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By W. Zapotek. Minnesota State University Moorhead. 2018.

Prior versions of this report can be accessed at the DERP website buy zudena 100 mg erectile dysfunction medicine ranbaxy. Triptans Page 2 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1 proven 100 mg zudena erectile dysfunction doctor in atlanta. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Bomhof Multicenter single-dose RCT Not stated 618 39 years I H S criteria 6-month history of migraine; 1-8 1999 conducted in Europe of 84% female 18-65 men and reports per month; no evidence naratriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Bomhof H. O cva, cardiovascular disease, Merck, co-investigator Permitted NR 1999 significant ecg abnormality, history or (maker of rizatriptan) drug or alcohol use, past use of study drugs Carpay 1997 Known narcotic/alcohol abuse Glaxo NR 142/124/124 ergotamine abuse pregnancy, breast-feeding history of ECG evidence of ischaemic heart disease significant concomitant disease significant psychiatric illness known hypersensitivity to/intolerance of sumatriptan current use of fluarizine Triptans Page 4 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Bomhof 96 (did not take study 1999 medication) Carpay 1997 NR/NR Triptans Page 5 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Charlesworth Multicentre, DB, Double- 42 centers in 1547 Mean age=19. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Charlesworth History of basilar, ophthalmoplegic AstraZeneca NR 1547/1383/1372 2003 migraine reported non-migraine > 10 days/month 6 months before study pregnancy, lactation, inadequate conception in women ischaemic heart disease, arrhythmias/cardiac accessory uncontrolled hypertension, use of monoamine oxidase-A inhibitors, methylergometrine within 2 weeks of study clinically significant abnormal laboratory result recent history of drug/alcohol abuse known hypersensitivity/adverse reaction to study treatments/triptans existing serious medical condition participation in another clinical study at same time of this study risk of transmitting Hep B/HIV Colman, 2001 Subjects could not have uncontrolled Pharmacia Rescue medications NR/NR/1255 Spierings, hypertension, defined as a diastolic allowed at 2 hours 2001 blood pressure higher than 95 mm Hg or a systolic blood pressure higher than 160 mm Hg, or clinically significant disease affecting any system but especially the cardiovascular or gastrointestinal tract Triptans Page 7 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Charlesworth 66/8 2003 Colman, 2001 NR/NR Spierings, 2001 Triptans Page 8 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Diez Multicenter, randomized, open, NR 436 Mean age: 36. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Diez Complex forms of migraine, pregnancy, Almirall Prodesfarma Rescue medication NR/436/372 2007 lactation, hypersensitivity to any permitted (NSAIDs) component of the study medications, history signs or symptoms of ischemic heart disease, cerebrovascular accidents, transient ischemic attack or peripheral vascular disease. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Diez 54/10 2007 DowsonDowson 32(14. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Gallagher Multicenter, multiple-dose Not stated 1212 39 years IHS criteria; 1 For women, use of reliable 1999, 2000 analysis of DB RCT, 6 month 85% female year history of contraception. Patients who had study; conducted in Europe of race/ethnicity migraine 2 or more migraines included in zolmitriptan vs. Garcia-Ramos Multicenter, single-attack, DB Not stated 548 Mean age=36. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Gallagher H/o ischemic heart disease, arrhythmia, Zeneca, co-investigator Some permitted NR 1999, 2000 hypertension, some types of migraine; drug or alcohol abuse, abnormal lab tests Garcia-Ramos 1) Coronary artery disease, heart failure, Pfizer Rescue medication 563 screened/548 2003 uncontrolled hypertension or abnormal allowed by 4 hours post- randomized/483 treated an UK/Latin ECG; dose (excluding any other attack America 2) frequent migraine or concommitant triptan, ergotamine, or nonmigrainous headache (<6 per month), ergotamine-like substance) Fair quality migraine variants (e. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Gallagher 233 who had only 1 1999, 2000 headache Garcia-Ramos 65 not treated/4 2003 withdrawn/1 (0. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Geraud Multicenter, single-dose DB Outpatient 1311 38 years IHS criteria; 1 Average of 1-6 attacks per 2000 RCT conducted in Europe and 85% female year history of month for the 6 months Australia of zolmitriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Geraud H/o ischemic heart disease, arrhythmias, Maker of zolmitriptan, co- Permitted NR 2000 uncontrolled hypertension, use of investigator psychoactive drugs, history of drug or alcohol abuse; certain types of migraine; any condition that could interfere with efficacy assessments, pregnant or breastfeeding Goadsby Hemiplegic or basilar migraine, tension- Almirall Prodesfarma Rescue medication (other NR/NR/1298 2007 type headache >4 days/month, inability than triptans) was to distinguish between tension-type and permitted migraine headache, history of ischaemic heart disease, severe or uncontrolled hypertension, cerebrovascular disease, peripheral artery disease, moderate to severe renal or hepatic disease, pregnancy, lactation, history of abuse of analgesics or ergot derivatives or triptans, allergy or sensitivity to sulfonamides or triptans Goadsby, 2000 >6 migraine attacks per month, frequent Pfizer, Ltd. Rescue medication NR/NR/857 Jackson, 1998 tension-type headaches, recent history allowed after 2 hours of alcohol or other substance misuse, serious allergic reactions to drugs, use of any experimental drug within the past month, pregnant or breastfeeding women, severely limited gastrointestinal absorption, any medical condition that might interfere with the interpretations of the study results, coronary artery disease, heart failure, uncontrolled hypertension, and receiving medication specifically contraindicated with sumatriptan Triptans Page 16 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Geraud 253; 225 did not take 2000 medication, 28 were lost to follow-up Goadsby 122/NR 2007 Goadsby, 2000 157/849 (18. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Gruffyd-JonesGruffydd-Jones Multicentre, randomized, open, NRMulticenter, double-dummy Not stated 1787401 Age range=18-42 years IHS criteriaMale or female Average of 1-6 attacks perHistory of migraine for at least 2001 RCT conducted in 21 countries 86% female 18-65 men and month for 2 months preceding of zolmitriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Gruffyd-JonesGruffydd-Jones Pregnancy, lactating, inadequateNR Astra-Zeneca, funderNR Most prohibitedRescue medication: 414/401/388NR 2001 contraception in females, ischemic heart disease, arrhythmias, cardiac accessory pathway disorders, hypertension, use of MAO inhibitors, recent history of alcohol or drug abuse, abnormal clinical lab result, STDs, hepatitis B. Havanka History suggestive of cardiovascular or Glaxo, co-investigator Prophylactic medications NR 2000 cerebrovascular disease; hypertension; stopped 1 week before the pregnant or lactating; history of drug or study; rescue drugs not alcohol or ergotamine abuse; use of permitted MAO inhibitors, SSRIs, lithium, or flunarizine. Triptans Page 19 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Gruffydd-JonesGruffyd-Jones 620, many because109/30% 2001 they did not have 6 attacks Havanka NR 2000 Triptans Page 20 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Kolodny 2004 Multicenter, randomized, NR 1288 mean age: 40 Male or female At least 6 month history of (b) placebo, crossover, DB years, adults, aged migraine White: 87% over 18 years good health standing Female: 86% that met IHS criteria for migraine Kolodny Multicenter, randomized, NR 1447 Mean age: 40 Male or female At least 6 month history of 2004(a) placebo, crossover, DB years, adults, aged migraine White: 87% over 18 years good health standing Female: 86% that met IHS criteria for migraine Lainez Randomized, open, crossover NR 439 Adults aged 18 Be in good health, 1 to 8 2006 to 65 years who migraines/month met IHS criteria for migraine Lines Multicenter single-dose DB Not stated 792 40 years I H S criteria 6-month history of migraine; 1-8 1997 RCT conducted in Sweden, 80% women 18-65 men and attacks per month Lines Norway, the United Kingdom ethnicity NR women. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Kolodny 2004 Use of monoamine oxidase inhibitors, Merck Standard antimigraine 1287/1287/1287 (b) methysergide/propranolol, participation prophylactic (with in study 1 exception of non-steroidal anti-inflammatory drugs, daily analgesics, or propranolol) Kolodny Use of monoamine oxidase inhibitors, Merck Standard antimigraine 1447/1447/1447 2004(a) methysergide/propranolol prophylactic (with exception of non-steroidal anti-inflammatory drugs, daily analgesics, or propranolol) Lainez Preponderance of mild attacks, baslar or NR Rescue medication 509/506/439 2006 hemiplegic migraines, difficutly permitted (NSAIDs) distinguishing migraine from tension or other interval headache, cardiovascular disease, ECG abnormality, uncontrolled hypertension, renal, hepati or other systemic disease Lines NR Merck, co-investigator Escape medications, NR 1997 consisting of standard Lines analgesics or anti-emetics, 2001 were allowed from 2 hours onwards. Triptans Page 22 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Kolodny 2004 NR/NR (b) Kolodny 13/18 2004(a) Lainez 67/0 2006 Lines 141 (did not take study 1997 medication) Lines 2001 Triptans Page 23 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Loder 2001 Multicenter, randomized, open, NR 384 Mean age=37.

Quality Assessment We assessed the internal validity (quality) of trials based on predefined criteria (Appendix B) developed 13 by the US Preventive Services Task Force (ratings: good-fair-poor) and the National Health Service 14 15 Centre for Reviews and Dissemination cheap zudena 100 mg with visa erectile dysfunction doctors near me. External validity (generalizability) was assessed and reported but did not influence quality ratings order zudena 100mg otc erectile dysfunction yeast infection. We did not rate the quality of descriptive studies (case series). Two independent reviewers assigned quality ratings; they resolved any disagreements by discussion and consensus or by consulting a third, independent party. Elements of internal validity assessment for RCTs included, among others, randomization and allocation concealment, similarity of compared groups at baseline, use of intention-to-treat analysis, and overall and differential loss to follow-up. Items assessed included selection of cases or cohorts and controls, adjustment for confounders, methods of outcomes assessment, length of follow-up and statistical analysis. Loss to follow-up was defined as the number of persons randomized who did not reach the endpoint of 17 the study, independent of the reason and the use of intention-to-treat analysis. Appendix C describes our procedure for assessing quality in greater detail. Trials that had a fatal flaw in one or more categories were rated poor quality; trials that met all criteria were rated good quality. Because of the lack of studies for this drug class we included poor quality studies in the synthesis of the evidence. For studies rated as poor, we provide the main reason for the poor rating in the in-text tables. Greater details about methodological shortcomings can be found in the evidence tables. Constipation Drugs Page 17 of 141 Final Report Drug Effectiveness Review Project Data Synthesis Throughout this report we synthesized the literature qualitatively. Because of the small number of studies and heterogeneous outcomes, no quantitative analyses were possible. Rating the Strength of a Body of Evidence We rated the strength of the available evidence in a three-part hierarchy based on an approach devised by 18 the GRADE working group. Developed to grade the quality of evidence and the strength of recommendations, this approach incorporates four key elements: study design, study quality, consistency of results, and directness. Directness refers to the availability of data on outcomes or populations of interest. GRADE also considers the presence of imprecise or sparse data, high probability of publication bias, evidence of a dose gradient, and magnitude of the effect. As shown in Table 6, we used three grades: high, moderate, and low (combining the GRADE category of 19 very low with low). Grades reflect the strength of the body of evidence to answer key questions on the general and comparative efficacy and harms of drugs to treat chronic constipation or IBS-C; the critical element is the extent to which new evidence might alter the confidence we would have in our findings. Due to the lack of evidence and heterogeneous outcomes, we were unable to rate the strength of the evidence for individual outcomes; instead, we provided summary ratings on the general and the comparative efficacy and harms. Definitions of the grades of the overall strength of evidence Grade Definition High Further research is very unlikely to change our confidence in the estimate of effect. Moderate Further research is likely to have an important impact on our confidence in the estimate of the effect and may change the estimate. Low Further research is very likely to have an important impact on our confidence in the estimate of the effect and is likely to change the estimate. We have assessed these additional factors and highlighted issues that could potentially bias our assessments (e. Constipation Drugs Page 18 of 141 Final Report Drug Effectiveness Review Project RESULTS We identified 535 citations from searches and reviews of reference lists. We included a total of 262 articles on an abstract level and retrieved those as full text articles for background information or to be reviewed for inclusion into the evidence report. Studies published as abstracts only are listed in Appendix B. In total we included 33 studies: seven head-to-head RCTs, 16 placebo controlled trials, one observational extension of an RCT, one meta-analysis, six observational studies, and two pooled data analyses. We retrieved 75 articles for background information. Reasons for exclusions were based on eligibility criteria (Figure 1, QUORUM Tree).

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Data Abstraction We designed and used a structured data abstraction form to ensure consistency in appraisal for each study quality 100 mg zudena erectile dysfunction gene therapy. A second reviewer read each abstracted article and evaluated the accuracy and completeness of the data abstraction order zudena 100mg with visa impotence treatment devices. We abstracted the following data from included trials: study design, population characteristics (including age, sex, asthma severity, smoking status), inclusion and exclusion criteria, interventions (drugs, dose, delivery device, duration), comparisons, numbers enrolled, additional medications allowed, outcome assessments, attrition, withdrawals attributed to adverse events, results, and adverse events reported. We recorded intention-to-treat (ITT) results if available. Controller medications for asthma 23 of 369 Final Update 1 Report Drug Effectiveness Review Project Validity Assessment (Quality Assessment) Two independent reviewers assigned quality ratings; they resolved any disagreements by discussion or by consulting a third, senior reviewer. We assessed the internal validity (quality) of trials based on the predefined criteria (see www. Preventive Services Task Force and the National Health Service Centre for 14, 15 Reviews and Dissemination (U. Elements of internal validity assessment for trials included, among others, the methods used for randomization, allocation concealment, and blinding; the similarity of compared groups at baseline; maintenance of comparable groups; adequate reporting of dropouts, crossover, adherence, and contamination; overall and differential loss to follow-up; and the use of intention- to-treat analysis. We assessed observational study designs based on the potential for selection bias (methods of selection of subjects and loss to follow-up), potential for measurement bias (equality, validity, and reliability of ascertainment of outcomes), and control for potential confounders. Systematic reviews which fulfilled inclusion criteria were rated for quality using predefined criteria (www. Studies that had a fatal flaw were rated “poor quality” and were not included in the evidence report. Trials that met all criteria were rated “good quality”. This includes studies that presumably fulfilled all quality criteria but did not report their methodologies to an extent that answered all our questions. As the fair-quality category is broad, studies with this rating vary in their strengths and weaknesses: the results of some fair-quality studies are likely to be valid, while others are only probably valid. A poor- quality trial is not valid—the results are at least as likely to reflect flaws in the study design as the true difference between the compared drugs. A fatal flaw is reflected by failing to meet combinations of items of the quality assessment checklist. Attrition, or loss to follow-up, was defined as the number of persons randomized who did 16 not reach the endpoint of the study, independent of the reason and the use of intention-to-treat analysis. We adopted no formal cut-off point for loss to follow-up because many studies defined withdrawals due to acute worsening of the disease as an outcomes measure. Data Synthesis We constructed evidence tables showing the study characteristics, quality ratings, and results for all included studies. Trials that evaluated one included medication against another provided direct evidence of comparative effectiveness and adverse event rates. In theory, trials that make comparisons with other drug classes or placebos can also provide evidence about effectiveness. This is known as an indirect comparison and can be difficult to interpret for a number of reasons, primarily issues of heterogeneity between trial populations, interventions, and assessment of outcomes. Data from indirect comparisons are used to support direct comparisons, where they exist, and are also used as the primary comparison where no direct comparisons exist. Such indirect comparisons should be interpreted with caution. Controller medications for asthma 24 of 369 Final Update 1 Report Drug Effectiveness Review Project In addition to discussion of the findings of the studies overall, quantitative analyses were conducted using meta-analyses on outcomes for which a sufficient number of studies reported and for studies which they were homogeneous enough such that combining their results can be justified. Random effects models were used 17 for the estimation of pooled effects. Forest plots are presented to graphically summarize the 18 2 study results and the pooled results. The Q-statistic and the I statistic (the proportion of variation in study estimates due to heterogeneity) were calculated to assess heterogeneity 19, 20 between the effects from the studies. Potential sources of heterogeneity were examined with subgroup analysis by factors such as study design, study quality, variations in interventions, and patient population characteristics. Meta-analyses were conducted using Comprehensive Meta Analysis V2. Grading the Strength of Evidence We graded strength of evidence using a modified GRADE approach that included assessment of the following domains: design, quality, consistency, directness, and magnitude of effect of the set of studies relevant to the question.

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Glutathione-S-transferase M1 Increase risk of cardiac iron loading discount zudena 100 mg with amex erectile dysfunction caused by fatigue, mechanism unknown Hematology 2013 355 Whole genome or exome sequencing using next-generation sequenc- a major predictor of survival in SCD cheap zudena 100mg overnight delivery erectile dysfunction therapy treatment, and low levels of HbF have ing technology in combination with well-defined phenotypes offers been associated with increased risk of brain infarcts in young the possibility of identifying new genetic variants. The uneven beneficial For both SCD and -thalassemia, factors that affect the primary effect of HbF on sickle-related complications could also be related event of the disease process will have a global effect on the disease to the different pathobiology of large and small vascular disease. These include the causative genotype, coexisting -thala- ssemia, and the innate ability to produce HbF. HbF levels vary considerably, from 1% to as high as 25% in individuals with SCD-SS, and behave as a quantitative genetic trait SCD should be considered as both a qualitative and quantitative as in healthy individuals. Three QTLs, one in cis to the HBB gene genetic disorder in that it is caused by the presence of an abnormal cluster represented by the Xmn1-HBG2 site (rs7482144), HBS1L- Hb variant (HbS, S, HBB glu6val, GAG 6 GTG), yet the MYB intergenic polymorphisms (HMIP) on chromosome 6q, and 2 2 likelihood of HbS polymerization and sickling is highly dependent BCL11A on chromosome 2p, are major regulators of common HbF on the intra-erythrocyte HbS concentration. In patients of African descent with SCD, the 3 loci with HbC (SCD-SC) or -thalassemia variants (SCD-S 0 thalasse- account for 16% to 20% of the variation in HbF levels with a mia and SCD S thalassemia). Simple heterozygotes for HbS demonstrated in the recently completed BABY HUG study. Under exceptional circumstances, Several studies have investigated the association of candidate genes however, such as intense physical activity and dehydration, the implicated in pathophysiology of vasoocclusion and vasculopathy, consequent increased intracellular HbS concentration can induce such as those encoding factors modifying inflammation, oxidant vasoocclusive pain. Of the numerous association studies reported, the reduces intracellular hemoglobin concentration, thereby reducing most robust is the association between serum bilirubin levels and HbS polymerization, reducing sickling, and decreasing hemolysis. A subsequent analysis of 40 elderly or small vessels. Patients with complications had a higher frequency of tetramers ( 2 2 ) inhibit HbS polymerization and the presence of the platelet glycoprotein allele HPA-5B. In this small study, most of HbF dilutes down the intracellular HbS concentration. In view of its the complications were osteonecrosis and only 4 individuals had impact at the primary level of disease pathology, one would expect more than one complication. Because traditional methods are often HbF levels to have a global beneficial effect. Indeed, HbF levels are inadequate in association studies of complex traits, methods of 356 American Society of Hematology evaluating multilocus data are promising alternatives. A GWAS was -globin production through coinheritance of extra -globin genes applied to SCD based on a disease severity score that was derived (triplicated, / or / ; quadruplicated, / ;or from a Bayesian network that integrates 25 different clinical and duplication of the whole -globin gene cluster, / / ) with laboratory variables. The severity of anemia depends on the number of extra telomere length regulator). However, it is important to remember -globin genes and the severity of the -thalassemia alleles. More recently, GWAS identified an SNP evident in non-transfusion-dependent 0 thalassemia patients who (rs7203560)inNPRL3 on chromosome 16p that was independently have a mild disease despite the complete absence of HbA. Again, the degree 2 2 rium with SNPs within the -globin gene regulatory elements of amelioration depends on the severity of -thalassemia alleles ( (HS-48, HS-40, and HS-33). At the primary level of chain imbalance, the proteolytic capacity of the erythroid precursors in catabolizing the excess -globin has Hydroxyurea remains a major treatment option for SCD; its main often been suggested, but this effect has been difficult to define. Clinical -hemoglobin–stabilizing protein, a molecular chaperone of -glo- response to hydroxyurea therapy, however, is variable with variable bin, has also been suggested as another genetic modifier, but its HbF response; a main determinant of response appears to be the impact on disease severity has been inconclusive. Numerous genetic association studies on HbF response to hydroxyurea have been reported, of which the associa- Genetic variants could also modify the different complications of tion with Xmn1-HBG2 seems to be the most robust. In the recently -thalassemia that are directly related to the anemia and ineffective completed BABY HUG trial, however, the HbF genetic modifiers erythropoiesis or to therapy, such as iron chelation treatment. The were not able to identify the “high” and “low” responders to secondary complications include jaundice and predisposition to hydroxyurea. The degree of In -thalassemia, as in SCD, the causative genotype, coinheritance iron loading, bilirubin levels, and bone mass are quantitative genetic of -thalassemia and HbF, are the main modifiers of clinical traits and thus will be modified by genetic variants regulating severity. These genetic factors have a major impact because they expression of these traits. Almost 300 mutations (deletions and point mutations) that -thalassemia and SCD, prompting decades of study into its down-regulate the -gene have been described (http://globin.

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