Wednesday, January 23, 2019

Verified Clinical Trials and ClinSpark® Now To Offer Single Access Point For eSource and Research Subject Verification To Prevent Duplicate Subjects in Clinical Trials

The global research subject duplicate enrollment prevention solution Verified Clinical Trials (VCT) and Foundry Health's eSource and phase I automation platform ClinSpark® are now electronically connected. The integration greatly simplifies the process for site users to check for duplicate subject enrollments and several other protocol violations. All relevant data is automatically synced, eliminating double entry of data and thereby reducing errors and diminishing workload. An eligibility check with the Verified Clinical Trials database is initiated from within the site's ClinSpark® interface. With just one button to press, the powerful technology of VCT is activated and the user instantly receives a response on the verification check within seconds. A full report with relevant details is automatically added to the source data in ClinSpark® and is accessible to all authorized study users.

Duplicate or over enrollment is a well-recognized and growing problem within the clinical trials industry. VCT and Foundry Health both strongly believe that technology can greatly enhance the safety of subjects in clinical trials and improve the quality of the data. VCT and Foundry Health now offer a simplified and more expedient process by developing a single combined access point for data entry and research subject enrollment status verification. Due to the web-based nature of each solution, a clear path towards collaboration between the technology providers emerged in a way that has not been seen with traditional on-premise solution providers. The results of this joint effort lead to enhanced compliance, a reduction in error rates, and improved efficiency. The one-click verification of research subject enrollment status step is a first step in this collaboration between the two companies.

Mitchell Efros MD FACS, CEO of VCT stated, "Volunteer safety is paramount in everything we do. Developing new technology as a means to achieve that is at the heart of our company. We are very pleased to see that ClinSpark® is built on those same values. This collaboration will enrich the clinical trial landscape as we know it today. We are very pleased with our alliance and it was great seeing the teams working so closely together to develop such a powerful yet efficient tool. We look forward to further enhancements as we continue our collaboration." Click here.

Brock Heinz, CEO of Foundry Health stated "The modern architecture of ClinSpark® empowers us to easily connect to anything: devices, databases, or other cloud-based solutions. Verified Clinical Trials is without question the world leader in solutions for preventing duplicate enrollment of subjects in trials. It has been a privilege to collaborate with them and have our systems and teams working closely together. ClinSpark® is focused on making it simple and easy to run a phase I trial for the clinic staff. Our interface with VCT is yet another step in achieving that goal." Read this for more information.

Kerri Weingard ANP COO of http://www.verifiedclinicaltrials.com added, "We strive to provide solutions to our clients that enhance the safety and quality of data yet do not over-burden research site staff. With increasingly complex clinical trials and a myriad of systems for site staff to log in to, we felt that a single access point to perform these functions would enhance the user experience and acceptance for both systems.

About Verified Clinical Trials
Verified Clinical Trials is a forward-thinking company developed by experts active in the clinical research community to improve research subject safety and data quality in clinical research trials by preventing duplicate enrollment and other protocol violations. Verified Clinical Trials defines itself as the world's leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials and has the scalability to reach all sites nationally as well as on a global level. Verified Clinical Trials offers optional fingerprint biometric verification to improve accuracy and speed. For more information, visit http://www.verifiedclinicaltrials.com.

About Foundry Health
Foundry Health is the company behind ClinSpark®, the modern cloud-based Phase I automation and eSource platform. Its modern infrastructure allows for easy connection to clinical devices, labs, databases and data review tools of all sorts. The solid (CDISC ODM certified) data structure ensures compliance with all regulatory and data standards. The modern 'mobile-first' user interface and fast bar-code enhanced navigation, make the system easy to use and contribute to the highest user experience ratings in the industry. ClinSpark® is offered as a SaaS (Software as a Service) solution with no long-term commitments, and a competitive 'pay-per-use' pricing structure. Being hosted on one of the world's most advanced cloud-infrastructures, ClinSpark® allows for almost infinite global scaling without performance degradation. For more information, visit http://www.foundryhealth.com/.

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VetStem Biopharma is Pleased to Announce Dr. Douglas Stramel of Advanced Care Veterinary Services is Successfully Using the Pall V-PET™ Platelet Therapy System

Dr. Douglas Stramel of Advanced Care Veterinary Services in Carrollton, Texas has been using the Pall Veterinary Platelet Enhancement Therapy System (V-PET™) for nearly three years. A proponent of Regenerative Medicine, Dr. Stramel has been credentialed to perform VetStem Regenerative Cell Therapy since 2007 and began using V-PET™ 2016. V-PET™ is a gravity filtration-based platelet therapy kit that produces a platelet concentrate rich in natural healing cells. Supported by veterinary peer-reviewed publications, V-PET™ has been shown to be an effective regenerative medicine solution for the treatment of joint disease, soft tissue injuries, and to assist in the resolution of wounds in both dogs and horses. Click here to read the latest news.

One of Dr. Stramel's recent patients is a Great Dane named Pinky. At seven years old and 170 pounds, Pinky is considered a senior dog. In mid-2018, Pinky slipped on a wet driveway and ruptured her cruciate ligament. She was unable to put any weight on her right rear leg, which for a dog her size, makes life pretty complicated. She could no longer go on walks and struggled to get in and out of the car. Playing could only be done while Pinky was lying on the floor. She could not go up stairs and had trouble getting on the couch and into the bed. She also struggled to go to the bathroom.

After being told surgery was Pinky's only option, her owner, Rebecca, took Pinky to Dr. Stramel for a second opinion. As a Certified Veterinary Pain Practitioner, Dr. Stramel is dedicated to providing an array of advanced pain-management techniques for his patients. For Pinky, he recommended treatment with the Pall V-PET™, in addition to acupuncture, laser therapy, and a nonsteroidal anti-inflammatory. Read this here.

Pinky received her first platelet therapy treatment on June 26th, 2018. After a simple blood collection, Pinky's blood was run through the specialized V-PET™ filter, which is designed to selectively capture platelets to produce a platelet concentrate. The concentrate was injected directly into Pinky's right knee. Platelets, when exposed to damaged tissue, are triggered to release growth factors that stimulate tissue repair. Since Pinky was both the donor and recipient, there was very little risk of rejection. Read here.

According to Dr. Stramel, Pinky noticeably improved eight days after receiving platelet therapy. Beginning in July, Pinky began weekly acupuncture and biweekly laser therapy sessions. On August 2nd, Pinky received a second injection utilizing the Pall V-PET™ kit. Like before, Pinky's blood was run through the V-PET™ filter and she received a concentrated dose of platelets into her right knee. Approximately two weeks after the second injection, Pinky was no longer limping. She received two more rounds of acupuncture and one more round of laser therapy at which point it was decided that Pinky was doing so well, she could discontinue both therapies. Currently, Pinky is maintained on one anti-inflammatory pill daily. Before and after videos of Pinky can be found here (after video in the comments). Be alert to read related news.

Though Pinky was non-weight bearing on her right rear leg prior to receiving platelet therapy, her mom reported that she was able to resume all of her normal activities after treatment. She goes on three walks a day, including one walk that is always over a mile. She jumps in and out of the car with ease and has no problem with stairs. Her mom said she has also run around the backyard chasing squirrels. Though Pinky is seven years old, a senior for a dog her size, she was able to bounce back from a torn cruciate ligament with the help of Dr. Stramel and Veterinary Platelet Enhancement Therapy. Pleased with Pinky's outcome, Rebecca stated, "I would highly recommend PRP as it was a miracle to see her recover so quickly." Read related news now.

About Douglas Stramel, DVM
Douglas Stramel received his Doctorate of Veterinary Medicine from Kansas State University in 1991. In 1994, he was accepted as an intern at Dallas Veterinary Surgical Center (DVSC), where he gained extensive knowledge in advanced surgical techniques. He is the first and only Certified Veterinary Pain Practitioner in the Dallas/Fort Worth area.

About VetStem Biopharma, Inc.
VetStem Biopharma is a veterinarian-lead Company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego, California, currently offers veterinarians an autologous stem cell processing service (from patients' own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 15 years and 17,000 treatments by veterinarians for joint, tendon or ligament issues, VetStem has made regenerative medicine applications a therapeutic reality. The VetStem team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. In addition to its own portfolio of patents, VetStem holds exclusive global veterinary licenses to a large portfolio of issued patents in the field of regenerative medicine.

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Tuesday, January 22, 2019

MyTana Introduces New M745 Workhorse, First Drain Machine with Variable Speed and Torque Protection

MyTana, a manufacturer and distributor of cleaning, maintenance and inspection tools for the plumber and drain cleaning markets, has released the new M745 Workhorse drain machine. With MyTana's new M745 Workhorse, drain-cleaning professionals can now adjust cable speed on-the-fly for maximum performance, and choose among two torque settings for safety. Read here.

The M745 incorporates MyTana's proprietary new SmartDrive technology. With SmartDrive, cable speed can be throttled (up to 300 rpm) to negotiate turns, strengthen cleaning force, and expedite feeds and retrievals—or reduced (as low as 100 rpm) for tackling obstructions and debris. SmartDrive also includes calibrated torque protection which is designed to safeguard the operator and extend the life of the machine's cable. SmartDrive sounds an alarm when cable torque approaches unsafe limits and then automatically cuts power when that limit is reached. The limit can be set high for large drains or low for sink lines. Operators can also select how tension is released: quickly with little resistance, or slowly with more resistance.

A versatile machine, the M745 comes fully equipped to work in 3"-4" lines with 100' of cable, slip-joint fittings, autofeed, blades and accessories. A sinkline kit is available to address 1 ½"-2" lines, and no tools are needed to swap reels due to the quick-release design of the drive system.

The M745 is compact to fit in tight spaces, has non-skid feet and balanced weight for stabilization during operation and transport, offers a telescoping adjustable handle that retracts easily for storage, and has built-in stair-rollers for enhanced mobility.

"This new M745 Workhorse gives control to sewer and drain cleaning professionals that is unprecedented," says Dale Graber, general manager for MyTana. "The M745 is a high-performing machine that saves time and money by working more quickly and accurately, and in turn, protects the safety of the operator and the longevity of the cable."

The M745 Workhorse with SmartDrive is available through the MyTana website at http://www.mytana.com/throttle or call 1-866-327-7176.

About MyTana Manufacturing
St. Paul, Minnesota-based MyTana is a full-service manufacturer of drain cleaning and inspection equipment, including cable machines, drain jetters and plumber cameras. The company also offers cables, blades, nozzles and other accessories for plumbers and drain cleaners. By selling direct, MyTana is able to maintain competitive pricing while offering a high level of personalized service and support. All MyTana equipment is factory-direct and American made. Visit MyTana online at http://www.mytana.com/

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LifeLearn Animal Health Unveils a Fresh New Website for 2019!

LifeLearn Animal Health is thrilled to announce the launch of its newly redesigned website at http://www.lifelearn.com—including all-new products and services—in celebration of LifeLearn's 25 years of innovation and excellence in the animal health industry.

"At LifeLearn, we're always asking ourselves one important question," says Randy Valpy, President and CEO of LifeLearn. "'How do we continue offering the best solutions and services to veterinarians, animal health companies and pet service businesses? Our new website reflects this core commitment. With a fresh new look, intuitive design, and new solutions, our relaunched LifeLearn website directly responds to the needs of today's busy animal health professionals."

Easier Navigation

From LifeLearn's beginnings in 1994 as a continuing education provider to veterinarians across North America, the UK, Australia and New Zealand, LifeLearn has continually expanded its range of products and services over 25 years to encompass Education, Communication and Optimization solutions for veterinary practices, as well as companies and non-profit organizations in the animal health and pet services industries.

This ECOsystem of products and services for veterinary practices includes:

New Solutions for Pet Service Businesses

From boarding kennels and dog-walking services to grooming services and dog daycare businesses, the pet service industry is booming. To help pet service businesses thrive against increasing competition, LifeLearn's new website unveils a range of solutions, including:

New Industry Solutions

For the past 20 years, LifeLearn's Industry Solutions have served animal health companies with veterinary-focused education, marketing services, and meetings agency services. To help animal health companies optimize sales-team performance and profitability, the new LifeLearn website includes Stratus, the simple, centralized way for organizations to better deploy, manage, and elevate the effectiveness of their campaigns and sales presentations online. Read all the latest news.

One-Stop Convenience

Different veterinary practices, animal health companies and pet service businesses have different needs. LifeLearn's simplified new website navigation makes it easier for veterinarians, animal health companies and pet service businesses to find what they need, whether they're just starting up, dealing with increased competition or focused on growth.

All New LifeLearn Videos

Even though LifeLearn's new product and service page descriptions are short, LifeLearn understands that time is always at a premium. That's why the new LifeLearn website includes short new explainer videos.

To see everything the new LifeLearn website now offers, visit http://www.lifelearn.com.

About LifeLearn Animal Health

LifeLearn, Inc. empowers animal health organizations to optimize client communications, maximize efficiency and improve profitability with the LifeLearn ECOsystem, a comprehensive suite of customizable online solutions that advance animal health and education worldwide. Founded in 1994 in Guelph, Ont., LifeLearn, Inc. helps veterinary, industry and pet service companies grow their business and improve compliance while saving valuable time with fast, easy access to the latest and most trusted animal health medical information, fully optimized for desktop and mobile devices. Celebrating 25 years of innovation and excellence, LifeLearn was named one of Canada's fastest-growing companies on the 2015, 2016 and 2017 PROFIT 500, and 2018 Growth 500.

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Developers at Pixel Film Studios Unveil ProChapter 3D Wedding for Final Cut Pro X

Bring new life to video with this set of 3D wedding presentation environments for Final Cut Pro X. ProChapter 3D Wedding uses source media as a starting point and pulls the camera back into a 3D environment where users can display additional information about a subject. ProChapter 3D Wedding is perfect for presentations and can be used in video productions of any nature. Featuring 30 uniquely designed corporate environments to choose from, ProChapter 3D Wedding is the ultimate presentation tool for Final Cut Pro X.

ProChapter 3D Wedding features 30 presentation environments made exclusively for Final Cut Pro X. This gives users a wide selection of options to use in productions. Each ProChapter 3D preset is ready-to-use in Final Cut Pro, but can be customized and adapted to any project.

Use ProChapter 3D Wedding to display a quote, provide a description, or present data. ProChapter 3D Wedding features a variety of customization options that give the user complete control over optimization. Versatility is the key with any ProChapter product.

ProChapter 3D comes with a drop-down layout menu so that users may easily select a preset layout for Left, Right, Top, Bottom and Center aligned media. After setting the layout, make further adjustments by tweaking the rotation of the media and the position/rotation of the text.

Each preset includes a set of color controls so that change the color of the background, foreground and rear objects. Just find the Hue/Saturation controls or find the Tint color pickers included in each respective section to easily change colors. Read all the related news.

Established in 2006, Aliso Viejo, California-based Pixel Film Studios is an innovative developer of visual effects tools for the post-production and broadcast community. Their products are integrated with popular non-linear editing and compositing products from Apple FCPX. Apple, the Apple logo, Mac OS X, and Macintosh are registered trademarks of Apple Inc. in the U.S. and/or other countries. All other trademarks and trade names are the property of their respective owners.

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Allergan Suspends Sales of Its Textured Breast Implants in Europe, Breast Implants Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

In December 2018, Allergan, one of the world's largest manufacturer of breast implants, suspended sales of its textured implants in Europe after the implants were denied renewed safety certificates in France because of concerns about BIA-ALCL. The French regulatory agency and a British association of plastic surgeons have recommended the use of smooth-surface implants in place of textured-surface products. Both European regulators and the U.S. FDA will hold meetings in 2019 to review further the safety of all breast implants but for now, textured implants remain approved for use in the U.S. *

"ALCL is a extremely rare cancer of the immune system, and questions have been raised about whether the incidence is higher in women undergoing breast reconstruction with breast implants," says Dr. Constance M. Chen, board-certified plastic surgeon and breast reconstruction specialist. The incidence of ALCL in the breast is 3 cases of ALCL in 100 million women (0.000003%). Dr. Chen adds that "BIA-ALCL has been associated in women who have breast implants for both cosmetic and reconstructive reasons. Women who have breast implants for breast reconstruction due to mastectomy or for cosmetic breast augmentation are at equal risk for developing BIA-ALCL. The simple fact of having a breast implant - of any type, for any reason - in her body places a woman at higher risk of developing BIA-ALCL." Dr. Chen adds that the current literature estimates that BIA-ALCL may develop in 1 in 3,817 to 30,000 women with textured breast implants.

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"While attention has been focused on textured breast implants, BIA-ALCL has actually been found in all types of breast implants: textured, smooth, silicone, saline," says Dr. Chen. As of 30 September 2017, the FDA had received 414 medical device reports of BIA-ALCL, including the death of 9 patients. Only 272 of the 414 reports included information on the implant surface. Of these cases, BIA-ALCL was found associated with 242 implants with textured surfaces and 30 implants with smooth surfaces. With regard to implant filling, BIA-ALCL was found associated with 234 implants filled with silicone gel and 179 implants filled with saline. About half of the reported cases were diagnosed within 7-8 years of breast implantation.

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The backstory:
In 2011, the U.S. Food and Drug Administration (FDA) first noted that the incidence of ALCL seemed slightly higher in patients with breast implants, but it was still very rare even in this population with 60 cases of ALCL worldwide in 5-10 million women (0.0006-0.0012%). Dr. Chen adds, "that at the time, many healthcare professionals believed that e incidence of ALCL in women with breast implants might have even been overestimated because some of the data collected may have been duplicate cases." However, in 2016 data collection improved due to an increased attention to ALCL and breast implants, and the World Health Organization (WHO) designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants.

Several recent journal articles explore risk factors for developing BIA-ALCL, including the role of biofilm. Dr. Chen notes that "textured implants have significantly more surface area than smooth implants, which may explain why there is a higher incidence of BIA-ALCL in textured implants than smooth implants." However, BIA-ALCL has clearly been found associated with every type of breast implant. Textured implants may be at slightly greater risk for ALCL than smooth implants, but findings are not conclusive. Dr. Chen points out that "this is important to note because many plastic surgeons have stopped using textured breast implants, but they continue using smooth breast implants. It is clearly not true that BIA-ALCL is limited to textured breast implants only. Since every type of breast implant has been associated with BIA-ALCL, it is a false sense of security to limit breast implant use to smooth breast implants. In reality, all types of breast implants can lead to BIA-ALCL."

Tips for Patients:
When ALCL occurs with breast implants, it is identified most frequently in patients undergoing implant revisions for late onset, persistent seroma (a fluid collection that develops around the implant), or other symptoms such as pain, lumps, swelling, or breast asymmetry. Dr. Chen advises that "any women experiencing these symptoms should see a plastic surgeon to be evaluated for BIA-ALCL."

The FDA already recommends that women with silicone breast implants undergo breast MRI every 2-3 years to evaluate for silent rupture of her silicone breast implants. Dr. Chen advises that if a patient with breast implants feels a change in her breasts, breast imaging can be obtained to evaluate for seroma. If a seroma is found, an interventional radiologist or a skilled breast radiologist can aspirate the seroma fluid to test for CD30 markers and lymphoma. If the cytology is positive, the patient will need to be treated.

Treatment of BIA-ALCL includes removal of the implant and capsule surrounding the implant and sometimes chemotherapy and radiation. If ALCL is diagnosed through imaging and testing of the fluid around the breast, treatment is generally the surgical removal of the implant and the entire capsule that surrounds it. In its early stages, all traces of cancer are generally removed by surgery. Further treatment is necessary only if all the cancer could not be removed or if the disease has spread to the lymph nodes or other parts of the body.

Dr. Chen clarifies that the FDA does not currently recommend prophylactic breast implant removal in patients without symptoms or other abnormalities. At present, breast implants are still approved in the USA when used as labeled for breast augmentation or breast reconstruction, as the risk of ALCL is still considered to be small and inconclusive. All of this may soon change, however, as new and better data is collected on BIA-ALCL. More info here.

"Women with breast implants who want to have their breast implants removed have options," says Dr. Chen. A woman facing breast reconstruction after mastectomy can consider autologous reconstruction, in which a new breast is created from her own tissue. If she is not a candidate for autologous reconstruction or if she prefers implants, she must be aware of the risk of BIA-ALCL. A woman who had breast implants for cosmetic breast augmentation can have her breast implants removed and undergo natural breast augmentation or accept a smaller size breast. Dr. Chen concludes, "even though breast implants of all types are still approved for use in the United States, any woman who has breast implants or is considering breast implants should be aware of BIA-ALCL so that she can be fully educated and consider the potential repercussions of breast implants on her health and well-being."

Constance M. Chen, MD, is a board-certified plastic surgeon with special expertise in the use of innovative natural techniques to optimize medical and cosmetic outcomes for women undergoing breast reconstruction. She is Clinical Assistant Professor of Surgery (Plastic Surgery) at Weill Cornell Medical College and Clinical Assistant Professor of Surgery (Plastic Surgery) at Tulane University School of Medicine. http://www.constancechenmd.com

*https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

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Start Up Establishments Benefit From Latest No Cost Offer For ezCheckprinting Business Software

Business owners with startup companies can save cost in many ways when switching to updated ezCheckprinting business software. There is a unique opportunity from Halfpricesoft.com to get this software at no cost when checking out through Trialpay.

"The latest edition of this popular ezCheckPrinting software, is now no cost for start up companies when checking out through Trialpay." said Halfpricesoft.com Founder, Dr. Ge.

With the new ezCheckPrinting software, customers can now print checks to pay bills, print blank checks to fill in manually and print draft checks to receive payments more easily.

ezCheckPrinting eliminates the need for expensive pre-printed checks. Customers can design and print professional checks with logo and MICR encoding easily and in-house. The extensive learning curve has also been eliminated for new customers peace of mind with a quick start guide and FAQ page.

The updated version of this business check software is now compatible as a network version and available to Windows 10 and 8.1 customers. Potential customers can download the trial version at https://www.halfpricesoft.com/product_ezCheck.asp with no cost or obligation.

Designed with ease to use in mind, ezCheckPrinting software is straightforward and user-friendly. The unique features of this MICR & laser cheque writing and printing software include:

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  • Add a company logo and other customizable design features for a professional, corporate look to company checks
  • No limit to the number of accounts that can be added
  • Write an unlimited number of checks
  • No internet connection needed
  • Add a second signature line for peace of mind and security
  • Prints MICR characters accepted by most banks (for use with laser printers) — no need to order expensive checks pre-printed with bank information
  • Include signature image on checks to save time signing checks
  • Customizable report features that are easy to use
  • Save time by printing multiple checks with one click
  • Starting at just $3 9 per installation for a single user version (Free through TrialPay offer). How does this work? Try or buy one offer from a preferred brand and get ezCheckprinting—free. TrialPay uses money from the advertiser to pay for ezCheckprinting. It's that easy! Read here.

    To learn more about ezCheckPrinting check writing software and all of the features, potential customers can visit https://www.halfpricesoft.com/product_ezCheck.asp.

    About Halfpricesoft.com
    Halfpricesoft.com is a leading provider of small business software, including online and desktop payroll software, online employee attendance tracking software, accounting software, in-house business and personal check printing software, W2, software, 1099 software, Accounting software, 1095 form software and ezACH direct deposit software. Software from Halfpricesoft.com is trusted by thousands of customers and will help small business owners simplify payroll processing and streamline business management.

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