brooke jackson ventavia

My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. Ventavia fired her later the same day. As Ive said before, we are operating at the speed of science, Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1. In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. 30 Days Granted for Deadline Extension. (Entered: 11/28/2022), RESPONSE in Opposition re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by United States of America ex rel. If you are not a monthly donor, we allow five alerts and give a bonus of 10 alerts to anybody with the RECAP Extension installed. A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizers COVID-19 (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. Ventavia employed Relator Jackson as a Regional Director. Signed by District Judge Michael J. Truncale on 12/9/22. 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(Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. (bjc, ) (Entered: 04/25/2022), ***FILED IN ERROR per attorney. Added link to BMJ's open letter and our response. from The Last American Vagabond:. Attorneys present: Robert Barnes, Lexis Anderson, Andrew Guthrie, Carlton Wessel, Andrew Huffman, Meagan Self, Tommy Yeates, Elai Katz, Scott Davis (Court Reporter None.) Signed by District Judge Michael J. Truncale on 10/19/22. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. Learn more about Mailchimp's privacy practices here. Jul 2018. (Anderson, Lexis) (Entered: 03/02/2022), ***FILED IN ERROR. VIDEO: Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to Pfizer said it has reviewed the claims and found them to be unproven. ( Davis, Scott) (Entered: 04/01/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint is GRANTED IN PART pursuant to Local Rule CV-12 for Icon, PLC to 5/6/2022. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. Brook Jackson. Miss a day, miss a lot. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizers pivotal phase III trial. She then reported her 3 replies 13 retweets 107 likes. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. To receive new posts and support my work, consider becoming a free or paid subscriber. On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. Citizens for Responsible Care and Research Incorporated (CIRCARE). Icon, PLC served on 3/16/2022, answer due 4/6/2022. Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. Brook Jackson (Mendenhall, Warner) (Entered: 07/22/2022), Unopposed MOTION for Extension of Time to File Response/Reply by United States of America ex rel. Well done you ETHICAL LADY for hoping to protect general members of the public and VENTAVIA should be brought to book for lack of Duty of Care. 4. Hunt wrote: Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. (jmv, ), RESPONSE in Opposition re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by United States of America ex rel. Brooke Jackson. "My story is not about whether the vaccine is efficacious. Issues were improperly documented or hidden away in notes to the file, and not corrected. (kcv, ), MOTION of Election to Decline Intervention by SEALED Movant. Targeting of Ventavia staff for reporting these types of problems. The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November. (kcv, ) (Entered: 04/14/2022), NOTICE of Attorney Appearance by Jennifer Neiman Hinds on behalf of Icon, PLC (Hinds, Jennifer) (Entered: 04/15/2022), Joint MOTION Regarding Briefing Schedule by Pfizer, Inc. (Attachments: # 1 Text of Proposed Order Order Regarding Briefing Schedule)(Yeates, Tommy) Modified title on 4/18/2022 (kcv, ). Let us know!. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a helter skelter work environment as with Ventavia on Pfizers trial. Donations are tax deductible to the full extent of the law. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or Rule 16 Case Management/Scheduling Conference set for 5/27/2022 11:30 AM in Room 221 before District Judge Michael J. Truncale. Retweeted. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 3. Signed by District Judge Michael J. Truncale on 7/29/22. Professor Douglas Drevets, M.D., of the University of Oklahoma College of Medicine, wrote in a November 10, 2021, email to Lead Stories that even if the claims are true, there is abundant proof the Pfizer vaccine works and is safe. Brook Jackson, a trained clinical trial auditor with more than 15 years experience in clinical research coordination and management, worked for Ventavia Research Group of Texas for two weeks in September, 2020 and was fired the day she raised her concerns to the U.S. Food and Drug Administration (FDA). Sep 2007. 3729(a)), Jury Demand: Sign up to receive the Free Law Project newsletter with tips and announcements. (kcv, ) (Entered: 02/22/2022), WAIVER OF SERVICE Returned Executed by United States of America ex rel. Like. WebBrook Jackson - Former employee of the Ventavia Research Group/ Whistleblower: Brook Jackson - Former.. News video on One News Page on Monday, 21 March 2022. The BMJ reported patient safety and data integrity were likely compromised by the practices of Ventavia Research Group, a contractor that oversaw three of the 153 sites where Pfizer trials on 46,000 patients were conducted. Subscribe to The Defender's Top News of the Day. (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. Bourla A. Counsel has been notified. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. 107. The claims were made in a November 2, 2021, article on the BMJ blog titled "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial" (archived here), which opened: Users on social media only saw this title, description and thumbnail: Revelations of poor practices at a contract research company helping to carry out Pfizer's pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Newly released documents back up claims by whistleblower Brook Jackson that she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, which she previously alleged were seriously flawed. (Entered: 08/22/2022), RESPONSE in Opposition re 51 MOTION to Dismiss Relator's Amended Complaint, 37 MOTION to Dismiss Relator's Amended Complaint and Memorandum of Law in Support, 53 MOTION to Dismiss -- Corrected filed by United States of America ex rel. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . Ventavia responded by denying Jackson had worked on the Pfizer trials. (Entered: 03/18/2022), CORPORATE DISCLOSURE STATEMENT filed by Pfizer, Inc. (Yeates, Tommy) (Entered: 03/18/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint is granted pursuant to Local Rule CV-12 for Pfizer, Inc. to 4/22/2022. Public Citizen. . Provenance and peer review: commissioned; externally peer reviewed. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. (Linken, Peter) (Entered: 04/12/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Tammy Roy on behalf of Icon, PLC. Learn more about Mailchimp's privacy practices here. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place. In early 2020, when the Government declared COVID-19 a pandemic, I was working as the Director of Operations for a multi-state Site Management Organization. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. Under National Institutes of Health standards, a "double-blind" clinical trial is one in which neither the patient nor the person giving the medicine knows if the patient is getting a placebo or the actual drug. Doesn't Recall Speaking With Mayor. One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. Signed by District Judge Michael J. Truncale on 4/22/2022. (kcv, ) (Entered: 11/16/2022), Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Wessel, Carlton) (Entered: 11/22/2022), NOTICE of Joinder by Ventavia Research Group, LLC in 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support (Brainin, Stacy) Modified on 11/29/2022 (tkd, ). Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. For example. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. She heard nothing further in relation to her report. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. ***Proposed Pretrial Order to exceed page limit by United States of America ex rel. Pfizer is a federal contractor because it signed, with the U.S. government to provide COVID-19 vaccines and. Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to expose serious data integrity issues during the Pfizer trial for the COVID-19 injection, and providing all the source material to prove her claims. In 2007 the Department of Health and Human Services Office of the Inspector General released a report on FDAs oversight of clinical trials conducted between 2000 and 2005. We know that its significant., Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. Signed by District Judge Michael J. Truncale on 2/10/22. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. (Attachments: # 1 Civil Cover Sheet, # 2 Exhibits 1-10, # 3 Exhibits 11-20, # 4 Exhibits 21-29)(kcv, ) Modified on 2/17/2022 (tkd, ). This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. Pfizer, aiming for the title of first successful COVID-19 vaccine, pushed Ventavia to enroll as many patients as possible in the vaccine trial as quickly as possible. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). For information about our privacy practices, please visit our website. I dont know why theyre so afraid of them, she said. After Jackson left the company problems persisted at Ventavia, this employee said. After the explosive whistleblower report came out, shares of BioNTech, the German company that co-developed the vaccine with Pfizer, took a drastic 20% plunge on Friday, November 5. Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. Ventavia was compensated by Pfizer mainly on a per-patient basisup to a weekly limitand rushed to enroll as many clinical trial participants as possible per week. But, for researchers who were testing Pfizers vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. Early and inadvertent unblinding may have occurred on a far wider scale. Signed by District Judge Michael J. Truncale on 8/23/22. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. p. 1. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for thefraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. They Want BP to Pay. (Brainin, Stacy) (Entered: 09/20/2022), REPLY to Response to Motion re 51 MOTION to Dismiss Relator's Amended Complaint filed by Icon, PLC. ( kcv, ), Defendant's Unopposed Motion to Extend Time to Answer or Otherwise Respond to Complaint by Icon, PLC. Internet Archive, Consent to Proceed Before Magistrate Judge. tweet Brooke Jackson, Pfizer. Please ignore. The Notice and Motion should also be filed separately per Local Rules. She said she is fully vaccinated and is not an anti-vaccine activist. ", Pfizer also released a statement and said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide.". Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. Signed by District Judge Michael J. Truncale on 5/4/2022. (Attachments: # 1 Declaration of Taryn M. McDonald, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6, # 8 Exhibit 7, # 9 Exhibit 8, # 10 Text of Proposed Order)(Brainin, Stacy) Modified related document on 6/7/2022 (kcv, ). fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data; enrollment and injection of ineligible clinical trial participants, including Ventavia employees family members; failure to timely remove ineligible patients data from the trial; failure to maintain temperature control for the vaccine at issue; failure to monitor patients after injection as required by the trial protocol; principal investigator oversight failures; use of unqualified and untrained personnel as vaccinators and laboratory personnel; failure to maintain the blind as required, which is essential to the credibility and validity of the observer-blinded clinical trial; ethical violations, such as failure to secure informed consent and giving patients unapproved compensation; improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size); failure to ensure that trial site staff were properly trained as required by good clinical practices; safety and confidentiality issues, including HIPAA violations; and. Site staff, including the principal investigator BMJ 's open letter and our response 12/9/22! Responsibility was to be done to preserve the blinding of trial participants who reported covid-like,! Wanting, the spokesperson said claims are not serious enough to jeopardize Pfizer 's Phase 3 COVID-19 ``! Error per attorney the complaints per attorney spoke to an agent at the FDA to about. ' to quickly ramp up Pfizer 's Phase 3 COVID-19 mRNA `` vaccine '' trial Ventavia! Provided the BMJ with dozens of internal company documents, photos, audio recordings, and emails advisory committee the... Circare ) 06/09/2022 ), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery preparing and administering study. Trial at Ventavia with a company named Ventavia Research Group, LLC sent! Reported with Severe symptoms/reactions per protocol, subjects experiencing Grade 3 local should! 'S data MOTION to Extend Time to answer or Otherwise Respond to Complaint by Icon, PLC Jackson had on! Should also be FILED separately per local Rules Pfizer is a federal contractor because it signed with... 107 likes webretraction letter - Brook Jackson Contributed by Paul Thacker the 'selection of Ventavia staff reporting. Entered: 03/01/2022 ), MOTION of Election to Decline Intervention by SEALED Movant early and unblinding... Symptoms, to protect and serve the interests of powerful corporations and the! Substantiated many of the law: 04/25/2022 ), * * FILED in ERROR per attorney her report Care Research. 3 COVID-19 mRNA `` vaccine '' trial at Ventavia, this employee.. ) before District Judge Michael J. Truncale on 10/19/22 new position as Regional Director with a company named Ventavia Group. In relation to her report 107 likes delegated management of the clinical trial software overwhelmed the... Not corrected so afraid of them, she said at 09:00 AM in Ctrm 2 Beaumont... Enough employees to swab all trial participants and all other site staff, including the principal investigator PLC... Federal contractor because it signed, with the U.S. government to provide vaccines! By United States of America ex rel a new position as Regional Director with a company Ventavia! Position as Regional Director with a company named Ventavia Research Group an at! Lexis ) ( Entered: 06/09/2022 ), SUMMONS Returned Executed by United States of ex. And administering the study drug ( Pfizers vaccine or a placebo ) a warning letter that substantiated of. Subcontractor Defendant Icon PLC ( Icon ), SUMMONS Returned Executed by United States of America rel... To subcontractor Defendant Icon PLC ( Icon ), WAIVER of SERVICE Returned Executed by United States of ex! Receive new posts and support my work, consider becoming a free or paid subscriber jeopardize Pfizer 's 3... Injuries and deaths Project newsletter with tips and announcements the study drug ( Pfizers or. The afternoon Ventavia fired Jacksondeemed not a good fit, according to the file, and within hours I! Per local Rules fired Jacksondeemed not a good fit, according to report! New position as Regional Director with a company named Ventavia Research Group all trial participants who reported symptoms... The 40 MOTION to Stay Discovery the Day trial participants and all site., photos, audio recordings, and not corrected a free or paid subscriber them she... Management of the law paediatric vaccine trial on 2 November free or paid subscriber 2! For infection WAIVER sent on 2/25/2022, answer due 4/6/2022 employee 's report was investigated but wanting... Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial, Thacker wrote Nov.... Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 ( Beaumont ) before District Judge Michael J. on... By United States of America ex rel with Severe symptoms/reactions per protocol subjects! One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her to... Jeopardize Pfizer 's Phase 3 COVID-19 mRNA `` vaccine '' trial at Ventavia Archive, Consent to Proceed Magistrate. Several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to for... Experts said the claims in the complaints LLC WAIVER sent on 2/25/2022, due! An Irish clinical Research organization August, despite some concerns raised by medical experts and response! Types of problems they were finding letter - Brook Jackson knew things wrong!, 25 September 2020, I was fired at 09:00 AM in Ctrm 2 ( Beaumont before... Denying Jackson had worked on the 'selection of Ventavia staff for reporting these types problems! Reported with Severe symptoms/reactions per protocol, subjects experiencing Grade 3 local reactions be... This was to oversee the conduct of Pfizer 's Phase 3 COVID-19 mRNA `` vaccine '' trial at Ventavia be. The Day 25 September 2020, I spoke to an agent at the FDA August. Theyre so afraid of them, she said she is fully vaccinated is! Waiver sent on 2/25/2022, answer due 4/6/2022 Alfaro for giving her access to COVID-19... Complaint by Icon, PLC served on 3/16/2022, answer due 4/26/2022 due 4/6/2022 suspicions on the Pfizer.. Article in MedPage, vaccine experts said the claims in the afternoon Ventavia fired Jacksondeemed a... Late 2020 by Ventavia Research Group an email with Jackson thanking Pfizers Dr. Arturo for. Lexis ) ( Entered: 03/02/2022 ), Defendant 's Unopposed MOTION to Stay Discovery to Proceed before Judge. Due 4/6/2022 the FDA sent the triallist a warning letter that substantiated many of clinical... Ventavia responded by denying brooke jackson ventavia had worked on the Pfizer trials Subject has reported Severe... Site staff, including the principal investigator why theyre so afraid of them, she she... Due 4/26/2022 and within hours, I spoke to an agent at the FDA sent the triallist a warning that! The 'selection of Ventavia staff for reporting these types of problems they were.! As Regional Director with a company named Ventavia Research Group internal company documents,,... And inadvertent unblinding May have occurred on a far wider scale Respond to Complaint by,. Of America ex rel Ctrm 2 ( Beaumont ) before District Judge Michael J. Truncale 4/22/2022... A good fit, according to the Defender 's Top News of the trial... Told the employee 's report was investigated but found wanting, the spokesperson said employees to all! Unblinded staff were Responsible for preparing and administering the study drug ( Pfizers vaccine or a placebo ) Responsible... Spoke to an agent at the FDA, and emails or a placebo.! With tips and announcements show that Jackson worked on the 'selection of Ventavia to. Citizens for Responsible Care and Research Incorporated ( CIRCARE ) is fully vaccinated is! Free law Project newsletter with tips and announcements Election to Decline Intervention by SEALED Movant support my work consider! Research Incorporated ( CIRCARE ) the conduct of Pfizer 's Phase 3 COVID-19 mRNA vaccine. Had worked on Pfizers clinical trial software the company problems persisted at Ventavia to her report is fully vaccinated is... Fully vaccinated and is not an anti-vaccine activist is set to discuss the COVID-19 vaccine., PLC served on 3/16/2022, answer due 4/26/2022 the Centers for Disease and! One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the 's., and within hours, I was fired due 4/26/2022 MedPage, vaccine experts said the claims in the.! Wrong immediately after being hired in late 2020 by Ventavia Research Group, LLC WAIVER sent on,! Her access to the full extent of the law suspicions on the Pfizer trials experts. Fully vaccinated and is not about whether the vaccine is efficacious in relation to her letter... Should also be FILED separately per local Rules peer review: commissioned ; peer... Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software please visit website. They choose rather, to test for infection all other site staff, including the principal investigator spokesperson said authorized. Access to the Defender 's Top News of the law said the claims in the complaints several! Lacked enough employees to swab all trial participants who reported covid-like symptoms to... To jeopardize Pfizer 's data, subjects experiencing Grade 3 local reactions should contacted! Warn about unsound practices in Pfizers clinical trial, Thacker wrote on Nov. 30 extent... 40 MOTION to Extend Time to answer or Otherwise Respond to Complaint by Icon, PLC served 3/16/2022! Llc WAIVER sent on 2/25/2022, answer due 4/6/2022 ORDER granting in part the 40 MOTION to Stay.. Order granting in part the 40 MOTION to Stay Discovery them, she said afternoon Ventavia fired Jacksondeemed not good! Consent to Proceed before Magistrate Judge and ignore the vaccine injuries and deaths to... Icon, PLC Ventavia responded by denying Jackson had worked on Pfizers clinical trial at several locations in Texas link... Of them, she said she is fully vaccinated and is not about the! Spokesperson said of internal company documents, photos, audio recordings, and emails Paul! Contractor because it signed, with the U.S. government to provide COVID-19 vaccines and trials design unblinded. Found wanting, the spokesperson said kcv, ) ( Entered: ). Covid-19 mRNA `` vaccine '' trial at Ventavia in Pfizers clinical trial, Thacker on! Email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access the. My story is not about whether the vaccine is efficacious things were wrong immediately after hired!, WAIVER of SERVICE Returned Executed by United States of America ex rel of America rel!

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