IBD Unit

Petah Tikva, Israel
Petah Tikva, Israel

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PubMed | St. George's University, Iatriko Kentro Athinon, Ospedale Luigi Sacco Polo Universitario, Leiden University and 9 more.
Type: | Journal: Journal of Crohn's & colitis | Year: 2016

This ECCO topical review of the European Crohns and Colitis Organisation [ECCO] focuses on the epidemiology, pathophysiology, diagnosis, management and outcome of the two most common forms of inflammatory bowel disease, Crohns disease and ulcerative colitis, in elderly patients. The objective was to reach expert consensus to provide evidence-based guidance for clinical practice.


PubMed | Amager Hospital, Dr Falk Pharma GmbH, Regional Hospital, Lund University and 9 more.
Type: Clinical Trial, Phase III | Journal: Gut | Year: 2015

This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9mg/day initially, tapered to 4.5mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase.Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5days (95% CI (9.0 to 14.0days)). The maintenance of clinical remission at 1year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious.Budesonide at a mean dose of 4.5mg/day maintained clinical remission for at least 1year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1year may be beneficial given the high relapse rate after budesonide discontinuation.http://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).


INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organisation (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD), which supports switching from reference infliximab to biosimilar infliximab.1 The ECCO statement covers several aspects related to biosimilars and the key positions are:1 This marks a significant shift in attitude from the previous ECCO position paper, which advised that switching from an established biologic to a biosimilar was inappropriate and called for more data on the safety and benefit of biosimilars in general.2 Professor Silvio Danese, President Elect of ECCO and Head of the IBD Unit, Humanitas Clinical and Research Center, Italy commented: “ Findings from the 2015 ECCO survey of IBD specialists found that around 80% of specialists are either totally confident, very confident or confident enough in using biosimilars, which is a huge change compared to 39% when a similar survey was conducted back in 2013.”3 Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “ This position paper comes amid a global trend encouraging the use of biosimilars. Rising healthcare costs and the consequent financial burden placed on health services are some of the biggest challenges many countries face. While biologics have positively impacted patient treatment, their high costs may limit patient access to these modern medicines. The availability of generally less expensive treatment options like biosimilars can reduce pressure on healthcare system resources. Biosimilars are a cost effective alternative to biological therapies and can eventually lead to potential budget savings and provide improved access to life-changing treatment for patients.” Celltrion Healthcare has already seen success with CT-P13 - the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The recently released NOR-SWITCH study revealed that efficacy and safety were maintained in patients switched to CT-P13 from originator infliximab and it is not inferior to those who continued treatment with the originator.4 These findings were presented at the 2016 United European Gastroenterology (UEG) Week in October and at the 2016 American College of Rheumatology (ACR) Annual Meeting in November. The European Crohn´s Colitis Organisation (ECCO) is the non-profit association founded in 2001 to improve the care of patients with inflammatory bowel disease (IBD) in Europe. ECCO is the largest forum for specialists in IBD in the world, representing 3,132 IBD experts as individual members. ECCO develops clinical guidelines that serve as standard references for IBD management in Europe. The first position statement of ECCO on the use of biosimilar medicines in the treatment of IBD was published in 2013 to define the collective view of European specialist in IBD concerning biosimilars. The biosimilar infliximab developed and manufactured by Celltrion, Inc. was the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s biosimilar infliximab in April 2016 under the trade name Inflectra™. Celltrion’s biosimilar infliximab is approved in more than 75 (as of September 20, 2016) countries including the US, Canada, Japan and throughout Europe. Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.5 They affect an estimated 2.5-3 million people in Europe;6 CD affects about three people per 1,000 and UC about five people per 1,000.5 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.6 Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ 1 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337.


INCHEON, Zuid-Korea--(BUSINESS WIRE)--Celltrion Healthcare is verheugd over de publicatie van de meest recente position paper van de Europese organisatie voor Crohn en Colitis (ECCO) over het gebruik van biosimilars voor inflammatoire darmaandoeningen (IBD). De position paper ondersteunt de overstap van het referentieproduct infliximab naar biosimilar infliximab.1 Dit markeert een belangrijke verandering in de houding ten opzichte van de vorige position paper van ECCO. Daarin werd gewaarschuwd dat de overstap van een gevestigd biologisch middel naar een biosimilar ongepast was en werd gepleit voor meer gegevens over de veiligheid en het voordeel van biosimilars in het algemeen.2 Professor Silvio Danese, President Elect van ECCO en hoofd van de IBD Unit, Humanitas Clinical and Research Center, Italië, merkte op: “ Uit de bevindingen van het ECCO-onderzoek van 2015 van de IBD-specialisten bleek dat ongeveer 80% van de specialisten ofwel helemaal zeker zijn van, ofwel veel vertrouwen of genoeg vertrouwen hebben in het gebruik van biosimilars. Dat is een enorme verandering in vergelijking met de 39% toen een vergelijkbaar onderzoek werd uitgevoerd in 2013.”3 Celltrion Healthcare heeft al succes ondervonden met CT-P13, 's werelds eerste monoklonaal antilichaam-biosimilar die goedgekeurd is door het Europees Geneesmiddelenbureau (EMA) en de Amerikaanse Food and Drug Administration (FDA). Uit de onlangs gepubliceerde NOR-SWITCH-studie is gebleken dat de werkzaamheid en veiligheid gehandhaafd bleven bij patiënten die de overstap hadden gemaakt van originator infliximab naar CT-P13 en dat deze niet onderdeden voor de gegevens van degenen die de behandeling met de originator voortzetten.4 Deze bevindingen werden gepresenteerd tijdens de 2016 United European Gastroenterology ( UEG) Week in oktober en op de jaarvergadering van 2016 van het American College of Rheumatology (ACR) in november. De Europese organisatie voor Crohn en Colitis (ECCO) is de non-profit organisatie opgericht in 2001 om de zorg voor patiënten met inflammatoire darmziekten (IBD) in Europa te verbeteren. ECCO is het grootste forum voor specialisten op het gebied van IBD ter wereld, dat 3132 IBD-deskundigen vertegenwoordigt als individuele leden. ECCO ontwikkelt klinische richtlijnen die dienen als standaard referenties voor het beheer van IBD in Europa. De eerste standpuntverklaring van ECCO over het gebruik van biosimilars bij de behandeling van IBD werd gepubliceerd in 2013 om de collectieve zienswijze van de Europese specialisten op het gebied van IBD met betrekking tot biosimilars te bepalen. De biosimilar infliximab, ontwikkeld en geproduceerd door Celltrion, Inc., was 's werelds eerste biosimilar monoklonale antilichaam dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september door de EMA goedgekeurd onder de handelsnaam Remsima® en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's biosimilar infliximab goed in april 2016 onder de merknaam Inflectra™. Celltrion's biosimilar infliximab is goedgekeurd in meer dan 75 (vanaf 20 september 2016) landen, waaronder de VS, Canada, Japan en heel Europa. Inflammatoire darmziekten (IBD), waaronder de ziekte van Crohn (CD) en colitis ulcerosa (UC), zijn chronische invaliderende gastrointestinale aandoeningen die van invloed zijn op het gehele leven van een patiënt.5 Ongeveer 2,5 - 3 miljoen mensen in Europa worden er door getroffen;6 CD treft ongeveer drie personen per 1000 en UC ongeveer vijf personen per 1000.5 Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ 1 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.


Sorrentino D.,University of Udine | Paviotti A.,University of Udine | Fiorino G.,IBD UNIT
Current Drug Targets | Year: 2010

Recurrence of Crohn's disease (CD) is extremely frequent after surgery and its prevention remains a fundamental problem in the medical management of these patients. As of today, none of the medications traditionally used to treat the spontaneous disease (i.e. mesalamine, steroids, immunosuppressives and antibiotics) has shown a clear benefit. Recent data, coming from our center and from a small RCT do indicate that infliximab is extremely effective in preventing this complication in the large majority of patients. While additional, larger studies may be desirable, the strength and consistency of the available data suggest that future trials may merely confirm these observations. A number of issues however remain to be solved and include the long term strategy in patients treated for years with infliximab, whether treating early endoscopic lesions may be as effective as preventing them and whether immuno-soppressives should be used together with infliximab. A thorough understanding of the mechanisms by which infliximab appears so effective in the postoperative setting may provide us with essential information regarding patients' management and, ultimately, highlight the molecular mechanisms at the very basis of Crohn's disease. © 2010 Bentham Science Publishers Ltd.


Tursi A.,Gastroenterology Service | Papa A.,Columbus University | Danese S.,IBD Unit | Danese S.,IBD Center
Alimentary Pharmacology and Therapeutics | Year: 2015

Background The incidence of diverticulosis and diverticular disease of the colon, including diverticulitis, is increasing worldwide, and becoming a significant burden on national health systems. Treatment of patients with diverticulosis and DD is generally based on high-fibre diet and antibiotics, respectively. However, new pathophysiological knowledge suggests that further treatment may be useful. Aim To review the current treatment of diverticulosis and diverticular disease. Methods A search of PubMed and Medline databases was performed to identify articles relevant to the management of diverticulosis and diverticular disease. Major international conferences were also reviewed. Results Two randomised controlled trials (RCT) found the role of antibiotics in managing acute diverticulitis to be questionable, particularly in patients with no complicating comorbidities. One RCT found mesalazine to be effective in preventing acute diverticulitis in patients with symptomatic uncomplicated diverticular disease. The role of rifaximin or mesalazine in preventing diverticulitis recurrence, based on the results of 1 and 4 RCTs, respectively, remains unclear. RCTs found rifaximin and mesalazine to be effective in treating symptomatic uncomplicated diverticular disease. The use of probiotics in diverticular disease and in preventing acute diverticulitis occurrence/recurrence appears promising but unconclusive. Finally, the role of fibre in treating diverticulosis remains unclear. Conclusions Available evidence suggests that antibiotics have a role only in the treatment of complicated diverticulitis. It appears to be some evidence for a role for rifaximin and mesalazine in treating symptomatic uncomplicated diverticular disease. Finally, there is not currently adequate evidence to recommend any medical treatment for the prevention of diverticulitis recurrence. © 2015 John Wiley & Sons Ltd.


Soderlund S.,Karolinska Institutet | Granath F.,Karolinska University Hospital | Brostrom O.,Karolinska Institutet | Karlen P.,Karolinska Institutet | And 4 more authors.
Gastroenterology | Year: 2010

Background & Aims: Reported differences in cancer risk between male and female animals after chronic inflammation suggest that estrogen has inflammation-modifying properties. Little is known about these effects in human beings. Inflammatory bowel disease (IBD) is associated with an increased risk of colorectal cancer (CRC); we studied differences in inflammation-associated CRC between men and women patients with IBD. Methods: By using a large population-based cohort (n = 7607) of individuals diagnosed with IBD from 1954 to 1989, we assessed the sex-specific incidence of CRC from 1960 to 2004. Incidence was determined within the cohort (modeled using Poisson regression) and compared with the general population (assessed as standardized incidence ratios) using data from national Swedish health and census registers. Results: During 171,000 person-years of follow-up evaluation, 196 new cases of CRC were observed (123 in males, 73 in females). Males with IBD had a 60% higher risk of CRC (relative risk [RR], 1.6; 95% confidence interval [CI], 1.2-2.2) than females (cumulative incidence 40 years after IBD diagnosis, 8.3% vs 3.5%). Compared with the rate of CRC among the general population, in males with IBD the RR was 2.6 and the 95% CI was 2.2-3.1, whereas in females the RR was 1.9 and the 95% CI was 1.5-2.4. The effect of sex was limited to the period after 10 years of follow-up evaluation (RR, 0.8 before vs 2.2 after), and to patients diagnosed before age 45 (RR, 2.1 before vs 1.0 after). Conclusions: IBD confers a lower risk of CRC to females than to males. © 2010 AGA Institute.


Gomollon F.,IBD UNIT | Gisbert J.P.,IBD UNIT
Drugs | Year: 2013

Anemia and iron deficiency anemia are very common in inflammatory bowel disease (IBD). In most cases, anemia is a consequence of mixed pathogenesis; inflammation and iron deficiency being the most important factors. Iron status should be evaluated carefully, as ferritin is unreliable in the presence of inflammation. It is always necessary to control disease activity; however, supplementation is usually required to fully correct iron deficiencies. Oral iron, intravenous iron, erythropoietin, and blood transfusions can be used in different clinical scenarios. Oral iron may be used in mild cases if the disease has no clinical activity. Intravenous iron should be preferred where oral iron is poorly tolerated or where it has failed in moderate to severe anemia, and in combination with erythropoietin. Iron sucrose is very safe and effective, but not very convenient, as the total needed dose must be divided into several infusions. Ferric carboxymaltose is much more convenient, and has been shown to be more effective than iron sucrose in a large randomized trial. Iron isomaltose shows theoretical promise, but very limited data are available from IBD populations. Blood transfusion can be necessary, especially in acute life-threatening situations, but the trigger for indication should be in the low range. With the correct use of available resources, anemia and iron deficiency should be well controlled in practically all IBD patients. © 2013 Springer International Publishing Switzerland.


Iborra M.,Polytechnic University of Valencia | Bernuzzi F.,Center for Autoimmune Liver Diseases | Correale C.,IBD Unit | Vetrano S.,IBD Unit | And 8 more authors.
Clinical and Experimental Immunology | Year: 2013

The altered expression of micro-RNA (miRNA) has been associated with Crohn's disease (CD) and ulcerative colitis (UC). The aim of this study was to establish specific miRNA expression patterns in the serum and mucosa of inflammatory bowel disease (IBD) patients (UC and CD with colonic involvement) at different stages of the disease. Serum and biopsies from nine active CD (aCD), nine inactive CD (iCD), nine active UC (aUC) and nine inactive UC (iUC) and serum from 33 healthy subjects were collected. Up to 700 miRNAs were evaluated by the TaqMan® human miRNA array. The ΔCt values were obtained using the mean expression values of all expressed miRNAs in a given sample as a normalization factor for miRNA real-time quantitative polymerase chain reaction data. The levels of serum miRNAs in CD and UC patients were different to healthy subjects. Thirteen serum miRNAs were expressed commonly in CD and UC patients. Two miRNAs were higher and four miRNAs were lower in the serum of aCD than iCD. No serum miRNA was regulated exclusively in aUC compared with iUC patients. Four miRNAs were higher and three miRNAs were lower in the mucosa of aCD than iCD. Two miRNAs were higher and three miRNAs were lower in the mucosa of aUC than iUC. No serum miRNAs coincided with tissue miRNAs in aCD and aUC patients. Our results suggest the existence of specific miRNA expression patterns associated with IBD and their different stages and support the utility of miRNA as possible biomarkers. This pilot study needs to be validated in a large prospective cohort. © 2013 British Society for Immunology.


Professor Silvio Danese, President Elect von ECCO und Head of the IBD Unit, Humanitas Clinical and Research Center (Italien), erklärte: „ Die Ergebnisse der 2015 ECCO Umfrage von IBD-Fachleuten belegen, dass rund 80% dieser Fachleute vollkommen überzeugt, sehr überzeugt oder hinreichend überzeugt sind, Biosimilars anzuwenden. Dies bedeutet einen signifikanten Wandel im Vergleich zu ehemals 39%, als eine vergleichbare Umfrage im Jahr 2013 durchgeführt wurde.”3 Die European Crohn´s Colitis Organisation (ECCO) wurde im Jahr 2001 als gemeinnützige Organisation für die Verbesserung der Pflege von Patienten mit entzündlichen Darmerkrankungen (IBD) in Europa gegründet. ECCO ist das bedeutendste Forum für IBD-Fachleute rund um den Globus und wird durch 3.132 individuelle Mitglieder repräsentiert. ECCO entwickelt klinische Leitlinien, die als Standardreferenzen für das IBD-Management in Europa dienen. Das erste Positionspapier von ECCO zur Anwendung von Biosimilar-Medikamenten im Rahmen der Behandlung von IBD wurde im Jahr 2013 veröffentlicht, um die gemeinsame Sicht von europäischen IBD-Fachleuten in Bezug auf Biosimilars darzulegen. Das Biosimilar Infliximab wird von Celltrion, Inc. entwickelt und hergestellt und war das weltweit erste monoklonale biosimilare Antikörper-Medikament, das von der Europäischen Arzneimittelagentur (EMA) zugelassen wurde. Es ist für die Behandlung von acht Autoimmunerkrankungen zugelassen, darunter rheumatoide Arthritis und entzündliche Darmerkrankungen. Das Arzneimittel wurde im September 2013 von der EMA unter dem Handelsnamen Remsima® zugelassen und kam Anfang 2015 in Europa auf den Markt. Die US-amerikanische Zulassungsbehörde FDA erteilte Celltrion die Zulassung für CT-P13 im April 2016 unter dem Handelsnamen Inflectra™. CT-P13 von Celltrion ist in mehr als 75 Ländern (Stand: 20. September 2016) zugelassen, darunter die USA, Kanada, Japan und ganz Europa. 1 Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn's and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198 2 Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. 3 Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. An updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090 4 Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L. 5 Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016 6 Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis. 7(4), 322-337.

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