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Stelara ulcerative colitis

The Truth About Colitis - Ulcerative Colitis Researc

Learn More About Enbrel®. Find The Prescribing Info, Safety Info & Boxed Warnin STELARA ® is a prescription medicine used to treat adults 18 years and older with moderately to severely active ulcerative colitis. STELARA ® is a prescription medicine used to treat adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills) This article is a collaboration between MedPage Today and: PHILADELPHIA -- Significantly more patients with moderate-to-severe ulcerative colitis (UC) given a single dose of ustekinumab (Stelara)..

A summary of clinical data regarding the monitoring of ustekinumab drug levels in patients with ulcerative colitis (UC) treated with STELARA® (ustekinumab). STELARA - Measuring Ustekinumab Drug Levels in Patients with Ulcerative Colitis Janssen's Stelara Wins FDA Approval for Ulcerative Colitis Published: Oct 21, 2019 By Alex Keown The U.S. Food and Drug Administration (FDA) green-lit Janssen ' s Stelara for the treatment of adult patients with moderately to severely active ulcerative colitis after clinical trials demonstrated the drug helped patients achieve clinical remission After the one-time IV infusion, you will receive STELARA ® as an injection under the skin (subcutaneous injection) every 8 weeks. There are 6 injections during the first year of treatment. Your doctor can administer at his or her office, or your doctor will decide if you or a caregiver may give your injections of STELARA ® at home The safety and efficacy of STELARA therapy for the treatment of adults with moderately to severely active ulcerative colitis (UC) was evaluated in the phase 3 clinical trial program (UNIFI). 1-3 During induction therapy at week 8, treatment with intravenous (IV) STELARA resulted in significantly higher rates of endoscopic improvement, histologic improvement, as well as histologic-endoscopic mucosal healing compared to the placebo group. 4 Additionally, histologic improvement at week 8 was. Just recently the United States Food and Drug Administration has approved the medicine STELARA for certain patients with Ulcerative Colitis. This happened towards the end of October 2019, and as is often the case, there are probably quite a few UC'ers in the US as well as other countries around the world who have been introduced to this medication probably by Gastro doctors

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STELARA® (ustekinumab) for Ulcerative Colitis STELARA

STELARA ® is a prescription medicine used to treat adults 18 years and older with moderately to severely active ulcerative colitis How long does Stelara take to work? Everyone responds differently when taking a new medicine, and Stelara doesn't work for everyone. Clinical trials have shown that some patients start to see results within three weeks in Crohn's disease and two weeks in ulcerative colitis, but most people who respond to Stelara see an improvement within six weeks STELARA ® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis: Induction dose: A single intravenous infusion using weight-based dosage regimen: 260 mg (weight ≤55 kg), 390 mg (weight >55 kg to 85 kg), or 520 mg (weight >85 kg)

Learn About STELARA® (ustekinumab) for Ulcerative Colitis

The National Institute for Health and Care Excellence (NICE) accepted ustekinumab (also known as Stelara) for use in people with Crohn's Disease in April 2017 and the Scottish Medicines Consortium approved it in July 2017. We want to hear from people with moderate to severe Ulcerative Colitis who have used the medicine ustekinumab (also known as Stelara) Evidence-based recommendations on ustekinumab (Stelara) for treating moderately to severely active ulcerative colitis in adults.. Is this guidance up to date? Next review: 2023. Guidance development process. How we develop NICE technology appraisal guidanc Stelara is the first biologic approved for any indication that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis, said Philippe Szapary, MD, MSCE, Vice President, Clinical Development, Janssen Research & Development STELARA® (ustekinumab) Now Approved for the Treatment of Adults with Moderate-to-Severe Ulcerative Colitis in Japan Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka; President and Representative Director: Masayuki Mitsuka; hereafter, Mitsubishi Tanabe Pharma) announced today that Janssen Pharmaceutical K.K. (Headquarters: Chiyoda-ku Johnson & Johnson (JNJ) receives European Commission's (EC) approval for the label expansion of Stelara for the treatment of adults with moderately-to-severely active ulcerative colitis (UC)

Stelara a Hit in Ulcerative Colitis MedPage Toda

New Phase 3 STELARA® (ustekinumab) Data Show Positive Results As Maintenance Therapy In Adults With Moderate To Severe Ulcerative Colitis One-year UNIFI data presented for the first time during. ustekinumab (Stelara) SMC ID: SMC2250. Indication: For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Pharmaceutical company European Commission Approves Expanded Use of Janssen's STELARA ® (ustekinumab) for the Treatment of Moderately to Severely Active Ulcerative Colitis in the European Union September 04, 2019 09.

STELARA - Measuring Ustekinumab Drug Levels in Patients

The Crohn's & Colitis Foundation is a non-profit, volunteer-fueled organization dedicated to finding the cures for Crohn's disease and ulcerative colitis, and to improving the quality of life of children and adults affected by these diseases. It was founded in 1967 by Irwin M. and Suzanne Rosenthal, William D. and Shelby Modell, and Henry D. Janowitz, M.D Stelara ustekinumab Remove Stelara from your drug comparison Add to compare Entyvio is an integrin receptor antagonist that may be used to reduce inflammation associated with moderate to severe ulcerative colitis or Crohn's disease Adults with ulcerative colitis will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour. Biospace - Janssen's Stelara Wins FDA Approval for Ulcerative Colitis Categories: Biologics , C-reactive protein (CRP) , CalProctetin , Colonoscopy , Crohn's Disease , Nutrition , One Great Gut Collection , Pharmaceuticals , RESEARCH , Resources , STORIES-OF-HOPE , The Crohn's And Colitis Summit , TREATMENT , and Ulcerative Colitis Abstract Background The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is u..

The FDA approved Stelara to treat adults with ulcerative colitis (UC), a condition that affects around 910,000 U.S. patients each year. Regulators based the decision on two phase 3 clinical trials. September 6, 2019. Johnson & Johnson's inflammatory disease drug Stelara has been approved in Europe for ulcerative colitis (UC), a new use for the multibillion dollar blockbuster Stelara induces remission in ulcerative colitis patients. 9th October 2018. by. Selina McKee. Janssen has presented new data showing that a single dose of its biologic Stelara induced clinical remission and response in patients with moderate to severe ulcerative colitis. Eight-week induction data from the pivotal Phase III UNIFI study showed. STELARA solution for intravenous infusion must be infused by a healthcare professional only and is given as an induction therapy for the treatment of Crohn's disease and ulcerative colitis. It is to be diluted prior to intravenous infusion and administered over at least 1 hour according to the DOSAGE AND ADMINISTRATION section of the STELARA full Prescribing Information.

NICE positive FAD recommends STELARA® for ulcerative colitis. Apr 28, 2020. The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the National Institute for Health and Care Excellence (NICE) positive Final Appraisal Document (FAD) recommending STELARA ® (ustekinumab) as an option for treating moderately to severely active. Despite Increased Competition from the Recent Launch of Janssen's Stelara, Takeda's Entyvio Continues to Shine as a Leading Ulcerative Colitis Treatmen J&J's IL-23 drug Tremfya is in a phase 2/3 ulcerative colitis trial with a primary completion date of June 2022. Stelara is cleared for use in ulcerative colitis but appears to be less effective.

January 22, 2020. The National Institute for Health and Care Excellence (NICE) has not recommended ustekinumab, Janssen's Stelara, for treating moderately to severely active ulcerative colitis in adults. Ulcerative colitis causes inflammation and ulcers in the bowel and rectum Dive Brief: Johnson & Johnson's top-selling drug Stelara appears well-positioned to continue the sales growth that made it a blockbuster, as new data from a pivotal trial released Tuesday showed the drug to be effective in treating ulcerative colitis (UC).; Treatment with the IL-12 and IL-23 antagonist led to higher clinical response and remission rates than placebo after eight weeks in. STELARA was evaluated in a randomized, double-blind, placebo-controlled phase 3 clinical trial program in adult patients with moderately to severely active ulcerative colitis (UNIFI). The clinical trial program consisted of an 8-week intravenous induction study followed by a 44-week subcutaneous randomized withdrawal maintenance study for a total of 52 weeks of therapy. The European Commission on Wednesday approved the expanded use of Stelara for adults with moderately to severely active ulcerative colitis, according to a company press release.The expanded use. Dr Sands: Ulcerative colitis is a chronic inflammatory condition of the large bowel that is lifelong incurable except by total proctocolectomy and has a number of available treatments but still, there are many patients who do not respond to existing medications and so there's a large need these patients suffer from chronic diarrhea, usually bloody diarrhea fatigue and many other.

Stelara TV Commercial, 'Enough: May Be Able to Help

Ulcerative colitis is found among people who take Stelara, especially for people who are female, 40-49 old, have been taking the drug for 1 - 2 years. The phase IV clinical study is created by eHealthMe based on reports of 52,738 people who have side effects when taking Stelara from the FDA, and is updated regularly Results from the Phase 3 pivotal trial, showed that more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids STELARA is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement. Ulcerative Colitis New Topic Reply Previous Thread I started Stelara last June, and also started a course of Budesonide (oral) and Uceris foam. (I had been off all treatments due to surgery in March, and Entyvio wasn't really working that great) Ulcerative colitis, or UC, affects nearly 907,000 people in the United States, with approximately 38,000 new cases diagnosed each year. 1 UC is a chronic disease of the large intestine, also known.

Janssen’s ulcerative colitis medicine not recommended by

Janssen's Stelara Wins FDA Approval for Ulcerative Colitis

  1. EC expands label of Janssen's Stelara to include ulcerative colitis Allie Nawrat 6 September 2019 (Last Updated September 6th, 2019 12:02) Johnson & Johnson subsidiary Janssen has announced the European Commission (EC) has approved Stelara (ustekinumab) for patients with moderately to severely active ulcerative colitis (UC)
  2. istration for STELARA. The phase 3 clinical trial program of STELARA in the treatment of ulcerative colitis (UC) did not evaluate dose optimization during maintenance therapy with 90 mg subcutaneous (SC) every 8 weeks (eg, higher doses or more frequent dosing). 1
  3. 1.4 Ulcerative Colitis . STELARA. is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 2 DOSAGE AND ADMINISTRATION Psoriasis Subcutaneous Adult Dosage Regimen • For patients weighing 100 kg or less , the recommended dose is 45 mg initially and 4 week
  4. Ulcerative Colitis . STELARA. is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 2 DOSAGE AND ADMINISTRATION Psoriasis Subcutaneous Adult Dosage Regimen • For patients weighing 100 kg or less , the recommended dose is 45 mg initially and 4 week
  5. Ulcerative colitis STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies(see section5.1)
  6. From September 2020, people living with moderate to severely active Ulcerative Colitis who have found that other treatments, including other biologic drugs such as adalimumab or infliximab, have not worked or have caused major side effects can be prescribed ustekinumab by the NHS.. Ustekinumab (Stelara) is already in use for Crohn's, psoriasis and psoriatic arthritis
  7. Ustekinamub (Stelara) is approved as a treatment for psoriasis. But it is used off-label for Crohn's disease. Stelara works by blocking cytokines that are important to the inflammatory process in Crohn's disease. One study showed that 70% of Crohn's disease patients respond to Stelara. History Ustekinumab (Stelara) was approved by the FDA as a treatment for psoriasis, [
Ulcerative Colitis Therapy Candidate ABX464 Gets a Trials

Ustekinumab (Stelara) has received approval from the US Food and Drug Administration for the treatment of moderate to severely active ulcerative colitis in adults. Adult patients with moderate to severely active ulcerative colitis have a new treatment option with the United States Food and Drug Administration (FDA)'s approval of ustekinumab. K51.80 Other ulcerative colitis without complications K51.81 Other ulcerative colitis with complications K51.90 Ulcerative colitis, unspecified, without complications K51.91 Ulcerative colitis, unspecified, with complications *These codes are not intended to be promotional or to encourage or suggest a use of drug that is inconsistent with FDA. STELARA ® is indicated in Canada for the treatment of adults living with Crohn's disease, ulcerative colitis, psoriasis, and active psoriatic arthritis, as well as for adolescent patients with. Janssen Research & Development clinical development vice president Dr Philippe Szapary said: STELARA is the first biologic approved for any indication that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis

Ulcerative Colitis STELARA. is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 2 DOSAGE AND ADMINISTRATION Psoriasis Subcutaneous Adult Dosage Regimen • For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks Ustekinumab (Stelara, Janssen) has a marketing authorisation that includes the following indication: 'treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic o Evidence-based recommendations on ustekinumab (Stelara) for treating moderately to severely active ulcerative colitis in adult To learn more about ulcerative colitis, click here. About Stelara (ustekinumab) Stelara is a drug that targets the IL-12/IL-23 molecular pathway. The approval comes following impressive results from a phase 3 clinical trial which tested the drug in patients with ulcerative colitis. Stelara is currently under consideration for approval by the US Food and Drug Administration (FDA) for the same disease

Stelara is a prescription medication approved by the Food and Drug Administration (FDA) to treat adults 18 and older who have moderate to severely active Crohn's disease. Stelara may be prescribed in cases where other immunomodulators and corticosteroids have failed or produced intolerances. Stelara is also known by its drug name, Ustekinumab Dr Sands: Ulcerative colitis is a chronic inflammatory condition of the large bowel that is lifelong incurable except by total proctocolectomy and has a number of available treatments but still, there are many patients who do not respond to existing medications and so there's a large need these patients suffer from chronic diarrhea, usually bloody diarrhea fatigue and many other manifestations that disrupt their lives Stelara (ustekinumab) är den första tillgängliga biologiska behandlingen som riktar sig till signalmedlen IL-12 / IL-23, som spelar en viktig roll i tarminflammation. Nordiska patienter inkluderad Preparation and Administration of STELARA ® 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis) STELARA ® solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique STELARA ®, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. STELARA ® is also approved for the treatment of adult patients (18 years or older) with active psoriatic arthritis

STELARA® (ustekinumab

Success with Stelara? Hey everyone! British researchers followed nearly 7,000 people with Crohn's disease or ulcerative colitis from 90 hospitals in the country. They found that less than half of patients who took Remicade mounted an immune response following coronavirus infection. I'm on Humira and,. K51.912 Ulcerative colitis, unspecified with intestinal obstruction K51.913 Ulcerative colitis, unspecified with fistula K51.914 Ulcerative colitis, unspecified with abscess K51.918 Ulcerative colitis, unspecified with other complication K51.919 Ulcerative colitis, unspecified with unspecified complication

Effects of STELARA on Endoscopic and Histologic Outcomes

Stelara is cleared for use in ulcerative colitis but appears to be less effective than pure IL-23 inhibitors in psoriasis. If Lilly shows pure IL-23 inhibitors have a similar edge over Stelara in.. moderate to severe active ulcerative colitis Stelara works differently than other medications, including other biologics used to treat Crohn's. Stelara binds to two small proteins (cytokines) that.. STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1). 4.2 Posology and method of administratio

STELARA Reviews (Ustekinumab - Ulcerative Coliti

Dr. William Sandborn, University of California San Diego, discusses his presentation of the pivotal phase 3 data for STELARA® (ustekinumab) as maintenance th.. Table 1. FDA-approved age and dosing limits of Ulcerative Colitis (UC) Agents.6-19,22 Medication Indication(s) Age Dosing Limits Interleukin-12 and -23 Inhibitors Ustekinumab (Stelara®) UC ≥ í8 years Initial IV Dose: ≤ ñ ñ kg: ò ì mg as a single dose. >55-85 kg: 390 mg as a single dose. >85 kg: 520 mg as a single dose

Stelara European Medicines Agenc

  1. In the treatment of ulcerative colitis, Stelara (given by infusion) was compared with placebo in 2 main studies. The first study involved 961 patients with moderately to severely active disease. The main measure of effectiveness was the number of patients whose symptom s were gone or almost gone 8 weeks after the infusion
  2. Stelara is the first biologic approved for any indication that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis, said Philippe Szapary, MD, MSCE, VP, clinical development, Janssen Research & Development, LLC
  3. ister my Stelara injection to help me help my Crohn's Disease. I go over t..

Ulcerative Colitis (UC) is a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, affecting approximately 910,000 people in the United States. STELARA is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines Introduction : Ulcerative colitis (UC) is a chronic relapsing disorder of the colonic tract. Dysregulated innate and adaptive immune pathways contribute to intestinal inflammation in IBD, and cytokines, including IL-12 and IL-23, play a key role. The blockade of both IL-12 and IL-23 may have a About Ulcerative Colitis (UC) UC affects up to 2.6 million people in Europe. 7 It is a chronic disease of the large intestine, also known as the colon, in which the lining becomes inflamed and. STELARA ® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. Important Safety Information For STELARA® STELARA ® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients Johnson & Johnson subsidiary Janssen has announced the European Commission (EC) has approved Stelara (ustekinumab) for patients with moderately to severely active ulcerative colitis (UC). Ulcerative colitis is a chronic inflammatory disease of large intestine; it is one of the main forms of inflammatory bowel disease

About STELARA® (ustekinumab) STELARA ® is indicated in Canada for the treatment of adults living with Crohn's disease, ulcerative colitis, psoriasis, and active psoriatic arthritis, as well as for.. Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis (UC)

Stelara to Treat Ulcerative Colitis in EU Favored by CHM

spondylitis; criteria added for new FDA indication for Stelara: ulcerative colitis; removed redirection to azathioprine, 6-mercaptopurine, or aminosalicylate for UC per 2019 ACG guidelines; references reviewed and updated. RT4: added Xeljanz XR 22 mg dose form and updated to indicate FDA approved use and dosing in UC with similar redirection a Ulcerative Colitis. The safety of Stelara was evaluated in two randomized, double-blind, placebo-controlled clinical studies (UC-1 [IV induction] and UC-2 [SC maintenance]) in 960 adult patients with moderately to severely active ulcerative colitis SMC accepts Janssen's ulcerative colitis drug Stelara for NHS use 16 April 2020 (Last Updated April 16th, 2020 12:56) Scottish Medicines Consortium (SMC) has accepted Janssen Pharmaceutical's Stelara (ustekinumab) for use on the National Health Service (NHS) Scotland to treat moderately to severely active ulcerative colitis (UC) in adults The objective of this study is to explore and describe the disease characteristics, treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia

Video: Stelara: Uses, Dosage, Side Effects - Drugs

STELARA® (ustekinumab) Healthcare Professional Sit

Stelara is cleared for use in ulcerative colitis but appears to be less effective than pure IL-23 inhibitors in psoriasis. If Lilly shows pure IL-23 inhibitors have a similar edge over Stelara in ulcerative colitis, it could carve out a piece of the market before facing competition from Skyrizi and Tremfya 14 Van Assche G, et al. Abstract DOP47: Sustained remission in patients with moderate to severe ulcerative colitis: Results from the Phase 3 UNIFI maintenance study. ECCO 2019. 15 Businesswire. New Phase 3 Stelara (Ustekinumab) Data Show Positive Results as Maintenance Therapy in Adults with Moderate to Severe Ulcerative Colitis Returning guest, Dr. William Sandborn, Chief of the Division of Gastroenterology at UC San Diego Health, discusses recent data from the Phase 3 UNIFI study e.. Stelara (ustekinumab) is an expensive drug used to treat plaque psoriasis, psoriatic arthritis and ulcerative colitis. This medicine is also used to treat Crohn's disease. It is not a cure. This drug is more popular than comparable drugs. There are currently no generic alternatives to Stelara

Children with Crohn's, Ulcerative Colitis Go into

NICE fails to recommend Stelara for ulcerative coliti

Ulcerative Colitis. A single body weight-based dose is given via intravenous infusion, followed by a maintenance dosing schedule of a 90 mg subcutaneous maintenance injection every 8 weeks. 1. Complete information about Stelara dosage and administration can be found in the official prescribing information listed in our references section. Ustekinumab (Stelara) is already in use for psoriasis and psoriatic arthritis. It works in a different way from other biological drugs, currently available for Crohn's Disease, by targeting two specific, naturally occurring proteins which play a key role in inflammatory and immune responses The FDA approved Stelara to treat adults with ulcerative colitis, a condition that affects around 910,000 U.S. patients each year, based on data from two phase 3 clinical trials Ulcerative colitis, in patients with moderate to severe active disease. In Crohn's disease and ulcerative colitis, a single weight-based dose is administered by intravenous infusion. Following induction therapy with the intravenous product, the recommended maintenance is Stelara

Janssen files Stelara in Europe for ulcerative colitis. 7th January 2019 . by. Anna Smith. Janssen has submitted a Group Type II Variation Application to the European Medicines Agency (EMA) seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) Generic Name: ustekinumab Brand Name: Stelara/Stelara I.V Manufacturer: Janssen Inc. Therapeutic Area: Ulcerative colitis Indications: Ulcerative colitis Manufacturer Requested Reimbursement Criteria 1: For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional.

Types of Rectal Bleeding with Crohn's Disease and IBDPsoriasis Treatment Results | STELARA® (ustekinumab)Cannabosides Show Positive Preclinical Results asEuropean Commission approves expanded use of ustekinumabIBD Research to Advance with Boehringer Ingelheim New
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