WO2018163209A1 - Complément pour la ménopause - Google Patents
Complément pour la ménopause Download PDFInfo
- Publication number
- WO2018163209A1 WO2018163209A1 PCT/IN2018/050126 IN2018050126W WO2018163209A1 WO 2018163209 A1 WO2018163209 A1 WO 2018163209A1 IN 2018050126 W IN2018050126 W IN 2018050126W WO 2018163209 A1 WO2018163209 A1 WO 2018163209A1
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- WO
- WIPO (PCT)
- Prior art keywords
- extract
- isoflavones
- composition according
- calcium
- menopause
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Classifications
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- 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
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
- A23L2/385—Concentrates of non-alcoholic beverages
- A23L2/39—Dry compositions
-
- 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
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
- A23L2/52—Adding ingredients
-
- 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
- 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
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- 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
- 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
- A23L33/155—Vitamins A or D
-
- 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
- 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
- A23L33/16—Inorganic salts, minerals or trace elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- 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)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
Definitions
- This invention relates to a supplement for menopausal women.
- the invention relates to a supplement for menopausal women, which primarily comprises phyto-estrogens derived from plants.
- Menopause is a transition between two phases of a woman ' s life and occurs when a woman permanently stops menstruating (having periods). It is a natural part of aging and there are nearly 50 million menopausal women in India.
- Peri-menopause is the 2-10 years stage since the age when the estrogen production begins diminishing, and lasts up to 1 year post the complete cessation of periods (menopause).
- Post-menopause means the period following the onset of menopause when the periods 33 ⁇ 4 finally stop.
- Menopause sets in between the ages of 45 to 60 years; however, in rural Indians it could set in earlier.
- estrogens are beneficial for the menopausal women, they are not advocated by healthcare professionals for their unrestricted use due to their potential to increase risk of causing cancers of breast and uterusfP rentice R L.
- E R estrogen receptors
- the prevalence rate of depression ranges from 12% to 36% percent among peri- and post-menopausal women [S liwinski J R, J ohnson AK and E lkins G R. Memory Decline in P eri- and Post-menopausal Women: The Potential of Mind ' Body Medicine to Improve C ognitive P erformance. Integr Med Insights 2014; 9: 17-23].
- Calcium is commonly given and consumed during the middle age and thereafter years for preventing weak bones especially due to menopause. However, calcium alone (and vitamin
- Vitamin K2 MK7 as a supplement during menopause synergizes with calcium (and vitamin D) for assuring deposition of this mineral into the bones.
- Bone is composed of a hard outer shell of calcium (primarily) and other minerals and a spongy matrix of inner tissues and is a living substance. T he entire skeleton s calcium
- 3 ⁇ 4 content is replaced every 7 to 10 years.
- the body releases calcium from the bone into the bloodstream and this is caused by osteoclasts - cells that break down the skeleton; osteoblasts - cells that build up the skeleton compensate for the loss of bone calcium by facilitating deposition of calcium into the bones.
- the bone- forming activity by osteoblasts
- the breakdown of bone by osteoclasts
- Osteoblasts produce osteocalcin, which helps take calcium from the blood circulation and bind it to the bone matrix.
- osteocalcin influences bone mineralization through its ability to bind to the mineral component of bone, hydroxyapatite, which in turn makes the skeleton stronger and less susceptible to fracture
- the newly made osteocalcin is inactive, and it needs vitamin K2 (MK-7) to become fully activated and bind calcium
- MK-7 vitamin K2
- 3 ⁇ 4 [Hauschka PV. Osteocalcin: The Vitamin K-dependent Ca++-binding Protein of Bone Matrix.
- the calcium-uptake facilitating action makes vitamin K2 a major player in bone health and a vital need for menopause duringwhich the skeleton becomes brittle in over half the women population [Aggarwal N, Raveendran A, Khandelwal N, SenRKJhakur J S, Dhaliwal LK, 3ft, Singia V and Manoharan SRM. Prevalence and Related Risk Factors of Osteoporosis in Peri- and Postmenopausal Indian Women. J Midlife Health 2011; 2(2): 81-85].
- compositions containing isoflavones derived from plant products rich in them in various combinations are as follows.
- This ingredient of this product are directed to provide relief from hot flushes, cold sweats, repeated urinary tract infections, narrowing of blood vessels and vaginal dryness [Poluzzi E, Piccinni C and De Ponti F. Phytoestrogens in Postmenopause: The State of the Art from a Chemical, Pharmacological and Regulatory Perspective.
- vitamin D Cholecalciferol
- Isoflavones provide relief from hot flushes, cold sweats, repeated urinary tract infections, narrowing of blood vessels and vaginal dryness; the calcium and vitamin D (C holecalciferol) can additionally, to some extent, benefit the brittle 3 ⁇ 4 bones.
- C ranberry extract of this product are directed to provide relief from repeated urinary tract infection, which is common for a menopausal woman [Bosmans J E , Beerepoot MAJ and G eerlings S E . C ost- Effectiveness of C ranberries vs Antibiotics to P revent Urinary Tract Infections in P remenopausal Women: A Randomized C linical Trial. P LoS One 2014; 9(4): e91839]. 3 ⁇ 4 4. Per serving (1 tablet):
- T he calcitriol of this product is directed to provide additional benefit in osteoporosis for a menopausal woman [Mok J O, J ung C H and Byun D-W.
- Black C ohosh provides relief primarily from symptoms such as hot 3 ⁇ 4 flushes for a menopausal woman but cannot tackle all the consequences of menopause [Kligler B. Black C ohosh. Am Fam P hysician 2003; 68(1 ); 1 14-1 1 6].
- menopause is a multi-symptom state and sexual organs degeneration, memory 3 ⁇ 4 lapses and cognitive dysfunction are an inherent part of the process [G enazzani AR, S pinetti A, Gallo Rand Bernardi F. Menopause and the central nervous system: intervention options. Maturitas 1999; 31 (2): 103-1 10].
- U pto 40% of menopausal women [Bachmann GA and Nevadunsky NS . Diagnosis and Treatment of Atrophic Vaginitis. American Family P hysician 2000; 61 (100): 3090-3096] have vaginal atrophy indicating degeneration and with & ⁇ consequential decline in sexual pleasures.
- This invention comprises a product comprising isoflavones.
- T his product reduces the risk of the consequences due to stoppage of periods including the long-term changes, which are known to occur during menopause.
- Isoflavone content of S oybeans is2-4 mg/g, and the same of lentils and beans is about 0.002 mg/g.
- T hus, soy and soy products are the richest source of isoflavones.
- S oybeans, soy flour and soy chips have significant concentrations of isoflavones as compared to inconsequential amounts present in tofu, soy milk and soy cheese.
- 3 ⁇ 4 the soybeans provide inactive " precursors of isoflavones that need to be converted to their active counterparts.
- T he first type predominant in raw soy products, is called an " isoflavone glycoside.
- the isoflavone is ft, attached to a sugar-like substance known as a " glycone.
- _ T he second type predominant in fermented soy products, is called an " isoflavone aglycone.
- _ T hese consist of isoflavones without a glycone attached, and are also called " free isoflavones. .
- the composition comprises, at least, following ingredients: (a) an extract of Angelica archangelica L. or alternatively, an extract of Angelica sinensis (Oliv.) Diels, (b) an extract ofWithaniasomnifera(L) Dunal, (c) an extract of C urcuma longa L, (d) an extract of Angelica archangelica L, (e) S oy isoflavones, (f) Calcium and (g) Vitamin D. Other therapeutically/P harmaceutically Active Ingredients may also be added to this composition. ft, The additional ingredients may comprise vitamins at a level of upto 100% R ecommended Daily Allowance (R DA) or, where R DA is not determined, at a level that is considered as desirable for general health maintenance.
- R DA recommended Daily Allowance
- the S oy isoflavone in this composition comprise a concentrated extract standardized to provide isoflavones genistin and genistein 24%, daidzin and daidzein 24%. 3 ⁇ 4
- the composition may also be added, further, Milk Calcium or any other source of highly bioavailable calcium; and flavors, sweeteners and other excipients.
- F lavors added in illustrative formulation are a cola flavor or cranberry flavor.
- This invention comprises a composition for oral consumption, which comprises active & ⁇ isoflavones: primarily genistein and daidzein.
- T he composition of this invention distinguishes itself over prior art soy composition on better and more reliable efficacy in terms of benefits it is capable of providing.
- There are an array of manifestations and implications of menopause which are not addressed so far in a single product meant for menopausal women; and the instant invention, for the first time, has addressed to all the known manifestations of significant importance as identified here 30% of women have complaints pertaining to changes in menopause; 25% opine that menopause is a negative influence [Bharadwaj J A, Kendurkar S M and Vaidya P R .
- the product of this invention has 40% content of active isoflavones, namely genistein and daidzein, 24 + 24 mg per 120 mg soy isoflavones, and in a ratio of 1 : 1.
- active isoflavones namely genistein and daidzein
- 24 + 24 mg per 120 mg soy isoflavones and in a ratio of 1 : 1.
- T he isoflavones genistein and daidzein, in the product can be derived through concentrated extract of soybeansthat are available in the market
- Symptoms include: [S rivastava M, S rivastava R and Pandit B. P resentation of Menopausal Symptoms: A Village Based C ommunity S tudy. Asian J Medical S ciences 2015; 6(1 ): 87-90].
- the isoflavones being phytoestrogens, are beneficial.
- the product of this invention comprises of the following attributes: e C ontains all ingredients necessary to combat most changes due to menopause.
- this formulation is provided, preferably, as a single serve sachet for convenient once daily intake as a drink. It is also possible to provide this 1& ⁇ formulation in any other unit dosage form, and without / with a measure, such as a spoon that would dispense daily dose of the formulation for the purpose of reconstitution for daily consumption.
- the illustrated composition is provided in a sachet and the contents of which are to be mixed in approximately 1 50 mL of water, preferably chilled water, in a glass; to be mixed briskly till the powder is well dispersed and then consumed as a drink once daily.
- the isoflavone-based product of this instant invention can be consumed on long-term basis during the postmenopausal period. If discontinued, benefits on account of ingredients in this product will cease.
- the composition of the supplement for menopausal 3 ⁇ 4 women comprises extracts of Angelica archangelica L. (or alternatively, extract of Angelica sinensis (Oliv) Diels, Withania somnifera L. Dunal, C urcuma longa L, Angelica archangelica L, S oy isoflavones, Calcium and Vitamin D.
- the composition may also additionally be supplemented with additional vitamins at a level of upto 100% R ecommended Daily Allowance (R DA) or, where R DA is not determined, at a level that is considered as desirableft, for general health maintenance.
- S oy isoflavones may be preferably sourced from a concentrated extract standardized to provide isoflavones G enistin and G enistein24%, Daidzin and Daidzein24%.
- Table 1 provides information on the active ingredients used in the illustrative composition of3 ⁇ 4 this invention, their action and their content in the composition.
- Table 1 The main benefit of various ingredients in the composition of this invention, (all articles full text enclosed as per the references quoted)
- Vitamin C responsible for 8-2000 mg daily 40 mg
- Vitamin E aging changes 1.5-1000 IU daily 7.5 IU
- Bioavailability of calcium is crucial and it differs from source-to-source.
- a product prepared 1& ⁇ from milk, commonly known as " Milk Calcium , is considered highly bioavailable source of calcium. This is used in current illustration.
- This is essentially a minerals concentrate commonly prepared from liquid skim milk by steps comprising separation of proteins, ultarfiltration, followed by precipitation of solids which are spray dried to provide a white to creamy powder having with characteristic flavor and bulk density of 3 ⁇ 4 IZl ⁇ , U, t& AlXT ii ⁇ CEfdDIE percent) having Moisture 5.0, Protein (DB) 5.0, Lactose 1.0, Fat % 0.5, pH (10% Dispersion at 201 C) 6.5 - 7.0, Total Minerals (DB) 75.0, Calcium 26.0, Phosphates 34.0, Sodium 1.0. Potassium 1.0, Chloride 1.0.
- any other course of calcium which has good bioavailability that is capable of providing the calcium stipulated in the examples provided below may be used to make
- Menopause is a complex physiological process with a multitude of symptoms as well as long-term consequences. It commences gradually and does not lead to any sufferings in many women leading to its non-recognition as a harbinger of complications later in life. S ince the estrogens are known protective for bones, bladder, brain and heart their depletion in the menopausal phase is a definite cause for complications that are bound to occur. E strogens 3 ⁇ 4 per se, if supplemented, can cause cancer of breast and uterus and hence the advocacy of HT is no more rampant. Instead, their natural counterparts, the relatively safer phytoestrogens, provide all the benefits without the associated cancer concern.
- phytoestrogens in the form of isoflavones cannot address all the long-term consequences of menopause such as mood swings and depression, memory lapses, cognition, brittle bones & ⁇ and diminished sexual gratification.
- isoflavones are suitably complemented by suitable other natural ingredients the end-benefit is comprehensive.
- this invention is a single serve sachet of blend of ingredients to tackle all symptoms as well as long-term consequences of menopause comprehensively. No composition meant for menopause currently available serve this purpose.
- this is a menopause composition that is available with flavors.
- the Examples in this specification have illustrated offer two flavors currently to suit most of the palates " cola and a popular fruity flavor " cranberry. A person skilled in the art shall understand that one or more of any other flavor suitable to popular palate may replace these flavors.
- T he illustrated composition is provided in a sachet and the contents of which are to be mixed with about 150 mLof water, preferably chilled water in a glass; mixed briskly till the powder is well dispersed and then consumed as a drink once daily.
- composition was made with following steps:
- Vitamins and Minerals were mixed to provide a Vitamins and Minerals- P remix.
- step 2-4 Mixtures of step 2-4 were sieved.
- This product has same ingredients and is made with same method as above with th exception that extract of Angelica archangelicais replaced with extract of Angelica sinensis.
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Abstract
La présente invention concerne une composition de dosage à usage unique pour femmes ménopausées efficace pour soulager des bouffées de chaleur, des sueurs froides, renforcer des os, protéger des radicaux libres responsables de provoquer le cancer et les rides de la peau et d'autres changements dus au vieillissement, réduire des conséquences de la ménopause à long terme et maintenir les contours du corps, préserver la mémoire qui pourrait être perturbée par la maladie d'Alzheimer, et un bénéfice adaptogène pour faciliter à la fois la bonne humeur ainsi qu'une intimité plaisante. La composition comprend, au moins, les ingrédients suivants : (a) un extrait d'Angelica archangelica L'ou en variante, un extrait d'Angelica sinensis (Oliv.) Diels, (b) un extrait de Withania somnifera (L.) Dunal, (c) un extrait de Curcuma longa L., (d) un extrait d'Angelica archangelica L, (e) des Isoflavones de soja, (f) le Calcium et (g) la Vitamine D. L'isoflavonesine de soja de cette composition comprend un extrait concentré normalisé pour fournir des isoflavones de Génistine et de Génistéine 24 %, de la Daidzine et de la Daidzéine 24 %.
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IN201721008533 | 2017-03-10 | ||
IN201721008533 | 2017-03-10 |
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WO2018163209A1 true WO2018163209A1 (fr) | 2018-09-13 |
WO2018163209A4 WO2018163209A4 (fr) | 2018-11-08 |
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PCT/IN2018/050126 Ceased WO2018163209A1 (fr) | 2017-03-10 | 2018-03-06 | Complément pour la ménopause |
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Cited By (1)
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