Rights being exercised for many inventions which, upon examination, would have been found non-patentable. In favour of the examination systems, it has been said that it avoid a mass of worthless, conflicting, and probably invalid patents, onerous to the public as well as bona fide owners of valid patents; that it prevents the fraudulent practice of registering and selling patents similar to the claims being patented by others; and that it drastically reduces the extent of court litigation 1958: 8 ; . We will revisit the issue of registration system in the light of recent experience later. Machlup has reviewed several suggestions for reform of the patent system about four decades ago, some of which are still relevant, such as: a ; Rewards to the patentees of a sufficiently high level to give general satisfaction to the inventors and those who have invested in their inventions financially in lieu of making inventions freely accessible to all. The rewards will have to be fixed according to the "assessed values created by the invention" Michael Polanyi, 1944 ; 26. b ; In this scheme "instead of making annual "participation payment" to the licensers in addition to the reasonable royalties received by them from licensees ; the government would buy the patents outright and open them to all, free of royalty Hamilton, 1957 ; 27 Another variant of this suggestion was the option to government to purchase any patent at a reasonable price if it was interested in making it available for general use. c ; The proposals for giving prices, bonuses are said to be as old as the patent system itself it is important to mention that opposition to the monopolistic features of patents have not come from socialists but mainly from economists believing in free enterprise and free trade ; . d ; Government should finance the research and development work so that if society wants some innovations it must pay for them in the first place. In different countries, combinations of incentives system have been followed. Even countries having strong patent systems have recognized the importance of government's investment in research, national awards and in occasional cases option of compulsory licenses. The examination system has been for disclosure rather than for invention or novelty as in the case of Switzerland. Their experience has been that percentage of patent which worked in the national system was not very different from the international patent system. Machlup quotes the famous analogy of the automobile brakes. These permit the motorists to drive it with greater speed. Unlike the real brakes in the motor, the patents put brakes on others regardless of "how fast or cautiously they proceed". He concludes that based on the evidence available till then, the implications for strengthening or weakening different features of patent law will not be same for a non-industrialized country or a newly industrialized country or US. In the post GATT phase, the consensus has veered towards harmonization of patent laws across the countries though some exemptions and more lead time has been given to the developing countries. The history only shows that the debate being witnessed now is not new and has never provided unambiguous answers.
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T. Matysiak-Budnik 1 , F. mgraud 2 , K. Mayo 2 , M. Moreau 3 , V. Gaboriau-Routhiau 3 , M. Heyman 1 . 1 INSERM EMI-0212, Paris, France, 2 Laboratoire de Bactriologie, Universit Bordeaux 2, France, 3 INRA, Jouy en Josas, France Background: The increase of absorption of intact antigens across the digestive epithelium infected with H. pylori, in vitro and in vivo, may interfere with the regulation of mucosal immune responses and favour development of food allergy. A gastro-protective agent, rebamipide, exerts a positive effect on the digestive epithelial barrier by reinforcing its integrity and by normalizing a macromolecular transport across this barrier. Aims: To study the capacity of Helicobacter infection to inhibit the development of oral tolerance to dietary antigen ovalbumin OVA ; and the capacity of rebamipide to interfere with this process. Methods: Forty eight C3H He 4-week old mice were divided into 4 groups: Gr I: Mice sensitized to OVA i.p. ; , Gr II: Mice tolerized to OVA oral ; , Gr III: Mice infected with H. felis and then tolerized to OVA, Gr IV: Mice infected with H. felis and then tolerized to OVA while treated with rebamipide 30 g day ; . At the end of the protocol, specific anti-OVA IgE and IgG1 IgG2a serum titres were measured by ELISA and intestinal anaphylaxis was assessed in intestinal fragments mounted in Ussing chambers. Results: H. felis infection led to a significant inhibition of oral tolerance to OVA IgE titers 1 200 vs 1 650 in tolerized vs infected-tolerized mice, respectively, p 0.05 ; but rebamipide treatment prevented this inhibition of tolerance by H. felis IgE titer: 1 300, p 0.05 ; . The same pattern was observed for IgG1 but not IgG2a response to OVA. No intestinal anaphylaxis to OVA was observed in sensitized or infected-sensitized mice. Conclusions: In C3H He mice, infection with H. felis inhibit the development of oral tolerance to OVA and this inhibition is prevented by rebamipide.
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Carisoprodol was nominated by the National Cancer Institute for toxicity testing because it is widely used as a skeletal muscle relaxant and analgesic, because toxicity and carcinogenicity data for carisoprodol are not available, and because the carbamate moiety in its structure is susceptible to nitrosation to form an analogue of N-methyl-N-nitrosourethane, a rat liver carcinogen. Plasma carisoprodol concentration analysis was included in the study design to further characterize the toxic effects of carisoprodol. Gavage was chosen as the route of administration because the drug is taken orally by humans. Two studies were conducted: one used 0.5% methylcellulose and the other corn oil as the gavage vehicle. Endpoints evaluated during these 13-week studies included histopathology rats and mice ; and clinical pathology rats ; . The effects of carisoprodol on reproduction were assessed by the evaluation of testicular and spermatozoal parameters and by determination of the length of the estrous cycle. In addition, the genetic toxicity of carisoprodol was assessed in studies in S. typhimurium, L5178Y mouse lymphoma cells, and cultured Chinese hamster ovary cells and by determination of the frequency of micronucleated erythrocytes in peripheral blood of mice from the 13-week studies.
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He 2006 ISPE Annual Meeting was held at Walt Disney World's Dolphin Resort in Orlando, Florida, November 5-8, with over 2, 000 delegates and committee members in attendance. The Boston Area Chapter was very well represented by President Michael Denault and Vice President Rick Pierro, Board Members Sylvia Beaulieu, Doyle Johnson, David Novak, Peter J.B. Teague, Mary Wojtyk, and Chapter Manager Amy Poole. The meeting proved to be one of ISPE's most exciting conferences ever! Entitled "A New World of Innovation, " it included more than 35 educational sessions and round tables, as well as a table top exhibition with over 270 leading suppliers to the pharmaceutical, biomedical, and medical deAccepting the Chapter Excellence Award for Service vice industries availto the Society Industry are from left to right ; Chapter able to discuss curManager Amy Poole, Vice President Richard Pierro, rent needs and upPresident Michael Denault and Past President Dave and trental.
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The absolute kidney weights of all dosed groups of males and females were significantly less than those of the vehicle controls Table C4 ; . Relative liver weights of all dosed groups of males and of females in the 1, 600 mg kg group were significantly greater than those of the vehicle controls. The absolute organ weight differences generally reflected body weight differences. At necropsy, no gross lesions considered related to carisoprodol administration were observed. The incidence of centrilobular hypertrophy of the liver was significantly increased in male mice in all dosed groups and in females in the 1, 200 and 1, 600 mg kg groups Tables 11, A3, and A4 ; . The severity of centrilobular hypertrophy was minimal in males in the 600 mg kg group and in both groups of females; the severity in the 1, 200 and 1, 600 mg kg groups of males was mild. Plasma carisoprodol concentrations of female mice evaluated at the end of the study generally increased with increasing dose, but the increase was not linear or proportional with dose Table E4 ; . In males, plasma carisoprodol concentrations appeared to have no pattern. Xarisoprodol concentrations were higher at 30 minutes postdosing in all groups of males and females compared to those at 60 minutes. Carlsoprodol concentrations were generally greater in males than in females receiving the same dose.
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Although the program will accommodate all students, regardless of their preparation, there is considerable benefit in improving one's fitness in preparation for their time at the Alpine School. In particular those who play little sport and have done little running should treat this as a priority. A very basic program is outlined below that: Will achieve a significant increase in general fitness May also identify any physical problems such as asthma, knee pain, foot problems, etc. which may also need to be dealt with prior to arriving. Basic Fitness Program This should include gentle stretches in preparation for exercise. Warm up Jog 400 metres - walk 200 metres Start with three repetitions Repeat three days a week with one day of rest in between Add one repetition per week for three weeks finishing at six repetitions Stay at six repetitions for two weeks. Warm - down If this program does not suit then exercise such as swimming, surfing, bicycle riding and roller-blading would also be greatly beneficial and celebrex.
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4.22 The effects of sodium fluoride on glucocorticoid-induced bone loss have been investigated in a number of randomised trials in patients requiring glucocorticoids for various indications.123129 In most of these studies sodium fluoride was given alone with or without calcium vitamin D ; but in two studies it was used in combination either with cyclic etidronate127 or calcidiol125. In all studies in which spine BMD was assessed, significant treatment benefits of sodium fluoride were demonstrated after one or two years' treatment with mean increases of up to 11%. In those studies in which femoral neck and forearm BMD were measured, no significant effect was demonstrated.123125, 127, 128 It should be noted that in postmenopausal women with osteoporosis, substantial increases in spine BMD induced by fluoride have not always been associated with a reduction in vertebral fractures and, in some studies, increased risk of non-vertebral fractures has been reported.130.
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Finds Dr. Baculi's review irrelevant, because it was done before Dr. Rosenstein found the Claimant's spinal problems were severe and would likely require a surgical repair. The other peer review physician, Dr. Bauer, implied that another narcotic medication might be necessary, but he rejected BUT ASA CAFF without explanation. The only evidence in the record is that the Claimant has been unable to work since his injury in . The records document that there is movement at L4-5, and that he has L4-5 stenosis and severe disc space narrowing at L4-5 and L5-S1. Apparently, conservative treatment has not resulted in healing, and Dr. Rosenstein plans to do a surgical repair consisting of an L4-5 decompression and fusion. Meanwhile, Dr. Rosenstein has documented that the Claimant has lower back pain, neck pain leading to headaches, and radicular pain into the lower left extremity. The pain is at a high level, ranging between 7 and 10. While the medications at issue have not enabled the Claimant to return to work, Dr. Rosenstein states they help him to maintain his activities of daily living. For those reasons, the medications are medically necessary, and the Provider should be reimbursed for them. III. FINDINGS OF FACT 1. On , Claimant ; was approximately 48 years old, when he tripped and fell while carrying an angle iron, heard a "pop" sound in his lower back, and injured his neck and low back. The Claimant had a prior lumbar laminectomy and fusion in 1993. The Claimant was originally treated by a chiropractor with complaints of pain in his neck, lower back, numbness in his feet, and headaches. A CT scan of the lumbar spine in September 2002 showed central disc protrusion at L4-5 with degeneration of the L4-5 disc. There was also left foraminal stenosis at L4-5. The Claimant's fusion was solid at L5-S1, but there was movement at L4-5. The Claimant's treating physician, Dr. Jacob Rosenstein, a neurosurgeon, has determined that the Claimant has not reached maximum medical improvement, and that he will need surgery B an L4-5 decompression and fusion. The Claimant has been unable to return to work. He has lower back pain, neck pain leading to headaches, and radicular pain into the lower left extremity. The pain is at a high level, ranging between 7 and 10. Dr. Rosenstein prescribed the medications, because they have enabled the Claimant to better achieve and maintain his participation in activities of daily living. They work as follows: a ; Carisoprodol B a skeletal muscle relaxant, relieves painful spasms; b ; BUT ASA CAFF B a combination of codeine, aspirin, and caffeine, helps relieve pain due to muscle contraction headaches; c ; Neurontin B an anti-convulsant agent helps relieve radicular pain; and d ; Promethazine B a medication that relieves nausea commonly associated with headaches and the Claimant's medications. Based on the foregoing, the medications referenced in Finding 6 are medically necessary, and the Provider, Highpoint Pharmacy, is entitled to reimbursement for supplying them to the Claimant between June 7 and December 2, 2002.
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Please see page 4 for a detailed description of this legend. Drug Name Drug Tier Notes: Drug Name B & O SUPPRETTES NO 15-A SUPP RECT B & O SUPPRETTES NO 16-A SUPP RECT BANCAP HC CAPSULE BUPRENEX AMPUL BUPRENORPHINE HCL SYRINGE butorphanol tartrate spray butorphanol tartrate vial CAPITAL W-CODEINE ORAL SUSP CATAFLAM TABLET chol sal magnesium salicylate liquid codeine phos acetaminophen elixir codeine phos acetaminophen tablet codeine phos aspirin tablet codeine phos carisoprodol asa tablet CODEINE PHOSPHATE SOLUTION CODEINE PHOSPHATE SYRINGE CODEINE PHOSPHATE TABLET SOL CODEINE SULFATE TABLET codeine apap caffeine butalb capsule codeine asa caffeine butalb capsule COMBUNOX TABLET DHE 45 AMPUL 6 Drug Tier 3 Notes!
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Z, Guzman M, and Galve-Roperh I 2005 ; The endocannabinoid system drives neural progenitor proliferation. FASEB J 19: 1704 1706. Aguado T, Palazuelos J, Monory K, Stella N, Cravatt B, Lutz B, Marsicano G, Kokaia Z, Guzman M, and Galve-Roperh I 2006 ; The endocannabinoid system promotes astroglial differentiation by acting on neural progenitor cells. J Neurosci 26: 1551 1561. Alger BE 2002 ; Retrograde signaling in the regulation of synaptic transmission: focus on endocannabinoids. Prog Neurobiol 68: 247286. Alger BE 2004 ; Endocannabinoids and their implications for epilepsy. Epilepsy Curr 4: 169 173. Allen JH, de Moore GM, Heddle R, and Twartz JC 2005 ; Cannabinoid hyperemesis: cyclical hyperemesis in association with chronic cannabis abuse. Gut 53: 1566 1570. Allister SD, Chan C, Taft RJ, Luu T, Abood ME, Moore DH, Aldape K, and Yount G 2005 ; Cannabinoids selectively inhibit proliferation and induce death of cultured human glioblastoma multiforme cells. J Neurooncol 74: 31 40. Alward WL 1998 ; Medical management of glaucoma. N Engl J Med 339: 1298 1307. Amaya F, Shimosato G, Kawasaki Y, Hashimoto S, Tanaka Y, and Ji RR 2006 ; Induction of CB 1 ; cannabinoid receptor by inflammation in primary afferent neurons facilitates antihyperalgesic effect of peripheral CB 1 ; agonist. Pain, in press. Ames FR and Cridland S 1986 ; Anticonvulsant effect of cannabidiol. S Afr Med J 69: 14. Anderson LA, Anderson JJ, Chase TN, and Walters JR 1995 ; The cannabinoid agonists WIN 55, 212-2 and CP 55, 940 attenuate rotational behavior induced by a dopamine D1 but not a D2 agonist in rats with unilateral lesions of the nigrostriatal pathway. Brain Res 691: 106 114. Andreasson S, Allebeck P, Engstrom A, and Rydberg U 1987 ; Cannabis and schizophrenia: a longitudinal study of Swedish conscripts. Lancet 2: 14831486. Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP, et al. 2003 ; Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. J Med Assoc 289: 20832093. Archer RA 1974 ; The cannabinoids: therapeutic potentials. Annu Rev Med Chem 9: 253259. Arevalo C, de Miguel R, and Hernandez-Tristan R 2001 ; Cannabinoid effects on anxiety-related behaviours and hypothalamic neurotransmitters. Pharmacol Biochem Behav 70: 123131. Arevalo-Martin A, Vela JM, Molina-Holgado E, Borrell J, and Guaza C 2003 ; Therapeutic action of cannabinoids in a murine model of multiple sclerosis. J Neurosci 23: 25112516. Arnone M, Maruani J, Chaperon F Thiebot MH, Poncelet M, Soubrie P, and Le Fur G 1997 ; Selective inhibition of sucrose and ethanol intake by SR141716, an antagonist of central cannabinoid CB1 ; receptors. Psychopharmacology 132: 104 106. Andersson M, Usiello A, Borgkvist A, Pozzi L, Dominguez C, Fienberg AA, Svenningsson P, Fredholm BB, Borrelli E, Greengard P, et al. 2005 ; Cannabinoid action depends on phosphorylation of dopamine- and cAMP-regulated phosphoprotein of 32 kDa at the protein kinase A site in striatal projection neurons. J Neurosci 25: 8432 8438. Ashton CH 1999 ; Adverse effects of cannabis and cannabinoids. Br J Anaesth 83: 637 649. Ashton CH, Moore PB, Gallagher P, and Young AH 2005 ; Cannabinoids in bipolar affective disorder: a review and discussion of their therapeutic potential. J Psychopharmacol 19: 293300. Ashton H, Golding J, Marsh VR, Millman JE, and Thompson JW 1981 ; The seed and the soil: effect of dosage, personality and starting state on the response to 9 tetrahydrocannabinol in man. Br J Clin Pharmacol 12: 705720. Ashworth B 1964 ; Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 192: 540 542. Attal N, Brasseur L, Guirimand D, Clermond-Gnamien S, Atlami S, and Bouhassira D 2004 ; Are oral cannabinoids safe and effective in refractory neuropathic pain? Eur J Pain 8: 173177. Avraham Y, Israeli E, Gabbay E, Okun A, Zolotarev O, Silberman I, Ganzburg V, Dagon Y, Magen I, Vorobia L, et al. 2006 ; Endocannabinoids affect neurological and cognitive function in thioacetamide-induced hepatic encephalopathy in mice. Neurobiol Dis 1: 237245. Awumey EM, Howlett AC, and Diz DI 2005 ; Is there a role for anandamide in cardiovascular regulation? Insights from studies of endocannabinoid metabolism. J Physiol 289: H520 H521. Azad SC, Eder M, Marsicano G, Lutz B, Zieglgansberger W, and Rammes G 2003 ; Activation of the cannabinoid receptor type 1 decreases glutamatergic and GABAergic synaptic transmission in the lateral amygdala of the mouse. Learn Mem 10: 116 128. Baker D and Pryce G 2003 ; The therapeutic potential of cannabis in multiple sclerosis. Expert Opin Invest Drugs 12: 561567. Baker D, Pryce G, Croxford JL, Brown P, Pertwee RG, Huffman JW, and Layward L 2000 ; Cannabinoids control spasticity and tremor in a multiple sclerosis model. Nature Lond ; 404: 84 87. Baker D, Pryce G, Croxford JL, Brown P, Pertwee RG, Makriyannis A, Khanolkar A, Layward L, Fezza F, Bisogno T, et al. 2001 ; Endocannabinoids control spasticity in a multiple sclerosis model. FASEB J 15: 300 302. Balerio GN, Aso E, and Maldonado R 2006 ; Role of the cannabinoid system in the effects induced by nicotine an anxiety-like behaviour in mice. Psychopharmacology 184: 504 513. Ballon N, Leroy S, Roy C, Bourdel MC, Charles-Nicolas A, Krebs MO, and Poirier MF 2006 ; AAT ; n repeat in the cannabinoid receptor gene CNR1 ; : association with cocaine addiction in an African-Caribbean population. Pharmacogenonics J 6: 126 130. Ban TA 2004 ; Neuropsychopharmacology and the genetics of schizophrenia: a.
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Alzheimer's patients suffer from false memories - remembering things that never happened. In their study, "Episodic memory in Alzheimer's disease: Separating response bias from discrimination" Neuropsychologia 2006 44: 2222-2232 ; , Dr. Andrew Budson and colleagues examined patients' false memory tendency, by observing how often they responded, "Yes, I've seen that before, " on a recognition memory test. Compared to healthy older adults, the patients showed worse memory and an abnormally liberal response bias responding "yes" too liberally to test items ; . They concluded that as AD progresses, two distinct memory abnormalities develop: worse discrimination and a more liberal response bias.
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AIHW Australian Institute of Health and Welfare ; 2003b. National health data dictionary. Version 12. Canberra: AIHW. AIHW Australian Institute of Health and Welfare ; 2003c. National housing assistance data dictionary. Version 2. Canberra: AIHW. AIHW, ACROD & NCDCO 2000. Data starter 1. How to find and use disability data: a project of the Disability Data Reference and Advisory Group. Canberra: AIHW. AIHW: Bricknell S 2003. Disability: the use of equipment and the role of the environment. Canberra: AIHW. Allen PF, McMillan AS & Walshaw D 2001. A patient-based assessment of implant-stabilized and conventional complete dentures. Journal of Prosthetic Dentistry 85: 14147. Amir ER, Van Den Veyver I, Wan M, Tran CQ, Franke U & Zoghbi H 1999. Rett Syndrome is caused by mutations in X-linked MECP2, encoding methyl CpG binding protein 2. Nature Genetics 23: 18588. Ashworth B 1964. Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 192: 34042. Atchison KA & Dolan TA 1990. Development of the Geriatric Oral Health Assessment Index. Journal of Dental Education 54: 68087. Awad MA, Locker D, Korner-Bitensky N & Feine JS 2000. Measuring the effect of intra-oral implant rehabilitation on health-related quality of life in a randomized controlled clinical trial. Journal of Dental Research 79: 165963. Badley EM 1993. An introduction to the concepts and classifications of the international classification of impairments, disabilities, and handicaps. Disability and Rehabilitation 15 4 ; : 16178. Badley EM, Rothman LM & Wang PP 1998. Modelling physical dependence in arthritis: the relative contribution of specific disabilities and environmental factors. Arthritis Care Research 11 5 ; : 33545. Barr JT 1995. The outcomes movement and health status measures. Journal of Allied Health Winter: 1328. Benjamin K 1995. Outcomes research and the allied health professional. Journal of Allied Health Winter: 312. Bickenbach J 2002. A proposal to include disability and functional status content into the next cycle of the Canadian Community Health Survey. Bickenbach JE, Chatterji S, Badley EM & Ustun TB 1999. Models of disablement, universalism and the international classification of impairments, disabilities and handicaps. Social Science & Medicine 48: 117387.
Members Present: Scott Johnston, Becky Drnas, Bob Schultz, Joyce Dailey, Bill Marsh Ex-officio: Gary Melinkovich, Aimee Lewis, Roxanne Homar, Deb Devereaux Members Excused: James Broomfield, Michael DeBisschop, Chad Panning, Marion Smith Guests: Antoinette Brown, Mark Helfand by phone- EPC ; , Marion McDonagh by phone- EPC ; , Debbie Kavanaugh Pfizer ; , Rob Hanson Pfizer ; , Larry Bridger Pfizer ; , Deb Guay Astra Zeneca ; , Susan Trieu Astra Zeneca ; , Jeff Jenkins Merck ; , Robert Calder Merck ; , Dyan McGrath Astra Zeneca ; , Betty Iverson Wyeth ; , Kathryn Keller Purdue ; , Alan Sloan Purdue ; , Dana Hill Takeda ; , Pat Teegarden Schering-Plough ; , Jeff Nesheim Janssen ; , Joan Solem Lilly ; , Paul Pereira TAP ; The meeting was called to order with introductions and comments by Aimee Lewis at 10: 00 am. Skeletal Muscle Relaxant Review: Mark Helfand, M.D. gave an overview of the Skeletal Muscle Relaxant review by phone. Slide presentation is available upon request. Public Comments: None Committee Discussion: Question 1: Is there any evidence that indicates that one or more skeletal muscle relaxant is safer than others? Dantrolene and chlorzoxazone have evidence of serious hepatotoxicity. Is that sufficient enough to include them in the review? Yes. Tizanidine added to list of those with safety issues, since it was monitored due to hepatotoxicity, otherwise they are all equally safe based on the evidence. Carisoprodol's addiction potentia l was questioned and Dr. Helfand responded that there are no good studies in regard to this that are current. Addiction potential of carisoprodol is seen in a retail clinical setting, and seems to be more so than the other skeletal muscle relaxants. No data on suicidal potential available.
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