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By D. Gelford. Fort Lewis College.

Tendons undergo continuous remodeling according to the physi- ologic stresses put on them discount 80 mg super cialis with visa. Older concepts of tendon injury being For simplicity buy generic super cialis from india, PRP can be classified primarily into 2 basic types: an inflammatory process have been replaced by the idea that tendon pathology occurs along a continuum purchase super cialis mastercard. In general, the systems that produce LR-PRP are systems reaching a state of reactive tendinopathy, then tendon disrepair, and that use faster centrifugation speeds or 2 centrifugations and the finally degenerative tendinopathy. If the tendon is loaded appropri- PRP is created from the buffy coat, resulting in a product that is 5 to ately at any point during this cycle, it has the capacity to reverse this process and repair itself3 (Figure 1). Systems that produce LP-PRP often use a single, slower centrifugation, with the RBCs and WBCs layering out in the lower part of the test tube while the platelets The effectiveness of any treatment for tendinopathy is likely to be remain suspended in the plasma. LP-PRP systems typically produce directly correlated with the stage of tendinopathy the patient is in a platelet count 1. In earlier reactive stages of tendinopathy, produced will vary dependent on the baseline platelet count of the simple rest may be enough to initiate healing in some patients. In patient and the efficiency and variability of the PRP collecting patients further along the continuum, eccentric exercises, extracor- device (Table 1 lists the different types of PRP). When evaluating poreal shock wave therapy (ESWT), or physical therapy techniques studies using PRP, it is important to assess what type of PRP is involving deep mechanical pressure may be required to reverse the being used. The efficacy or lack thereof in some studies could be trend. Further still along the continuum, needling the tendon (also related to the quality of the PRP. Ideally, the exact content of the called tenotomy), autologous blood injection, or PRP injection may PRP injected would be consistent and characterized, but this is be needed. There are currently no commonly used clinical stages of rarely the case. PRP is typical used at IL receptor antagonist (IL-1RA) for musculoskeletal indications, the far end of the continuum, in severe degenerative tendinopathy, 620 American Society of Hematology Table 1. Different types of PRP Leukocytes Platelet count Brand names of commercially available systems LR-PRP Buffy coat based Yes 5-9 baseline Biomet GPS III, Harvest, Arteriocyte, Cytomedix Angel LP-PRP Plasma based Minimal 1. Both groups underwent similar rehabilitation consisting of rest for 48 hours, followed by stretching PRP in tendinopathy at 1 week after injection and a standard eccentric exercise program 4-11 beginning at 2 weeks. They are difficult to compare directly because they Results of this study showed that both groups improved. The PRP examine different tendons, use different types of PRP, include group improved their VISA-A score by 21. With so many variables, it is difficult to because there was no difference in outcome between the PRP group ascertain to which variables differences in outcomes may be and the saline group. This conclusion is problematic for several attributed; however, closer examination of the literature, particu- reasons. First, all participants in the DeVos study were eccentric larly the randomized trials, can provide a better understanding of the exercise naive. In a study by Rompe, eccentric exercises alone were potential benefits or lack thereof of PRP injections. Subjects were required to have symptoms for only 2 a difference between treatment groups. In addition, there was no months (although the average patient had symptoms for 9-10 true control group. A true control group would have been a months) and they could not have previously tried eccentric exercises wait-and-see group as in the Rompe study; however, a wait-and-see (exercises in which the muscle is lengthening as it is being used). A true, blinded, control group in invasive Eccentric exercises are standard first-line treatment for Achilles and tendinopathy treatment is difficult to achieve. Tenotomy alone has been shown to improve chronic punctures sites and 5 needle passes made at each site, for a total of tendinosis 60% of the time,21-24 and injection of any fluid with 15 passes in each tendon. The primary outcome measure was the subsequent disruption of the matrix of the tendon may have some Victorian Institute of Sport Assessment-Achilles questionnaire effect on tendon healing. What this study did show was that in a (VISA-A), a functional activity and pain score ranging from 0 to group of eccentric exercise-naive patients, PRP injection was no 100 that is commonly used for sports-related Achilles tendon more effective than saline injection. In the VISA-A, 0 represents no activity and maximum in combination with the Rompe study,20 the recommendation that pain and 100 represents full activity and no pain. Another randomized controlled study by Peerbooms et al looked at the use of PRP in chronic lateral epicondylosis. Subjects were required to have had pain for at least 6 months and to have failed prior treatment. They could not have received a corticosteroid injection in the previous 6 months. Injections were performed without ultrasound guidance at the point of maximal tenderness with 5 needle penetrations in a peppering technique. Rehabilitation for both groups was 24 hours of rest followed by 2 weeks of stretching and then an eccentric exercise program. The primary outcome measure was a 25% reduction in the Disabilities of the Shoulder, Arm, and Hand (DASH) score, a validated functional outcome score for the upper extremity. Results of this study showed that 73% of the PRP group and 49% of the corticosteroid group met the primary outcome measure at 1 year. The corticosteroid group had initial relief of pain and improvement Hematology 2013 621 622 American Society of Hematology Figure 2. DASH scores at 1 year in the PRP and corticosteroid groups in the Peerbooms et al study. The primary outcome measure was 8 weeks; however, by 12 weeks, the scores were nearly identical, the percentage of patients who rated their treatment as “good or after which time the corticosteroid group returned to near baseline excellent” as measured by the modified Blazina scale and an but the PRP group continued to improve. This cohort was followed improvement on the Victorian Institute Sport Assessment-Patella for an additional year and there was continued improvement in the (VISA-P), a validated pain and functional activity scale for patellar PRP group without similar improvement in the corticosteroid group tendon injury analogous to that used for the Achilles. The third randomized controlled trial was by Krogh et al comparing PRP (n 20), saline (n 20), and corticosteroid (n 20). There are 4 for 25 months; however, the PRP and saline group had only had randomized controlled studies but their numbers are small. Three of symptoms for 17 months whereas the corticosteroid group had these studies show benefit from PRP and one did not have an end symptoms for 36 months. The primary outcome measure was the point long enough to assess whether PRP was effective. Conclu- Patient Rated Tennis Elbow Evaluation (PRTEE) score, a validated sions that can be drawn at this point are that PRP should be pain and function score for the elbow. This study was initially considered after other conservative treatments have failed, in designed to look at outcomes at 6 months and 1 year; however, more particular eccentric exercises. In addition, if effective, PRP takes 3 than half of the study participants in all groups had dropped out by 6 to 6 months to show benefit, but healing can continue out to 2 years. At 1 month, the corticosteroid group had better PRTEE activity modification, which may adversely affect both physical and scores than the other groups; however, at 3 months, all groups had mental health. More research is needed, such as studies that include statistically equivalent scores. At the time the study was ended, the corticosteroid group was returning toward its baseline and the PRP group was trending toward improvement. It is PRP in arthritis unfortunate that 6- and 12-month data were not available as in other OA is a degenerative disease of the joints that affects the articular 6,12,14,25 cartilage, synovium, and subchondral bone.

The authors performed a series of post-hoc exploratory analyses to identify subgroups of patients who did not have a favorable net clinical benefit discount super cialis 80mg without a prescription. Net benefit (presumably hazard ratio <1) or net harm (presumably hazard ratio >1) was defined as the rate of death from any cause buy 80 mg super cialis, nonfatal myocardial infarction cheap super cialis 80mg mastercard, nonfatal stroke, or non-coronary artery bypass graft-related nonfatal major bleeding. Patients who had a previous stroke of transient ischemic attack had net harm from prasugrel (hazard ratio, 1. Patients weighing less than 60 kg had no net benefit from prasugrel (hazard ratio, 1. Newer antiplatelet agents 45 of 98 Final Update 2 Report Drug Effectiveness Review Project In 20 332 patients with recent ischemic stroke who participated in the good-quality 42 PRoFESS trial, the finding of noninferiority of the fixed-dose combination of extended-release dipyridamole plus aspirin over clopidogrel for the primary outcome of recurrent stroke was consistent in subgroups of patients with obesity (8. One fair-quality, head-to-head trial that compared clopidogrel 75 mg and ticlopidine 200 mg in Japanese patients with prior stroke for 52 weeks provided insufficient data to determine how the relative difference between the 2 drugs was impacted for the outcome of any recurrent 41 cardiovascular events. When multivariate analysis was performed using combined data from the clopidogrel and ticlopidine groups, the presence of diabetes (adjusted hazard ratio, 2. No comparison of clopidogrel and ticlopidine in patient subgroups based on diabetes or hyperlipidemia status was reported, however. Indirect evidence 21 In a subset analysis of CURE, patients with diabetes had a lower incidence of the first primary outcome on clopidogrel plus aspirin than placebo plus aspirin (14. Likewise, patients without diabetes also had a lower incidence of the first primary outcome with clopidogrel plus aspirin than placebo plus aspirin (7. Patients with diabetes had higher event rates than nondiabetics but within the diabetic group, those on clopidogrel plus aspirin showed a benefit compared to placebo plus aspirin. In several prespecified subgroup analyses using the primary endpoint in the 23 CHARISMA trial, patients with and without a history of diabetes, hypertension, hypercholesterolemia, stroke, prior coronary artery bypass graft surgery or percutaneous coronary intervention, or prior myocardial infarction were evaluated. In addition to these groups, current smoking, body mass index, gender, and age were also included in the analyses. All subgroups, except patients with no history of myocardial infarction or coronary artery bypass graft surgery and patients with a 30 or greater body mass index score fared better with clopidogrel plus aspirin than aspirin alone as represented by the hazard ratios for each subgroups (see also gender section). Diabetes was prevalent in 42% of the study population. Hazards ratios for other subgroups mentioned in the text including patients with and without peripheral arterial disease or prior transient ischemic attack were not depicted. In ESPS-2, rates of first stroke (fatal and nonfatal) were evaluated in subgroups of patients with noninsulin-dependent diabetes mellitus and insulin-dependent diabetes mellitus. In patients with noninsulin-dependent diabetes mellitus, compared to taking aspirin alone, rate of first stroke was slightly higher with the fixed-dose combination of extended-release dipyridamole plus aspirin (12. However, comparative statistics within subgroups were not provided. The analysis used external stroke validated Newer antiplatelet agents 46 of 98 Final Update 2 Report Drug Effectiveness Review Project models from the Framingham Study and the Stroke Prognostic Instrument II (SPI-2) to estimate the risk. Estimated risk categories based on the ESPS-2 baseline variables were converted to risk scores using these 2 models. Compared with aspirin alone, treatment with extended-release dipyridamole/aspirin resulted in substantial relative hazard reductions for stroke within some of the specific risk factor subgroups including those younger than 70 years of age, those with hypertension, prior myocardial infarction, prior stroke or transient ischemic attack, and any prior cardiovascular disease, and current smokers. The greatest relative hazard reduction for stroke or vascular events was among patients who already had experienced a stroke or transient ischemic attack before the qualifying event. Those who already had at least 2 prior events (transient ischemic attack/stroke), of which 1 was the qualifying events for inclusion into the study, had the least incidence of subsequent stroke compared to those who had only 1 prior event (the qualifying transient ischemic attack/stroke). Patients with a history of myocardial infarction who were treated with extended-release dipyridamole/aspirin had a 36. Patients with any prior cardiovascular disease had a 27. Patients taking extended-release dipyridamole/aspirin had a greater relative hazard reduction for the endpoint of combined stroke or vascular events among those patients with a prior stroke or transient ischemic attacks, previous myocardial infarction, 72 and among current smokers. The annual risk for recurrent stroke among those treated with aspirin increased from 3. Relative hazard reductions favored the combination of aspirin plus extended- release dipyridamole in all the subgroups, and were greatest for the high-risk Framingham group and the moderate-risk SPI-2 subgroup. Similar results were observed for stroke or vascular events. The post-hoc analysis suggested that extended-release dipyridamole/aspirin provides greater benefit for patients with a higher risk for stroke, as per predicted stroke probabilities. Newer antiplatelet agents 47 of 98 Final Update 2 Report Drug Effectiveness Review Project Table 6. Stroke or vascular event rates in ESPS-2: extended-release 72 dipyridamole/aspirin or aspirin monotherapy Number With extended- With a of release aspirin Relative hazard P a Risk group subjects dipyridamole/aspirin only reduction (CL) values Annual stroke rates Framingham stroke risk score 1453 3. Abbreviations: CL, confidence limit For Framingham Study model: the 10-year stroke probability (primarily first stroke) is low (≤0. Other Medications Proton pump inhibitors We found no head-to-head trials that directly compared different newer antiplatelet agents in subgroups of patients based on proton pump inhibitor use. Indirect evidence of the effects of individual newer antiplatelet agents taken with or without a proton pump inhibitor was found only for prasugrel and clopidogrel. Outcomes with concurrent use of clopidogrel and proton pump inhibitors were evaluated 73 74-90 in 1 randomized controlled trial and numerous observational studies. We found 1 randomized controlled trial that was prospectively designed to evaluate the concomitant use of 73 proton pump inhibitors and newer antiplatelet agents. In the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT), a total of 3873 patients with an indication for long- term dual antiplatelet therapy with aspirin and clopidogrel (e. However, because the fixed-dose combination product was not yet approved for use in the United States or Canada Newer antiplatelet agents 48 of 98 Final Update 2 Report Drug Effectiveness Review Project at the time of this review, we did not include or fully appraise the quality or results of COGENT and did not draw any conclusions about its findings. Many observational studies have examined whether the cardiovascular effectiveness of 74-84 clopidogrel is decreased in patients taking a proton pump inhibitor. However, as observational studies were included in our review only to evaluate harms and not effectiveness outcomes, we did not fully evaluate the quality or results of these studies. But, according to the Expert Consensus Document released in November 2010 by the American College of Cardiology 91 77-80, 84 Foundation (ACCF) Task Force, some studies found a significant increase in risk of various composite cardiovascular endpoints with concomitant proton pump inhibitor use that ranged from an odds ratio of 1. In contrast, other studies found no significant difference in 74-76, 81-83 cardiovascular outcomes with or without use of a proton pump inhibitor. We identified 9 observational studies that evaluated the potential benefit of taking a 74, 75, 82, 85-90 proton pump inhibitor to reduce clopidogrel-related gastrointestinal bleeding. Four observational studies evaluated bleeding outcomes with concurrent use of clopidogrel and proton pump inhibitors in broadly-defined patient populations with average risk of gastrointestinal 74, 75, 82, 85 75, 82 bleeding. Two were good-quality large-scale, population-based cohort studies, 1 was a post-hoc, observational analysis of patients in each arm of the TRITON-TIMI 38 74 85 trial, and 1 was a small, cohort study of patients from a single university hospital. The small cohort study was rated poor quality because it had significant differences in clinical characteristics between groups at baseline, but conducted no statistical analysis to adjust for these potential confounders. The 2 good-quality cohort studies had somewhat consistent results regarding effects of 75, 82 proton pump inhibitor use on overall gastrointestinal bleeding outcomes. The first cohort study used data from the Danish National Patient Registry to identify 56 406 patients discharged 75 after first-time myocardial infarction with a prescription for clopidogrel. When a time- dependent, propensity score-matched, Cox proportional hazards regression analysis was performed (N=13 112), the reduction in risk for any gastrointestinal bleeding in patients receiving a proton pump inhibitor compared to those not receiving a proton pump inhibitor did not reach statistical significance (hazard ratio, 0. Specific sources of gastrointestinal bleeding were not evaluated separately.

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C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or buy super cialis 80mg free shipping,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed L ah meyer cheap 80mg super cialis fast delivery, Patients h ad to h ave a h istory Patients were excluded ifth ey:(a) M eanage (SD): 178/ 27/ 31 days Z olpidem 1997 (F air) ofa minimum of3 month s of h ad used any investigationaldrug 44 cheap super cialis online mastercard. Patients wh o were sh iftworkers and womenwh o were breastfeeding were also excluded. Inaddition, patients with coexistingmedicalor psych iatricconditions (based ona prestudy evaluationofmedicaland sleeph istory,ph ysicalexamination, vitalsigns,clinicaland laboratory tests,EC G and urinalysis)were excluded from th e study. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed L ofaso,1997 A llincluded patients were Patients were excluded ifph ysical M eanage (SD):46 N R / N R / 7 days Z olpidem; (F air) subjects with U A R S takenfrom examination,laboratory tests (9); a groupofh eavy snorers wh o (serum creatinine and h epatic complained ofdaytime enz ymes)electrocardiograph tiredness and/orsleepiness. Subjects with a currentmedicalillness ora h istory ofserious psych iatricdisease or wh o were takingmedicationknown to affectsleeporvigilance were excluded. Patients were also required to h ave a h abitual consumptionofmore th anfour caffeine-containingbeverages per day and to h ave no h istory of alcoh olabuse. Beverages containingalcoh olorcaffeine were proh ibited duringth e days ofstudy. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M cC all2006 Patients aged 64-86 years wh o Patients were excluded ifth ey h ad M eanage (SD): 782/ 9/ 2 weeks Esz opiclone; (F air) metDSM -IV criteria for secondary insomnia orany 71. A mean severe C O PDoradvanced sleep W A SO of20 mins ormore, ph ase syndrome,orifth ey used with no nigh t<15 mins,a mean drugs knownto affectsleepwith in3 L PS of20 mins ormore with nodays,melatoninorany h erbal nigh t< 15 mins. Patients with supplements with alleged C N S comorbid conditions th atwere effects with in14 days orST. M edical were allowed ifth eirdisease abnormalities orunstable ch ronic was stable. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M oldofsky, Diagnosis ofF M was based on Patients were excluded ifth ey h ad M eanage (SD):42 N R / 3/ 4 days Z olpidem 5mg; 1996 (F air) th e A mericanC ollege of a serious medicalorpsych iatric (2); R h eumatology criteria to disorderoreith ersleepapnea or diffuse myalgia,atleast11 to sleeprelated periodicinvoluntary 18 tenderpoints inspecific limbmovementdisorderon anatomicregions,ch ronic polysomnograph y. O th erwise,allpatients were determined to be ingood h ealth based ona medicalh istory, examination,electrocardiogram, and laboratory analyses ofblood and urine samples. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onch esky, A dults patients were enrolled Pregnancy and breast-feeding; M eanage (SD):N R N R / 0/ 7 days Z olpidem; 1986 (F air) wh o h ad suffered from concomitantuse ofneuroleptics, (N R ); insomnia foratleastth ree sedatives,analgesics,or month s and metatleasttwo ofantidepressants;a h istory ofdrug th e followingcriteria:(1)sleep abuse oraddiction;a h istory of latency of45 minutes ormore, serious psych iatric,h epatic,renal, (2)more th anth ree nigh tly ormetabolicdisorders;epilepsy;a awakenings with difficulty in knownh ypersensitivity to h ypnotic fallingasleepagain,(3)early drugs;abnormalliverorrenal finalmorningawakening,and function;abnormalh emogram (4)totalsleeptime ofusually values;and anestablish ed 0% female; N R / 2/ Placebo; less th anfive h ours and always diagnosis ofsleepapnea R ace/eth nicity:N R 99 91 ; less th ansixh ours. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onch esky, M ale and female sh iftworkers Subjects previously receiving M eanage (SD): N R / N R / 12 days Z opiclone; 1989 (F air) betweenth e ages of22 and 55 h ypnoticmedicationwere eligible to 34. To be excluded ifth ey were pregnant, included inth e study, lactatingorwere notusinga participants h ad to alternate medically recogniz ed contraceptive betweena two-week day sh ift meth od. Subjects wh ose sleep (07:00 to 15:30 h )and a two- performance was disrupted by week nigh tsh ifts (18:00 to externalfactors and th ose taking 02:30 h )foratleastone year. During ofh ypersensitivity to one ormore each sh ift,two 10-minbreaks, h ypnoticdrugs were excluded. Sh ift psych iatricormedicaldisorderwere workers h ad to presenta also excluded as were th ose with a h istory ofinsomnia ofth ree or h istory ofalcoh olism,drugabuse or more consecutive day ornigh t caffeine overuse. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onti,1996 A llpatients were sufferingfrom Pregnantwomen,womenofch ild- M eanage (SD): N R / N R / 27 days Z olpidem; (F air) atleast2 ofth e followingsleep bearingage with inadequate 44. A lcoh olabuse orintake ofh ypnotics oranxiolytics and/orantidepressants inth e seven days priorto th e baseline period 83% female; N R / N R / Placebo; also led to exclusion. R ace/eth nicity:N R 12 12 ; ; Insomnia 44 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onti,2000 Patients aged between27 and Patients with poorh ealth ,acute or M eanage (SD): N R / N R / 15 days Z olpidem; (Poor) 59 years,with ch ronicprimary ch ronicpain,decompensated 51. Patients with poorh ealth ;acute orch ronic pain;h epatic,renal,respiratory, cardiac,orneuropsych iatric diseases [subjects with a score of H A M D> 18,ora score ofH A M A (14 items)>16 were notincluded]; knowndrugallergy orabuse; periodiclegmovements during sleep;restless legs;orsleepapnea were excluded from th e study,as also were pregnancy women, breast-feedingmoth ers,subjects deemed insufficiently compliant,or th ose with clinically significant deviations inth eirlaboratory tests. A lcoh olabuse,intake ofh ypnotics oranxiolytics inth e sevendays priorto baseline period,ora positive benz odiaz epine urine screeningalso led to exclusion. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed Parrino (F air) H ypnoticnaïve subjects and h istory ofanxiety disorders,major M eanage (SD): N R / 4/ 6 days Z olpidem; metallcriteria fordiagnosis of depressioncriticalmedical 32. Sleepapnea, periodiclimbmovementand oth er 50% female; N R / 0/ Placebo; sleepdisorders R ace/eth nicity:N R 12 8 Z olpidem; Placebo; Perlis,2004 Patients aged 18 to 64 years Exclusioncriteria included M eanage (SD): 322/ 10/ 84 days Z olpidem; (F air) were eligible forth e study presence ofany significant 40. A dditionally,female patients were ineligible ifth ey were breastfeeding,pregnant,ornot usingdouble-barriercontraceptive meth ods. A 2-nigh t medicationwith in1 and 2 weeks (screening)meanPSG W A SO priorto screening,respectively. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed >= 40 minutes (not<30 R ace/eth nicity: 205 N R ; minutes oneith ernigh t),and 95. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed R oth () A dults 18-64 years ofage with DSM =IV axis I psych iatric M eanage (SD): N R / 20/ 21 days Z olpidem; primary insomnia,DSM -IV disorderorany sleepdisorder, 44. Two nigh tmean wk priorto screeningh aving W A SO ofatleast30 mins and received any substance with C N S TST between3 and 7 h our effects 58% female; N R / 1/ Placebo; each screeningnigh t R ace/eth nicity: 212 212 ; C aucasian90% ; A tscreening:65 years orolder Significantpsych iatricormedical M eanage (SD): N R / 0/ 9 weeks R amelteon ,diagnosis ofch ronicprimary illness as determined by th e 70. A t ramelteon)includingsleepaids and randomiz ation:meanL PS =20 h erbalpreparations with C N S mins on2 nigh ts with neith er effects,with in3 weeks ofbaseline nigh t<15 mins and a mean orwh o h ad flownacross more th an W A SO =60 mins with a wake 3 time z ones with in7 days of time =45 mins oneach ofth e 2 screening. A trandomiz ation: 63% female; N R / 0/ R amelteon8 nigh ts. A H I>15 orperiodiclegmovements mg; with arousalindex>20 onPSG. R ace/eth nicity: 100 100 Placebo; C aucasian:95% A sian:1% H ispanic:4% Black, N ative A merican, O th er:0% ; Insomnia 48 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed R amelteon 4mg; R amelteon 8mg; Placebo; ; R oth 2006 A ge 65 years orolderwith a Patients could noth ave h ad any M eanage (SD): N R / 128/ 5 weeks R amelteon4 (F air) diagnosis ofprimary insomnia significantmedicalorpsych iatric 72. Body mass indexmust h ave beenbetween18 and 34, inclusive,and h abitualbedtime musth ave beenbetween8:30 pm and 12:00 am. F orsubset ofpatients with severe sleep onsetdifficulties (sSL =60) 0% female; N R / N R / R amelteon8 receiving8 mgorplacebo were mg; included inposth ocanalysis R ace/eth nicity:N ot 829 N R Placebo; reported ; Sch arf,2005 M enand womenbetweenth e Patients with a priorh istory of M eanage (SD): 353/ 21/ 14 days Esz opiclone (F air) ages of65 and 85 years wh o allergies to z opiclone orany 72. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed excluded. R ace/eth nicity:N R 119 119 Placebo; ; Insomnia 50 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed Soares 2006 W omenaged 40-60 yrs wh o obstructive sleepapnea,h istory of M eanage (SD):49 642/ 51/ 4 weeks Esz opiclone; metDSM -IV criteria for substance abuse ordependence, (); insomnia inth e contextof consumptionofmore th an2 menopausaltransition,peri alcoh olicbeverages perday or14 menopausalorearly post perweek,use ofprescription menopausalwith variable cycle medications knownto affectsleep, length ;late menopausal and th e use ofoverth e counter transitionwith two ormore medicationaffectingsleepormood. Sleeplatency >= 45 minand sleepduration <= 6h ,>= 3x/wk for1 month ; insomnia symptoms post-date 100% female; N R / N R / ; onsetofperi-menopausal R ace/eth nicity: 410 410 ; symptoms,with no oth ercause C aucasian:77% ofsecondary insomnia Black:15% H ispanic:8% ; Soubrane DSM -IV-defined primary A ny DSM -IV A xis I psych iatric M eanage (SD): N R / 20/ 3 weeks Z olpidem M R ; (poster)(F air) insomnia,W A SO 1 h ourper disorder,sleepdisorder,h istory of 44. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup h ours pernigh tduringth e 2 counterorprescriptionsleep Enrolled A nalyz ed weeks priorto enrollment. C aucasian,10% oth er ; Terz ano, patients metth e criteria forth e patients h ad nocturnalmyoclonus M eanage (SD): N R / N R / 1 days Z olpidem; 1992 (Poor) diagnosis ofpersistent orsleepapnea syndrome 49. W A SO ofatleast30 circadianrh yth m disorder, mins oneach nigh twith a parasomnia,and dyssomnia), meanW A SO ofatleast40 h istory ofepilpesy,parasomnia and mins,a totalsleeptime of dissomnia),h istory ofepilepsy, between3 and 7 h ours on myasth enia gravis,evidence ofany each nigh t clinically significant,severe or unstable progressive,progressive, medicalorsurgicaldisorder,h isotry ofsubstance abuse,lifestyle th at precludes diagnosis ofprimary insomnia,use ofsleepmedication inth e previous 2 weeks, concommitantuse ofany psych otropicdrugoroth er substance knownto affectsleep with inth e previous week. Insomnia 52 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup p Enrolled A nalyz ed 57% female; N R / 0/ Placebo; R ace/eth nicity: 205 203 ; W h ite:95. Patients h ad to be off ofoth erinsomnia medications at 0% female; N R / 80/ Placebo; screening.

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Prevention of postoperative nausea and vomiting: Head-to-head trials… generic super cialis 80 mg visa. generic super cialis 80 mg without a prescription. super cialis 80mg for sale. Quality assessment of the head-to-head trials for the prevention of postoperative nausea and vomiting…………………………………………………………………. Prevention of postoperative nausea and vomiting: Active-control and placebo-controlled trials………………………………………………………………………………. Quality assessment of active-control and placebo-controlled trials for prevention of postoperative nausea and vomiting…………………………………………………. Treatment of established postoperative nausea and vomiting: Systematic reviews…………………………………………………………………………………………………. Treatment of established postoperative nausea and vomiting: Comparative clinical trials……………………………………………………………………………………………. Quality assessments of the comparative clinical trials of treatment of established postoperative nausea and vomiting……………………………………………………482 Evidence Table 16. Long term uncontrolled intervention studies of safety and adverse events…………………………………………………………………………………………………... Quality assessment of long term uncontrolled intervention studies of safety and adverse events…………………………………………………………………………………… 492 Note: A scan of the medical literature relating to the topic is done periodically (see the Drug Effectiveness Review Project website at http://www. The Drug Effectiveness Review Project governance group elected to proceed with another update of this report. Please see the timeline on the DERP website for details on the date of its release. Prior versions of this report can be accessed at the DERP website. Antiemetics Page 2 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity C h ildren Jaing granisetronpo0. N R 5 Antiemetics Page 3 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics C h ildren Jaing 2004 35/33/33 0/0/33 Acutelym phoblastic leukem ia:100% M ulticenter 3 F orni 2000 N R /N R /90 N R /0/90 N R N otspecified 5 Antiemetics Page 4 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults C h ildren G ranisetronvsO ndansetron Jaing Com pleteresponse:noem etic episodesandnoneedforrescuem edication: 2004 W ithin24h:60. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents C h ildren Jaing 2004 "Them ostfrequentlyreportedAE swerem ildheadacheandconstipation. N oconcom itantantiem etic therapyapartfrom thestudydrugswasgivento M ulticenter TheAE swerethesam einboth groups. W ithdrawaldata:N o casesof dosereductionof antiblastics;in2ptstheifosfam ide(ifo)cycle wasstopped(ondays4& 5of infusion)becauseof neurotox icity. In N otspecified HeadachewastheonlyAE theauthorsreported;theystatedthatitwasof cisplatin-Adriam ycincyclesthecom pleteprotection(CP)ratedecreased 5 m ildintensityanditsfrequencywasthesam einall3treatm entgroups. O nthethirddaywhenAdriam ycinwas given,thetotalprotection= 44% (P<0. CP wasachievedin 19% onlyforonetypeof chem ocycle;therem aining 71% ex perienced em esisinboth cyclesforatleast1day. Antiemetics Page 6 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity Sepulveda- M eanage:11years Vildosola 2 R CT,D B, O ndansetronIV 8m g/m R ange:2-15 2008 N one N R N R /N R Parallel PalonosetronIV 0. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics Sepulveda- Vildosola Previoustreatm entwith chem otherapy:86% 2008 N R /N R /100 N R /N R /100 N auseaorvom iting inpreviouschem otherapy:76% SingleCenter 2-5 Antiemetics Page 8 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults PalonosetronvsO ndansetron Com pletecontrolof em etic eventsatday1:92% vs72% Com pletecontrolof em etic eventsatday2:72% vs46% Com pletecontrolof em etic eventsatday3:78% vs54% Com pletecontrolof em etic eventsatday4:88% vs84% Sepulveda- Com pletecontrolof em etic eventsatday5:98% vs90% Vildosola Com pletecontrolof em etic eventsatday6:100% vs94% 2008 Com pletecontrolof em etic eventsatday7:100% vs96% SingleCenter 2-5 Absenceof nauseaatday1:74% vs38% Absenceof nauseaatday2:62% vs18% Absenceof nauseaatday3:72% vs30% Absenceof nauseaatday4:88% vs58% Absenceof nauseaatday5:98% vs88% Absenceof nauseaatday6:98% vs92% Absenceof nauseaatday7:98% vs94% Antiemetics Page 9 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents Sepulveda- Vildosola 2008 N R SingleCenter 2-5 Antiemetics Page 10 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity W h ite D ex am ethasone2-4m g 8 2000 D BR CT O ndansetroniv 5m g/m 2 Children,kinetosis powasgivenalong with N o/N R 58%m ale M ulticenter Parallel O ndansetronpo 8m g studyantiem etics N R 4,5 Antiemetics Page 11 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics W h ite M eanweight(+/-SD )= 28. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults O ndivvsO ndpo Com pletecontrolof em esis(0episodes) Treatm entphaseA:73% vs71%,N S O verall(A+B):62% vs62%,N S Treatm entD ay1:81% vs78%,N S M ajorcontrolof em esis(1-2episodes): Treatm entA:16% vs17%,N S W h ite O verall(A+B):23% vs20%,N S 2000 Treatm entD ay1:10% vs13%,N S M ulticenter M ildN ausea 4,5 Treatm entD ay1:21% vs21%,N S PhaseA (alittlebitnauseous):26% vs26%,N S O verall(A+B):36% vs33%,N S N onauseaex perienced: Treatm entD ay1:73% vs70%,N S O verall(PhasesA +B):52% vs56%,N S PhaseA:64% vs64%,N S % with reducedappetiteduring treatm ent:increasedby7% from baselinevsincreasedby12% from baseline,N S Antiemetics Page 13 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents O ndpoadm inisteredasanoralsyrup,notatablet. Studym edication adm inisteredduring 2phases:phasesA andB. Ptsallowedtoreceive1or2single daysof noorlow em etogenic chem oinbetweenthedaysthattheyreceived O ndivvsO ndpo m oderately/highlyem etogenic chem o. W h ite AllAdverseE vents:20% vs19%,N S Treatm entphaseBdefinedasthe2daysim m ediatelyfollowing cessation 2000 Abdom inal/gastrointestinaldiscom fortandpain:4% vs3%,N S of m oderately/highlyem etogenic chem o(orif ptsreceivedchem oof low M ulticenter F ever/pyrex ia:3% vs3%,N S em etic potentialfor≥2consecutivedays). AllptsreceivedO nd4m g po 4,5 D iarrheaandheadaches:2% vs2%,N S during phaseB. AllptsreceivedO nd4m g po+D ex 2-4m g po6-8h after SeriousAE s:≤2% vs≤2%,N S receiving theIV. D ex givenaccording tothebodysurfacearea(BSA): 4m g/dforptswith BSA≤ 0. Thisregim en wasfollowedeach dayof m oderateorhighlyem etogenic chem o. Antiemetics Page 14 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity Allreceived O rch ard O ndansetronivm g dex am ethasoneiv10 38. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics Conditioning regim en:Chem oonly:22% Chem oplusradiation:75% W eight(range)= 72kg (11-132kg) Autologoustransplant:35% Allogeneic transplant:26% U nrelatedtransplant:35% O rch ard N onm alignancy:16% 1999 Aplastic anem ia:7% N R /N R /193 4/2/187 SingleCenter Im m unedeficiency:2% 5 M etabolic disorder:8% Acutelym phocytic leukem ia:3% AM L /M D S:21% Chronic m yeloidleukem ia:25% L ym phom a:10% Breastcancer:6% O therm alignancy:15% C orapcioglu 2005 N R N R /N R /22 N R /N R /22 N R 5 Antiemetics Page 16 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults O ndansetronvsG ranisetron M eanno. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents Patientswereundergoing hem atopoietic celltransplants;resultswere O ndansetronvsG ranisetron stratifiedbyage(<18,n= 51;≥ 18n= 136)andanalyz ed. Thepediatric populationof thisstudywasreceiving SingleCenter D iz z iness:2% vs4%, HSCT fornonm alignantconditionsatam uch higherpercentage(51% vs. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity A dult A prepitantvs ondansetron 59 63% m ale Asian:17. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics A dult A prepitantvs ondansetron Historyof m otionsickness:5. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults A dult A prepitantvs ondansetron Aprepitantgroup vscontrolgroup Com pleteresponse0-120h aftersurgery:72% vs60.

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A subgroup analysis showed that depressed alcoholics who were cocaine abusers (N=17) had a significantly worse outcome than depressed alcoholics who were not (N=34) purchase super cialis with paypal. Cocaine abusers showed significantly worse outcomes on both the HAM-D (P=0 buy 80mg super cialis fast delivery. A fair generic super cialis 80mg with amex, small RCT assessed the efficacy and tolerability of fluoxetine treatment (20-60 mg/d) compared to placebo for the treatment of major depression in 44 methadone-maintained 312 opioid addicts. Study duration was 3 months; loss to follow-up was 15. Both groups had significantly decreased scores on BDI and HADRS (z = 2. Efficacy did not Second-generation antidepressants 96 of 190 Final Update 5 Report Drug Effectiveness Review Project differ significantly between placebo and fluoxetine treatment. However, the sample size was small and the study is likely to be underpowered (no power calculations were reported). A poor quality study investigated the efficacy of fluoxetine (40 mg/d) in 68 cocaine- 313 dependent patients with MDD. The trial was rated poor for efficacy due to its high attrition rate (53%), but we included it here because of the dearth of evidence on this topic. Results showed no difference in efficacy between fluoxetine and placebo at the end of this 12-week study. One fair 16-week RCT assessed the efficacy and tolerability of fluoxetine (20 mg/d) plus cognitive behavior therapy compared with placebo plus cognitive behavior therapy in 126 adolescents (mean age 17. Decreases in Childhood Depression Rating Scale-Revised (CDRS-S) scores were greater in fluoxetine- than placebo-treated patients (-22. There were no differences between groups in substance abuse disorder, conduct disorder or urine drug screen. In addition, there were no differences between groups in the incidence of adverse events. A small, fair-rated 12-week RCT of 50 patients compared the efficacy of fluoxetine (20mg/d) versus placebo for the treatment of depressive symptoms and drinking behavior in 311 adolescents (15-20 years of age) with comorbid MDD and an alcohol use disorder. All study participants also received sessions of cognitive behavioral therapy and motivation enhancement therapy. While participants in both arms experienced improvements in depressive symptoms and drinking-related outcomes, no significant differences in depressive symptoms or drinking behavior between the treatment groups were found. Nefazodone compared with placebo One randomized trial compared nefazodone and placebo in the treatment of depressed patients 315 with depression and comorbid alcohol dependence over a 10-week period. HAM-D scores at endpoint showed no significant difference between treatment groups in depressive symptoms (P=0. More nefazodone-treated patients were abstinent during treatment; however, the difference did not reach statistical significance (P=0. Paroxetine compared with placebo A fair study randomized 42 subjects with social anxiety disorder and a co-occurring alcohol use 316 disorder to paroxetine (10-60 mg/d) or placebo for 16 weeks. Decreases in total LSAS scores were significantly greater for paroxetine- compared to placebo-treated patients (53% compared with 32%, P=0. A higher percentage of paroxetine-treated patients were CGI responders (defined as improvement score of 1 or 2) compared to placebo-treated patients (55% compared with 27%). The mean reductions in Social Phobia Inventory (SPIN) results were greater in the paroxetine group but did not reach statistical significance (46% compared with 31%, P=0. Three specific adverse events occurred significantly more frequently in paroxetine-treated patients: tremor (45% compared with 14%, P=0. Second-generation antidepressants 97 of 190 Final Update 5 Report Drug Effectiveness Review Project Sertraline compared with placebo Three fair RCTs compared sertraline and placebo in the treatment of patients with depression and 317-319 co-occurring alcohol dependence. A 24-week study compared sertraline (50-150 mg/d) with placebo in recently detoxified 317 alcohol-dependent patients with current depressive symptoms. Response (> 50% decrease in MADRS score) was slightly higher in sertraline- than placebo-treated patients (44% compared with 39%). Both groups experienced significant improvements in HAM-D and MADRS scores during the study, but the two groups did not differ significantly. Relapse rates were higher in sertraline- than placebo-treated patients (31. Adverse event rates were similar for both treatment groups. The overall attrition rate was greater than 40 percent; however, there was not a significant difference in withdrawal between groups (sertraline, 45% compared with placebo, 44%). In this fair study, 82 currently depressed, actively drinking alcohol-dependent subjects were randomized to sertraline (50-200 mg/d) or placebo. There was no significant difference between groups in depression symptoms. However, in women, treatment with sertraline was associated with less depression at the end of treatment than those receiving placebo based on HAM-D scores (P=0. There was no difference between groups in time to first heavy drinking day (P=0. Sertraline-treated subjects had fewer drinks per drinking day compared to placebo-treated subjects; the difference was significant (P=0. Less drinking during the study was associated with improved depression outcomes. Serious adverse events occurred in four subjects: three treated with sertraline and one treated with placebo. Loss to follow-up was twice as high in the placebo group (33%) compared to the sertraline group (16%); however, details were not reported on withdrawals due to tolerability or lack of efficacy. This study randomized 328 patients with co-occurring MDD and alcohol dependence to sertraline (50-200 mg/d) or placebo for 10 weeks. After the run-in period, two groups of patients were randomized separately based on HAM-D scores: Group A scores were > 17 while Group B scores were < 16. Mean reduction in HAM-D scores did not differ significantly between all sertraline-treated (-10. There were significant differences in HAM- D response rates by group stratification. In Group A, sertraline led to significantly higher response rate than placebo (64% compared with 47%, P=0. However, in Group B, sertraline patients had a significantly lower response rate than placebo patients (58% compared with 77%, P=0. There were no significant differences between medication groups in the reduction in BDI score from baseline to endpoint nor within Group A or Group B. No significant differences were detected between medication groups in drinking measures. Overall, the incidence of adverse events was similar between medication groups; however, significantly more sertraline-treated patients discontinued due to adverse events than placebo-treated patients (P<0.

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