WO2024013649A2 - Article gonflable relatif à la nutrition - Google Patents
Article gonflable relatif à la nutrition Download PDFInfo
- Publication number
- WO2024013649A2 WO2024013649A2 PCT/IB2023/057084 IB2023057084W WO2024013649A2 WO 2024013649 A2 WO2024013649 A2 WO 2024013649A2 IB 2023057084 W IB2023057084 W IB 2023057084W WO 2024013649 A2 WO2024013649 A2 WO 2024013649A2
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- WO
- WIPO (PCT)
- Prior art keywords
- item according
- swellable item
- swellable
- poroelastic
- cellulose
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
Definitions
- Obesity is a global epidemic.
- the World Health Organization (WHO) estimates that in 2016, more than 1.9 billion adults (or 1 in 3 worldwide!) were overweight, and of those, over 650 million were obese.
- the prevalence of obesity has increased dramatically in recent decades, from about 10% in 1975, to over 30% of adults worldwide (2016).
- Obesity is associated with a number of chronic diseases, including heart disease, stroke, type 2 diabetes, and cancer. It is also a major risk factor for premature death.
- the solutions are broadly segmented by product type and intervention.
- product type there are weight loss supplements, drugs, surgical solutions, and weight loss programs.
- the weight loss supplements segment stands out as being one of the most natural and safe of all weight loss solutions.
- Weight loss drugs are very expensive, require prescription, and have significant side effects and compliance challenges. Side effects include indigestion, pancreatitis and hypoglycemia; Weight loss surgery is exercised almost only with morbid obesity patients due to its risk profile (including risk of death during surgery), invasiveness, long term side effects and detrimental effects on quality of life.
- FIG. 1 illustrates an example of a sponge like open cell porous thick filament fiber
- FIG. 2 illustrates an example of a sponge like open cell porous thick filament fiber after cutting and in an expanded state
- FIG. 3 illustrates an example of a sponge like open cell structure manufactured by extrusion foaming and particulate or polymer leaching
- FIG. 4 illustrates an example of a sponge like open cell structure manufactured by spinning (electro spinning, dry jet wet spinning or other methods of spinning) of non- porous thin filament fibers spun helically through a spinneret perpendicular to the drawing axis to create a "yam like" tangle non-woven fabric;
- FIG. 5 illustrates an example of a porous filament fibers spun (twisted) to a compressed yam.
- Any reference in the specification to an swellable item should be applied mutatis mutandis to a method for manufacturing the swellable item and/or should be applied mutatis mutandis for a method for administering the swellable item and/or should be applied mutatis mutandis to a method for consuming the swellable item.
- an orally swellable item that includes a dissolvable surrounding element that is dissolvable in gastro-intestinal fluids and a poroelastic structure (which is highly porous and elastic), held compressed by the dissolvable surrounding and exhibits a compression ratio that exceeds ten.
- compression ration expansion ratio
- compression and expansion ratio refer to a relationship between a volume of a structure when expanded to the volume of the structure when compressed. The expanded volume exceeds the compressed volume.
- the swellable item is configured to the following: a. Transfer from the mouth, through the esophagus to the stomach while the structure is in compressed state. b. The structure expands to its original size, in the stomach or in the duodenum, after the surrounding dissolves, exposed to gastro-intestinal fluids. c. The structure absorbs gastro-intestinal fluids with dissolved nutrients and chyme particles while expanding. d. The expanded structure maintains the majority of the gastro-intestinal fluids with dissolved nutrients and chyme particles while transferring through the small intestine, until exiting the ileocecal valve. e. The structure releases most of the gastro-intestinal fluids while being mechanically compressed and/or disintegrated (by bacterial fermentation) in the colon.
- the dissolvable surrounding element is configured to surround the structure and maintain the structure in a compressed form before being dissolved.
- the swellable item is safe for human consumption.
- the swellable item may be formed solely from Generally Recognized as Safe (GRAS) materials - as defined Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act.
- GRAS Generally Recognized as Safe
- the poroelastic structure is made of cellulose.
- the poroelastic structure is made of regenerated cellulose.
- the poroelastic structure includes cellulose and a plasticizer.
- the poroelastic structure includes cellulose and an additive that has a higher bacterial fermentability than the cellulose.
- the cellulose can include a blend of high average degree of polymerization (e.g. 100-1500) and/or higher crystallinity index (e.g. a>30%) cellulose for good mechanical charasteristics and low average degree of polymerization (e.g. ⁇ 100) and/or low crystallinity (e.g. a ⁇ 30%) cellulose for good bacterial fermentation and dismantling.
- the poroelastic structure is configured to absorb specific materials through its building materials or coating, as an example, it can be oleophylic in order to enhance fatty acid absorption.
- the swellable item is further integrated or impregnated or combined or co-administered with edible food coloring and or food flavors and/or edible fragrances to improve taste, smell or appearance.
- the porosity of the poroelastic structure exceeds ninety eight percent.
- the swellable item is a powder particle (multiparticulate).
- the swellable item is a powder particle having a length that ranges between 100 and 700 microns.
- the swellable item is a capsule, encapsulating multiple such poroelastic structures in compressed state.
- a volume of the daily orally delivered amount of swellable items will not exceed few tens of cubic centimeters, and According to an embodiment, the volume of the daily swelled amount of poroelastic structures when uncompressed will be few hundreds cubic centimeters.
- a diameter of the expanded poroelastic structure does not exceed three millimeters and a length of the expanded poroelastic structure does not exceed ten millimeters.
- the poroelastic structure is configured to withstand one cycle of full compression to the swellable item and full expansion after the surrounding dissolves, and also thousands of partial compression and expansion cycles within the small intestine.
- the poroelastic structure is configured to be dismantled in a colon.
- the structure includes multiple groups of pores, According to an embodiment, pores of each group of pores are in fluid communication with each other.
- the poroelastic structure is a spongelike structure element of an interconnected pores network type ("open cell”: fluid flow is possible to penetrate among the pores and to and from the outside).
- the structure includes multiple non-porous fibers that are spun to provide a poroelastic yarn.
- the poroelastic structure is manufactured by a manufacturing process that includes generating a structure that includes fully enclosed pores ("closed cell”); and forming holes that link the pores among themselves and to the outside (“open cell”).
- swellable item may include a swellable "sponge like” structure ("open cell” porous structure), which is swallowed while in compressed state within an outer case or coating and reaches its target expansion location (the stomach or the upper small intestine - duodenum or Jejunum), captures (absorbs) gastro-intestinal fluids with dissolved nutrients and chyme particles while expanding (before most of the nutrients absorption in the small intestine takes place), move along the gastro-intestinal tract transferring most of these materials while in expanded state throughout the small intestine to the colon and either transfers it outside the body or releases most of the trapped liquid and materials within the colon (with or without poroelastic structure full or partial dismantling in the colon).
- open cell the target expansion location
- gastro-intestinal fluids with dissolved nutrients and chyme particles while expanding (before most of the nutrients absorption in the small intestine takes place)
- move along the gastro-intestinal tract transferring most of these materials while in expanded state throughout the small intestine to the colon and
- the mixture of gastro-intestinal fluids and chyme can be partially in the form of a solution (dissolved materials, e.g. nutrients such as carbohydrates), a mixture of the fluids with small (up to 1mm diameter) non-soluble particles or emulsion (e.g. fatty acid micelles).
- a solution dissolved materials, e.g. nutrients such as carbohydrates
- a mixture of the fluids with small (up to 1mm diameter) non-soluble particles or emulsion e.g. fatty acid micelles.
- the total volume of absorbed chyme should be in the order of at least several 100's of CC, while a reasonable volume for swallowing such swellable items is few CC to very few 10's of CC.
- the poroelastic structure should have very high porosity (e.g. >98%) and very high compression ratio (e.g. >95%).
- Gastric motility is characterized by relatively weak pressure waves in the upper stomach ( ⁇ 20 mmHg) and relatively strong and short (several seconds) pressure waves (40 - >100 mmHg) in the distal antrum and pylorus.
- Small bowel motility is characterized by medium pressure waves (both peristalsis and segmental, ⁇ 25mmHg), short (several seconds) with maximal frequency of 8-12 cycles per minute.
- Colon motility is characterized by stronger pressure waves (50-100 mmHg) which are short (several seconds) in the proximal colon but much longer (up to almost static) in the distal colon.
- the poroelastic structure should be elastic enough (not brittle) to withstand at least one cycle of compressing to its compressed packed state and decompressing to its expanded state in the gastro-intestinal tract.
- the poroelastic structure can be dismantled within the colon (e.g. through degradation by bacteria fermentation), and/or compressed by the pressures in the colon to release most of the trapped fluids and particles, since there is no significant nutrients absorption at this stage.
- poroelastic structure It is preferred that all the materials of which the poroelastic structure are built from should be generally recognized as safe and permitted to be used as food, food supplements or dietary supplements, no new dietary ingredients (e.g. regenerated cellulose).
- Different swellable items can be used for different populations (e.g. adults vs. children), for example: different delivering options (multiparticulates Vs. capsules), different poroelastic structure dimensions (e.g. 1mm Vs. 3 mm diameter in expanded state) etc.
- Expanding in the small intestine has several advantages: (i) gastric fluids low acidity (after neutralizing in the duodenum), so release of some of the fluids further in the small intestine or the colon due to external pressure will not cause any acid bums, (ii) not accumulating in the stomach, which could have negative impacts such as stomach pain, nausea and vomiting, and (iii) lower viscosity fluids (easier absorption in the poroelastic structure).
- expanding within the stomach can also improve the satiety, especially if the expanded poroelastic structures are too big to exit the pyloric sphincter during standard digestion so it accumulates and released to the small intestine mostly during the interdigestive migrating motor complex, which means that the mass of expanded poroelastic structures remains in the stomach for a longer period of time.
- the dimension requirements can be on the swellable items (before surrounding dissolving and poroelastic structures expanding) as well as on the expanded poroelastic structures.
- the requirements are for the following: (i) delivering (swallowing), (ii) Passing from the stomach to the small intestine (through the pyloric sphincter), and (iii) Passing along the small intestine and through the ileocecal valve to the colon.
- Pills capsules
- the diameter of each ingested capsule should be ⁇ 8mm, and the length ⁇ 20mm, the volume is in the range of 0.5-1 CC.
- the main drawback is the large number of such capsules required to deliver large volumes and the fact that many people (especially young) cannot or dislike swallowing large pills,
- Multiparticulates A large number of small particles, having dimensions in the 100's of microns range (e.g. 200- 500pm), delivered as a "powder” and drunk mixed with water. This delivery option is much easier for large volumes (e.g. 10's of CC), replacing 10's of capsules.
- the main drawback is the grittiness "sandy" feeling.
- particles In order to pass from the stomach through the pyloric sphincter to the small intestine in parallel to the chyme during the postprandial period, particles should be up to 2mm in diameter and 5-10 mm length (depending on its stiffness, elastic structures can be somewhat larger).
- Poroelastic structure that should expand in the stomach can be up to 2-3 mm diameter in expanded state, in which case it would transfer to the small intestine during the postprandial period, or larger than this and accumulate in the stomach until the mmc cycle, causing longer satiety period but with the risk of over accumulation in the stomach.
- Poroelastic structure that should expand in the small intestine should be up to 2-3mm diameter in compressed state, in order to pass to the small intestine during the postprandial period and capture nutrients dissolved in the gastric fluids.
- each particle will easily pass through the pyloric sphincter during digestive period in compressed (and probably also expanded) state.
- the manufacturing process for these "sponge like" open cell porous structure can be based on a wide variety of known methods, either for textile fibers and non-woven fabrics manufacturing (e.g. cellulose regeneration for fibers such as rayon fibers), filtration polymer membrane manufacturing (e.g. casting plus particulate leaching), tissue engineering / polymer scaffold manufacturing (e.g. extrusion foaming followed by porogen leaching) or even aerogel manufacturing (e.g. polymer dissolving, solvent exchange and freeze drying).
- textile fibers and non-woven fabrics e.g. cellulose regeneration for fibers such as rayon fibers
- filtration polymer membrane manufacturing e.g. casting plus particulate leaching
- tissue engineering / polymer scaffold manufacturing e.g. extrusion foaming followed by porogen leaching
- aerogel manufacturing e.g. polymer dissolving, solvent exchange and freeze drying.
- the manufacturing process can start with a solution (polymer dissolved in a solvent), a molten or softened thermoplastic polymer or a liquid containing monomers or non crosslinked polymer that will later on precipitate or coagulate into a polymeric structure.
- a solution polymer dissolved in a solvent
- a molten or softened thermoplastic polymer or a liquid containing monomers or non crosslinked polymer that will later on precipitate or coagulate into a polymeric structure.
- These methods include for example: (i) thermoplastic foaming (either extrusion or injection molding), creating mostly closed cell foam, followed by opening holes in the closed cells to make an open cell foam structure, e.g.
- phase separation e.g. mixing a polymer-solvent solution with nonsolvent.
- Emulsion templating e.g. PolyHIPE.
- Porogen/particulate leaching e.g. table salt or calcium carbonate
- Polymer leaching e.g. water soluble polymer such as PEO.
- Freeze drying e.g.
- a manufacturing process produces an "endless”, “sponge” like, poroelastic thick yarn (few millimeters diameter in non-compressed state) which has all the required mechanical and physical properties. This yam is then twisted (spinned) in order to be compressed, coated in order to hold it in compressed state and to withstand gastro-intestinal conditions until required expansion and cut to appropriate length.
- the "endless" yarns can be drawn through all production stages (from fiber creation until cutting), it could be beneficial to roll "endless” filament fibers after process steps and un-roll in proceeding process stages.
- One benefit can be load balancing of manufacturing processes, using several such fibers in parallel for slow processes (e.g. saponification).
- Another benefit could be performing different manufacturing stages at different locations (e.g. by sub-contractors).
- the manufacturing process starts with extrusion foaming of a cellulose thermoplastic derivative (e.g. ester derivative such as cellulose acetate or cellulose acetate butyrate, viscose: cellulose xanthate, cellulose propionate, ether derivative such as ethylcellulose, cellulose nitrite etc.).
- a cellulose thermoplastic derivative e.g. ester derivative such as cellulose acetate or cellulose acetate butyrate, viscose: cellulose xanthate, cellulose propionate, ether derivative such as ethylcellulose, cellulose nitrite etc.
- the extrusion is from a 200-300pm diameter die into an "endless" closed cell porous single filament fiber yarn with a diameter of 2-3mm.
- the foaming can be done with the help of chemical or physical blowing agents, e.g. water, SC-CO2, N2, isobutene etc. Better volume expansion ratio is achieved with larger blowing agent molecules (lower diffusion) and lower process temperatures
- nucleating agents can be added to improve the foaming uniformity, pores size and the volume expansion ratio.
- a plasticizer e.g. glycerol, glycerol tri-acetate etc.
- the yarns will be drawn and dipped in baths for further reticulation and/or leaching (opening the pores into "open cell” form and enlarging the porosity).
- the cellulose can be regenerated (e.g. by saponification of ester derivatives such as cellulose acetate, for example by dipping in a solution of NaOH/H2O, NaOH/Ethanol or NaOMe/MeOH, similar to saponification of acetate rayon fibers to rayon as done in the case of Fortisan fibers, described in US patent 2,053,766).
- ester derivatives such as cellulose acetate
- Cellulose regeneration e.g. deacetylation of cellulose acetate
- the compressed yarn goes through a bath (or air spray coating) in order to be coated with a coating that will hold the yam compressed until dissolving.
- Such hard crystalline coating that can hold the twisted fibers is similar to hard panning of sugar, polyol (e.g. sugar alcohols), sucrose esters etc., performed by coating with multi thin layers of a syrup which crystallizes.
- Another option is similar to soft panning, a syrup that would not crystallize but be utilized as an adhesive to a powder (e.g. confectionary sugar, sugar mixed with starch etc.) "dusted" afterwards.
- Another coating can be applied for delayed expansion, either in acidic environment (stomach) or neutral environment (small intestine).
- An example for such coating that can be used as enteric (dissolving only in the neutral acidity small intestine) is stearic or palmitic fatty acid (also generally recognized as safe food).
- the coatings for mechanically holding the compressed poroelastic structure and delayed expansion can be one or two different coatings.
- the second coating can also be provided after cutting the yam, since coating before cutting the fibers means that the fibers are not coated at the cut sides, but only around the cylindrical surface.
- the last stage is cut the coated, compressed twisted yam to required length (in the case of multiparticulates: 200-500pm).
- the manufacturing process starts with extrusion (without foaming) of an endless solid (non-porous) thick (2-3mm) yarn comprised of cellulose thermoplastic derivative combined with large amount of soluble particles.
- the materials can be the same as in embodiment one, the main difference from embodiment one is that the extrusion is of a solid polymer thick fiber (through a 2-3 mm diameter die) and not a foamed thick fiber (that expands after extrusion through 200-300pm diameter die).
- the open cell porous structure is formed by porogen/particulate leaching within a bath filled with an appropriate solvent (e.g. water for water soluble particles).
- an appropriate solvent e.g. water for water soluble particles.
- the manufacturing process starts with filament fibers spinning (e.g. solution blow spinning through spinnerets) of "endless" thin non-porous filament fibers which build a non-woven, tangled, "thick yarn like” poroelastic fabric.
- filament fibers spinning e.g. solution blow spinning through spinnerets
- An example for such a fabric creation is by spinning helical shapes downwards while the fabric is drawn to the side.
- the spinning can be using single or multiple nozzles.
- the helices are built in several layers and the outcome is an "endless" few hundred microns to few millimeters wide (about the helix diameter in one axis and the number of layers multiplied by the fiber diameter on the other axis, both perpendicular to the "endless” drawing axis).
- the spinning can be of molten thermoplastic cellulose derivative, as well as dissolved cellulose derivative (e.g. viscose: cellulose xantate or dissolved cellulose diacetate in acetone) or dissolved pure cellulose (e.g. lyocell process).
- dissolved cellulose derivative e.g. viscose: cellulose xantate or dissolved cellulose diacetate in acetone
- pure cellulose e.g. lyocell process
- Each fiber can be l-100pm diameter; the fabric should be 2-3 mm diameter (can also be of rectangular shape, compressed to 200-300pm diameter after twisting).
- the materials can be the same as in embodiment one, the main difference from embodiment one is that the extrusion is of solid polymer thin fibers and not a foamed thick fiber.
- This structure is inherently "open cell" (the gaps between the thin fibers), so there is no need for particulate leaching or reticulation.
- a method for weight reduction of a human comprises swallowing a swellable item illustrated in the specification and/or drawings and/or claims.
- the human may be a human that suffers from excess weight and/or a patient that was diagnosed as suffering for excess weight.
- a method for weight reduction of a human comprises administering to a person a swellable item illustrated in the specification and/or drawings and/or claims.
- the human may be a human that suffers from excess weight and/or a patient that was diagnosed as suffering for excess weight.
- a method for weight reduction of a animal comprises swallowing a swellable item illustrated in the specification and/or drawings and/or claims.
- a method for weight reduction of a animal comprises administering to a person a swellable item illustrated in the specification and/or drawings and/or claims.
- any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved.
- any two components herein combined to achieve a particular functionality may be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermedial components.
- any two components so associated can also be viewed as being “operably connected,” or “operably coupled,” to each other to achieve the desired functionality.
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Abstract
Article gonflable comprenant (i) un élément environnant dissoluble dans les fluides gastro-intestinaux et (ii) une structure poroélastique, présentant un rapport de compression et de dilatation supérieur à dix et conçue pour absorber les nutriments dissous et les particules de chyme lorsqu'elle se dilate en présence de fluides gastro-intestinaux et pour conserver une majorité des nutriments dissous et des particules de chyme jusqu'à ce qu'ils sortent de l'intestin grêle. L'élément environnant dissoluble est conçu pour entourer la structure et la maintenir sous une forme comprimée avant d'être dissoute. L'article gonflable est sans danger pour la consommation humaine.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202263359893P | 2022-07-11 | 2022-07-11 | |
| US63/359,893 | 2022-07-11 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2024013649A2 true WO2024013649A2 (fr) | 2024-01-18 |
| WO2024013649A3 WO2024013649A3 (fr) | 2024-03-28 |
Family
ID=89536095
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2023/057084 Ceased WO2024013649A2 (fr) | 2022-07-11 | 2023-07-11 | Article gonflable relatif à la nutrition |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2024013649A2 (fr) |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2669699B2 (ja) * | 1989-11-28 | 1997-10-29 | 日本碍子株式会社 | 空燃比センサ |
| WO1994028881A1 (fr) * | 1993-06-11 | 1994-12-22 | Merix Corporation | Formulation de retention a liberation retardee pour adsorbant d'acides biliaires |
| KR101224323B1 (ko) * | 2004-12-17 | 2013-01-21 | 다우 글로벌 테크놀로지스 엘엘씨 | 레올로지 개질된 폴리에틸렌 조성물 |
| US9757346B2 (en) * | 2008-09-03 | 2017-09-12 | Volant Holdings Gmbh | Compositions and methods for treating insulin resistance and non-insulin dependent diabetes mellitus (type II diabetes) |
| WO2011109520A1 (fr) * | 2010-03-03 | 2011-09-09 | Gavin Braithwaite | Produit de synthèse remplissant le volume gastrique |
| MX373516B (es) * | 2012-03-28 | 2020-04-30 | Ethicon Endo Surgery Inc | Compensador de grosor de tejido que comprende una expansión y liberación controladas. |
| CN106062055A (zh) * | 2014-03-12 | 2016-10-26 | 富士胶片株式会社 | 纤维素多孔质粒子的制造方法及纤维素多孔质粒子 |
| CA2974967C (fr) * | 2015-01-29 | 2023-06-27 | Gelesis Llc | Procede pour la production de d'hydrogels a module d'elasticite eleve couple avec une haute densite optique |
| CA2989511A1 (fr) * | 2015-07-07 | 2017-01-12 | Perora Gmbh | Composition comestible comprenant un polysaccharide et un lipide |
| KR101896476B1 (ko) * | 2017-06-19 | 2018-10-18 | 재단법인대구경북과학기술원 | 공용매를 이용한 고결정성 재생 셀룰로오스 섬유의 제조 방법 |
| ES2984169T3 (es) * | 2020-10-06 | 2024-10-29 | Tensive S R L | Matriz implantable tridimensional con respuesta reducida a cuerpos exógenos |
-
2023
- 2023-07-11 WO PCT/IB2023/057084 patent/WO2024013649A2/fr not_active Ceased
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| Publication number | Publication date |
|---|---|
| WO2024013649A3 (fr) | 2024-03-28 |
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