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News Article | April 19, 2017
Site: www.techtimes.com

A handheld vagus nerve stimulation device used for the treatment of episodic cluster headaches has been approved by the Food and Drug Administration (FDA) on April 18. Also known as "suicide headaches," these headaches are extremely severe and affect fewer than 1 percent of people — mostly men. The illness comes and goes in clusters and episodes, with patients not experiencing pain for months and then suffering several sudden headaches in a single day or more. Prior to the FDA approval, there has not been any specific treatment for cluster headaches, but patients do take migraine drug sumatriptan, which is delivered through auto-injector, as well as inhaled oxygen. These methods are limited and often inconvenient. Now, the FDA approved the use of handheld device called GammaCore, which was developed by a New Jersey-based company known as ElectroCore, in the United States. This special device has long been available in Europe and treats pain by sending mild electrical stimulation to the vagus nerve. The device is applied to the neck during a headache. Data shows that more than 350,000 people in the United States suffer from cluster headaches. The FDA release was based on two trials: the placebo-controlled ACT1 and ACT2 trials. The first trial involved 85 patients with episodic cluster headaches. In the study, 34 percent of the respondents who used the device reported pain reduction compared to 10.6 percent of the placebo group. The second trial included 27 patients with 182 total pain attacks. The findings showed that 47.5 percent of those treated with GammaCore were pain-free after 15 minutes, while only 6.2 percent of those who used the placebo were pain-free. In 2016, a study found that vagus nerve stimulation therapy is effective in easing pain among rheumatoid arthritis patients. Researchers said treatment using the vagus nerve stimulation device displayed mild and transient side effects. Dr. Stephen Silberstein, director of the Headache Center at Jefferson University, said GammaCore does not have dose limitations or side effects commonly found in prescribed treatments. There is no need for invasive surgical procedures, which can be high-risk, inconvenient, and costly. Silberstein also said the approval is a milestone for the treatment of cluster headaches. "It is a way for patients to treat their symptoms as often as they need to use the device," he added. Meanwhile, ElectroCore warned that the vagus nerve stimulation device should not be used by patients with active implantable medical device, such as hearing aid implant or pacemaker; patients with hypotension, hypertension, tachycardia, or bradycardia; as well as children or pregnant women. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


News Article | May 8, 2017
Site: www.eurekalert.org

CINCINNATI--Changes in female hormones may trigger headaches in adolescent girls, but their effect may depend on age and their stage of pubertal development, according to a new study from researchers at University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center. The study, "Ovarian Hormones, Age and Pubertal Development and their Association with Days of Headache Onset in Girls with Migraine: An Observational Cohort Study" is currently available in the online edition of Cephalalgia, the scholarly journal of the International Headache Society. The study found that higher levels of the sex hormone progesterone were associated with fewer headaches in older teenagers, while lower levels resulted in more headache in that group. In younger girls, the opposite appears to be true. "Ours is the first study to show that migraine headaches might also be influenced by female hormones in girls with migraine," says Vincent Martin, MD, professor in the UC Division of General Internal Medicine and co-director of the Headache and Facial Pain Center at the UC Gardner Neuroscience Institute. "While low and declining estrogen levels are thought to precipitate migraine in adult women we found that progesterone to be the most important trigger factor in these young girls. However, this effect seemed to differ depending on the age of the girls and their pubertal development." Nationally, about 10 percent of school age children suffer from migraine, according to the Migraine Research Foundation (MRF). As adolescence approaches, the incidence of migraine increases rapidly in girls and by age 17 about 8 percent of boys and 23 percent of girls have experienced migraine, the MRF reports. Past studies have shown that female hormones are an important contributor for migraine in adult women, explains Martin, also a UC Health physician. Two thirds of adult women will develop migraine attacks of that occur shortly before or during menstrual bleeding. These attacks have been called "menstrual migraine." Low and declining levels of estrogen are thought to trigger attacks of menstrual migraine. Prior to this study the contribution of female hormones on migraine was unknown in girls and at what age this might occur, says Martin. "There is a dramatic change in the way that female hormones affect migraine that occurs during puberty," says Martin. "Prior to puberty progesterone has little effect on migraine, but after puberty high progesterone levels are associated with fewer headaches and low progesterone levels have more headache." Researchers as part of a 13-month study examined 34 girls experiencing migraine distributed across three age strata, ages 8 to 11, 12 to 15 and 16 to 17. Daily urine samples were collected and the occurrence and severity of headaches was recorded in diary for a 90-day period. The urine samples were evaluated for metabolites of the sex hormones estrogen and progesterone to determine if their presence was associated with days of headache onset or severity. All participants were patients of Cincinnati Children's Headache Center. The adolescents were offered a nominal stipend to encourage study compliance. Higher levels of progesterone appeared to be associated with reduced frequency of headaches in older teens. In the 16 to 17 age group there was a 42 percent chance of having a headache when levels of progesterone were low in urine samples, while when levels of the hormone was higher the chance of headache dropped to 24 percent, says Martin. In the 8 to 11 age group, there was 15 percent chance of suffering from migraine or headache when levels of progesterone were low, but a 20 percent chance of migraine or headache when high levels of progesterone were found in the urine, explains Martin. "The shifting contribution of female hormones to migraine occurrence from pre-pubertal girls through puberty into adulthood suggests a very dynamic process," says Andrew Hershey, MD, PhD, endowed chair and director of neurology at Cincinnati Children's Hospital Medical Center. "As the brain is developing in these girls there may be differences in the brain receptors sensitivity and their roles in migraine occurrence. The role of these receptors appear to shift from progesterone to estrogen as these girls progress through puberty. As the brain matures it could respond differently to hormones than a non-maturated brain." Girls may first start entering puberty between age 8-10 years old, although their first period may not be until age 12 or later. As they progress through this pubertal development, there may be cyclic hormonal fluctuations and irregular menstrual periods, explains Hershey. "We have previously demonstrated that a monthly headache pattern can begin during these early stages. As they age, their menstrual periods become more regular as do hormone fluctuations and by age 17, most girls are demonstrating adult hormone patterns," says Hershey. "But just having fluctuations in hormones or regular menstrual periods isn't enough to account for the differences in headache severity and onset displayed by younger girls compared to older teens." Martin says the research team was able to account for cyclic changes of hormones and that they were not found to be predictive of headache onset. "What I can say with the urine progesterone levels is that they were preventive in the older teens and that was more of an adult response; it is what you would expect to see in older women." "Our study suggests that female hormones play an important role in triggering headaches in young girls and that their response to hormones seems to change at the time of puberty," says Martin. "Since migraine commonly begins during puberty in girls one might ask whether a change in response to hormones might represent the initiating factor for migraine in some girls- kind of like the "big bang" theory of migraine." Martin and Hershey teamed with Scott W. Powers, PhD, professor of pediatrics at UC and co-director of the Cincinnati Children's Headache Center; Marielle Kabbouche, MD, professor of pediatrics at UC and director of the Acute and Inpatient Headache Program at Cincinnati Children's; Hope O'Brien, MD, associate professor of pediatrics at UC and program director of Headache Medicine Education at Cincinnati Children's; and Joanne Kacperski, MD, assistant professor of pediatrics at UC and director of the Post Headache Concussion Program at Cincinnati Children's. Team members also included Cincinnati Children's researchers, Janelle Allen, Susan LeCates, Polly Vaughan and Shannon White and Timothy Houle, PhD, Harvard University. The study received financial support from the National Headache Foundation and the Driskill Foundation. Martin is president of the National Headache Foundation. He is a speaker for Teva Pharmaceutical Industries, Allergan Plc., Avanir Pharmaceuticals and Depomed, Inc. Martin is also a consultant for NeuroScion, Avanir Pharmaceuticals, Depomed, Inc., Eli Lilly and Company, Amgen Inc., and Alder Biopharmaceuticals. Hershey is a consultant for Allergan Plc., Amgen Inc., Curelator Headache, Depomed, Inc. and Eli Lilly and Company.


News Article | April 21, 2017
Site: www.techtimes.com

The Food and Drug Administration approved on April 18 a handheld vagus nerve stimulation device for treating episodic cluster headaches. These “suicide headaches,” however, are only one among different chronic conditions that experts seek to address through the use of vagus nerve stimulation, which consists of sending a low electric pulse through the vagus nerve situated in the neck. In fact, a new report stated that increasing innovation in the field has led to greater knowledge of these VNS devices. For instance, patients that have resistance toward anti-epileptic drugs are being treated using the devices, while surgeons increasingly focus on minimizing the potential side effects of using the tools. GammaCore, the patient-administered handheld device for stimulating the vagus nerve, was developed by New Jersey-based neuroscience and technology firm ElectroCore. It transmits a mild electrical stimulation to the nerve through the skin, leading to pain reduction. “It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk,” assured Dr. Stephen Silberstein, director of Jefferson University’s Headache Center in a statement. Long available in Europe, the device is applied to the neck during a headache. But while the FDA release was based on two trials, it is important to note that using the device could lead to mild, transient side effects. It should also be avoided by patients with active implantable medical devices; those with hypotension, hypertension, tachycardia (rapid heartbeat), or bradychardia (slow heartbeat); and children and pregnant women. Adjunctive vagus nerve stimulation, too, was shown to improve antidepressant effects among patients with treatment-resistant depression. “APA [American Psychiatric Association] recommends VNS as a treatment option for patients who have not responded to at least four adequate trials of depression treatments, including electroconvulsive therapy,” wrote Dr. Scott Aaronson and his colleagues. Patients who underwent VNS demonstrated improved clinical outcomes than those who received the usual treatment, including a significantly greater f-year cumulative response rate or 67.6 percent versus 40.9 percent. VNS therapy is used to help people overcome drug addiction, with the process consisting of helping the patient’s addicted brain adopt new behaviors and replace the ones linked to the need for drug intake. "When a subject is addicted to a drug, extinction is a method to help them relearn behaviors - so they are able to take different actions," said lead author and assistant professor Sven Kroener. The treatment aims to reinforce positive behavior as opposed to the drug-related one, placing the two types of behaviors in direct contradiction. When applied correctly, it could also decrease the relapse rates in drug-addicted individuals. Last year, a study found that rheumatoid arthritis patients who received VNS displayed “robust” responses. Researchers from the Feinstein Institute, SetPoint Medical, and the University of Amsterdam conducted a trial to see if a direct inflammatory reflex stimulation can minimize rheumatoid arthritis symptoms. Prior studies done on animals already showed great promise and success rates. Here, the team recruited 17 patients whose vagus nerve was surgically given a stimulation device, and then measured their response and progress for 42 days. Many of the patients whose previous rheumatoid arthritis treatments failed exhibited significant developments, according to the study. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


Pro S.,Headache Center | Tarantino S.,Headache Center | Capuano A.,Headache Center | Vigevano F.,Headache Center | And 2 more authors.
Clinical Neurophysiology | Year: 2014

Although primary headaches are very prevalent also in pediatric age, most neurophysiologic studies in these diseases concerned only the adulthood. The neurophysiologic investigation of the pathophysiological mechanisms subtending migraine and tension-type headache in children and adolescents could be particularly interesting, since during the developmental age the migrainous phenotype is scarcely influenced by many environmental factors that can typically act on adult headache patients. The neurophysiologic abnormality most frequently found in adult migraineurs, that is the reduced habituation of evoked potentials, was confirmed also in migraine children, although it was shown to involve also children with tension-type headache. Some studies showed abnormalities in the maturation of brain functions in migraine children and adolescents. While the visual system maturation seems slowed in young migraineurs, the psychophysiological mechanisms subtending somatosensory spatial attention in migraine children are more similar to those of healthy adults than to those of age-matched controls. There are some still unexplored fields that will have to be subjects of future studies. The nociceptive modality, which has been investigated in adult patients with primary headaches, should be studied also in pediatric migraine. Moreover, the technique of transcranial magnetic stimulation, not yet used in young migraineurs, will possibly provide further elements about brain excitability in migraine children. © 2013 International Federation of Clinical Neurophysiology.


News Article | October 27, 2016
Site: www.eurekalert.org

CINCINNATI - Prescribed medications are no more effective than a sugar pill when used to prevent migraines in children and teens. A study to be published Oct. 27 in The New England Journal of Medicine shows no significant differences among amitriptyline, topiramate and placebo in reducing headache days or related disability. "The study was intended to demonstrate which of the commonly used preventive medications in migraine was the most effective. What we found is that we could prevent these headaches with either a medication or a placebo," says Andrew Hershey, MD, PhD, co-director of the Cincinnati Children's Headache Center and senior author of the study. "This study suggests that a multi-disciplinary approach and the expectation of response is the most important, not necessarily the prescription provided." Researchers conducted the Childhood and Adolescent Migraine Prevention (CHAMP) study at 31 sites in the United States. Cincinnati Children's served as the Clinical Coordinating Center (CCC) for the study, and was responsible for all clinical oversight activities. The Clinical Trials Statistical and Data Management Center (CTSDMC) at the University of Iowa served as the Data Coordinating Center for the study. It had primary responsibility for data management, implementing the electronic data capture system, and all statistical aspects of the study. The 24-week clinical trial included 328 eligible patients. The trial used a clinically meaningful endpoint of a 50 percent or greater reduction in headache days from the 28 days prior to randomization to the final four weeks of the 24-week study. Sixty-one percent of those on a placebo saw the days they had a headache reduced by 50 percent or more. For the two medication groups, 52 percent of those taking amitriptyline and 55 percent of those taking topiramate had this level of reduced headache days. The responder rates were not statistically different between the three groups. Compared to placebo, those on the two active drugs had a significantly higher rate of side effects, including fatigue, dry mouth and, in three cases, mood alteration. Thirty-one percent of those on topiramate had paresthesia - a "pins and needles" tingling in the hands, arms, legs or feet. The results raise questions about the best way to prevent migraines, particularly given that it's unethical to prescribe a placebo without the patient's knowledge, according to the authors. They add it's likely the expectation of responding to a medication may override the actual biochemical and pharmacological changes that are thought to occur with pharmacotherapy. Major pediatric headache centers, such as Cincinnati Children's, incorporate a multi-disciplinary approach that includes acute therapy, preventive therapy and behavioral treatment in a systematic approach, says Hershey. The CHAMP study incorporated this approach across all 31 study sites to ensure uniformity. The study authors stress that further studies need to be done to identify the optimal way to incorporate multi-disciplinary strategies. One of the preventive therapies often used is cognitive behavior therapy (CBT). CBT refers to a group of psychological treatments that are based on scientific evidence. While CBT has not been directly compared to a pill placebo for pediatric migraines, neurologists and psychologists view it as a helpful and critical component in a treatment plan. "Our national team was hoping to develop evidence to drive the choice by medical providers of the first line prevention medication for helping youth with migraine, but the data showed otherwise, says Scott Powers, PhD, pediatric psychologist, co-director of the headache center at Cincinnati Children's, and first author of the paper. "We see this as an important opportunity for health care providers, scientists, children, and families because our findings suggest a paradigm shift. First line prevention treatment will involve a multidisciplinary team approach and focus on non-pharmacological aspects of care. The good news is we can help children with migraines get better." Powers says the study also underscores the importance of conducting more research with a developmental focus on children and young adults. This will allow innovations that can be applied directly to a chronic illness of childhood. "The interpretation of these results is very challenging. In most situations, trials that fail to show benefit of an intervention do so because study participants do not improve. That was not the situation here. A majority of all study participants improved, regardless of their assigned treatment group," says Chris Coffey, PhD, director of the CTSDMC and professor of biostatistics in the University of Iowa's College of Public Health, and lead statistician for the study. "Further research is needed to better understand the results and to determine what future strategies might optimize the treatment of headaches in these childhood and adolescent populations." The study was supported by the National Institute of Neurological Disorders and Stroke and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health through grants U01NS076788 and U01NS077108.


Zidverc-Trajkovic J.,University of Belgrade | Zidverc-Trajkovic J.,Headache Center
Headache | Year: 2013

Background According to the International Classification of Headache Disorders diagnostic criteria, the differences between migraine and cluster headache (CH) are clear. In addition to headache attack duration and pain characteristics, the symptoms accompanying headache represent the key features in a differential diagnosis of these 2 primary headache disorders. Just a few studies of patients with CH exist examining the presence of nausea, vomiting, photophobia, phonophobia, and aura, the features commonly accompanying migraine headache. The aim of this study was to determine the presence of migraine-like features (MF) in patients with CH and establish the significance of these phenomena related to other clinical features and response to treatment. Methods One hundred and fifty-five patients with CH were studied, and 24.5% of them experienced at least one of MF during every CH attack. Nausea and vomiting were the most frequently reported MF. The clinical presentation between CH patients with and without MF was not significantly different with the exception of aggravation of pain by effort (20.6% vs 4.1%) and facial sweating (13.2% vs 0.85%), both more frequent in CH patients with MF. Conclusion Inferred from the results of our study, the presence of MF in CH patients had no important influence on the diagnosis and treatment of CH patients. The major differences of these 2 primary headache disorders, attack duration, lateralization, and the nature of associated symptoms, as delineated in the International Classification of Headache Disorders, are still useful tools for effective diagnosis. © 2013 American Headache Society.


Blumenfeld A.,Headache Center | Silberstein S.D.,Thomas Jefferson University | Dodick D.W.,Mayo Clinic Arizona | Aurora S.K.,University of Washington | And 2 more authors.
Headache | Year: 2010

Chronic migraine (CM) is a prevalent and disabling neurological disorder. Few prophylactic treatments for CM have been investigated. OnabotulinumtoxinA, which inhibits the release of nociceptive mediators, such as glutamate, substance P, and calcitonin gene-related peptide, has been evaluated in randomized, placebo-controlled studies for the preventive treatment of a variety of headache disorders, including CM. These studies have yielded insight into appropriate patient selection, injection sites, dosages, and technique. Initial approaches used a set of fixed sites for the pericranial injections. However, the treatment approach evolved to include other sites that corresponded to the location of pain and tenderness in the individual patient in addition to the fixed sites. The Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) injection paradigm uses both fixed and follow-the-pain sites, with additional specific follow-the-pain sites considered depending on individual symptoms. The PREEMPT paradigm for injecting onabotulinumtoxinA has been shown to be safe, well-tolerated, and effective in well-designed, controlled clinical trials and is the evidence-based approach recommended to optimize clinical outcomes for patients with CM. © 2010 American Headache Society.


News Article | September 1, 2016
Site: motherboard.vice.com

When the twinkle of pain behind your eye turns into a crippling migraine, you’re left with two options: riding it out, or taking drugs with side-effects that could make you even more sick. For many of us dealing with the chronic pain of migraines, navigating treatments can feel like stomping through a minefield. Anyone who has ever been prescribed migraine medication knows that it’s a crapshoot. Often, doctors will use trial-and-error to land on a treatment that works best for you. But this imperfect system leaves many patients dissatisfied with their pain regimen, as a new national survey from Health Union reveals. According to the study, which polled 3,900 individuals who experience migraines, only 40 percent of patients are happy with their medication. While the results suggest that no two migraine sufferers are alike, they also highlight a pharmaceutical industry that has ignored the demand for better, safer drugs. Currently, three categories of migraine medication exist. They are abortive, preventative, and rescue. The most popular of these, as reported by the study, are abortive treatment options, which are used by 66 percent of migraineurs who depend on prescription pain relief. Drugs like Imitrex and certain nasal sprays are popular because they can stop a migraine from progressing if you’ve already started to feel its effects. But even the most preferred and well-studied migraine treatments aren’t always perfect. Triptans, which are a class of abortive drugs, and have received the most scientific evaluation, work by binding to serotonin receptors in the brain. They constrict the swelling of blood vessels, which can prevent the painful evolution of a migraine. In 2014, a comparative study of triptans found that when most effective, they provide two-hour pain relief 68 percent of the time, and 24-hour pain relief 54 percent of the time. And the side-effects of triptans are myriad, leaving many patients feeling dizzy, nauseous, numb, or weak; and not everyone can use them. When taken by people who are also on antidepressants, a life-threatening reaction called “serotonin syndrome” could occur, causing toxic levels of the chemical to flood the body. One of the reasons why migraine drugs are so unpredictable has to do with the disease’s variability. According to the Health Union survey, migraine triggers range from barometric pressure changes to overpowering smells to stress, and even sunshine. Symptoms run the gamut, too, including pain, sensitivity to light, fatigue, and irritability. While 97 percent of people are aware of their triggers, the study notes, most admit that avoiding them is next to impossible. Earlier this year, a paper published in the journal Headache accused pharmaceutical researchers of failing to study the impact of migraine drugs on a wide array of sufferers. As the authors pointed out, clinical trials for certain treatments can exclude some categories of migraineurs—either assuming that all types of migraines are the same, or failing to investigate the different effects that a drug might have on different subsets of migraines. “There are not enough medicines out there to appropriately manage migraine headaches,” author Brad Klein, a doctor and medical director of the Headache Center at Abington Hospital-Jefferson Health, said in a statement. “At a time in history when an unprecedented number of people are getting hooked on narcotic opiates by way of prescribed medications—as is the case with migraine sufferers as well—we owe it to ourselves as physicians to try medications that could work without the risk of addiction.” As a result of poor migraine treatments, as well as a general misunderstanding of what migraines actually are, patients can become overwhelmed by more than just pain. When asked how migraines affect their personal lives, 64 percent of respondents were constantly worried about disappointing people in the struggle to manage their symptoms. Approximately 46 percent were embarrassed about their disease, and 41 percent of participants confessed to hiding their migraines from others. In the past couple of years, there has been more of an effort to destigmatize migraines, though some campaigns are more eager to promote drugs than awareness. Researchers are now looking at experimental medications to stop migraines before they start, however, it could be years until newer, safer treatment options reach market. “No one took my symptoms seriously until I was in my 20s. I have had chronic migraine since I was age 11, but was not diagnosed until I was 25. When I was kid, most people thought I was making excuses to skip school,” said Kerrie Smyres, a patient advocate for the community website Migraine.com. “In all those years that my symptoms were dismissed, I internalized the stigma of migraine. I'm nearly 40 and, after three years of intense therapy, have finally stopped questioning if my symptoms were as severe as I believe them to be.” Want more Motherboard in your life? Then sign up for our daily newsletter.


Mainardi F.,Headache Center
Current neurology and neuroscience reports | Year: 2013

The headache attributed to airplane travel, also named "airplane headache", is characterized by the sudden onset of a severe head pain exclusively in relation to airplane flights, mainly during the landing phase. Secondary causes, such as upper respiratory tract infections or acute sinusitis, must be ruled out. Although its cause is not thoroughly understood, sinus barotrauma should be reasonably involved in the pathophysiological mechanisms. Furthermore, in the current International Classification of Headache Disorders, rapid descent from high altitude is not considered as a possible cause of headache, although the onset of such pain in airplane travellers or aviators has been well known since the beginning of the aviation era. On the basis of a survey we conducted with the courteous cooperation of people who had experienced this type of headache, we proposed diagnostic criteria to be added to the forthcoming revision of the International Classification of Headache Disorders. Their formal validation would favour further studies aimed at improving knowledge of the pathophysiological mechanisms involved and at implementing preventative measures.


Buzzi M.G.,Headache Center | Tassorelli C.,University of Pavia
Handbook of Clinical Neurology | Year: 2010

In vitro studies on animal and human cephalic vessels allow the measurement of second messengers or intracellular calcium concentrations and the evaluation of the role of endogenous neuropeptides in perivascular nerve endings involved in migraine pathophysiology. In addition, in vitro human models allow the assessment of receptorial cranial selectivity and the collection of reliable information regarding the behavior of these vessels in migraine headache. The availability of animal models of migraine has favoured impressive advances in understanding the mechanisms and mediators underlying migraine attacks, as well as the development of new and more specific therapeutic agents. The trigeminovascular system (TVS) has emerged as a critical efferent component, and the mediators of its activity have been identified and characterized, as have some of the receptors involved. The similarity of the trigeminal innervation across species has made it possible to draw conclusions on the neurophysiological responses to electrical or chemical stimulation of the trigeminal fibers. Studies involving substances known to induce migraine-like attacks, i.e., nitric oxide (NO) donors, have provided interesting insights into the central nuclei probably involved in the initiation and repetition of migraine attacks. The neuronal and vascular effects of such substances might yield an increasing body of evidence for a better understanding of the pathophysiology of migraine attacks. © 2011 Elsevier B.V.

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