Some parents have always cited concerns about safety for declining to get the HPV vaccine for their kids. Syncope (fainting) is sometimes observed with Gardasil, as with other vaccines. Before Merck brought Gardasil to market, the company negligently designed and conducted clinical trials to prevent the clinical trials from revealing the vaccine's true risks, including autoimmune diseases, the lawsuit alleges. One other con of the HPV vaccines is that theyre limited in what they do: Whos most at risk of getting HPV if theyre not vaccinated? To date, no serious side effects have been shown to be caused by the vaccines. Evaluation of durability of a single dose of the bivalent HPV vaccine: The CVT trial. About 60 per cent of 12-year-olds were immunized in 2018-19. Another prevention strategy that is being explored is topical microbicides. Changes in the prevalence of human papillomavirus following a national bivalent human papillomavirus vaccination programme in Scotland: A 7-year cross-sectional study. Durability of cross-protection by different schedules of the bivalent HPV vaccine: The CVT trial. 2022 Gardasil Lawsuit Update. "In speaking with other parents of Gardasil-injured children, I can tell you there is a lot of concern regarding a possible IVIG shortage in the near future," says Mrs. Roglitz-Walker. In 2015, 13% of parents had cited safety concerns as the main reason for declining the HPV vaccine. In 2020, the Centers for Disease Control and Prevention (CDC) approved the HPV vaccine to prevent even more cancers: head and neck cancers, like those in the back of the throat or base of the tongue. Most private insurance plans cover HPV vaccination. Not only does vaccination protect vaccinated individuals against infection by the HPV types targeted by the vaccine that is used (and possibly other types, depending on the extent of cross protection), but vaccination can also reduce the prevalence of the vaccine-targeted HPV types in the population, thereby reducing infection in individuals who are not vaccinated (a phenomenon called herd protection, or herd immunity). If your doctor does not stock HPV vaccine, ask for a referral. Furthermore, the complaint alleges that Merck knew or should have known that its poorly designed clinical trials and studies were insufficient to test Gardasil's true long-term safety and efficacy. Cervical cancer is the fifth most common cancer among Thai women, with the human papillomavirus (HPV) a major cause. It seems that younger doctors are more aware of current recommendations concerning the HPV vaccine and that most doctors working in specialties where they qualify young people for . They were also less likely to recommend on-time vaccination for boys than for girls. sex without a condom or other barrier method, a routine of smoking or chewing tobacco, which weakens the immune system, a diet thats low in important vitamins, minerals, and other nutrients. Dietary intakes of selected nutrients and food groups and risk of cervical cancer. It can be given as early as age 9. It prevents infection with the following nine HPV types: Cervarix prevents infection with types 16 and 18, and Gardasil prevents infection with types 6, 11, 16, and 18. You can learn more about how we ensure our content is accurate and current by reading our. Research suggests the. The Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American Academy of Family Physicians have each been urging doctors to maintain vaccination schedules. Human papillomavirus (HPV) and cervical cancer. Strong backers of the vaccine include the American Academy of Pediatrics, the American Academy of Family Physicians and the Centers for Disease Control and Prevention. Human papillomavirus-attributable cancers - United States, 20122016. (I very much doubt that a properly carried out RCT was ever done to prove that the HPV vaccine protects against cervical cancer because, in general, cervical cancer develops late in life (i.e. This vaccine protects against nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58). DOI: Piyathilake CJ, et al. Merck allegedly used the DNA adjuvant to prolong Gardasil's immunological effects but illegally omitted it from its list of substances and ingredients in the vaccine. They have the potential to eradicate disease and save millions of lives. HPV vaccination is recommended at ages 1112 years. What research is being done on strategies to prevent HPV infection? Kreimer AR, Gonzalez P, Katki H, et al. All preteens need HPV vaccination, so they are protected from HPV infections that can cause cancer later in life. Some health reports were hearsay and lacked sufficient information to be verified, she added. This is because getting them before a person's first sexual contact can offer lifelong protection against HPV-related . Certain strains of HPV can cause genital warts, cervical cancer, and other types of cancer. 2020 research indicates that not only does HPV vaccination prevent the viruses . Doctors recommend that women should either get HPV DNA screening every five years or at least get vaccinated against HPV. Mix JM, Van Dyne EA, Saraiya M, Hallowell BD, Thomas CC. Over the years, several vaccines have been cleared for use by the U.S. Food and Drug Administration (FDA). by Sharon Reynolds, National Cancer Institute said that while the motion filed could start a "legal flood against our vaccination system," it will not stop the . by Carmen Phillips, December 2, 2022, Common Gardasil 9 side effects may include: pain, swelling, redness, itching, bruising, bleeding, and a lump where the shot was given; nausea, diarrhea, stomach pain; headache; The first dose is routinely recommended at ages 11-12 years old. What are the benefits of the HPV vaccine? The Front Line Covid-19 Critical Care Alliance, formed in 2020 to "prevent and treat covid," is touting ivermectin for common respiratory infections amid a dramatic drop in prescriptions for the drug as clinical . Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink. The recombinant quadrivalent vaccine protects against HPV types 6, 11, 16, and 18 and reduces the incidence of cervical, vaginal, and vulvar intraepithelial lesions and adenocarcinoma in situ . The combination of HPV vaccination and cervical screening can provide the greatest protection against cervical cancer. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. ", Young Woman Diagnosed with POTS After Receiving Gardasil Shot. Since late 2016, only Gardasil-9 (9vHPV) is distributed in the United States. Papillomavirus Research 2019; 8:100177. She spent the next five years being severely disabled and unable to attend school or participate in activities she once enjoyed. A year later, her medication regimen was up to 55 pills per day. We performed a systematic literature search in Pubmed to identify statistical approaches that have . Decline in in-patient treatments of genital warts among young Australians following the national HPV vaccination program. Maya Dronca said she wanted to grow up to be a doctor, treating cancer patients just like her mother, a Mayo Clinic oncologist. 1. Our suspicion is that the rising safety concerns are probably being driven by [the] use of social media and people trying to find vaccine information online, said the studys lead researcher, Kalyani Sonawane, Ph.D., of UTHealth School of Public Health in Houston, Texas. First, the group of doctors championed ivermectin as a covid panacea. The human papillomavirus vaccine provides a safe, robust immune response against HPV in reproductive-aged women who have had a stem cell transplant. Tsang SH, Sampson JN, Schussler J, et al. Cookies used to make website functionality more relevant to you. The primary cause of cervical cancer is a persistent infection of the genital tract by some specific types . Some people report having very mild side effects, like a sore arm from the shot. These studies also support that people who receive this vaccine are not at a higher risk of any negative events when compared to receiving any other vaccine, whether immediately after vaccination or in the long-term future. Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: A nested analysis within the Costa Rica Vaccine Trial. Our firm has always foughtand will continue to fightfor the rights of consumers to be fully and honestly informed about risks associated with any drug, vaccine, chemical, medical device, or consumer product. She was homeschooled through the majority of 6th through 12th grades, mostly bedridden and confined to a wheelchair. A total of 758 serious health problems that arose after HPV vaccination were reported in VAERS during that time. (2018). Although HPV vaccines have been found to be safe when given to people who are already infected with HPV, the vaccines provide maximum benefit if a person receives them before he or she is sexually active (32, 33). DOI: Centers for Disease Control and Prevention (CDC). Arana JE, Harrington T, Cano M, et al. The Gardasil vaccines also protect against strains 6 and 11. The firm co-led two of the Roundup cancer trials against Monsanto, obtaining in 2019, a $2 billion verdict on behalf of Alva and Alberta Pilliod, which was the second highest verdict in the nation and the ninth largest in U.S. history. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. MADISON, Wis., Nov. 18, 2020 /PRNewswire/ -- Gardasil attorneys from the national law firm of Baum Hedlund Aristei & Goldman filed a lawsuit against Merck on behalf of a young woman who alleges she developed Postural Orthostatic Tachycardia (POTS) and a host of other serious injuries after receiving the human papillomavirus (HPV) vaccine. 6 min read. You can get the vaccine until age 45. Multiple large studies published in 2013, 2014, and 2016 of HPV vaccination demonstrated that the vaccine is as safe as any other vaccination. HPV is an extremely common STI that many people who are sexually active will have at some point in their lives. Here are five reasons why it's especially important for males. Within a month after the shot she was bedridden, and wheel-chair bound if she had to be transported. The most recent safety data review for HPV vaccines continues to indicate that these vaccines are safe (29, 30). In England, girls and boys aged 12 to 13 years are routinely offered the 1st HPV vaccination when they're in school Year 8. They can share the virus unknowingly, so it's important to make sure they do everything they can to avoid getting it and spreading it." "Antivaccine rhetoric was also not given much space in the media" during the pandemic, she says. Human papillomavirus. Senkomago V, Henley SJ, Thomas CC, e al. Management of cervical dysplasia and human papillomavirus. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Should HPV vaccines be given to people who are already infected with HPV or have cervical cell changes? Arnheim-Dahlstrm L, Pasternak B, Svanstrm H, Sparn P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: Cohort study. As the incidence of cervical cancer has declined in the United States, due mainly to cervical cancer screening, the incidence of HPV-associated oropharyngeal, vulvar, and anal cancershas been increasing (25). Men get cancers caused by HPV in large numbers, too. It is likely that someone previously infected with HPV will still get some residual benefit from vaccination, even if he or she has already been infected with one or more of the HPV types included in the vaccines. Very rarely, severe (anaphylactic) allergic reactions might occur after vaccination. Because HPV vaccines do not protect against all HPV types that can cause cancer, women who have been vaccinated are advised to follow the same screening recommendations as unvaccinated women. Human papillomavirus, or HPV, can cause cancer in men and women and will infect three in four Canadians during their lifetime, according to the Canadian Cancer Society. Our website services, content, and products are for informational purposes only. Some people are concerned that HPV vaccination may have serious side effects or long-term impact, such as on fertility. The HPV vaccine is well-studied and safe; it has been in use since 2006. If Merck had provided adequate and truthful warnings and properly disclosed and disseminated the true risks, limitations, and lack of efficacy associated with Gardasil to medical providers, patients and the public, Ms. Walker's medical providers would never have offered or recommended the Gardasil vaccine, and Ms. Walker would never have suffered the disabling physical and emotional injuries she continues to endure. The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up. Quadrivalent human papillomavirus vaccine and the risk of venous thromboembolism. A controlled trial of a human papillomavirus type 16 vaccine. Maldonado. Is one dose of human papillomavirus vaccine as effective as three? A better approach, Dr. Kobrin went on, would be to say, Lets all talk about why we believe what we believe. This makes the vaccines highly effective. Different strains of HPV are linked to most cervical cancers, genital warts, and some rare forms of cancer of the anus, vagina, penis, mouth, and throat. Cision Distribution 888-776-0942 DOI: HPV vaccine for preteens and teens. Use of a 2-dose schedule for human papillomavirus vaccination Updated recommendations of the Advisory Committee on Immunization Practices. Human papillomavirus vaccination for adults: Updated recommendations of the Advisory Committee on Immunization Practices. Lower red blood cell folate enhances the HPV-16-associated risk of cervical intraepithelial neoplasia. Only two doses are needed if the first dose was given before 15. However, these people should be told that the vaccination will not cure them of current HPV infections or treat the abnormal results of their Pap test (31). Human papillomavirus vaccination coverage among adolescents, 20072013, and postlicensure vaccine safety monitoring, 20062014--United States. Assessing impact of HPV vaccination on cervical cancer incidence among women aged 1529 years in the United States, 19992017: An ecologic study. Meanwhile, the rate of nonserious health issues following HPV vaccination reported in VAERS dropped from 43 to 28 per 100,000 vaccine doses. It failed to live up to the hype. Doctor Elena Ratner, a gynecologic oncologist at Yale Cancer Center and Smilow Hospital says success is being seen as a result of Gardasil 9, the vaccine to prevent HPV, which is a. 4 In 2020, the global market volume for HPV vaccines is anticipated to reach approximately 44.5 million doses (Figure 4),14 having increased from an average of 30-35 million doses a year over 2010 to 2016,15 representing an increase of 21 per cent over the past 4 years. The current HPV vaccines are based on virus-like particles(VLPs) that are formed by HPV surface components. The HPV vaccine, approved by the FDA in 2006, is recommended for girls ages 9 and older, before they become sexually active. Clinical obstetrics & gynaecology 2018; 47:5972. Enhertu May Be Preferred Therapy for Some Metastatic Breast Cancers, Adjuvant Immunotherapy Approved for Some Patients with Lung Cancer, If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. 3:20-cv-01048) includes allegations of negligence, failure to warn, and manufacturing defects, among others. Children aged 9 through 14 years who have received two doses of HPV vaccine less than 5 months apart will need a third dose. The vaccine for human papillomavirus, or HPV, works best when given to children in late childhood and early adolescence before they're sexually active according to some experts. New England Journal of Medicine 2002; 347(21):16451651. New England Journal of Medicine 2011; 364(5):401411. Koutsky LA, Ault KA, Wheeler CM, et al. Healthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. This ensures that theyre protected against HPV before theyre likely to have exposure to the virus. Gardasil is a vaccine intended for girls and young women between the ages 9 to 26 to protect . But since she became sick and disabled within days of getting the shot, we firmly believe her adverse reactions were caused by the Gardasil vaccine. Safety of the 9-valent human papillomavirus vaccine. There are several, Coronary artery disease reduces blood flow to your heart. Thank you for taking the time to confirm your preferences. (2016). The protection provided by HPV vaccines lasts a long time. HPV infection. Vaccine 2018; 36(13):17811788. Infectious Diseases 2017; 17(12):12931302. Herrero R, Quint W, Hildesheim A, et al. The Centers for Disease Control and Prevention (CDC) recommends that the HPV vaccine be given to girls and boys between ages 11 and 12. HPV is a group of more than 200 related viruses, of which more than 40 are spread through direct sexual contact. Gardasil 9 has, since 2016, been the only HPV vaccine used in the United States. There has been a rise in negative and incorrect informationalso called misinformationabout HPV vaccines on social media in recent years, Dr. Sonawane noted. Cervical cancer is the second most common cancer after breast cancer to affect women aged 15-44 years in the European Union. What is the evidence? Published Apr 22, 2009. When the researchers looked at the data by state, they found that the number of parents citing safety concerns increased in 30 states and more than doubled in California, Mississippi, South Dakota, and Hawaii. In addition, Cervarix has been found to provide substantial protection against a few additional cancer-causing HPV types, a phenomenon called cross-protection (16). Pediatrics 2019; 144(6):e20191791. Reports of serious health issues after HPV vaccination were consistently rarearound 1.8 per 100,000 HPV vaccine doses, or 0.0018%. Impact of human papillomavirus (HPV) 16 and 18 vaccination on prevalent infections and rates of cervical lesions after excisional treatment. Journal of Biomedical Science 2016; 23(1):75. She also receives a very expensive Intravenous Immune Globulin (IVIG) treatment at home every three weeks through a central line in her chest. Gee J, et al. They can tell you more about the vaccine and advise you on whether its right for you or your child. In this new study, Merck researchers used data from the National Immunization Survey-Teen 2017-2020, as well as a retrospective cohort of nearly 20,000 teens aged 15-17 years old who initiated HPV . Sadly, Merck learned no lessons. cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-fact-sheet, cdc.gov/vaccines/parents/diseases/teen/hpv.html, cdc.gov/vaccines/vpd/hpv/public/index.html, naturopathic.org/article_content.asp?article=788, mayoclinic.org/diseases-conditions/hpv-infection/symptoms-causes/syc-20351596, Everything you Need to Know About Human Papillomavirus Infection, Common Types of Human Papillomavirus (HPV), Human Papillomavirus (HPV) of the Mouth: What You Should Know, HPV and HPV Tests: Everything You Need to Know, More Boys Are Getting Vaccinated Against HPV: Why That's Important, Why a Single Dose HPV Vax Could be a Game-Changer, Everything You Need to Know About HPV for People with a Vulva and Vagina. Now, the CDC recommends that all adults through age 26 should get vaccinated if they missed it during the middle-school years, and adults aged 27 through 45 should ask their doctors if the HPV vaccine is right for them, even if they're sexually active. To change peoples minds, the key is to not be judgmental and to provide the time and space for in-depth conversations, Dr. Kobrin noted. HPV is responsible for 70% of these diseases, which are grouped together as oropharyngeal cancer. Like other immunizations that guard against viral infection, HPV vaccines stimulate the body to produce antibodies that, in future encounters with HPV, bind to the virus and prevent it from infecting cells. These two strains are known to cause genital warts. The next generation of HPV vaccines: Nonavalent vaccine V503 on the horizon. The HPV vaccine is designed to help protect against the related viruses and cancers that may cause cervical cancer. ACIP recommends that people who have an HPV infection and/or an abnormal Pap test result that may indicate an HPV infection should still receive the HPV vaccine if they are in the appropriate age group (9 through 26 years) because the vaccine may protect them against high-risk HPV types that they have not yet acquired. The list of casualties and grim injuries continues to multiply. Clinical Microbiology and Infection 2019; 25(2):210216. Knowing the type of HPV you have can help determine if you're at increased, Human papillomavirus (HPV) that occurs in the mouth is a sexually transmitted infection (STI). Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. From 2013 to 2017, there were approximately 25,000 cases of HPV-associated cancers in women and 19,000 in men, according to the Centers for Disease Control and Prevention. These include having: Fortunately, many of these risk factors can be controlled. Both vaccines are still used in some other countries. If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. It's imperative that there be more robust checks and balances as well as increased transparency in order for the medical community and the public to make genuinely informed decisions. Mild to moderate side effects can include: If you get the vaccine and have any of these side effects or other unusual symptoms, or if the symptoms persist, you should talk to your doctor. Expert Review of Vaccines 2014; 13(11):12791290. Porras C, Tsang SH, Herrero R, et al. Hancock G, Hellner K, Dorrell L. Therapeutic HPV vaccines. "It would be devastating for my daughter and for anyone with Autoimmune Autonomic Neuropathy, Small Fiber Neuropathy, POTS, dysautonomia, and other neurological conditions who need this treatment just to keep them from being bedridden.". The findings highlight an urgent need for doctors and public health leaders to address these concerns with parents, according to the scientists who led the study. They help us to know which pages are the most and least popular and see how visitors move around the site. Dehlendorff C, Baandrup L, Kjaer SK. An interim analysis of data from a randomized clinical trial showed that consistent use of a lubricant gel that contains carrageenan reduced the risk of genital HPV infection in healthy women (36). Centers for Disease Control and Prevention. I want to warn people of the potential for serious adverse reactions and let others who have been hurt know that they are not alone. Now, my life is full of accommodations and medical interventions. More than 12 years of safety monitoring show that the vaccines have caused no serious side effects. She soon had fevers and began excessively sleeping, reporting extreme fatigue while awake. We will hold Merck accountable for the harm the company has caused. These vaccines work by stimulating the immune system to specifically target and kill infected cells. (About 80% of Japan's population is fully vaccinated against COVID-19.) And research has shown that parents who are exposed to misinformation about HPV vaccines on social media are less likely to vaccinate their children. A recent VSD study of the 9-valent HPV vaccine (Gardasil 9), for example, tracked new vaccinations over a 2-year period and identified no new safety issues. Some people should not get some HPV vaccines if: HPV vaccines are safe for children who are mildly ill, like those with a low-grade fever of less than 101 degrees, a cold, runny nose, or cough. Probably the most important con for the HPV vaccine is potential side effects. MMWR Morbidity and Mortality Weekly Report 2019; 68(32):698702. The HPV vaccine helps protect against cancers caused by HPV, including: cervical cancer some mouth and throat (head and neck) cancers some cancers of the anal and genital areas It also helps protect against genital warts. Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: Long-term follow-up results from the Costa Rica Vaccine Trial. Ms. Walker is seeking punitive damages against Merck for creating a substantial risk of significant harm to children and patients who were injected with the Gardasil HPV vaccine. One hundred thirty-five million human papillomavirus (HPV) shots delivered in the United States and counting. According to the complaint, Merck knew or had reason to know Gardasil is defective and ineffective, but instead of warning consumers about the dangers, the company wrongfully concealed information and further made false statements concerning the safety and efficacy of Gardasil. Nearly all cervical cancers are caused by HPV, according to the American Cancer Society. What Causes Immunotherapys Heart-Related Side Effects? There are different approaches to estimate the vaccine effectiveness/efficacy against persistent HPV infections. Following a number of Gardasil POTS lawsuits being filed by young adults and teens nationwide left with debilitating autoimmune disorders after receiving the HPV . Although the results are yet to be published, the studies suggest that well-respected local organizations can have a positive influence on peoples perceptions about HPV vaccines, Dr. Kobrin said. Drolet M, Bnard , Prez N, Brisson M; HPV Vaccination Impact Study Group. HPV vaccination and the risk of invasive cervical cancer. Morbidity and Mortality Weekly Report 2019; 68(33):724728. Sahara Walker seeks to hold Merck accountable for its negligent, reckless, and fraudulent conduct, and for the physical and emotional injuries she sustained after receiving the Gardasil vaccine. Ali H, Guy RJ, Wand H, et al. NCI has funded 11 research projects to explore the influence local organizations have on community members with HPV vaccine hesitancy. The HPV vaccine protects against some types of HPV-related cancers, but not all. All rights reserved. You cant tell people theyre wrong if you actually want them to hear alternative information. It often has few or no symptoms, which is why getting. One week later, on Oct. 3, 2013, she began to experience severe body aches to go along with the vomiting and headaches from the week prior. The rates of adverse side effects were consistent with what was seen in safety studies carried out before the vaccine was approved and were similar to those seen with other vaccines. It is the most common sexually transmitted infection in the United States. With little to no relief from her symptoms, Sahara was unable to engage in the activities she had enjoyed before receiving the Gardasil vaccine. He co-founded a successful biotech. Falsifying science, defrauding regulators and injuring and killing its customers is the only business model this company knows. Our firm wishes to stress that we are not against vaccines. Trials and real-world data from population-based studies have now demonstrated that the vaccines greatly reduce the risk of precancers and cancers of the cervix, vagina, and vulva in vaccinated women (1013). She suggests that doctors who commonly administer the HPV vaccine, including family practice physicians, obstetricians/gynecologists and pediatricians, should focus on the fact that the HPV vaccine has enormous potential to prevent cancers and has a strong safety profile from over a decade of vaccine administration. There are no formal screeningprograms for the non-cervical cancers, so universal HPV vaccination could have a large public health impact. In 2020, 54.5% of adolescents aged 13-15 years had received 2 or 3 doses of human papillomavirus (HPV) vaccine as recommended. Morbidity and Mortality Weekly Report 2014; 63(RR-05):130. Melissa Roglitz-Walker. After undergoing testing to assess her post-Gardasil symptoms and adverse events, Sahara was diagnosed with various medical conditions, including Neurocardiogenic Syncope (NCS), Postural Orthostatic Tachycardia (POTS), a form of Orthostatic Intolerance (OI) called Orthostatic Hypotension (OH), Small Fiber Neuropathy, and severe Autoimmune Autonomic Neuropathy. She thought she was being a really good, responsible parent. "Merck is using the same development and marketing playbook for Gardasil that it used when it promoted Vioxx as a headache pill knowing it caused heart attacks" says co-counsel Robert F. Kennedy, Jr. "Vioxx killed hundreds of thousands of Americans and Merck paid $7 billion in penalties and damages and agreed to stop falsifying science. The medical-freedom movement takes dollars spent by sick and desperate people on long-shot, unproven treatments and . 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