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Differential impact of combination antiretroviral therapy in preventing Kaposi’s sarcoma with and without visceral involvement purchase slimex 10 mg fast delivery weight loss pills usa. Phase II AIDS Malignancy Consortium trial of topical halofuginone in AIDS- related Kaposi sarcoma buy slimex paypal weight loss pills not approved fda. Phase II trial of imatinib in AIDS-associated Kaposi’s sarcoma: AIDS Malignancy Consortium Protocol 042 best buy slimex weight loss pills research. Kowalkowski MA, Kramer JR, Richardson PR, Suteria I, Chiao EY. Use of Boosted Protease Inhibitors Reduces Kaposi Sarcoma Incidence Among Male Veterans With HIV Infection. Liposomal pegylated doxorubicin versus low-dose recombinant interferon Alfa-2a in the treatment of advanced classic Kaposi’s sarcoma; retrospective analysis of three German centers. Pilot study of oral valganciclovir therapy in patients with classic Kaposi sarcoma. Krown SE, Lee JY, Dittmer DP; AIDS Malignancy Consortium. Krown SE, Li P, Von Roenn JH, Paredes J, Huang J, Testa MA. Efficacy of low-dose interferon with antiretroviral therapy in Kaposi’s sarcoma: a randomized phase II AIDS clinical trials group study. AIDS-associated Kaposi’s sarcoma: is there still a role for interferon alfa? Human herpesvirus 8 presence and viral load are associated with the pro- gression of AIDS-associated Kaposi’s sarcoma. Immune reconstitution inflammatory syndrome associated with kaposi sarcoma: higher incidence and mortality in Africa than in the UK. Treatment of HIV-1-associated Kaposi’s sarcoma with pegylated lipo- somal doxorubicin and HAART simultaneously induces effective tumor remission and CD4+ T cell recovery. Weekly docetaxel is safe and effective in the treatment of advanced- stage acquired immunodeficiency syndrome-related Kaposi sarcoma. Phase 2 study of pegylated liposomal doxorubicin in combination with inter- leukin-12 for AIDS-related Kaposi sarcoma. Lorusso D, Di Stefano A, Carone V, Fagotti A, Pisconti S, Scambia G. Pegylated liposomal doxorubicin-related palmar-plantar erythrodysesthesia (‘hand-foot’ syndrome). Kaposi sarcoma (KS)-associated herpesvirus microRNA sequence analysis and KS risk in a European AIDS-KS case control study. Pegylated liposomal doxorubicin plus highly active antiretroviral therapy versus highly active antiretroviral therapy alone in HIV patients with Kaposi’s sarcoma. Long-term prognosis of HIV-infected patients with Kaposi sarcoma treated with pegylated liposomal doxorubicin. Remission from Kaposi’s sarcoma on HAART is associated with sup- pression of HIV replication and is independent of protease inhibitor therapy. A Martinez V, Tateo M, Castilla MA, Melica G, Kirstetter M, Boué F. Lenalidomide in treating AIDS-related Kaposi’s sarcoma. Treatment response and mortality among patients starting antiretrovi- ral therapy with and without Kaposi sarcoma: a cohort study. The kaposin B protein of KSHV activates the p38/MK2 pathway and stabilizes cytokine mRNAs. Kaposi’s Sarcoma 419 Ramirez-Amador V, Esquivel-Pedraza L, Lozada-Nur F, et al. Kaposi Sarcoma in HIV-negative men who have sex with men. Peginterferon alfa-2a for AIDS-associated Kaposi sarcoma: expe- rience with 10 patients. HIV protease inhibitors are potent anti-angiogenic molecules and promote regression of Kaposi sarcoma. Risk of cancers during interrupted antiretroviral therapy in the SMART study. Cumulative incidence of cancer among individuals with acquired immunod- eficiency syndrome in the United States. Sirolimus for Kaposi’s sarcoma in renal-transplant recipients. Paclitaxel for anthracycline-resistant AIDS-related Kaposi’s sarcoma: clinical and angiogenic correlations. Clinical activity of lenalidomide in visceral human immunodeficiency virus- related Kaposi sarcoma. Retrospective analysis of the efficacy of gemcitabine for previously treated AIDS-associated Kaposi’s sarcoma in western Kenya. Kaposi sarcoma herpes virus antibody response and viremia follow- ing highly active antiretroviral therapy in the Swiss HIV Cohort study. Multicenter trial of low-dose paclitaxel in patients with advanced AIDS- related Kaposi sarcoma. A phase II study targeting vascular endothelial growth factor with the humanized monoclonal antibody bevacizumab in the treatment of patients with HIV-associated kaposi sarcoma. Malignant Lymphomas CHRISTIAN HOFFMANN Malignant lymphomas are neoplastic diseases of the lymphatic system that grow rapidly and aggressively, and lead to death within a few weeks or months if left untreated. Hodgkin lymphoma (HL) is distinguished from the large group of non- Hodgkin lymphomas (NHL). In comparison to the general population, HIV+ patients are affected significantly more frequently by all types of lymphoma. Aggressive non- Hodgkin lymphomas of B cell origin are particularly frequent. The incidence of lymphomas has been markedly reduced by the introduction of antiretroviral therapy. Nonetheless, risk remains greatly elevated relative to the general population (Gibson 2014, Table 1) and there is evidence that this reduction overall was not as impres- sive as with KS or most other opportunistic infections (COHERE 2009, Franceschi 2010). Thus, the relative proportion of lymphoma among all AIDS-associated ill- nesses is increasing. The decline of incidence seems to be greater for lymphoma sub- types that mainly occur in severe immunodeficiency (Kirk 2001, Polesel 2008). In some HIV cohorts, malignant lymphomas have already overtaken KS as the most frequent malignancy.
Detailed assessment 206-211 Six reviews evaluated the safety profiles of statins 10 mg slimex sale weight loss challenge. In addition to the reviews of safety with statins buy 15mg slimex weight loss pills inland empire, we reviewed the 83 head-to-head statin low-density lipoprotein cholesterol-lowering trials to determine whether there were any significant differences in adverse events buy 15 mg slimex otc weight loss 51. One meta- analysis of 18 randomized placebo-controlled trials comparing the adverse event rates for the different statins determined the number needed to harm compared to placebo to be 197 for 211 overall adverse events. Over 85% of the data came from trials of simvastatin and pravastatin. Serious events (creatine kinase greater than 10 times the upper limit of normal or rhabdomyolysis) were infrequent (number needed to harm, 3400 for myopathy and 7428 for 211 rhabdomyolysis). Another large meta-analysis reviewed 119 randomized controlled trials from 209 the years 1982 to 2006 that involved 86 000 study participants. Most of the data came from Statins Page 58 of 128 Final Report Update 5 Drug Effectiveness Review Project trials of pravastatin and simvastatin with only 2 involving rosuvastatin. Although there was an increased incidence of myositis (odds ratio, 2. One meta-analysis of 4 randomized controlled trials evaluated the adverse events of intensive dose statin therapy of atorvastatin, simvastatin, or pravastatin compared to moderate 210 dose therapy. They found that the number needed to harm for any adverse event was 30 (odds ratio, 1. The number needed to harm for discontinuing therapy due to an adverse event was 47, for elevated transaminases was 86, and for elevation in creatine kinase greater than 10 times the upper limit of normal was 1534. There were no differences in the rate of rhabdomyolysis. From their analysis, treating 1000 patients would prevent significant health outcomes (4 cardiovascular deaths, 10 myocardial infarctions, and 6 strokes) while causing 33 adverse events: 21 adverse events requiring drug discontinuation and 12 instances of elevated liver function test values. Thus for every outcome prevented, there would be 8 adverse events of 210 any type. A postmarketing analysis of adverse event data reported to the US Food and Drug Administration compared events reported in the first year of rosuvastatin use to events reported for atorvastatin, simvastatin, and pravastatin during the same period and during their first years 212 of marketing. Data from the first year of use of cerivastatin was also included. The primary analysis was a composite endpoint of rhabdomyolysis, proteinuria, nephropathy, or renal failure. Secondary analyses of overall adverse event rates and specific adverse events were also conducted. In the concurrent time period analysis, the rate of rosuvastatin-associated adverse events (composite endpoint) was significantly higher than simvastatin, pravastatin, and atorvastatin. In the analysis of the first year of marketing, the rate of rosuvastatin-associated adverse events was significantly higher than pravastatin and atorvastatin, but not simvastatin. Events with rosuvastatin were less frequent compared with the first year of marketing of cerivastatin. In secondary analyses, the rate of all adverse events was significantly higher with rosuvastatin than with simvastatin, pravastatin, and atorvastatin. Results for both the concurrent time period and first-year of marketing analyses were similar. For serious adverse events, the rate for rosuvastatin was significantly lower than simvastatin and cerivastatin, but was significantly higher than atorvastatin or pravastatin. This observational study was limited in that it was not possible to compare adverse event rates for different statins at comparable low-density lipoprotein cholesterol lowering doses. Also, the time period in which each drug was studied may have influenced results. Certain adverse events may not have been recognized as being related to a particular class of drugs for some time, leading to underreporting for older drugs. Publicity and heightened public awareness may also have lead to over reporting of events for newer drugs. Since that time, 3 additional large cohort studies have evaluated the safety of rosuvastatin 213-215 compared to other statins. No increased risk for rhabdomyolysis, acute renal failure, or significant hepatic injury was observed for rosuvastatin compared to other statins. Rhabdomyolysis was found to be rare with an incident rate of 2. In 16 head-to-head randomized-controlled trials, most of which were open label, 15-17, 19-24, 28, 86, 87, 91, 98, 113 adverse event rates were similar in all treatments. The Mazza 2008 open label randomized-controlled trial comparing rosuvastatin 10 or 20 mg to atorvastatin 20 mg was a 48-week study and did show a significant increase in alanine aminotransferase for atorvastatin Statins Page 59 of 128 Final Report Update 5 Drug Effectiveness Review Project relative to baseline (24. The significance of asymptomatic transaminase elevation remains uncertain however. One 24-week head-to-head randomized-controlled and open-label trial compared high- 20 dose rosuvastatin to high-dose atorvastatin and reported adverse events. They found similar adverse event rates except for an increase risk of hematuria, which was detected in 10. One meta-analysis of 25 head-to-head randomized-controlled trials of rosuvastatin compared to atorvastatin found no significant 13 differences in adverse event rates. Myotoxicity 206-209, 211 Five reviews evaluated the safety profile of statins. Six additional reviews specifically 216-220 assessed myotoxicity with the statins. In addition to the reviews of safety with statins, we reviewed the 83 head-to-head statin low-density lipoprotein cholesterol-lowering trials to determine whether there were any significant differences in myotoxicity and/or elevation of liver enzymes. We also included 3 218, 221, 222 observational studies with statins. Magnitude of risk 222 Gaist and colleagues conducted a population-based observational study in which 3 cohorts of patients were identified. The first cohort consisted of patients (n=17 219) who had received at least 1 prescription for lipid-lowering drugs. The second cohort consisted of patients (n=28 974) who had a diagnosis of hyperlipidemia but did not receive lipid-lowering drugs. The third cohort consisted of people (n=50 000) from the general population without a diagnosis of hypercholesterolemia. Using diagnostic visit codes recorded by participants in the U. General Practice Research Database, they identified and verified cases of symptomatic myopathic pain. A potential case of myopathy was confirmed with the clinician when the patient presented at least 2 of the following criteria: (1) clinical diagnosis of myopathy confirmed by the general practitioner; (2) muscle weakness, muscle pain, or muscle tenderness (2 of these symptoms); and (3) creatine kinase concentration above the reference limit. By this definition, the incidence of myopathy in the lipid-lowering group was 2. In 17 086 person-years of statin treatment, there were only 2 cases of myopathy.
In the “Targeting SYK” section purchase slimex 10mg on line weight loss pills di phenylalanine, in the seventh sentence of the ﬁrst paragraph under the heading order slimex 15 mg free shipping weight loss 8 weeks, “Clinical experience purchase slimex once a day weight loss reddit,” “B-cell malignancies” should have been “CLL” and “phase 3” should have been “phase 2. The porphyrias: advances in diagnosis and treatment. On page 22 in the Hematology 2012 American Society of Hematology Education Program, “/kg” was omitted from the standard regimen in the sixth sentence of the section titled “Treatment of acute attacks. Novel therapeutic strategies: hypomethylating agents and beyond. On page 67 in the Hematology 2012 American Society of Hematology Education Program, there were errors in Table 2. For the drug “Decitabine” in the “Reference” column, the reference “4” was misplaced in the second row. For the drug “Azacitidine” in the “Dose/schedule” column, there are ﬁve rows with errors. The third row, “75 mg/m2/d SC 5-2-2” should have read, “75 mg/m2/d SC/IV 5-2-2. The errors have been corrected in the online version, which now differs from the print version. Clinical studies with hypomethylating agents in IPSS lower-risk MDS patients Drug Dose/schedule N ORR Reference Decitabine 15 mg/m2/TID IV 3 d 28 30% 3 20 mg/m2/d IV 5d 20 mg/m2/d SC 5d 19 47% 4 10 mg/m2/d IV 10 d 20 mg/m2/d IV 5 d 53 50% 8 Azacitidine 75 mg/m2/d SC 7 d 23 60% 6 75 mg/m2/d SC 5/7 d 74 45. Emerging role of kinase-targeted strategies in chronic lymphocytic leukemia. On page 90 in the Hematology 2012 American Society of Hematology Education Program, there are errors in the information described for follow-up studies. In the “Targeting SYK” section, in the seventh sentence of the ﬁrst paragraph under the heading, “Clinical experience,” “B-cell malignancies” should have been “CLL” and “phase 3” should have been “phase 2. Garcia1 and Wendy Lim2 1University of Washington, Seattle, WA; and 2McMaster University, Hamilton, ON A 44-year-old otherwise healthy woman has completed 3 months of anticoagulation therapy for a ﬁrst episode of unprovoked pulmonary embolism. At the time of diagnosis and before the initiation of anticoagulation, she was found to have an elevated IgG anticardiolipin antibody (ACLA), which was measured at 42 IgG phospholipid (GPL) units (reference range, 15 GPL units) with negative lupus anticoagulant (LAC) testing. Should this laboratory ﬁnding affect the recommended duration of anticoagulant therapy? The decision about whether to stop or continue anticoagulation after included studies found 109 recurrent VTEs in 588 patients with aPL 3 months of therapy for a ﬁrst episode of unprovoked venous compared with 374 VTEs in 1914 patients without aPL (relative risk thromboembolism (VTE) can be inﬂuenced by multiple factors, [RR] 1. However, to justify the risk of major ACLA, the unadjusted RR was 1. However, the quality of the evidence was low and the estimate of Several patient characteristics and clinical factors appear to increase the effect of a positive aPL test on the risk of recurrence was the risk of recurrence, including male sex, signs and symptoms of imprecise. Persistence of aPL, as states) in patients presenting with a ﬁrst episode VTE is controver- documented by positive testing on more than one occasion (testing sial, many experts recommend that patients with an antiphospho- lipid antibody (aPL), particularly those patients with antiphospho- separated by a minimum of 12 weeks) and evidence of moderate-to- lipid syndrome (APS), receive extended anticoagulation therapy high titer antibodies (ACLA 40 MPL or GPL units or exceeding because they are believed to have a higher risk of recurrence than the 99th percentile) meet criteria for “deﬁnite APS” and appear to other patients with a ﬁrst unprovoked VTE. Indeed, the whether laboratory evidence of an aPL (ACLA or LAC) is risk estimate for recurrent thrombosis in patients with deﬁnite APS associated with an increased risk of recurrence among patients who as deﬁned by the updated Sapporo criteria10 would almost certainly have experienced a ﬁrst episode of VTE. Relative risk for recurrent VTE in patients with an aPL compared with patients without an aPL. Relative risk for recurrent VTE in patients with an ACLA compared with patients without laboratory evidence of any aPL. Switching to aspirin (ASA) therapy after 3 to 12 months of anticoagulation could be considered. Until these studies are performed, clinicians must still assess However, ASA is less effective in preventing VTE compared with whether positive aPL testing warrants extended anticoagulation. In standard-intensity warfarin and a dedicated study of ASA for making clinical decisions about secondary VTE prevention, clini- secondary VTE prevention in patients with an aPL has not been cians should consider that laboratory evidence of aPL can be found done. Newer, target-speciﬁc anticoagulants (ie, apixaban, dabiga- in up to 8% of the general population,11 and that the circumstance tran, and rivaroxaban) appear to be at least as safe and effective as underlying the index event (provoked vs unprovoked) is a powerful warfarin for secondary VTE prevention. Although these agents have independent predictor of recurrence risk. In the above patient scenario, the patient had a single positive aPL test but did not meet the consensus criteria for deﬁnite APS. In such Disclosures a scenario, we recommend repeat testing for aPL (including ACLA, Conﬂict-of-interest disclosure: D. Although there is little high-quality has received research funding from Leo Pharma, has consulted for evidence establishing risk for recurrent thrombosis in patients with Pﬁzer, and has received honoraria from Leo Pharma and Pﬁzer. It is unclear whether thrombosis risk Correspondence decreases in patients whose previously positive aPL testing be- David A. Garcia, MD, Professor, Division of Hematology, Univer- comes persistently negative. The unprovoked nature of this patient’s event predicts a 1. Identifying unprovoked substantial risk of recurrence irrespective of laboratory test results. Relative risks for recurrent VTE in patients with an LAC compared with patients without laboratory evidence of any aPL. Predicting disease ies in predicting adverse pregnancy outcome: a prospective recurrence in patients with previous unprovoked venous throm- study. Inﬂuence of hereditary or acquired thrombophilias thrombo-occlusive events and death: a prospective cohort on the treatment of venous thromboembolism. Antithrombotic therapy consensus statement on an update of the classiﬁcation criteria for VTE disease: Antithrombotic Therapy and Prevention of for deﬁnite antiphospholipid syndrome (APS). Predictors of venous thromboembolism: a systematic review. Harris EN, Chan JK, Asherson RA, Aber VR, Gharavi AE, 2000;160(6):761-768. Thrombosis, recurrent fetal loss, and thrombocyto- 13. Predictive value of the anticardiolipin antibody test. Arch recurrent venous thromboembolism in relation to clinical and Intern Med. Incidence of a ﬁrst antibodies: a four-year prospective study from the Italian thromboembolic event in asymptomatic carriers of high-risk Registry. Initial reports were based on an unusual increase in the inci- dence of Kaposi sarcoma (KS) and Pneumocystis pneumonia (PCP), diseases that were considered at that time to occur rarely. Because the initially affected population were men who had sex with men (MSM) the disease as well as those with the disease were highly stigmatized. Though at first lifestyle and behavioral factors were hypothesized to be causally related, finally in 1983 the human immunodeficiency virus (HIV) was identified as the true cause of AIDS.
The most common adverse events in the PEG 3350 group were dizziness (5%) and fatigue (3 discount slimex 10 mg on-line weight loss workout plan for women. Constipation Drugs Page 51 of 141 Final Report Drug Effectiveness Review Project Table 23 cheap slimex 10mg online weight loss pills lipozene. Summary of trials assessing the comparative harms of constipation drugs Author buy discount slimex 15mg on line weight loss pills 2014 uk, year Study N; Study Comparisons Population, % Results Quality design duration female, rating setting LACTULOSE VS. French and No significant Poor (No 43 1999 single- weeks PEG 3350 Scottish differences in median ITT blind, patients with daily scores for analysis) open-label chronic diarrhea, abdominal constipation, pain, flatulence, or 82% female, bloating. Fewer days general and with flatulence in the geriatric PEG group (3. Mean number of liquid stools was higher in the PEG group (2. Adults with No significant Poor 66 1991 open-label weeks lactulose chronic differences for (High constipation, abdominal pain or for attrition) % female straining (P NR). Evidence profile ofth e generaltolerability and h arm s ofconstipationdrugs inadults Evidence Profile:G eneraltolerability and h arm s ofconstipationdrugs inadults N o. Evidence profile ofth e com parative tolerability and h arm s ofconstipationdrugs inadults Evidence Profile:C om parative tolerability and h arm s ofconstipationdrugs inadults N o. Summary of findings General tolerability and safety in children The evidence is very poor quality and sparse. We found no studies on the general tolerability and safety of docusate calcium, docusate sodium, lactulose, lubiprostone, and psyllium that met our expanded eligibility criteria. All of the studies we found were rated poor quality for the assessment of adverse events and results should be interpreted with caution. We found three poor quality studies that reported safety or tolerability information for PEG 3350 without a comparison group. The most common adverse events reported were diarrhea in 10-13%, bloating/flatulence in 6-18%, and pain/cramping in 2-5%. They found no significant laboratory abnormalities and reported that PEG 3350 was well tolerated by children. We found one RCT that reported on the tolerability and harms of tegaserod for the treatment of postpubertal adolescents with constipation predominant IBS. The study reported that no adverse events were observed in any patient and there were no dropouts. Comparative tolerability and safety in children The evidence was limited to one poor quality RCT comparing PEG 3350 with lactulose in children. This study reported more abdominal pain, pain at defecation, and straining at defecation in those treated with lactulose and worse palatability with PEG. The results should be interpreted cautiously due to the poor quality of the study. Detailed assessment General risk of harms Table 26 summarizes the trials assessing the general harms of constipation drugs in children; Table 29 summarizes the evidence profile for the general tolerability and safety of individual drugs. Docusate calcium, Docusate sodium, Lactulose, Lubiprostone, and Psyllium We did not find any studies on the general harms of these medications in children that met our eligibility criteria. Constipation Drugs Page 55 of 141 Final Report Drug Effectiveness Review Project Polyethylene glycol We found no studies reporting the general safety of PEG that included a placebo comparison group. The other study did not report a source of funding or any conflicts of interest, but was by the same group of authors as the prospective cohort study. The most common adverse events reported were diarrhea in 10-13%, bloating/flatulence in 6-18%, and pain/cramping in 2-5%. Results of these studies should be interpreted with caution due to the poor quality. Previous therapies for constipation had been attempted in 82% of subjects prior to enrollment. For safety and adverse events, the study reported diarrhea in 10%, abdominal pain in 2%, bloating or flatulence in 6%, elevated alanine aminotransferase (ALT) in 11%, and elevated aspartate transaminase (AST) in 4%. Of the 9 patients with abnormal ALTs during treatment, 8 had repeat values 8 weeks later. Seven of the 8 had normal repeat values; one subject had a level 1. The duration and dose of PEG was not different between those with elevated liver function tests (LFTs) and those with normal labs. All children (n = 68, 82%) who had used other therapies in the past preferred PEG to other laxatives. Although they were not required to have chronic constipation, the mean duration of constipation was 10 months (range 0. Diarrhea was reported in 7% of 71 subjects followed for up to 4 months and in an additional 2% of 47 subjects followed for over 6 months. Parents did not report increased flatus, abdominal distention, vomiting, or new onset abdominal pain in any subjects. Lab tests (CBC, electrolytes, and LFTs) were occasionally done in some subjects and all those checked were normal. The study was rated poor quality for several reasons including: no comparison group, adverse events were not defined, adverse events were not clearly pre-specified, and high attrition. Constipation Drugs Page 56 of 141 Final Report Drug Effectiveness Review Project 69 One dose response study was a prospective, double-blind, parallel trial that randomized children aged 3 to 18 years with chronic constipation to 4 doses of PEG 3350 without electrolytes (Miralax, 0. All groups were treated for 3 days and evaluated 5 days after beginning treatment. They enrolled forty-one subjects referred to a pediatric gastroenterology clinic for evaluation of chronic constipation with evidence of fecal impaction. For all subjects, the following adverse events were reported: diarrhea (13%), nausea (5%), vomiting (5%), bloating/flatulence (18%), and pain/cramping (5%). Diarrhea was more prevalent in the high dose groups than the low dose groups (25% vs. No patients had clinically significant abnormal laboratory values after the use of PEG 3350. For tolerability, 95% of children took the medication on the first attempt. In addition, all children said that they would repeat a 3-day regimen of PEG 3350 to help treat a future fecal impaction. The results of the study should be interpreted with caution due to poor quality (no control group). Tegaserod As described in the tegaserod section for general harms in adults (see above), the FDA issued a public health advisory to inform patients and health care professionals that the sponsor of tegaserod agreed to 12 stop selling the medication because of cardiovascular adverse events. We found one RCT that reported on the safety and harms of tegaserod for the treatment of postpubertal adolescents with constipation 53 predominant IBS. The study reported that no adverse events were observed in any patient, including diarrhea, dehydration, vomiting, rectal bleeding, weight loss, or headache. Constipation Drugs Page 57 of 141 Final Report Drug Effectiveness Review Project Table 26. Summary of trials assessing the general safety and harms of constipation drugs in children Author, year Study design N; Study Comparisons Population, Results Quality duration % female, rating setting PEG 3350 Pashankar Prospective 83, 3-30 PEG 3350 Children > 2 No major AEs.
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