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For more detail about the drug approval process, visit the pages on the FDA website listed below. They include graphic flow-charts of various stages of the process: fda.gov cder handbook ind Describes the investigational new drug IND ; application process, which occurs before an experimental drug can begin clinical trials in people. fda.gov cder handbook develop Describes drug development from test tube, animal, and human studies through the FDA's review of a New Drug Application N DA ; . fda.gov cder handbook nda Describes the process beginning with the submission of a New Drug Application NDA ; through to the approval or not ; of an experimental drug for marketing. The FDA offers a number of free email lists at this site: fda.gov emaillist . Click on "FDA HIV AIDS" to subscribe to the list that emails you information about HIV AIDS-related products and issues, including approvals, label changes, safety warnings, and notices of upcoming public meetings. hivma . Go to "Advocacy" at the top of the page and click on "Medicare." The HIV Medicare and Medicaid Working Group is made up of national and regional HIV AIDS organizations. To participate, email Project Inform's Treatment Action Network at tan projectinform or The Access Project at theaccessproject aol.
Discussion ET has been shown to cause vasocontraction in various vessels of experimental animals.711 14 The present study shows that ET-1 also induces a dosedependent contractile response in the human artery. The dose range of ET-1 needed to produce contraction of the human mesenteric artery was low, with an EC50 value of 2.9 x 10-9 M. This value is smaller than those of other vasoconstrictors, for example, NE 3.9x10-7 M, the present study; 1.2x 106 M20 ; , serotonin 2.xlO -7 M21 ; , or neuropeptide Y 3.0xlOM22 ; . The contractile effect of vasopressin 2.0x 10. 9 M23 ; is comparable to that of ET-1 in the mesenteric artery. However, ET-1 and vasopressin exert distinct actions, depending on the vascular tissues. For example, while vasopressin causes vasoconstriction in various peripheral arteries, it induces an endotheliumdependent relaxation of the canine cerebral artery.24 In contrast, ET-1 produced only potent contractions in every kind of blood vessel thus far examined in vitro in our laboratory cerebral arteries of cats, dogs.
Reality: Smoked marijuana is not medicine. The scientific and medical communities have determined that smoked marijuana is a health danger, not a cure. There is no medical evidence that smoking marijuana helps patients. In fact, the Food and Drug Administration FDA ; has approved no medications that are smoked, primarily because smoking is a poor way to deliver medicine. Morphine, for example has proven to be a medically valuable drug, but the FDA does not endorse smoking opium or heroin. Congress enacted laws against marijuana in 1970 based in part on its conclusion that marijuana has no scientifically proven medical value, which the U.S. Supreme Court affirmed more than 30 years later in United States v. Oakland Cannabis Buyers' Cooperative, et al., 532 U.S. 483 2001 ; . Marijuana remains in schedule 1 of the Controlled Substances Act because it has a high potential for abuse, a lack of accepted safety for use under medical supervision, and no currently accepted medical value.7 The American Medical Association has rejected pleas to endorse marijuana as medicine, and instead urged that marijuana remain a prohibited schedule 1 drug at least until the results of controlled studies are in.8 The National Multiple Sclerosis Society stated that studies done to date "have not provided convincing evidence that marijuana benefits people with MS" and does not recommend it as a treatment.9 Further, the MS Society states that for people with MS "long-term use of marijuana may be associated with significant serious side effects."10 The British Medical Association has taken a similar position, voicing "extreme concern" that downgrading the criminal status of marijuana would "mislead" the public into thinking that the drug is safe to use when, "in fact, it has been linked to greater risk of heart disease, lung cancer, bronchitis, and emphysema."11 In 1999 the Institute of Medicine IOM ; undertook a landmark study reviewing the alleged medical properties of marijuana. Advocates of so-called medical marijuana frequently tout this study, but the study's findings decisively undercut their arguments. In truth, the IOM explicitly found that marijuana is not medicine and expressed concern about patients' smoking it because smoking is a harmful drug-delivery system. The IOM further found that there was no scientific evidence that smoked marijuana had medical value, even for the chronically ill, and concluded that "there is little future in smoked marijuana as a medically approved medication."12 In fact, the researchers who conducted the study could find no medical value to marijuana for virtually any ailment they examined, including the treatment of wasting syndrome in AIDS patients, movement disorders such as Parkinson's disease and epilepsy, or glaucoma. The IOM found that THC13 the primary psychoactive ingredient in marijuana ; in smoked marijuana provides only temporary relief from intraocular pressure IOP ; associated with glaucoma and would have to be smoked eight to 10 times a day to achieve consistent results. And there exists another treatment for IOP, as the availability of medically approved once- or twice-a-day eye drops makes IOP control a reality for many patients and provides round-the-clock IOP reduction.14 For two other conditions, nausea and pain, the report recommended against marijuana use, while suggesting further research in limited circumstances for THC but not smoked marijuana.15 Before any drug can be marketed in the United States, it must undergo rigorous scientific scrutiny and clinical evaluation overseen by the FDA. For example, the FDA has approved Marinol dronabinol ; -a safe capsule form of synthetic THC that meets the standard of accepted medicine and has the same properties as cultivated marijuana without the high- for the treatment of nausea and vomiting associated with cancer chemotherapy and for the treatment of wasting syndrome in AIDS patients.
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The egg jelly-stimulated acrosome reaction artificially initiated by ionomycin, which produces calcium influx, and nigericin, which activates potassium channels in sperm. These findings provide additional evidence that the cannabinoid receptor in sperm plays role in blocking the acrosome reaction, indicating that anandamide or related molecules may be the natural ligand for the cannabinoid receptor in sea urchin sperm, and suggest that binding of anandamide to the cannabinoid receptor modulates stimulus secretion coupling82. Anandamide parallels THC in activating the hypothalamo-pituitary-adrenal axis via mediation of a central mechanism which involves the secretion of CRF-4183. Anandamide has shown significant tolerance to the inhibitory effect on electrically-evoked twitch response of the mouse vas deferens pretreated with THC whereas it did not show tolerance to the hypothermic effect in mice pretreated with THC. Anandamide and fluoroanandamide have shown cross-tolerance to THC. These observations suggest that cannabinoid tolerance is primarily pharmacodynamic in nature than pharmacokinetic84. POTENTIAL USES OF CANNABINOIDS The potential uses of cannabinoids include analgesia, attenuation of nausea and vomiting in cancer chemotherapy, appetite stimulation, diarrhea, AIDS, glaucoma, antiinflammatory, antirheumatic and antipyretic actions, and convulsion Table 3 ; 85. The typical behavioral effects of marijuana such as smoking, appetite stimulation, relief of anxiety, and sedation have been correlated with presence of cannabinoid receptors in hypothalamus and the limbic system. Therefore, endocannabinoids have a general function as stress recovery factors, appetite stimulant, sedative, impair cognition and neuroprotectants. Thus "relax, eat, sleep, forget and protect" might be some of the messages that are produced by the actions of endocannabinoids. CANNABIS: USE TO BE LEGALIZED? To everyone, the marijuana and its products conjure up images of illicit drug use, yet cannabinoids are useful in many diseases. Interest in cannabis, its active constituents and endocannabinoids has increased recently. Of the 60 or so cannabinoids, only THC dronabinol ; and its analogue, nabilone are commercially available. In 1997 both the National.
Even when serum Cbl levels are within normal limits.12, 13 These uncertainties pose problems for the clinician attempting to determine how aggressively to pursue the diagnosis and treatment of Cbl deficiency in patients presenting with what appears to be CSPN. The most definitive proof of Cbl-deficiency PN would come from a prospectively evaluated, objective improvement in response to Cbl replacement therapy. However, the literature provides conflicting information regarding how well Cbl-deficiency PN patients improve in response to replacement therapy.1, 14 In an attempt to address these questions, we investigated how often Cbl deficiency might be a cause of PN. We compared PN patients with definite or possible Cbl deficiency and CSPN patients with respect to clinical, laboratory, and electrophysiologic features. The yield of a serum Cbl assay was compared with that of tests of serum metabolite levels.
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INDIVIDUALS WITH SPECIAL HEALTH CARE NEEDS PROGRAM DESCRIPTION Overview Individuals with Special Health Care Needs ISHCN ; require a broad range of primary, specialized medical, behavioral health and related services. ISHCN have ongoing health conditions, high or complex service utilization, and low to severe functional limitations. Children ages 0-19 ; make up the largest enrolled member population for CHPW, accounting for nearly 60% of CHPW total enrollment. Utilization analysis shows that these members account for 24% of CHPW expenses for medical services equaling over million per year. Within this population, the most costly 1% of members consumes 50% of total medical expense. The ISHCN program at CHPW is a comprehensive program that will enable the Plan to identify, risk screen, track and provide Plan interventions for children who are at an increased risk for chronic physical, developmental, behavioral, or emotional conditions that require health and related services of type or amount beyond that required by children generally. The program will identify appropriate members through a variety of methods including medical claims data, pharmaceutical data, health risk assessment survey results and program referrals from our Primary Care sites. In addition, for children, the program will track the State identified Title V children, identified on our monthly eligibility file. The Individuals with Special Health Care Needs program integrates 6 steps: Member Identification, Risk-screening, Acuity Determination, Tracking plan database and clinic registry software ; , Needs Assessment and Care Planning and Outreach Intervention. Plan interventions may include case management activities such as assisting the individual family in coordination of care, completing necessary "open" referrals, allowing seamless access to necessary care, and connecting the individual family to community resources that are available to them. Those individuals that do not meet the selection criteria for Plan level case management will be referred to their Primary Care Provider for follow-up and collaborative care planning. Purpose of the Program The purpose of the ISHCN Program is to: Identify high-risk and high-cost children with chronic or complex medical and or psychosocial needs, assess treatment options and opportunities, and determine most appropriate interventions to improve the quality and efficacy of care. Assist special needs children as they transition to adulthood with new care coordination needs. Identify individuals that have ongoing health conditions, high or complex service utilization and dss.
According to Martin Draper, Regional Director at LDC, `There is improved optimism in the Midlands and trade buyers returning to the market are increasing competition.' Mark Freer, Investment Director at LDC, reiterates the point: `Confidence is returning and this can be seen by the re-emergence of the trade buyer. After a period of introspection, trade buyers are actively seeking out acquisition opportunities.' Although the return of the trade buyer is good news for private equity investors on the sell side, competition for investment opportunities will inevitably increase. In the recent environment, characterised by rising leverage ratios, synergies offered by trade players have been comfortably offset by the increasingly aggressive financial structures employed by financial buyers. However, one local corporate financier insists that trade buyers enjoy certain advantages over private equity practitioners: `Trade players understand the industries better than financial buyers and, as a result, they are burdened by due diligence demands that are less onerous than those facing private equity investors.'.
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Tetracycline resistance determinant on transposon Tn10, when given an energy source Fig. 3A ; [19, 20]. Cells that were energy depleted took up the same amount of tetracycline, however, when resistant cells were treated with the oxidative uncoupling agent 2, 4-dinitrophenol DNP ; , the opposite occurred. Tetracycline accumulated in the resistant cells, whereas the susceptible cells showed no accumulation Fig. 3B ; . This pointed to an active efflux mechanism in the strain possessing the resistance plasmid that removed tetracycline via an energy-dependent process. Since this discovery over 20 years ago, the tetracycline efflux family of proteins have been found to be proton-motive-force and dulcolax.
NOTE U Operating Segments and Geographic Areas Continued Transfers between operating segments are generally valued at cost. Transfers of products to the Agricultural Sciences segment from the other segments, however, are generally valued at market-based prices. The revenues generated by these transfers were immaterial in 2002. The revenues generated by these transfers in 2004 and 2003 are provided in the following table. Operating Segment Information.
Loss nortriptyline cyproheptadine dexamethasone dronabinol marinol ; megestrol acetate megestrol ; metoclopramide reglan ; prednisone mirtazepine generic ; remeron ; mirtazapine remeron sol-tab ; oxandrolone oxandrin ; anxiety restlessness alprazolam generic xanax ; buspirone generic buspar ; chlorpromazine diazepam haloperidol lorazepam oxazepam generic serax ; abh suppositories agitation associated w dementia antipsychotics risperidone risperdal ; risperidone m-tab olanzapine zyprexa ; olanzapine zyprexa zydis ; haloperidol molindone moban ; quetiapine seroquel ; ziprasidone geodon ; aripiprazole abilify ; asthenia fatigue & weakness ; dexamethasone methylphenidate generic ritalin ; pemoline generic cylert ; prednisone copd duoneb albuterol & ipratropium ; albuterol sol and duragesic.
Monoclonal gammopathy of undetermined significance MGUS ; : A category of myeloma characterized by comparatively low amounts of myelomaassociated protein levels and bone marrow plasma cells as well as an absence of certain myeloma-related symptoms i.e., anemia, renal failure, hypercalcemia, and lytic lesions ; . Myeloma: A cancer of bone marrow plasma cells. Cancerous plasma cells are called myeloma cells. Nephrotic syndrome: A group of diseases characterized by a massive excess of serum protein in the urine. Nephrotoxicity: The quality of being toxic or destructive to kidney cells. Nonsteroidal anti-inflammatory drug NSAID ; : A drug used to reduce fever, swelling, pain, and redness. Osteoblast: An immature cell that is associated with bone production as it matures. Osteoclast: A cell that destroys the bone. Osteoporosis: Thinning and weakening of the bone. Pathologic fracture: Fracture due to weakening of the bone structure from disease. Phlebitis: Inflammation of a vein. Skeletal-related event SRE ; : New bone damage or fracture. Smoldering myeloma: A category of myeloma characterized by comparatively low amounts of myelomaassociated protein levels and bone marrow plasma cells as well as an absence of certain myeloma-related symptoms i.e., anemia, renal failure, hypercalcemia, and lytic lesions ; . Although the quantities of protein levels and plasma cells are relatively low, they are higher than in patients with monoclonal gammopathy of undetermined significance MGUS ; . Steroid: A type of drug that is used to reduce swelling and inflammation. A negative effect of steroid treatment is the reduction of bone mass. Systemic treatment: Treatment using substances that travel through the bloodstream to reach and affect cells in the entire body.
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Cardiovascular cardiovascular effects the cardiovascular adverse side effects of dronabinol are inconsistent; however, the following side effects may occur during therapy: hypotension, hypertension, syncope, tachycardia, palpitations, vasodialtion, and facial flush prod info marinol r ; , 1999; chang et al, 1979; ohlsson et al, 1980 and echinacea!
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Least one lesion in the central nervous system.7 26 We allowed concurrent spasm related pain or other pain if the patient was able to distinguish it from central pain. We excluded patients who had used marihuana within the last three months, and those who were unwilling to stop using marijuana during the study period. We designed the study as a randomised double blind placebo controlled crossover trial. We allocated patients to treatment after a one week baseline period. We planned for the patients to receive three weeks' 18-21 days' ; treatment with dronabinol and three weeks' 18-21 days' ; treatment with placebo, with a washout period of at least 21 days between the treatment periods. Any analgesic drug except paracetamol ; was discontinued at least one week before the first visit. During active treatment, the initial dose of dronabinol was 2.5 mg daily one capsule ; , and the dose was increased by 2.5 mg every other day to a maximum dose of 5 mg two capsules ; twice daily. The placebo capsules were identical to the dronabinal capsules in appearance, taste, and smell. Assignment and masking We assigned patients to treatment using a computer generated randomisation code. Both investigators and patients were blinded to treatment allocation, and we maintained blinding until the data analysis was completed. At the end of the study we asked the patients to identify the treatment period in which they received the active treatment and which of the two treatments they preferred. Assessments The predefined primary outcome measure was median spontaneous pain intensity in the last week of treatment. Secondary outcome measures were median radiating pain intensity in the last week of treatment, pain relief, use of escape medication, patient preference, health related quality of life SF-36 ; , expanded disability status scale score, and quantitative sensory testing and efalizumab.
These medications include opiates and anti-inflammatory drugs for pain, while for hiv wasting, the synthetic hormone megestrol acetate, dronabinol and somatropin are fda-approved
Was added to the regimen. Approximately three weeks later, his vision improved and there was resolution of the oral ulcers and rashes. Prednisone was tapered and eventually stopped; he likewise refused to continue the methotrexate. One month later, there was recurrenceof mouthulcers and iritis whichdisappeared spontaneously after three days. Case No. 4 A.R., a 51 year old male, presented with blurred vision of the left eye and recurrentoral ulcers of six months duration. He was diagnosedto have vitritis, OS and started on oral prednisoneat 40 mgs day with improvement. His symptoms however recurred whenever the steroids were tapered. He was then referredto the Rheumatology and Clinical ImmunologySectionwhere Behcet'sdisease was considered. In March 1991, bilateralfiltering procedure was done because of glaucoma. There were no arthritis, photosensitivity, fever nor Raynaud's phenomenon. CBC, ESR, AP'I-I"and platelet count were all within normallimits. Prednisone was continued however he was lost to follow up. Case No. 5 R.P., a 20 year old male, presented withconjunctivitis, oral and genitalulcers. In August 1989, he first noted the appearancesof oral ulcerswhichresolved and eletriptan.
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P.A. James, J.S. Bendle, N. Carbarns & J.E. Salmon In response to the introduction of the third Generation Cephalosporins in the early 1980's certain Gram-negative bacterial enzymes, TEM and SHV, acquired mutations which extended their spectrum of activity conferring protection against these new antibiotics. The modified enzymes were designated Extended Spectrum -Lactamases ESBL's ; and there followed a rapid proliferation and diversification of the class of enzymes. In 1998 an ESBL was described which preferentially hydrolysed Cefotaxime CTX-M ; . These enzymes have become common in the UK over the last 5 years and increased surveillance at the three Microbiology Laboratories comprising the Gwent Healthcare Trust has facilitated the detection and isolation of ESBL producing strains. The strains isolated each month over the period 1st April 2004 to 30th September 2005, 134 in total, were investigated and epidemiological data was gathered to provide an insight into the sample type and patent age sex demographics. It was found that ESBL producing strains isolated from in-patients outnumbered those submitted by GP practises by a ratio of 2: 1. 73% of ESBL producing strains isolated from urine samples were from female patients and 27% were from males. An increase in the frequency of ESBL isolation was noted in elderly patients of both sexes. A sample of 12 isolates, collected in different months of the study were further characterized. Nine were identified as strains of E. coli and three were Klebsiella pneumoniae. MIC's to a range of antibiotics were established using BD Phoenix. Antibiograms were produced using disc-diffusion methods and read using BSAC guidelines. They were referred to the ARMRL, Colindale for typing. Ten were CTX-M1, one was CTX-M9 and one was a non-CTX-M strain and dronabinol.
Occasionally, you may see ID cards from Blue members from a foreign country.these ID cards also reflect the three-character alpha prefix. The steps that you follow for domestic Blue Plan members are the same steps that you should follow for foreign Blue Plan members: 1. Verify eligibility and benefits by sending an electronic eligibility 270 transaction ; to Blue Cross Blue Shield of Tennessee or call the BlueCard Eligibility line at 1-800-676-BLUE 2573 ; and provide the three-character alpha prefix. Blue Cross Blue Shield of Tennessee will be your focal point for claims filing, claims collection, payment, and problem resolution for health care claims incurred by international Blue Plan members. Follow the same payment collection practices as you do for Blue Plan domestic members: collect copayment amounts; do not collect any other charges up front with the exception of noncovered services These members and elidel.
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T033. Fertilizing potential of human spermatozoa: a simple predictive assay Al-Hussaini T.1-2 and Stevenson A.F.G.2 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt and 2Department of Obstetrics and Gynecology, Kiel's University Hospital, Michaelisst. 16, 24105 Kiel, Germany Introduction: Male subfertility is one of the indications for assisted reproduction. One of the true limiting factors in male.
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Sodium channels in planar lipid bilayers. Ion permeation and block. J Gen Physiol 89: 841 872, GRESSER MJ, MYERS JA, AND BOYER PD. Catalytic site cooperativity of beef heart mitochondrial F1 adenosine triphosphatase. Correlations of initial velocity, bound intermediate, and oxygen exchange measurements with an alternating three-site model. J Biol Chem 257: 12030 12038, GRINSTEIN S AND FURUYA W. Amiloride-sensitive Na H exchange in human neutrophils: mechanism of activation by chemotactic factors. Biochem Biophys Res Commun 122: 755762, 1984. GRINSTEIN S AND FURUYA W. Cytoplasmic pH regulation in phorbol ester-activated human neutrophils. J Physiol Cell Physiol 251: C55C65, 1986. GRINSTEIN S, ROMANEK R, AND ROTSTEIN OD. Method for manipulation of cytosolic pH in cells clamped in the whole cell or perforated-patch configurations. J Physiol Cell Physiol 267: C1152 C1159, 1994. GROS G AND MOLL W. Facilitated diffusion of CO2 across albumin solutions. J Gen Physiol 64: 356 371, GROS G, MOLL W, HOPPE H, AND GROS H. Proton transport by phosphate diffusion--a mechanism of facilitated CO2 transfer. J Gen Physiol 67: 773790, 1976. GRZESIEK S AND DENCHER NA. Dependency of pH-relaxation across vesicular membranes on the buffering power of bulk solutions and lipids. Biophys J 50: 265276, 1986. GU X AND SACKIN H. Effect of pH on potassium and proton conductance in renal proximal tubule. J Physiol Renal Fluid Electrolyte Physiol 269: F289 F308, 1995. GUERRIERI F AND PAPA S. Effect of chemical modifiers of amino acid residues on proton conduction by the H -ATPase of mitochondria. J Bioenerg Biomembr 13: 393 409, GULBIS JM, MANN S, AND MACKINNON R. Structure of a voltagedependent K channel subunit. Cell 97: 943952, 1999. GUNNER MR AND ALEXOV E. A pragmatic approach to structure based calculation of coupled proton and electron transfer in proteins. Biochim Biophys Acta 1458: 63 87, GUTKNECHT J. Proton hydroxide conductance through lipid bilayer membranes. J Membr Biol 82: 105112, 1984. GUTKNECHT J. Proton conductance through phospholipid bilayers: water wires or weak acids? J Bioenerg Biomembr 19: 427 442, GUTKNECHT J. Proton conductance caused by long-chain fatty acids in phospholipid bilayer membranes. J Membr Biol 106: 8393, 1988. GUTKNECHT J, BISSON MA, AND TOSTESON FC. Diffusion of carbon dioxide through lipid bilayer membranes: effects of carbonic anhydrase, bicarbonate, and unstirred layers. J Gen Physiol 69: 779 794, GUTKNECHT J AND TOSTESON DC. Diffusion of weak acids across lipid bilayer membranes: effects of chemical reactions in the unstirred layers. Science 182: 1258 1261, GUTMAN M AND NACHLIEL E. Time-resolved dynamics of proton transfer in proteinous systems. Annu Rev Phys Chem 48: 329 356, GUTMAN M, NACHLIEL E, AND TSFADIA Y. Propagation of protons at the water membrane interface. Microscopic evaluation of a macroscopic process. In: Permeability and Stability of Lipid Bilayers, edited by Disalvo EA and Simon SA. Ann Arbor, MI: CRC, 1995, p. 259 276. GUTMAN M, TSFADIA Y, MASAD A, AND NACHLIEL E. Quantitation of physical-chemical properties of the aqueous phase inside the phoE ionic channel. Biochim Biophys Acta 1109: 141148, 1992. HAGIWARA S AND TAKAHASHI K. The anomalous rectification and cation selectivity of the membrane of a starfish egg cell. J Membr Biol 18: 61 80, HAINES TH. Anionic lipid headgroups as a proton-conducting pathway along the surface of membranes: a hypothesis. Proc Natl Acad Sci USA 80: 160 164, HAINES TH. Do sterols reduce proton and sodium leaks through lipid bilayers? Prog Lipid Res 40: 299 324, HALL JE, VODYANOY I, BALASUBRAMANIAN TM, AND MARSHALL GR. Alamethicin A rich model for channel behavior. Biophys J 45: 233247, 1984. prv and eligard.
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