WO2015040067A1 - Préparation et son utilisation pour la dermatite atopique - Google Patents

Préparation et son utilisation pour la dermatite atopique Download PDF

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Publication number
WO2015040067A1
WO2015040067A1 PCT/EP2014/069814 EP2014069814W WO2015040067A1 WO 2015040067 A1 WO2015040067 A1 WO 2015040067A1 EP 2014069814 W EP2014069814 W EP 2014069814W WO 2015040067 A1 WO2015040067 A1 WO 2015040067A1
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WO
WIPO (PCT)
Prior art keywords
oil
acid
epax
omega
vitamin
Prior art date
Application number
PCT/EP2014/069814
Other languages
German (de)
English (en)
Inventor
Gisela Rauch-Petz
Original Assignee
Pg Naturpharma Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pg Naturpharma Gmbh filed Critical Pg Naturpharma Gmbh
Publication of WO2015040067A1 publication Critical patent/WO2015040067A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/60—Fish, e.g. seahorses; Fish eggs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics

Definitions

  • the present invention relates to a composition containing fish oil, borage oil and / or evening primrose oil, vitamin D and vitamin E.
  • composition on which the invention is based is used, for example, as a supplementary balanced diet for skin diseases such as psoriasis or atopic dermatitis, which is also known as atopic dermatitis or atopic dermatitis.
  • the diseases of the atopic form of the population increase. Even in infants and toddlers, the diseases can be diagnosed. They cause minor impairments in quality of life, including serious illnesses of those affected, including hospitalization, mental health and work loss.
  • atopic diseases are in addition to asthma and allergic rhinitis in particular, the allergic reactions of the skin, namely the atopic dermatitis (atopic dermatitis, atopic dermatitis) to call.
  • atopic dermatitis there is no generally accepted therapy recommendation. Rather, being in medical
  • Treatment usually developed an individualized treatment plan. So far, various drug therapies with cortisone, antihistamines and leukotriene antagonists are combined with consistent skin care, plant ointments, thalassotherapy, brine baths, but also autogenic training. In the case of dietary measures, the recommendations for avoiding ingestion outweigh the known allergens.
  • Balanced diets are "dietary foods for special medical purposes.” They were included as a new product category in Section 1 (4a) of the German Diet Ordinance (Di expediV) in 2001. They are subdivided into fully balanced diets (No.1) and supplemented balanced diets (No. 2) and include compositions that are specially processed or formulated. Balanced diets are being developed for the dietary treatment of individuals who derive a specific medical indication
  • This nutritional need must not be achieved by modifying the normal diet, using other foods for a particular diet, or a combination of both at a reasonable cost, for example, a condition that is susceptible to nutrition, such as for example, in diabetics.
  • the supplemented balanced diets are intended to partially nourish patients with impaired, disabled or disturbed ability to ingest, digest, absorb, metabolize or excrete some common
  • Supplementary balanced diets in contrast to fully balanced diets, are not intended for the exclusive nutrition of patients. Rather, they must be consumed in addition to the normal diet to complete the
  • compositions with a standard nutrient formulation or with a condition specific for or specific to a particular disease or disorder
  • composition significantly different from the foods of daily consumption
  • WO 2010/067206 A1 the treatment of atopic dermatitis and itchy skin symptoms in domestic animals by means of a mixture of hemp, linseed and rapeseed oil is described.
  • the ratio of linoleic acid to a-linolenic acid should be at least 2: 1 and the ratio of ⁇ -linolenic acid to
  • Stearidonic be at least 2: 1.
  • Omega-3 and omega-6 acids such as linoleic, linolenic and
  • Eicosapentaenoic acid is combined with other substances in GB 2 453 157 A1 to provide a composition for the treatment of skin diseases, i.a. to treat atopic dermatitis and eczema.
  • the composition is applied purely externally.
  • EP 1 634 599 A1 and EP 1 781 307 B1 protect a nutritional supplement or pharmaceutical composition containing a fat component, a protein component and a carbohydrate component and include whey and casein.
  • This dietary supplement or pharmaceutical composition has a weight ratio of casein to whey of 1: 1 to 1: 2.4 and the
  • Composition contains:
  • the "double heart system eyes plus eyesight + protection" capsules contain in a 1st capsule 15 mg lutein, 1 mg zeaxanthin, 0.4 mg vitamin A, 2 mg vitamin B6, 1, 0 pg vitamin B12, 10 mg zinc, 40 pg selenium, 60 mg vitamin C, 4 mg vitamin E, 640 mg sea fish oil with 140 mg DHA and in a second capsule 725 mg sea fish oil with 160 mg docosahexaenoic acid, 68 mg borage oil with 15 mg gamma-linolenic acid, 5 pg vitamin D, 2 mg of vitamin B2, 13.6 mg of vitamin E.
  • These capsules are called
  • a composition which can be used as a food, dietary supplement and especially as a supplemental balanced diet in atopic dermatitis.
  • especially herbal ingredients should be present.
  • composition for the supportive treatment of atopic dermatitis containing borage oil, St. John's wort oil and / or evening primrose oil and omega-3 acid rich fish oil in concentrations so the ratio of ⁇ -linolenic acid to eicosapentaenoic acid is from 1.33: 1 to 1.66: 1.
  • the Applicant has found that it is precisely in this ratio, the ingredients of borage oil, St. John's Wort oil and / or evening primrose oil and omega-3 acid-rich fish oil are particularly effective in skin diseases of the atopic Formennikes.
  • the borage oil advantageous for the invention has a content of from 18 to 25% by weight, preferably from 17 to 18% by weight, of ⁇ -linolenic acid.
  • the composition according to the invention contains the oil of fatty fish, which is generally rich in omega-3 fatty acids.
  • omega-3 fatty acids may be included in the composition in the form of triglycerides, but there may also be ethyl esters of said fatty acids. These ethyl esters are partially synthetic substances obtained from fish oil by work-up.
  • Omega-3 fatty acids are in part essential for the human organism. Above all, the predominantly herbal ⁇ -linolenic acid (ALA) is an essential nutrient, since it can not be formed by the body. ⁇ -linolenic acid will turn into the formation of the omega-3 fatty acids docosahexaenoic acid (DHA) and
  • Eicosapentaenoic acid (EPA) is needed.
  • ⁇ -linolenic acid is present in vegetable oils such as linseed oil (56-71%), hemp oil (28%), walnut oil (about 15%), rapeseed oil (5-16%) and soybean oil (4-1 1), also low in animal fats contain.
  • the fish oils described here mainly contain eicosapentaenoic acid and docosahexaenoic acid as omega-3 fatty acids.
  • the most suitable fish oil is a purified and / or winterized and / or deodorized fat oil derived from family Engraulidae (anchovies), Carangidae (spiny mackerels), Clupeidae (herring), Osmeridae (stinte),
  • Salmonidae (salmonidae), Scombridae (mackerel and tuna) and
  • Ammodytidae (sand eels) is obtained. Winterization is carried out to prevent clouding of the oil at low temperatures (e.g., in the refrigerator)
  • the oil is cooled to a low temperature, for example 5 - 10 ° C.
  • the omega-3-rich fish oil is a content
  • Elcosapentaen Yaron, Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., Inc., the concentration of elcosapentaenoic acid as the free fatty acid is calculated for this concentration indication, even if the oil of elcosapentaenoic acid is present as triglyceride or ethyl ester.
  • Fish oils with a content of elcosapentaenoic acid, calculated as free fatty acid, of 38 to 51% by weight are particularly suitable for the present invention.
  • the fish oils from Epax AS selected from EPAX 6000 TG / N, EPAX 6000 TG, EPAX 6000 EE, EPAX 4510 TG, EPAX 6500 EE, EPAX 5500 EE, EPAX 4020 TG, EPAX 4020 EE, EPAX 6015 TG and EPAX 6015 EE.
  • EPAX 6015 TG and EPAX 4020 TG Particularly suitable are EPAX 6015 TG and EPAX 4020 TG. Also preferred are EPAX 4510 TG, EPAX 4020 EE and EPAX 6015 EE.
  • composition according to the invention is mixed from said oils, the omega-3-acid-rich fish oil and the ⁇ -linolenic acid-rich borage, Johanniskern and / or evening primrose oil such that the ratio of gamma-linolenic acid to elcosapentaenoic acid of 1, 33 : 1 to 1, 66: 1.
  • oils used so the composition in unit doses e.g.
  • Soft gelatin capsules packaged or dosed in a multidose dosing with measuring cups, measuring spoons or the like so that an adult with the number of prescribed single doses or single doses per day 250-450 mg of elecosapentaenoic acid from omega-3 acid-rich fish oil and 450 to 600 mg ⁇ -linolenic acid from borage oil, evening primrose oil and / or Johanniskernöl takes.
  • this distribution of the daily dose can easily achieve a reduced dosage by reducing the number of prescribed single doses or single doses of a multi-dose dosage form according to body weight.
  • composition can be provided which
  • This amount corresponds to the dosage per day in adults.
  • the daily dosage may be divided up to 12 individual doses. These single doses may be, for example, soft gelatin capsules.
  • the composition can also be packaged as a liquid in a bottle and provided with a measuring cup or measuring spoon for dosing. Also conceivable would be a dosage form in drinking ampoules. The Weichgeiatinekapseln can be given due to the lamination of the taste here certainly the preference.
  • Vitamin D is in a concentration of 800 to 2,000 I.E. Based on the daily dosage for an adult advantageous.
  • Vitamin E can be calculated in concentrations of 40 to 100 mg, preferably from 60 to 80 mg to the daily dosage of one
  • composition according to the invention is used in particular for the supportive treatment of atopic dermatitis, atopic dermatitis or psoriasis.
  • RRR-alpha-tocopherol concentrate 25.76 mg

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

L'invention concerne une composition pour le traitement symptomatique de la dermatite atopique, contenant de l'huile de bourrache, l'huile de graine de caroube et/ou de l'huile d'onagre et de l'huile de poisson riche en acides oméga-3 dans des concentrations telles que le rapport de l'acide γ-linolénique sur l'acide eicosapentaénoïque est de 1,33:1 à 1,66:1.
PCT/EP2014/069814 2013-09-17 2014-09-17 Préparation et son utilisation pour la dermatite atopique WO2015040067A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202013008190U DE202013008190U1 (de) 2013-09-17 2013-09-17 Zubereitung und deren Verwendung bei atopischer Dermatitis
DE202013008190.2 2013-09-17

Publications (1)

Publication Number Publication Date
WO2015040067A1 true WO2015040067A1 (fr) 2015-03-26

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PCT/EP2014/069814 WO2015040067A1 (fr) 2013-09-17 2014-09-17 Préparation et son utilisation pour la dermatite atopique

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DE (1) DE202013008190U1 (fr)
WO (1) WO2015040067A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11077136B2 (en) 2016-04-18 2021-08-03 Bioiberica, S.A.U. Compositions for the skin

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002325558A (ja) * 2002-04-08 2002-11-12 Nippon Meat Packers Inc 食肉製品及びその製造方法
EP1634599A1 (fr) 2004-08-20 2006-03-15 N.V. Nutricia Aliment infantile à activité immunostimulatrice
GB2453157A (en) 2006-09-29 2009-04-01 Carmen Maria Jose Wheatley Compositions and their use for treating skin conditions
WO2010067206A1 (fr) 2008-12-11 2010-06-17 Olini Ltd. Composition lipidique pour traiter les problèmes cutanés d'animaux de compagnie

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002325558A (ja) * 2002-04-08 2002-11-12 Nippon Meat Packers Inc 食肉製品及びその製造方法
EP1634599A1 (fr) 2004-08-20 2006-03-15 N.V. Nutricia Aliment infantile à activité immunostimulatrice
EP1781307B1 (fr) 2004-08-20 2009-04-01 N.V. Nutricia Aliment infantile à activité immunostimulatrice
GB2453157A (en) 2006-09-29 2009-04-01 Carmen Maria Jose Wheatley Compositions and their use for treating skin conditions
WO2010067206A1 (fr) 2008-12-11 2010-06-17 Olini Ltd. Composition lipidique pour traiter les problèmes cutanés d'animaux de compagnie

Non-Patent Citations (14)

* Cited by examiner, † Cited by third party
Title
BELCH JJ; HILL A: "Evening primrose oil and borage oil in rheumatologic conditions", AM. J. CLIN. NUTR., vol. 71, no. 1, 2000, pages 352S - 6S
BENT, STEPHEN; BERTOGLIO, KIAH; HENDREN, ROBERT L.: "Omega-3 Fatty Acids for Autistic Spectrum Disorder: A Systematic Review", J AUTISM DEV DISORD, vol. 39, no. 8, March 2009 (2009-03-01), pages 1145 - 54, XP019730322, DOI: doi:10.1007/s10803-009-0724-5
BJORNEBOE A ET AL: "Effect of dietary supplementation with eicosapentaenoic acid in the treatment of atopic dermatitis", BRITISH JOURNAL OF DERMATOLOGY 1987 GB, vol. 117, no. 4, 1987, pages 463 - 469, XP002731422, ISSN: 0007-0963 *
DATABASE WPI Week 200342, Derwent World Patents Index; AN 2003-443509, XP002731421 *
EVANGELOS C. RIZOS; EVANGELIA E. NTZANI; EFTYCHIA BIKA, MD; MICHAEL S. KOSTAPANOS; MOSES S. ELISAF; FASA, FRSH: "Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease Events: A Systematic Review and Metaanalysis", JAMA, vol. 308, no. 10, September 2012 (2012-09-01), pages 1024 - 1033
FAN, YANG-YI; ROBERT S. CHAPKIN: "Importance of Dietary y-Linolenic Acid in Human Health and Nutrition", JOURNAL OF NUTRITION, vol. 128, no. 9, 9 September 1998 (1998-09-09), pages 1411 - 4
GIORGIO LANDI: "ORAL ADMINISTRATION OF BORAGO OIL IN ATOPIC DERMATITIS", JOURNAL OF APPLIED COSMETOLOGY., vol. 11, no. 4, 1 January 1993 (1993-01-01), IT, pages 115 - 120, XP055147639, ISSN: 0392-8543 *
HORROBIN, DAVID: "Essential fatty acid metabolism and its modification in atopic eczema", AMERICAN JOURNAL OF CLINICAL NUTRITION, vol. 71, no. 1, 1 January 2000 (2000-01-01), pages 367S - 72S
MELNIK B C ET AL: "Treatment of atopic dermatitis with Glandol(R) and Epoleum(R) - A comparative study", AKTUELLE DERMATOLOGIE 1995 DE, vol. 21, no. 7, 1995, pages 215 - 219, XP009180865, ISSN: 0340-2541 *
RASMUSSEN J E: "MANAGEMENT OF ATOPIC DERMATITIS", ALLERGY, WILEY-BLACKWELL PUBLISHING LTD, UNITED KINGDOM, vol. 44, no. SUPPL. 09, 1 January 1989 (1989-01-01), pages 108 - 113, XP000576610, ISSN: 0105-4538 *
RUGGIERO C; LATTANZIO F; LAURETANI F; GASPERINI B; ANDRES-LACUEVA C; CHERUBINI A: "Omega-3 polyunsaturated fatty acids and immune-mediated diseases: inflammatory bowel disease and rheumatoid arthritis", CURR PHARM DES, vol. 15, no. 36, 2009, pages 4135 - 48
VAN DE REST, O.; GELEIJNSE, J. M.; KOK, F. J.; VAN STAVEREN, W. A.; DULLEMEIJER, C.; OLDERIKKERT, M.G.M.; BEEKMAN, A. T.F.; DE GRO: "Effects of Fish Oil on cognitive performance in older subjects", NEUROLOGY, vol. 71, no. 6, August 2008 (2008-08-01), pages 430 - 38
WALL R; ROSS RP; FITZGERALD GF; STANTON C: "Fatty acids from fish: the antiinflammatory potential of long-chain omega-3 fatty acids", NUTR REV, vol. 68, no. 5, 2010, pages 280 - 9
WILLIAMS, HYWEL C: "Editorial: Evening primrose oil for atopic dermatitis-Time to say goodnight", BMJ, vol. 327, no. 7428, 13 December 2003 (2003-12-13), pages 1358 - 9

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11077136B2 (en) 2016-04-18 2021-08-03 Bioiberica, S.A.U. Compositions for the skin

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