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The incidence of oral warts due to human papillomavirus HPV ; has dramatically increased in the potent antiretroviral therapy era. Studies at the author's institution indicate that the risk of HPV-associated oral warts is associated with a 1-log10 or greater decrease in plasma HIV RNA level within the 6 months prior to oral HPV diagnosis, suggesting that the develop145.
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Diagnosed with and without thrombus or SEC, were compared in terms of IR and other characteristics. Twelve 27% ; patients had SEC, 2 5% ; patients had thrombus on LAA. Ischemic stroke occurred in 2 4.5% ; patients and transient ischemic attack developed in 4 9% ; patients. HOMA-IR was significantly higher in the patients who had SEC or thrombus 6.3 vs 2.4, p 0.01 ; and thromboembolic events 5.1 vs 1.5, p 0.001 ; compared with patients who had no. There was a significant correlation between the IR and SEC grade R 0.464, p 0.009 ; . In multivariable analysis, while independent variables for SEC and thrombus formation were LA diameter, IR, and the duration of AF and independent variables for cerebrovascular events were the existence of SEK and thrombus in LA, and IR. Conclusions: IR may a contributing factor on development of SEC, thrombus, or thromboembolic events in patients with lone AF. Thromboembolic events despite the effective anticoagulation in patients with AF connote other possible mechanisms. One of them might be IR. 134 Diastolic function of the left atrium and relation with recurrences of paroxysmal atrial fibrillation I. Vogiatzis1 , I.M. Vogiatzis1 , V .M. Sachpekidis1 , M.T. Konstantinidou1 , A.C. Sideropoulos1 , E.C. Kambitsi1 1 General Hospital of Veria, Cardiology, Veria, Greece Background: The relationship between mechanical remodeling of the atria and chronic atrial fibrillation AF ; is well established. Few data exist valuating the effects of frequent recurrences of paroxysmal AF to the mechanical properties of the atria. The aim of our study was to assess possible correlations between the frequency of recurrences of paroxysmal AF and functional properties of the left atrium as obtained through transthoracic echocardiography. Methods: 126 patients 58 male 68 female, mean age: 63.68.7 y ; who presented with an episode of paroxysmal AF were studied. All patients were submitted to assessment of the systolic and diastolic function of the left ventricle LV ; and left atrium LA ; during the initial hospitalization for the episode of paroxysmal AF. The patients were thereafter followed prospectively for 1 year and new episodes of AF, if any, were documented. Based on the collected data the patients were divided into two groups: Group A 64 patients, mean age 61.59.6 ; if no other episode of AF was documented and Group B 62 patients, mean age 64.89.9 ; if they had one or more recurrences of paroxysmal AF. Results: Impaired diastolic function of the LA concerning both relaxation and filling phases was observed in patients in Group B, as seen by the reduced S D ratio of the pulmonary vein flow velocities A: 1.380.6 vs B: 1.140.41, p 0.04 ; and the reduced deceleration time of D wave A: 313.899.6 ms vs B: 258.987.1 ms, p 0.03 ; compared with patients in Group A. Moreover, a negative correlation was found between the S wave velocity pulmonary vein flow during LV systole and LA relaxation ; and the frequency of recurrences of AF r -0.43, p 0.02 ; . No other significant differences were observed concerning clinical, epidemiological or the rest echocardiographic data between the two groups. Conclusions: Frequent recurrences of paroxysmal AF alter the diastolic function of the LA resulting in remodeling of the latter, as estimated by the study of the pulmonary vein flow velocities with the transthoracic echocardiographic examination. These changes favour the recurrence of AF and possibly are partially responsible for creating a suitable environment for the formation of thrombi in the LA. 135 Left atrial shape may influence volume underestimation using ellipse formula in patients with atrial fibrillation D.C. Cozma1 , L. Petrescu1 , C.T. Luca1 , S. Pescariu1 , R. Dan1 , C. Blaj1 , S.I. Dragulescu1 1 Institute of Cardiovascular Medicine, Cardiology Department, Timisoara, Romania Background: complete geometrical and shape characterization of left atrium LA ; in patients with atrial fibrillation AF ; has not been perEuropace Supplements, Vol. 9 Supplement 3, June 2007 iii25.
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The Annual Clinical Focus 2004, Caring for America's Aging Population, is a program of the American Academy of Family Physicians, developed in cooperation with the AARP, the Agency for Healthcare Research and Quality, the American Cancer Society, the American Diabetes Association, the American Geriatrics Society, the American Heart Association, the National Cancer Institute, and the National Institute on Aging. This monograph is supported by educational grants to the AAFP from Merck Schering-Plough Pharmaceuticals Joint Venture, Aventis Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb Sanofi Pharmaceuticals Partnership, Forest Pharmaceuticals, Inc., and Ortho Biotech. The views and opinions expressed herein are those of the authors and do not necessarily represent the views of the AARP, the American Cancer Society, the American Geriatrics Society, the American Heart Association, the supporting partners, American Family Physician or its publisher, the American Academy of Family Physicians. Any recommendation made by the authors must be weighed against the physician's own clinical judgment, based on but not limited to such factors as the patient's condition, benefits versus risks of suggested treatments, and comparisons with recommendations of pharmaceutical compendia and other authorities.
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Originally developed as a potential HIV treatment but dropped for that indication owing to safety concerns associated with a 60 mg dosing, Adefovir dipivoxil in 10 mg doses is under review in the US and Europe to treat e-antigen positive and negative HBV and chronic lamivudine-resistant hepatitis B. GlaxoSmithKline markets its Epivir-HBV lamivudine to treat chronic HBV in the US, China, Europe and elsewhere. Also in its hepatitis B portfolio is the Energix-B recombinant hepatitis B vaccine and the Twinrix combined hepatitis A and hepatitis B vaccine.
Low-density lipoproteins. Very-low-density lipoproteins transport triacylglycerols from liver to extrahepatic tissues 32 ; . Corticosteroids also influence the expression of 16 transporters Table 9 ; . Because many of these transporters are located on the sinusoidal membranes of hepatocytes, they may influence a variety of functions such as small molecule metabolism. For example, Slc22a7 is involved in the hepatic uptake of organic anions such as salicylate 33 ; . The downregulation of this gene could alter the metabolism of such drugs. The next 10 genes are grouped because they are involved in cellular fates, proliferation, differentiation, and apoptosis Table 10 ; . We have included ornithine decarboxylase 1 Odc1 ; and ornithine decarboxylase antizyme inhibitor oazin ; because polyamines are important to cell proliferation. Odc, the first enzyme in polyamine synthesis, is regulated by a destabilizing antizyme that both inhibits its activity and accelerates it degradation. Oazin binds and traps the anti and kytril.
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| Combivir epivirNDA 21-003 S-010 NDA 21-004 S-010 Page 16 more frequent in lamivudine-containing arms for a retrospective analysis of HIV HBV dually infected patients in one study ; , and amylase elevations. Please see the complete prescribing information for EPIVIR Tablets and Oral Solution for more information. Pediatric Patients With Hepatitis B: Most commonly observed adverse events in the pediatric trials were similar to those in adult trials; in addition, respiratory symptoms cough, bronchitis, and viral respiratory infections ; were reported in both lamivudine and placebo recipients. Posttreatment transaminase elevations were observed in some patients followed after cessation of lamivudine. Pediatric Patients With HIV Infection: In early open-label studies of lamivudine in children with HIV, peripheral neuropathy and neutropenia were reported, and pancreatitis was observed in 14% to 15% of patients. Observed During Clinical Practice: The following events have been identified during post-approval use of lamivudine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to lamivudine, or a combination of these factors. Post-marketing experience with lamivudine at this time is largely limited to use in HIV-infected patients. Digestive: Stomatitis. Endocrine and Metabolic: Hyperglycemia. General: Weakness. Hemic and Lymphatic: Anemia including pure red cell aplasia and severe anemias progressing on therapy ; , lymphadenopathy, splenomegaly. Hepatic and Pancreatic: Lactic acidosis and steatosis, pancreatitis, posttreatment exacerbation of hepatitis see WARNINGS and PRECAUTIONS ; . Hypersensitivity: Anaphylaxis, urticaria. Musculoskeletal: Rhabdomyolysis. Nervous: Paresthesia, peripheral neuropathy. Respiratory: Abnormal breath sounds wheezing. Skin: Alopecia, pruritus, rash. OVERDOSAGE There is no known antidote for EPIVIR-HBV. One case of an adult ingesting 6 g of EPIVIR was reported; there were no clinical signs or symptoms noted and hematologic tests remained normal. Because a negligible amount of lamivudine was removed via 4-hour ; hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required. DOSAGE AND ADMINISTRATION Adults: The recommended oral dose of EPIVIR-HBV for treatment of chronic hepatitis B in adults is 100 mg once daily see paragraph below and WARNINGS ; . Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known see PRECAUTIONS ; . The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients dually infected with HBV and HIV. If lamivudine is administered to such patients, the higher.
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Did at the last meeting, the question was -- and if we are going to think about using a surrogate marker -- in the people who are eradicated, what is the recurrence rate? So, that was our initial analysis that we were asking for. If you just took the people who were eradicated, what is the recurrence rate, including saying that the people who dropped out recurred and they were a failure. DR. FREDD: My concern about coming to a.
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EPIVIR should be used with caution. Treatment with EPIVIR should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur see ADVERSE REACTIONS ; . Lactic Acidosis Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering EPIVIR to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with EPIVIR should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations ; . Important Differences Among Lamivudine-Containing Products: EPIVIR Tablets and Oral Solution contain a higher dose of the same active ingredient lamivudine ; than in EPIVIR-HBV Tablets and Oral Solution. EPIVIR-HBV was developed for patients with chronic hepatitis B. The formulation and dosage of lamivudine in EPIVIR-HBV are not appropriate for patients dually infected with HIV and HBV. Lamivudine has not been adequately studied for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. If treatment with EPIVIR-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely to result because of the subtherapeutic dose and the inappropriateness of monotherapy HIV treatment. If a decision is made to administer lamivudine to patients dually infected with HIV and HBV, EPIVIR Tablets, EPIVIR Oral Solution, or COMBIVIR lamivudine zidovudine ; Tablets should be used as part of an appropriate combination regimen. COMBIVIR a fixed-dose combination tablet of lamivudine and zidovudine ; should not be administered concomitantly with EPIVIR, EPIVIR-HBV, RETROVIR, or TRIZIVIR. Posttreatment Exacerbations of Hepatitis: In clinical trials in non-HIV-infected patients treated with lamivudine for chronic hepatitis B, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA. Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from and viramune.
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NDA 21-003 S-010 NDA 21-004 S-010 Page 17 dosage indicated for HIV therapy should be used as part of an appropriate combination regimen, and the prescribing information for EPIVIR as well as EPIVIR-HBV should be consulted. Pediatric Patients: The recommended oral dose of EPIVIR-HBV for pediatric patients 2 to 17 years of age with chronic hepatitis B is 3 mg kg once daily up to a maximum daily dose of 100 mg. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known see PRECAUTIONS ; . EPIVIR-HBV is available in a 5-mg ml oral solution when a liquid formulation is needed. Please see information above regarding distinctions between different lamivudine-containing products. ; Dose Adjustment: It is recommended that doses of EPIVIR-HBV be adjusted in accordance with renal function Table 8 ; see CLINICAL PHARMACOLOGY: Special Populations.
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WARNING LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING LAMIVUDINE AND OTHER ANTIRETROVIRALS SEE WARNINGS ; . HUMAN IMMUNODEFICIENCY VIRUS HIV ; COUNSELING AND TESTING SHOULD BE OFFERED TO ALL PATIENTS BEFORE BEGINNING EPIVIR-HBV AND PERIODICALLY DURING TREATMENT SEE WARNINGS ; , BECAUSE EPIVIR-HBV TABLETS AND ORAL SOLUTION CONTAIN A LOWER DOSE OF THE SAME ACTIVE INGREDIENT LAMIVUDINE ; AS EPIVIR TABLETS AND ORAL SOLUTION USED TO TREAT HIV INFECTION. IF TREATMENT WITH EPIVIR-HBV IS PRESCRIBED FOR CHRONIC HEPATITIS B FOR A PATIENT WITH UNRECOGNIZED OR UNTREATED HIV INFECTION, RAPID EMERGENCE OF HIV RESISTANCE IS LIKELY BECAUSE OF SUBTHERAPEUTIC DOSE AND INAPPROPRIATE MONOTHERAPY. SEVERE ACUTE EXACERB ATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY INCLUDING EPIVIR-HBV ; . HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DIS CONTINUE ANTI-HEPATITIS B THERAPY. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED SEE WARNINGS ; . DESCRIPTION EPIVIR-HBV is a brand name for lamivudine, a synthetic nucleoside analogue with activity against hepatitis B virus HBV ; and HIV. Lamivudine was initially developed for the treatment of HIV infection as EPIVIR. Please see the complete prescribing information for EPIVIR Tablets and Oral Solution for additional information. The chemical name of lamivudine is 2R, cis ; -4amino-1- 2-hydroxymethyl-1, 3-oxathiolan-5-yl ; - 1H ; -pyrimidin-2-one. Lamivudine is the - ; enantio mer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as - ; 2, 31 and mysoline.
Absence of drug interactions with lamivudine or adefovir dipivoxil. Antimicrob Agents Chemother. 2006; 50: 2309-2315. Hu P, Jiang J, Wang H, et al. Singledose and multiple-dose pharmacokinetics and safety of telbivudine after oral administration in healthy Chinese subjects. J Clin Pharmacol. 2006; 46: 9991007. Zhou XJ, Lloyd DM, Chao GC, Brown NA. Absence of food effect on the pharmacokinetics of telbivudine following oral administration in healthy subjects. J Clin Pharmacol. 2006; 46: 275-281. Baraclude [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2005. 11. Epivir-HBV [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2006. 12. Hepsera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2006. 13. Zhou XJ, Myers M, Chao G, Dubuc G, Brown NA. Clinical pharmacokinetics of telbivudine, a potent antiviral for hepatitis B, in subjects with impaired hepatic or renal function [abstract]. Hepatology. 2004; 40 suppl 1 ; : 672A. 14. Zhou XJ, Myers M, Chao G, Dubuc G, Brown N. Clinical pharmacokinetics of telbivudine, a potent antiviral for hepatitis B, in subjects with impaired hepatic or renal function [abstract]. J Hepatol. 2004; 40 suppl 1 ; : 134.
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REMEMBER: - involve the group in the talk as much as possible - keep it short and simple do not talk too much ; - use visual aids and other health education methods e.g. role plays, songs, demonstrations ; as much as possible, because seeing and doing things helps people to remember - at the end of the talk ask if there are any questions and get feedback from the group. iv ; Format for the talk a ; Opening * Open the talk by welcoming everyone, introduce yourself and, if appropriate, ask someone to say a prayer * Create a friendly atmosphere with the group by showing personal interest in them or commenting on common experiences. b ; Content of the talk s ; * Follow the lesson plan, use visual aids and involve the group in demonstrations * Allow time for any final questions and feedback c ; * * * * Ending Summarise the main information given Thank the group Arrange a follow-up talk, if necessary Close with prayer, as appropriate and atrovent.
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INDICATION: ATRIPLATM efavirenz 600 mg emtricitabine 200 mg tenofovir disoproxil fumarate 300 mg ; is a prescription medication used alone as a complete regimen or with other medicines to treat HIV infection in adults. ATRIPLA does not cure HIV and has not been shown to prevent passing HIV to others. See your healthcare provider regularly. IMPORTANT SAFETY INFORMATION: Contact your healthcare provider right away if you experience any of the following side effects or conditions associated with ATRIPLA: Nausea, vomiting, unusual muscle pain, and or weakness. These may be signs of a buildup of acid in the blood lactic acidosis ; , which is a serious medical condition. Light colored stools, dark colored urine, and or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems. If you have HIV and hepatitis B virus HBV ; , your liver disease may suddenly get worse if you stop taking ATRIPLA. Do not stop taking ATRIPLA unless directed by your healthcare provider. Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Hismanal astemizole ; , Propulsid cisapride ; , Versed midazolam ; , Halcion triazolam ; , or ergot derivatives for example, Wigraine and Cafergot ; . In addition, ATRIPLA should not be taken with: Combivir lamivudine zidovudine ; , Emtriva emtricitabine ; , Epivir or Epivir-HBV lamivudine ; , EpzicomTM abacavir sulfate lamivudine ; , Sustiva efavirenz ; , Trizivir abacavir sulfate lamivudine zidovudine ; , Truvada emtricitabine tenofovir disoproxil fumarate [DF] ; , or Viread tenofovir DF ; , because they contain the same or similar active ingredients as ATRIPLA. Vfend voriconazole ; should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA. Fortovase, Invirase saquinavir mesylate ; should not be used as the only protease inhibitor in combination with ATRIPLA. Taking ATRIPLA with St. John's wort Hypericum perforatum ; is not recommended as it may cause decreased levels of ATRIPLA, increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-HIV drugs. This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, and herbal supplements you are taking or plan to take. Contact your healthcare provider right away if you experience any of the following side effects or conditions.
Among patients recommended for treatment in accordance with guidelines of the AASLD and the AsiaPacific Association for Study of the Liver APASL ; were those who were HBeAgpositive with ALT levels at two or more times the upper limit of normal ULN ; . HBeAg loss or HBeAg seroconversion undetectable serum HBV DNA ; and virological response favored telbivudine. The rate of failed treatment was lower in the telbivudine group, as follows: HBeAg-positive patients: 6.8% with telbivudine, 18.8% with lamivudine P .001 ; HBeAg-negative patients: 0.9% with telbivudine, 7.6% with lamivudine P .001 ; Two analyses found less resistance for telbivudine than for lamivudine in all pairwise comparisons P .001 ; . Adverse events were similar between the two groups, but there were more ALT elevations in the lamivudine patients, especially after week 24. Dr. Lai concluded that telbivudine brought about greater therapeutic response; higher reductions in HBV DNA; a higher number of patients becoming HBV DNAnegative as shown on the polymerase chain reaction [PCR] assay ; more quickly; and more responses in patients whose ALT values had been two or more times the ULN. Di Bisceglie et al. A further GLOBE trial analysis, reported by Adrian M. Di Bisceglie, MD, Chairman of Public Policy for AASLD and Professor of Internal Medicine at Saint Louis University School of Medicine, confirmed the clinical value of early HBV suppression in nucleoside-treated patients with chronic HBV infection. Dr. Di Bisceglie noted that prior results with lamivudine Epivir-HBV ; and adefovir dipivoxil Hepsera, Gilead ; had suggested that early viral suppression, at either six or 12 months, predicted the lowest rate of subsequent resistance. Similarly, early viral suppression was linked to improved therapeutic outcomes. Understanding the quantitative relationships between early viral suppression and subsequent responses could help in developing optimal patient management strategies, he said. Investigators evaluated two-year outcomes separately in HBeAg-positive and HBeAg-negative patients in relation to four strata of HBV DNA levels achieved by week 24: undetectable levels according to PCR: below 300 copies ml quantitation limit: to 103 copies ml, to 103 to 104 copies ml, or to more than 104 copies ml Among patients achieving PCR-undetectable levels, the data analysis revealed a strong correlation between antiviral efficacy at week 24 and HBV DNA suppression at two years in both the telbivudine and lamivudine groups; however, there was generally greater suppression for all strata for telbivudine in both HBeAg-negative and HBeAg-positive patients. The difference was most pronounced in patients with more than four log reductions at 24 weeks 20% for telbivudine and 7% for lamivudine in HBeAg-positive patients and 20% for telbivudine and 5% for lamivudine in HBeAg-negative patients ; . General Considerations What should clinicians do for patients whose responses are weak or declining early in treatment? In the past, Dr. Di Bisceglie explained, clinicians were reluctant to treat patients too early, partly to save therapy for those with more severe disease and in part because of the paucity of treatment options. He said that with the advent of more treatment approaches, "we are more willing to embark on longerterm treatment strategies." For initial therapy, either entecavir Baraclude, BristolMyers Squibb ; or telbivudine would be good choices; however, he added and synthroid.
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We thank Alan Williams and Rebecca Sitsapesan for critiquing a draft of this report. The authors received support from the following sources: S.P., J.A.A., and J.L.S. from National Institutes of Health grants HL53677 and AR45112; N.G.P. and J.L.S. from a National Science Foundation EPSCoR grant EPS0132556; H.H. from National Institutes of Health grant GM55651; and J.E.H. from National Institutes of Health grant GM57998.
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