美国食品药品监督管理局表示,堕胎药可以在零售药店销售了
2023-01-12 jiangye111 7603
正文翻译
U.S. FDA says abortion pills can be sold at retail pharmacies

美国食品药品监督管理局表示,堕胎药可以在零售药店销售了



新闻:

The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban medication abortion.

美国食品和药物管理局周二表示,尽管越来越多的州寻求禁止药物流产,但该机构将首次允许零售药店在美国出售堕胎药。

The regulatory change will potentially expand abortion access as President Joe Biden's administration wrestles with how best to protect abortion rights after they were sharply curtailed by the Supreme Court's decision to overturn the landmark Roe v Wade ruling and the state bans that followed.

由于最高法院决定推翻具有里程碑意义的罗伊诉韦德案裁决,以及随后各州的禁令,堕胎权利受到了严重限制,美国总统乔·拜登的政府正在努力解决如何最好地保护堕胎权利的问题,监管改革可能会扩大堕胎的覆盖面。

Pharmacies can start applying for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescxtion from a certified prescriber.

药店可以开始向生产堕胎药米非司酮的两家公司之一申请认证,如果成功,它们将能够在收到经过认证的处方师的处方后直接向患者配药。

The FDA had first said it would be making those changes in December 2021 when it announced it would relax some risk uation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily in 2021 due to the COVID-19 pandemic.

食药管理局首次表示将在2021年12月做出这些改变,当时它宣布将放松对避孕药的一些风险评估和缓解策略,这些策略自该机构2000年批准以来一直存在,并在2021年因新冠大流行而暂时取消。

The changes included permanently removing restrictions on mail order shipping of the pills and their prescxtion through telehealth.

这些变化包括永久取消对通过远程医疗邮购药物及其处方的限制。

The agency finalized the changes on Tuesday after reviewing supplemental applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the United States.

食药管理局在审查了在美国生产该药的两家公司Danco Laboratories和GenBioPro的补充申请后,于周二最终确定了这些变化。

"Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber," the agency said on its website on Tuesday.

该机构周二在其网站上表示:“根据修改后的米非司酮风险评估和缓解策略计划,米非司酮及其获批准的仿制药可以由认证药店、或由认证处方师开具或在其监督下发放。”

Mifeprex is the brand name version of mifepristone which, in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy in a process known as medication abortion.

Mifeprex是米非司酮的品牌版本,它与另一种名为米索前列醇的药物结合使用,具有多种用途,包括流产管理,可在怀孕10周内诱导流产,这一过程被称为药物流产。

Abortion rights activists say the pill has a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescxtion to induce abortion.

堕胎权利活动人士表示,避孕药长期以来一直是安全有效的,没有过量服用或上瘾的风险。在包括印度和墨西哥在内的几个国家,女性可以在没有处方的情况下自行购买人工流产药。

"Today's news is a step in the right direction for health equity," Planned Parenthood President Alexis McGill Johnson said in a statement.

“今天的新闻是朝着健康公平的正确方向迈出的一步,” 生育计划主席亚历克西斯·麦吉尔·约翰逊在一份声明中说。

"Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescxtion is a game changer for people trying to access basic health care," Johnson added.

约翰逊补充说:“对于那些试图获得基本医疗保健的人来说,能够通过邮件或像其他处方一样亲自从药店领取堕胎处方药是一个改变游戏规则的事情。”

NO EQUAL ACCESS
The regulatory change will, however, not provide equal access to all people, GenBioPro, which makes the generic version of mifepristone, said in a statement.

没有平等的机会
然而,生产米非司酮仿制药的GenBioPro公司在一份声明中表示,监管变化不会为所有人提供平等的机会。

原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped the 1973 Roe v. Wade ruling last year.

自从美国最高法院去年废除了1973年罗伊诉韦德案的裁决,推翻了宪法规定的终止怀孕的权利以来,堕胎禁令,其中一些针对米非司酮,已经在十几个州生效。

Women in those states could potentially travel to other states to obtain medication abortion.

这些州的妇女可能会前往其他州进行药物流产。
原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


The president of anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, said the latest FDA move endangers women's safety and the lives of unborn children.

美国反堕胎组织SBA反生命协会主席马乔里·丹南费尔瑟表示,食药管理局的最新举措危及女性安全和未出生孩子的生命。

"State lawmakers and Congress must stand as a bulwark against the Biden administration's pro-abortion extremism," she said in a statement.

她在一份声明中说:“州议员和国会必须成为抵制拜登政府支持堕胎的极端主义的堡垒。”
原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


FDA records show a small mortality case number associated with mifepristone. As of June 2021, there were reports of 26 deaths lixed with the pill out of 4.9 million people estimated to have taken it since it was approved in September 2000.

食药管理局记录显示与米非司酮相关的少量死亡病例数。据报道,自2000年9月批准使用该药物以来,截至2021年6月,估计有490万人服用了该药物,其中有26人死亡。

Retail pharmacies will have to weigh whether or not to offer the pill given the political controversy surrounding abortion, and determine where they can do so.

鉴于堕胎引发的政治争议,零售药店将不得不权衡是否提供这种药物,并决定在哪里可以提供这种药物。
原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


A spokesperson for CVS Health (CVS.N) said the drugstore chain owner was reviewing the upxed REMS "drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy."

CVS健康公司的一位发言人表示,连锁药店所有者正在审查更新的风险评估和缓解策略“米非司酮的药物安全计划认证要求,以确定在不限制选择性终止妊娠处方药物分发的州分发的要求。”

A spokesperson for Walgreens (WBA.O), one of the largest U.S. pharmacies, said the company was also reviewing the FDA's regulatory change. "We will continue to enable our pharmacists to dispense medications consistent with federal and state law."

美国最大的药店之一沃尔格林的发言人表示,该公司也在评估食药管理局的监管变化。“我们将继续使我们的药剂师能够按照联邦和州法律分发药物。”

评论翻译
Any-sao
Could states ban this? I understand the Supremacy and Commerce Clauses well enough, but I also don’t see why this could not be legally recognized by a red state as a controlled substance.
Different states have different policies on marijuana for medical use, ranging from complete bans to regular medical prescxtions. Could these abortion pills not also be regulated the same way?

各州可以禁止这种行为吗?我很理解“至上条款”和“商业条款”,但我也不明白为什么红色州不能在法律上承认这是一种受管制的物质。
不同的州对医用大麻有不同的政策,从完全禁止到常规的医疗处方。这些堕胎药能不能也受到同样的监管呢?

JudgeHoltman
Yes they can. Many have.
But the USPS is Federal. And they cannot open your mail, as that's government interference with your freedom of speech.
So if you were to have some abortion pills shipped to you, you'd be breaking the law. Anyone shipping it to you would potentially be breaking the law too.
But the only people that know if you bought these drugs are you and the shipper, then this law is pretty unenforceable since you're probably not going to go snitching on yourself.
Same thing happens with any number of drugs right now. Odds are your local postman is the biggest drug dealer in town anymore.
I should note that the USPS can still sniff the packages for drugs, or fully open and inspect any packages given probable cause. They do this for narcotics with Drug Dogs & other high-tech sensors that don't open or read the package, but can give them the probable cause they need.
But abortion pills would be packaged by professional pharmaceutical companies, and it's standard practice to make those airtight and sterile, and therefore very tough to pick up on any scanner.

是的,它们可以。许多州已经禁止了。
但是美国邮政管理局是联邦单位。他们不能打开你的邮件,因为这是政府对你言论自由的干涉。
所以如果有人给你寄堕胎药,你就是犯法了。任何把它寄给你的人都可能触犯法律。
但是唯一知道你是否买了这些药的人是你和发货人,那么这项法律是无法执行的,因为你可能不会自己告发自己。
现在任何一种药物都会发生同样的事情。你当地的邮递员很可能就是镇上最大的“毒贩”。
我应该指出的是,美国邮政仍然可以嗅出包裹中的药物,或者根据可能的原因完全打开并检查任何包裹。他们用缉毒犬和其他高科技传感器来检查药品,这些传感器不会打开或读取包装,但可以给他们提供他们所需要的(打开包裹的)可能原因。
但堕胎药是由专业制药公司包装的,标准做法是让这些药密封无菌,因此很难在扫描仪上发现。

Amelaclya1
FYI, the FDA has already said its perfectly legal to ship abortion drugs through USPS. They lifted the ban during COVID so women could get telehealth abortions, and then reiterated that it was a permanent policy after the Dobbs decision.
So all you have to do is order them through one of the many online prescribers and it's all 100% legal.
Well, I guess actually possessing and taking them might not be legal in certain states, but no one will ever know unless you tell them. Even if you are one of the extremely rare cases that need medical care after doing a medical abortion, they have no way of knowing it wasn't a natural miscarriage, as the drugs are undetectable.

供你参考,食药管理局已经表示通过美国邮政运输堕胎药物是完全合法的。在新冠肺炎期间,他们取消了禁令,这样女性就可以进行远程医疗堕胎,然后在多布斯案做出决定后,他们重申这是一项永久性政策。
所以你所要做的就是通过众多的网上处方者之一订购它们,这都是100%合法的。
好吧,我猜在某些州拥有和拿走它们可能是不合法的,但除非你告诉他们,否则没人会知道。即使你是极少数在做了药物流产后需要医疗护理的病例之一,他们也无法知道这不是自然流产,因为流产药物是无法检测到的。

Hot_Sorbet5982
Good, give women the choice of whether or not they want a 20+ year financial, emotional commitment.

很好,让女性自主选择是否想要20多年的财务和情感承诺。

Damdamfino
Add physical in there, as well. People need to realize pregnancy is not a walk in the park, put the kid up for adoption and move on with your life as if nothing happened. It changes your body and health permanently. From something as small as losing control of your bladder, to tooth decay, and many more all the way up to possible death.

也要加上身体上的。人们需要意识到怀孕不是在公园里散步,把孩子送去领养,然后继续你的生活,就像什么都没发生过一样。它会永久地改变你的身体和健康。小到膀胱失控,到腐烂,大到可能死亡。

Hot_Sorbet5982
After my first child I got post partum depression, which turned into major depressive disorder, which then turned out to be bi polar disorder

生完第一个孩子后,我患上了产后抑郁症,后来变成了重度抑郁症,后来又变成了躁郁症
原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


GailMarie0
The movement to outlaw abortion will be as successful as Prohibition was. When 60 percent of the population supports abortion, it will be impossible for 40 percent to impose their will on the rest of the population. But like Prohibition, there will be unintended consequences. Women will suffer, lose their ability to conceive, and die unnecessarily. In the process, we're now providing third-world medical care to half our population.

禁止堕胎的运动将会像禁酒令一样“成功”。当60%的人口支持堕胎时,40%的人不可能把他们的意志强加给其余的人。但就像禁酒令一样,这将带来意想不到的后果。妇女将遭受痛苦,失去生育能力,并无谓地死亡。在这个过程中,我们现在为我们一半的人口提供第三世界水平的医疗服务。

IcyOrganization5235
As great as this sounds, and it is great, the next step is for the GOP and religious crowd to try to regulate the drugs we can take. That's scary AF

这听起来很棒,也确实很棒,但下一步是共和党和宗教人群试图规范我们可以服用的药物。这太可怕了

bettinafairchild
They're already trying to do this, there is no next step. This is an attempt to prevent the antiabortion crowd from controlling these pills. Best I can understand, this pill, mifepristone, previously was only available directly from a doctor at the office. Now it can be sold in pharmacies, including mail-order pharmacies. And the government is asserting that the FDA, not the states, has jurisdiction over what medications can be legal and what can't, and it's not something states can override. Meaning online pharmacies can mail abortion pills to states where abortion is illegal.
Meanwhile, antiabortion forces have sued to make mifepristone illegal on the basis that when it was approved by the FDA 20 years ago, they rushed the approval process. And the second pill in the medical abortion protocol, misoprostol, which already is available by prescxtion at pharmacies, can be hard to get, even impossible, in anti-abortion states. Pharmacists can and have simply refused to dispense it (it has numerous other important medical uses besides abortion). That's another reason why it's important to be able to get from mail-order pharmacies.

他们已经在这么做了,不用下一步。这是为了防止反堕胎人群控制这些药物。据我所知,这种药,米非司酮,以前只能直接从坐诊医生那里开到。现在它可以在药店出售,包括邮购药店。政府声称,食药管理局,而不是各州,对哪些药物可以合法,哪些不合法拥有管辖权,这不是各州可以推翻的。这意味着在线药店可以将堕胎药直接邮寄到堕胎非法的州。
与此同时,反堕胎势力提起诉讼,要求将米非司酮定为非法药物,理由是20年前食药管理局批准米非司酮时,批准过程很匆忙。此外,医学堕胎协议中的第二种药物米索前列醇已经可以在药店处方购买,但在反对堕胎的州很难买到,甚至根本不可能买到。药剂师可以而且已经拒绝配发它(除了堕胎,它还有许多其他重要的医疗用途)。这也是为什么能从邮购药店买到这种药很重要的另一个原因。

Spicy_Lobster_Roll
This is progress but this medication should be OTC given its stellar safety record and to foil forced pregnancy proponents.

这是一种进步,但这种药物应该是非处方药,因为它具有良好的安全记录,并且可以挫败强迫怀孕的支持者。

CopenHaglen
I completely disagree. Medical abortions can have extreme physical and psychological effects on the patient, that both they should be made aware of and be assessed for viability for by a medical professional. You should be able to acquire it easily, but seeing a doctor about it first is important. This medication is not a walk in the park.

我完全不赞同。药物流产可能对患者产生极端的生理和心理影响,医疗专业人员应当使患者意识到这一点,并评估其生存能力。你应该可以很容易地获得它,但首先看医生是很重要的。用这种药可不是在公园里散步那么简单。

rocko7927
Finally a bit of good news. I hope Roe v Wade can be re-formed. The ability to perform an abortion should be the basic right of anybody in the USA.
I would like to see the statistics on stores that allow the sale of these products. Say for example if Shoppers will sell them in California but not in Texas or if they will still sell them everywhere.
I am not entirely sure of how the laws work in these states with selling abortion medication such as the 'Plan B' pill. Where is the line drawn between contraception and abortion medication?

终于有一点好消息了。我希望罗伊诉韦德案可以重新审理。在美国,堕胎应该是每个人的基本权利。
我想看看允许销售这些产品的商店的统计数字。比如,销售者是否会在加州销售,但不会在德克萨斯州销售,或者他们是否仍然会在各地销售。
我不完全确定在这些州销售堕胎药物如“B计划”药的法律是如何运作的。避孕和堕胎药物之间的界限在哪里?

sloopSD
Left: Abortion, Right: Guns. Can someone explain why these two things are always brought up together? Is it just that they are political pressure points?

左:堕胎,右:枪支。有人能解释一下为什么这两件事总是同时出现吗?仅仅是因为它们是政治压力点吗?

LID919
Because it's a really easy "gotcha" in either debate.
In a debate on gun control, the left might say they are trying to protect children from being murdered (school shootings). The right will reply that the left doesn't actually care about stopping children from being murdered, because they support abortion.
In a debate on abortion, the right might say they are trying to protect children from being murdered (aborted). The left will reply that the right doesn't actually care about stopping children from being murdered, because they're against gun control.

因为这在任何一场辩论中都很容易被“抓住”。
在一场关于枪支管制的辩论中,左派可能会说,他们是在试图保护儿童不被谋杀(校园枪击案)。右派会回答说,左派实际上并不关心阻止儿童被谋杀,因为他们支持堕胎。
在一场关于堕胎的辩论中,右派人士可能会说,他们是在试图保护儿童不被谋杀(堕胎)。而左派会回答说,右派实际上并不关心阻止儿童被谋杀,因为他们反对枪支管制。

TY_subie
I had a medical abortion 10 years ago. There were criteria I had to meet to be able to have a medical (vs surgical) abortion. If I had twins or an ectopic pregnancy, I would have had to move to a surgical abortion due to health safety concerns. For that reason, I’m unsure if abortion medication will be able to be prescribed by patients not receiving a transvaginal ultrasound- ie you still have to go to a facility to have the meds prescribed.

我十年前做过药物流产。我必须满足一些标准才能进行药物流产(而不是手术流产)。如果我有双胞胎或宫外孕,出于健康安全考虑,我将不得不进行手术流产。出于这个原因,我不确定没有接受经阴道超声检查的患者是否能开堕胎药物——也就是说,你仍然必须去医院才能拿到处方药物。

a_stray_bullet
Have had to use this method once before with a partner. It is not something to be taken lightly or without care, it is harrowing. Every woman I know that has used this method has sworn never to use it again, and would rather go to an abortion clinic.

我以前和一个搭档用过这种药物流产。这不是一件可以掉以轻心或毫不在意的事情,这是很悲惨的。我认识的每一个用过这种方法的女人都发誓再也不会用了,宁愿去堕胎诊所。
原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


Wolfgirl90
Every woman I know that has used this method has sworn never to use it again, and would rather go to an abortion clinic.
Well, first off, nine times out of ten, if a woman is terminating her pregnancy, she's going to be at an abortion clinic anyway, regardless of the method that is ultimately used.
Second, most abortions are going to be harrowing, either physically or mentally. And even suction and D&E abortions can result in cramping and bleeding just like with medication abortions.

“我认识的每一个用过这种方法的女人都发誓再也不会用了,宁愿去堕胎诊所”
好吧,首先,十有八九,如果一个女人要终止怀孕,她无论如何都会去堕胎诊所,不管最终使用的堕胎方法是什么。
其次,大多数堕胎都是痛苦的,无论是身体上还是精神上。即使是抽吸和剖腹产也会像药物流产一样导致痉挛和出血。

Suolucidir
And thus prescribed confidentially by USPS anywhere in the country then, right?

因此现在在全国任何地方都能通过美国邮政秘密地开堕胎药了,对吧?

RantoniFantoni
There's already a movement for pharmacists to deny medication based on their religious principles. This is only going to gas them up some more.
I had a former coworker from Germany who originally came to the US to live for a while with the American side of her family (daughter of US army soldier and German national) and experience life in America. So she moved to rural Mississippi to stay with them. She told me how offended she was that her local pharmacist would judge her for her birth control prescxtion and be passive-aggressive about it when she went to pick her prescxtion and gave her dirty looks.
I told her that this is to be expected in redneck America.

现在已经有一场药剂师基于宗教原则拒绝用药的运动了。这只会让他们更进一步。
我有一个来自德国的前同事,她最初来到美国和她的美国家人(美国军人的女儿和德国国民)一起生活了一段时间,并在美国体验生活。所以她搬到了密西西比州的农村和他们住在一起。她告诉我,当地的药剂师会因为她的节育处方而对她指指点点,当她去取处方时,还会对她恶狠狠地瞪她一眼,这让她非常生气。
我告诉她,这在乡下人的美国是很正常的。

16semesters
The problem is not delivery by mail -- that's already legal per the article.
The problem is telemedicine laws and licensing are based on where the patient is located.
So if the patient is in Texas, doesn't matter that the doctor is in Oregon, they have to adhere by the laws/licensing of Texas.

问题不在于邮寄——根据条款,邮寄已经是合法的了。
问题是远程医疗的法律和许可是基于病人所在的位置。
所以如果病人在德克萨斯州,医生在俄勒冈州并不重要,但他们必须遵守德克萨斯州的法律/许可。

wdwerker
With tele medicine they should make a online consultation, prescxtion and mail the medication to anyone in the nation bypassing the states and anti crowd completely.

通过远程医疗,他们可以进行在线咨询,开处方和邮寄药物给全国的任何人,完全绕过州和反对人群。

remck1234
There are some people who do this, aidaccess offers to mail the abortion pill to any state where it is allowed and it is way cheaper than it would be at a clinic. Not a lot of people know about services like that but they are around.

有一些人会这样做,AidAccess组织提供援助,将堕胎药邮寄到任何允许堕胎的州,这比在诊所便宜得多。并不是很多人知道这样的服务,但它们就在身边。

Sharkictus
Should also be standard to test for it if a woman is pregnant and wants it, but is having issues all of a sudden.
Forced abortion is absolutely a thing, and OTC can be horrendously abusable.
Lovers, parents, or hell employers can easily buy it and poison happily pregnant women with it.
This will however lower other violence against pregnant women, since the vile people can be more subtle.

如果一个怀孕的女人想要它,但突然出现了意外——这也应该是测试的标准。
强迫堕胎绝对是一件问题,并且非处方药也可能被可怕地滥用。
情人,父母,甚至雇主都可以轻易地购买它,用它毒害高兴的孕妇。
然而,这将降低其他针对孕妇的暴力行为,因为卑鄙的人可能手段更加微妙了。

原创翻译:龙腾网 https://www.ltaaa.cn 转载请注明出处


DuncanAndFriends
Should be free for low income families and single mothers. Last thing we need is more kids growing up in poverty resorting to crime to survive

低收入家庭和单身母亲应该免费获得。我们最不需要的就是更多在贫困中长大的孩子为了生存而犯罪

ripe_mood
Wow, finally. After over 100 years in women's rights struggles we have a sliver of autonomy back. Good work gals.

哇,终于。经过100多年的女权斗争,我们终于有了一点自主权。干得好,姑娘们。

izzgo
This won't last past the next presidential election. Until then, pharmacies are free to refuse to dispense them, depending on the religion of the pharmacist.

这种情况不会持续到下届总统大选的。在此之前,药店可以根据药剂师的宗教信仰,自由拒绝配药。

Going_my_own_way73
But what good is this policy if the women have to deal with a pharmacist who won’t fill the prescxtion due to their religious beliefs? I’m sure that will be a lightning rod issue. And the Governors of states that have banned medical abortions will wholeheartedly back these pharmacists.

但如果女性不得不面对因为宗教信仰而不给配药的药剂师,这一政策又有什么用呢?我相信这将是一个避雷针问题。那些禁止药物堕胎的州的州长们将全心全意地支持这些药剂师。

SammyLoops1
Still no cracking down on pharmacists who refuse to do their job and fill prescxtions. That should be illegal. If they won't do their job, they shouldn't be in it.

仍然没有打击那些拒绝履行职责、不给配药的药剂师。这应该是非法的。如果他们不履行他们的职责,那他们就不应该呆在里面。

Thepowerisreal
Good to know, now to hopefully never need them so me and my gf can avoid getting judged by the old Christian lady working the counter.

很高兴听到这个消息,现在希望永远不需要它们,这样我和我的女朋友就可以避免被柜台工作的基督教老妇人评判了。

Dye_Harder
Don't forget how to shut down all these "pro-life" fascists;
"Why aren't you guys talking about taking down the death penalty now?"

别忘了如何堵住所有那些“反堕胎”的法西斯分子的嘴:
“你们为什么现在不讨论废除死刑?”

Jzxky
That’s not a great comparison. They’re pro-innocent life, not against anyone dying ever. In general, at least the people on death row did something so horrible they could be judged and sentenced to death.

这不是一个很好的比较。他们支持无辜生命,而不是反对任何人死亡。一般来说,至少死刑犯做了一些可怕的事情,他们可以被判死刑。

TheGrumpyBear92
Yeah, that means nothing when the Supreme Court can strip the FDA of power at will.

好吧,但是当最高法院可以随意剥夺食药管理局的权力时,这就没什么意义了。

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