amongst others. (Starts around 8m30)

https://rumble.com/v4endcr-system-update-live-show-231.html?mref=6zof&mrefc=3

6
-5
Heretic
Heretic
1 year ago

“Post Office boss ‘should have faced questions’ over working for Church, says Justin Welby”

More importantly, Billionaire Sunak should be facing questions now over helping his Billionaire father-in-law, one of the world’s richest men, avoid losing £millions in compensation pay-outs to the Postmasters. Is Billionaire Sunak delaying the compensation to give his Billionaire father-in-law time to offload his investments before compensation is paid?

“Sunak’s in-laws are up to their necks in this, and stand to lose a great deal of money if compensation is paid out. They have millions invested in Infosys/Horizon/Liberty Global and his father-in-law is a director.”

Hence the Fake Labour Opposition’s complete silence over this, while the whole of Parliament kicks up over Irrelevant Gaza to distract the public.

Last edited 1 year ago by Heretic
10
-1

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