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A Phase III clinical trial is now underway in the pivotal study of interferon alfa-2b gene therapy in pleural mesothelioma. After promising results from the Phase II clinical trial, scientists and researchers are hopeful they are just one step away from FDA approval for this cancer treatment that is over 20 years in the making.  Europe-based gene therapy company Trizell, is sponsoring the trial.

This study involves TR002 – which is a gene therapy drug, used in an immunotherapy setting. The goal of gene therapy is to get at the root cause of a disease. Since genes hold the instructions for making proteins and other building blocks necessary for cell function, if a gene’s instructions are incorrect or missing, the “ingredients” for a healthy cell and person may be lacking. Instead of dealing with the errant effects of faulty genes after the fact, gene therapy attempts to deliver the proper instructions to cells, avoiding the negative affects altogether. Immunotherapy treatments attempt to work with the body’s own immune system, repairing it so the body can fight off cancer naturally, and without all the negative side effects associated with other traditional cancer treatments.

TR002 is a modified virus that triggers the production of interferon, a protein that kills cancer cells. Since it is genetically engineered, it is unable to reproduce like a virus does, but is still able to provide the protein necessary for terminating cancer cells. This treatment will be used in combination with chemotherapy. Phase II trials used the standard chemotherapy treatment pemetrexed , but this study will use gemcitabine chemotherapy.  

This Phase III trial will look at 300 patients across the United States, Canada, Russia, UK and Australia. TR002 will be administered one time by catheter directly to the pleural cavity. Two weeks later, the patient will then begin rounds of gemcitabine chemotherapy.  This trial has already begun at The University of Toledo Eleanor Dana Cancer Center in Ohio. The New York University School of Medicine, the University of Pennsylvania are next to follow. In the end, over 50 locations worldwide are to begin the trial this month. This Phase III trial is especially for mesothelioma patients whose standard treatment has stopped working.

The promising results from the Phase II trial showed an 87.5 percent disease control rate and an average survival rate of 17 months and have scientists and researchers hopeful for even better results with the Phase III trial.

Phase III trials compare promising new drugs or procedures with the current standard treatment. Large numbers of people from across the nation usually participate in Phase III trials and receive either the new treatment or the standard treatment. In order to be sure the study results are accurate, trial participants in all phases must fit a certain profile. Eligibility for mesothelioma trials are often specific as to age, how long it has been since therapy, stage of disease, and other characteristics. To find our more information, visit our Clinical Trails page.

Source:

Biospace, “Trizell ltd. announces phase 3 pivotal study of interferon alfa-2b gene therapy in malignant pleural mesothelioma,” (March 20, 2019). [Link]

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Predicting pleural mesothelioma survival is a difficult task, as a number of factors are needed to make an accurate calculation. Currently, the TNM Staging system in place as one of the ways to predict life-expectancy and survival after a mesothelioma patient has had surgery. However, researchers from Peking University in China have recently discovered what may be a more accurate tool called a nomogram, in determining life expectancy than the TNM Staging system.

What is the TNM Staging System?

  • T – size of the main tumor, also known as the primary tumor. Classified from X (the main tumor cannot be measured) to 4, where the higher the number the larger the tumor
  • N – lymph nodes nearby. Classified from X (lymph nodes cannot be measured) to 4, where the higher the number, the more lymph nodes contain cancer
  • M- metastasis, or whether or not the cancer has spread. Classified from X (cannot be measured) and then 0-1, where M1 indicates that cancer has spread throughout the body.

In many cancer cases, the higher the TNM stage the poorer the prognosis. However, scientists and researchers found that with mesothelioma (after surgery), they were not able to significantly associate the TNM stage with survival.

A Visual Representation
Researchers and scientists from Peking University turned to what is known as a nomogram, which is a mathematical tool that will visually represent the characteristics of those suffering from mesothelioma. Their goal was to find a better plan for individualized treatment and give a more accurate prognosis by using these patient’s unique characteristics as plot points as a guide. Information was taken from The Surveillance, Epidemiology, and End Results (SEER) database from the National Cancer institute.

Researchers were able to investigate age, gender, cancer subtype and stage, and treatment given as survival factors. This data created the nomogram, which consisted of 312 mesothelioma patients. By using a calibration plot, researchers were able to compare probability and predict one-year and three-year survival rates with a relatively high accuracy. Results were then compared to other prior research and it was found that elderly men who had surgery for mesothelioma typically did not live as long, which has been the consensus in most cases.

Determining the stage of cancer after any treatment – not just surgery – is vital in uncovering not only what treatment methods could be used next, but also in establishing a more accurate prognosis.

Source:

Zhuo M. et al. “Survival analysis via nomogram of surgical patients with malignant pleural mesothelioma in the Surveillance, Epidemiology, and End Results database,” Thoracic Cancer (April 5, 2019). [Link]

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Asbestos Awareness Week starts today. The Asbestos Disease Awareness Organization (ADAO) is kicking off this global campaign of education and awareness about the risks of asbestos and the need for a ban with a candlelight vigil. Throughout the week, they’ll be presenting information from doctors, activists, and victims of asbestos diseases.

Asbestos Awareness Week was founded in 2005 by the Asbestos Disease Awareness Organization (ADAO) that since its founding in 2004 has dedicated time and resources to educate the public about the misconceptions associated with asbestos.  The awareness originally began as just a singular day dedicated to the cause but in 2007, the ADAO asked to the U.S. Senate to extend the day to a week-long event.  The ADAO is also holding its 15th  International Asbestos Awareness and Prevention Conference in Washington, DC April 5 to April 7, 2019.

Asbestos Exposure Is Deadly

There is no known safe level of asbestos exposure and in many instances those suffering from mesothelioma were only exposed to asbestos for a short while; a summer job in construction, or a couple years in the shipyard. The lack of knowledge regarding the presence of asbestos in the work place further complicates the connection, as many workers were unaware they were even handling asbestos-containing products.

Mesothelioma is a rare, aggressive, and typically fatal cancer caused by asbestos exposure. The latency period between asbestos exposure and illness can range anywhere between 20 to 50 years, making it difficult for workers to connect their cancer with asbestos exposure. A mesothelioma diagnosis is grim as it is often discovered in the advanced stages of the disease. Most treatments are ineffective in the later stages and victims generally have less than 12 months to live.

Contact A Mesothelioma Attorney Today

Over the last 30 years, GPW has built a reputation as a leading asbestos law firm, not only in the states in which we have offices (Pennsylvania, West Virginia, and Michigan), but throughout the country. We have grown into the largest law firm in Pennsylvania representing injured workers, specifically those injured by asbestos.

We have been involved in asbestos lawsuits since the 1970s, when cases were first coming to trial. Because of GPW’s involvement in asbestos litigation from the beginning, we have a clear understanding of what is required to succeed in asbestos and mesothelioma lawsuits. Contact us today  by filling out the form below or calling 1-800-Complex for a free no obligation consultation.

Article first published on www.gpwlaw.com

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Surgical techniques for those suffering from mesothelioma depend on how far the cancer has spread and if the patient is healthy enough to withstand such an invasive procedure. In many cases, the cancer has already spread too far and quickly, so surgery is not an option. For those able to treat their cancer with surgery, there are a several techniques that aim to provide curative effects. A recent study published in the Seminars in Thoracic and Cardiovascular Surgery investigated two common surgical techniques for mesothelioma – Pleurectomy/Decortication  (P/D)  and  Extrapleural  Pneumonectomy (EPP) – and found drastic differences between overall survival between the two.

Pleurectomy/Decortication and Extrapleural Pneumonectomy

Used in cases of malignant pleural mesothelioma, a pleurectomy involves the removal of part of the pleura, which is the initial infection point for the disease. Decortication is the surgical removal of all or part of the membrane and/or outer layer of an organ.  In the case of a lung, this would indicate the removal of the visceral pleura. This means that P/D is a type of surgery that removes the lining of the lung and all visible tumors in the chest cavity. P/D spares removing the lung so it often has less risks and complications. However, the cancer may not be able to be removed in its entirety.

Surgery to remove an infected lung is known as a pneumonectomy, but to remove the lung and the surrounding pleura, diaphragm, and pericardium, is called EPP. EPP is much more invasive, and recovery time is longer. There are typically more complications that arise from EPP, but if all the cancer is completely removed, researchers theorized this would prolong survival.  However, results from this latest study have shown that is not necessarily the case.

Between April 2004 and July 2016, 152 mesothelioma patients underwent treatment at the Hyogo College of Medicine in Japan. Of those 152 patients, 117 received surgery as part of their treatment. All but three patients had received chemotherapy prior and over 90 percent of the patients had epithelial cell mesothelioma.  Patients were then gathered into three groups. Group 1 received traditional EPP, Group 2, a less invasive form of EPP, and Group 3, P/D. The overall average survival between groups is as follows:

  • Group 1, EPP = 18.5 months
  • Group 2, less invasive EPP = 41.9 months
  • Group 3, P/D = 43.4 months

The study concluded that P/D is the better option in prolonging survival, and also has fewer complications, risks, and less recovery time that EPP. It is less invasive than EPP, which is why there are less surgical risks associated. It’s recommended that patients who are undergoing surgery for pleural mesothelioma receive the less aggressive lung-sparing surgical procedure.

Source:

Hasegawa, S. et.al., “Surgical Risks and Survival Associated with Less Invasive Surgery for Malignant Pleural Mesothelioma,” Seminars in Thoracic and Cardiovascular Surgery (January 2019). [Link]

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In early 2017, the Centers for Disease Control and Prevention (CDC) reported that despite the decline of asbestos use once the product became regulated in the United States, mesothelioma rates continue to rise, with a total of 45,221 deaths in the United States alone from 1999 to 2015. Scientists and researchers struggle to pinpoint reasoning behind this while anti-asbestos advocates believe current government regulations are not enough.

Occupational Exposure
Decades of widespread asbestos use in the United States means that today asbestos can be found in most infrastructures built before 1980. Asbestos can be found in insulation, drywall, flooring, and roofing in ordinary buildings. As years pass and the buildings begin to deteriorate, construction workers are called for either renovation or demolition. It is during repair and demolition that asbestos fibers may become disturbed and airborne, increasing the threat of exposure. If construction workers do not take the necessary precautions, these workers may find themselves suffering from an asbestos-caused illness decades into the future.

Age of Diagnosis
Mesothelioma affects the elderly the most, with the CDC reporting that the number of deaths has increased overall in individuals over the age of 85. However, the CDC also suspects a number of factors that contribute to asbestos exposure in today’s youth, affecting those between the ages of 25 and 44 years. While occupational exposure is the most likely risk factor, environmental exposure and bystander exposure contribute to mesothelioma incidence rates among a younger generation.

Government Regulations
The Occupational Safety & Health Administration (OSHA) limits how much asbestos can be present in the workplace, but a 2003 CDC report of air samples collected in the construction industry show 20 percent of samples exceed the permissible exposure limit (PEL). The EPA attempted to ban asbestos in the late 1980s, but the ban was over turned in 1991 and asbestos products continue to be imported to the United States. In fact, asbestos consumption nearly doubled in the past year from 343 tons in 2015 to 705 tons in 2016. These imports come from mainly Brazil and Russia, but with Brazil banning the mineral outright in 2017, the United States will now turn to Russia as its main supplier.

With mesothelioma on the rise even in 2018, anti-asbestos advocates believe that current legislation in place is not enough to prevent illness from exposure. OSHA set a PEL of 0.1 fibers per cubic centimeter (f/cc), but admits the PEL is not meant to establish a safe level of exposure. There is no “safe” level of asbestos exposure for any type of asbestos fiber.

This article first appeared on www.gpwlaw.com. January 2018

Source:
Jacek M. Mazurekm MD, PHD. et. al. “Malignant Mesothelioma Mortality – United States, 1999-2015,” Centers for Disease Control and Prevention (March 3, 2017). [Link]

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Late last month, the Clinical Respiratory Journal released their findings on the efficacy of intrapleural immunotherapy, which is a highly targeted approach of receiving immunotherapy treatment for those suffering from mesothelioma.

Mesothelioma is a cancer caused only by asbestos exposure. Since asbestos is the only known cause, mesothelioma is sometimes referred to as “asbestos cancer.” Asbestos fibers are small, nearly invisible, and easily inhaled. Once inhaled, the fibers travel through the body and become embedded in soft tissue or lining of various organs (known as the mesothelium). The fibers cause scarring and inflammation, which damages the cell’s DNA and allows the cells to grow uncontrollably and form tumors.  The cancer starts in mesothelial cells. Mesothelioma is difficult to treat; the cancer is often in the advanced stages when detected. Typical treatments include chemotherapy, radiation, and surgery, but with the ongoing success of immunotherapy in cancer treatment, this latest method is gaining in popularity.

Immunotherapy works with and strengthens the body’s own immune system so the body can fight off the cancer naturally, and without the sometimes debilitating side effects that come from other treatments like chemotherapy.

Immunotherapy treatments may:

  • Stop or slow down the growth of cancer cells
  • Stop the cancer from spreading
  • Destroy cancer cells, without causing any damage to the surrounding healthy cells.

Side effects are typically less severe.

This latest study regarding intrapleural immunotherapy investigated different methods one could receive this treatment in hopes of finding the most successful approach. Data reviewed was from conference reports published over a 20-year span between 1998 and 2018 with 26 different clinical trials. Three of those trials are still in progress. Methods of administration are as follows:

  • Gene-mediated cytotoxic immunotherapy – cells receive cancer-killing genetic information
  • Adoptive transfer of intrapleural CAR T- cell therapy – mesothelioma tumors are attacked by modified T-cells
  • Oncolytic virus therapy – a virus is administered to boost immune response
  • Direct cytokine-mediated immunotherapies – rapid immune system signaling to communicate and target a response
  • Innate immunomodulators – drugs that control the immune system

Results from the data revealed that the therapies have showen a lot of promise generating durable tumor-specific responses. As to which method is the most successful, scientists and researchers do not have definitive results, but explain that each method warrants a closer look.

Source:

Murthy, V et. al. “Intrapleural Immunotherapy: An Update on Emerging Treatment Strategies for Pleural Malignancy,” Clinical Respiratory Journal (February 27, 2019). [Link]

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Asbestos was once considered something of a wonder material for its durability and its resistance to heat and corrosion. There was a time when it could be found in textiles, drywall, clothing, gaskets, insulation, cement, pumps, brakes, machinery and other building materials. That changed years ago when it was discovered that asbestos exposure could be linked to serious health conditions such as asbestosis, lung cancer, and mesothelioma. Even though asbestos isn’t as prominent as it once was, asbestos-related illnesses still affect thousands of Americans every year.

What is Asbestos?

Asbestos is a group of naturally-occurring fibrous minerals. The minerals have thin, microscopic fibers that are highly resistant to heat, corrosion and pressure, which is why they were so widely used in the construction, steel mill, chemical plant, power generating and shipbuilding industries. If left alone, materials containing asbestos are relatively harmless, but when they are disturbed they can shed microscopic fibers that can be ingested or inhaled. These fibers can remain in the body for years and cause some serious health issues if they accumulate. The most deadly condition associated with asbestos exposure is mesothelioma, a rare form of cancer that affects the lining around the lungs and abdomen. However, asbestos exposure has also been linked to other conditions such as asbestosis and lung cancer.

Who is At Risk of Asbestos Exposure

Typically, health conditions associated with asbestos develop several years after exposure. It is most common in patients who worked in factories, construction sites, chemical plants, power generating stations and steel mills when asbestos use was more common, but these workers’ families may also have been put at risk due to asbestos dust being tracked into their homes.

Common Signs and Symptoms of Asbestos Exposure

Most of the problems associated with asbestos exposure begin in the respiratory system. The symptoms of asbestos exposure vary depending on the disease, but they typically include a persistent cough, chest pain, chest tightness, a loss of appetite and a crackling sound that can be heard in the lungs when inhaling. Some patients may also experience weight loss, bowel obstructions, anemia and fever if the exposure is in the abdomen. These are symptoms of peritoneal mesothelioma.

What to Do if You Have Been Exposed to Asbestos

If you suspect that your health problems are associated with asbestos exposure, the first thing you should do is speak to your doctor and receive a proper diagnosis. Many of the symptoms of mesothelioma, lung cancer and asbestosis won’t present themselves until the conditions are in advanced stages, but treatment may still be possible. You and your family may also be entitled to compensation from the parties responsible for the asbestos exposure.

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A new immunotherapy treatment that has recently been administered to a patient suffering from mesothelioma has researchers and scientists optimistic that if results are positive, this treatment could be more effective than Keytruda, the immunotherapy treatment that has had major success in non-small cell lung cancer  The name of the treatment is CA-170, and while clinical trials have been underway for this drug since 2016, it has only just recently been administered to a patient suffering from mesothelioma. Results are still pending, as the study is slated to continue through early 2020.

Mesothelioma cells produce a protein known as VISTA, which stands for V-domain Ig-containing Suppressor of T cell Activation. VISTA is a type 1 transmembrane protein. These proteins allow substances to move across membranes that cover the cell, constantly changing to be able to do so. VISTA levels become heightened in a tumor environment and are specifically released from mesothelioma cells. T-cell (a subtype of white blood cells that plays a pivotal role in maintaining a healthy, strong immune system) responses become suppressed  by this, and leave the body in a weakened state, unable to fight off cancer. Ninety percent of mesothelioma cells have high levels of VISTA. CA-170 blocks both VISTA and PD-L1, another protein found over expressed on cancer cells (and what is targeted by Keytruda).

What Exactly Is Immunotherapy?

Chemotherapy has long been the standard for cancer treatment, but in the last few decades, immunotherapy has become more prominent, and plays a vital role in the future of treating cancer. The purpose of immunotherapy is to boost the body’s own immune system, so that the cancer can be fought in a more natural way. This is done by either stimulating the immune system to attack cancer cells, or by giving the immune system a man-made “boost,” (often a type of protein) to kick the immune system into high gear. One of the draws to immunotherapy is the lack of harsh side effects, as is typically seen with chemotherapy. Healthy cells are able to remain healthy and are otherwise unaffected by treatment with immunotherapy, whereas with chemotherapy, the healthy cells many become weakened.

Early results for CA-170 for those with advanced tumors and lymphomas showed T-cell proliferation and cytokine production.  This multi-center, open-label, Phase 1 trial administers CA-170 orally in adult patients in a once or twice daily schedule.

Criteria for those to participate is as follows:

  • Males and females ≥ 18 years of age;
  • Life expectancy of at least 3 months;
  • ECOG PS ≤ 1;
  • Acceptable bone marrow and organ function at screening;
  • Ability to swallow and retain oral medications;
  • Negative serum pregnancy test in women of childbearing potential;
  • Measurable disease;
  • Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective. For patients enrolling into backfill of dose levels at or below the MTD/RP2D, patients with tumor types known to have a high VISTA expression (such as metastatic malignant pleural mesothelioma of epithelioid histology).

More information about Phase I Clinical Trial

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Monday, February 4, 2019, was World Cancer Day and around the world, communities held seminars, festivals, and walks to promote and raise awareness about an illness that affects millions of people each year.  During World Cancer Day, communities educate people about cancer risks, signs and symptoms, and available treatments and support. Risk factors for cancer can range from unhealthy lifestyles, to genetic factors, to hazardous exposures, like asbestos.

Cancers Linked to Asbestos Exposure

Lung Cancer
Lung cancer was the first cancer linked with asbestos exposure and affects thousands of Americans each year. Airborne asbestos fibers are easy to inhale and can become trapped inside the lung. As the fibers work themselves deeper into the tissue of the lungs, the infected areas become inflamed and scarring occurs (fibrosis known as asbestosis). Studies found that the risk of lung cancer in relation to asbestos exposure varies due to the length of exposure, the industry worked, and the type of asbestos used. Often, asbestos-related cancer victims also suffer from asbestosis, a scarring of the lung tissue caused by asbestos exposure. About one in seven people with asbestosis will eventually develop lung cancer.

Mesothelioma
Perhaps the most well-known cancer linked to asbestos exposure is mesothelioma – a rare disease that is found in the lining (the mesothelium) of the heart, lungs, abdomen, or the internal reproductive organs. Statistically, mesothelioma is rare, with only about 3,000 Americans diagnosed each year. The latency period between the first exposure to asbestos and the time of diagnosis  can be decades, so often times by the time mesothelioma is discovered it is already in the advanced stages.

There are different types of mesothelioma based upon the organ in which the disease occurs. Pleural mesothelioma, which is the most common type, affects the lining of the lungs and chest cavity. Peritoneal mesothelioma refers to the cancer in the abdominal lining; pericardial, the lining of the heart; and testicular mesothelioma/ mesothelioma of the uterine serosa, the lining of the reproductive organs. There is no cure for mesothelioma. Prognosis after diagnosis is typically under one year.

Colon Cancer, Colorectal Cancer, and Rectal Cancer
Colon cancer, colorectal cancer, and rectal cancer can affect both men and women and be the result of asbestos exposure. Asbestos fibers that are inhaled can bypass the lung or are swallowed into the stomach and enter the bloodstream. The fibers are then able to become embedded in the lining of the colon, which causes tumors to develop. These tumors have the ability to spread to various parts of the body, and once the cancer cells begin to spread, the cancer is very hard to control.

Laryngeal and Throat Cancer
Cancers arising out of the pharynx (throat) and larynx (voice box) have been associated with high levels of asbestos exposure. When asbestos is inhaled, the thin, needle-like fibers can be caught in the squamous cells that line the airway of the larynx. Asbestos fibers can then become embedded into the larynx and cause tumors to develop which can ultimately negatively affect breathing, swallowing, and the vocal chords.

If you suspect your cancer was caused by asbestos exposure, contact the attorneys at GPW by calling 1-800-COMPLEX or filling out the evaluation form at the bottom of the page for a free consultation.

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Cancer is the second most leading cause of death in the United States affecting over 500,000 people. However, is estimated that 1/3 of all cancers could be prevented through daily activities such as eating healthy, exercising, or simply applying sunscreen on a sunny day.  Cancers caused by asbestos exposure are life-threatening, but perhaps the most striking about asbestos cancers like mesothelioma, is that it is considered almost wholly preventable. There is no safe level of asbestos exposure so it is important to know how you can protect yourself and your family from this toxic carcinogen that is still legal in the United States.

Government Regulations
While asbestos may not be illegal in the United States, it is heavily regulated by the U.S. government. Different government agencies have their own rules and regulations for asbestos control to maintain exposure levels in the workplace and the environment.  Those who work directly with asbestos consistently have a higher chance of contracting a fatal disease than those who do not. Government organizations like the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), and the Centers for Disease Control (CDC) have regulated asbestos to determine the acceptable level of asbestos to which humans can be exposed, how to remove asbestos from a facility safely, and what you are required to do by law if you discover asbestos.

OSHA Fact Sheet

EPA Asbestos Laws and Regulations

CDC Guidelines to Limit Asbestos Exposure

Asbestos In Your Home
Since Asbestos was used for decades and was a popular building material throughout the mid-20th century, chances are if your home was built before 1980, your home could contain asbestos. If you are unsure whether or not your home contains asbestos, contact a certified asbestos professional to find out. A visual inspection will often not be enough to determine if there is asbestos in your home. If asbestos is found then the Department of Housing and Urban Development enacts a combination of asbestos abatement and the Operations and Maintenance (O&M) Program, which is an operation focusing on proper training, cleaning, work practices and surveillance to maintain and control asbestos and asbestos containing materials in buildings that are in good condition.

Asbestos that is not disturbed or exposed in any way does not pose a health threat; however, if you are planning on renovating or the material has become damaged overtime, then you are at risk for asbestos exposure.

February is National Cancer Prevention Month. Understanding the causes of cancer are the first steps to prevention. Donate today and help fund cancer research, care, treatment, and education.

This article first appeared on www.gpwlaw.com
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