scholarly journals Impact of Iron Supplementation on Patient Outcomes in Women Undergoing Gynecological Procedures: Systematic Review and Meta-Analysis of Randomized Trials

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 59-59
Author(s):  
Emily Sirotich ◽  
Erin Jamula ◽  
Andrea Wang ◽  
Donald M. Arnold ◽  
Michelle P. Zeller

Background. Perioperative red blood cell (RBC) transfusion is associated with poor patient outcomes. RBC transfusion rates have been decreasing across different types of surgeries as a results of implementing Patient Blood Management (PBM) strategies; while RBC transfusion rates in gynecologic surgeries have remained static. Women are at increased risk of anemia, specifically iron deficiency anemia from gynecologic blood loss putting them at increased risk of requiring perioperative RBC transfusion. PBM encourages preoperative iron supplementation to optimize patients' hemoglobin (Hb) levels; however, evidence specific to gynecological procedures is lacking. This systematic review was conducted to address the question: Does the use of iron supplementation during the perioperative period impact patient outcomes in women undergoing gynecological procedures when compared to no treatment, placebo, or standard of care? Methods. MEDLINE, EMBASE, CENTRAL, CINAHL, and Web of Science were searched up to July 2019. Additional records were identified through searching theses, conference proceedings, trials, and grey literature. All randomized controlled trials (RCTs) comparing an intervention group provided with iron supplementation perioperatively to women undergoing gynecological procedures with a comparator were included. Two authors independently assessed studies for inclusion and risk of bias using the Cochrane Risk of Bias tool, extracted data, and evaluated the certainty of evidence using the GRADE approach. Data were pooled using the random-effects (DerSimonian and Laird) method of meta-analysis. Results. A total of eleven RCTs met inclusion criteria. Two RCTs were then excluded; one RCT compared iron supplementation to no intervention but subset data for gynecology patients was unavailable and the full text of another RCT was unavailable. Seven RCTs (n=447) were amenable to meta-analysis; however iron supplementation was used in both treatment arms: four compared iron with erythropoietin stimulating agents (ESA) to iron alone and three compared iron with gonadotropin-releasing hormone (GnRH) analogue/agonist to iron alone. Six studies were judged to be overall low risk of bias and one to be at high risk of bias. RBC Transfusions: There was a statistically significant reduction in RBC transfusions during the perioperative period when iron was used in combination with a blood optimization compound (BOC) compared to iron alone (RR 0.33; 95%CI 0.16 to 0.70; p=0.003) (Figure 1). Preoperative Hb Level: Women who had taken a BOC plus iron had a median preoperative Hb level of 12.87g/dl [95% CI 11.13, 14.61 g/dl]), which was significantly higher (Δ1.16 g/dl; 95% CI 1.01, 1.31g/dl; p<0.00001) than those who took oral iron supplements alone. Postoperative Hb Level: Among 336 women in six RCTs, women who had taken a BOC in addition to iron had a postoperative Hb of 11.53g/dl (95% CI 6.92 g/dl, 16.14g/dl). This was significantly higher (Δ0.96 g/dl; 95% CI 0.45 g/dl, 1.47 g/dl; p<0.00001) than those who took iron supplements alone. Adverse Events (AEs): Five studies including 289 participants reported the incidence of AEs. The addition of a BOC did not have a statistically significant effect on the occurrence of AEs (RR 0.98; 95%CI 0.83, 1.17; p=0.85). One RCT with available data compared iron supplementation to placebo. Meta-analysis was not possible; however, the study found a significant increase in postoperative Hb and decrease in RBC transfusions in patients receiving iron supplementation compared to placebo. Conclusion. Perioperative use of iron in combination with a BOC in women undergoing gynecological procedures may reduce the need for perioperative RBC transfusions and improve preoperative Hb levels with high certainty of evidence. There was very low certainty of evidence for the impact of iron plus BOC on postoperative Hb levels and the number of AEs. The results of this systematic review suggest that the use of perioperative iron with BOC may improve patient outcomes. Lack of RCTs comparing iron to placebo is a limitation. More studies are needed to address the role of perioperative iron supplementation for gynecological procedures, including evaluating different routes of administration. Analysis of existing observational studies may offer additional data to supplement the results of this meta-analysis. Disclosures Arnold: Rigel: Consultancy, Research Funding; Bristol-Myers Squibb: Research Funding; Novartis: Honoraria, Research Funding; Principia: Consultancy. Zeller:Pfizer: Other: Advisory Board; Canadian Blood Services: Consultancy; Ontario Ministry of Health and Long Term Care: Consultancy.

2021 ◽  
Vol 11 ◽  
Author(s):  
Eder da Silva Dolens ◽  
Mauricio Rocha Dourado ◽  
Alhadi Almangush ◽  
Tuula A. Salo ◽  
Clarissa Araujo Gurgel Rocha ◽  
...  

ObjectiveOver many decades, studies on histopathological features have not only presented high-level evidence of contribution for treatment directions and prognosis of oral squamous cell carcinoma (OSCC) but also provided inconsistencies, making clinical application difficult. The 8th TNM staging system of OSCC has acknowledged the importance of some histopathological features, by incorporating depth of invasion (DOI) to T category and extranodal extension (ENE) to N category. The aim of this systematic review with meta-analysis is to determine the most clinically relevant histopathological features for risk assessment and treatment planning of OSCC and to elucidate gaps in the literature.MethodsA systematic review was conducted using PRISMA guidelines, and the eligibility criteria were based on population, exposure, comparison, outcome, and study type (PECOS). PubMed, Cochrane, Scopus, and Web of Science were searched for articles exploring the impact of histopathological features on OSCC outcomes with Cox multivariate analysis. Pooled data were subjected to an inverse variance method with random effects or fixed effect model, and the risk of bias was evaluated using quality in prognosis studies (QUIPS). Quality of evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.ResultsThe study included 172 articles published from 1999 to 2021. Meta-analyses confirmed the prognostic potential of DOI, ENE, perineural invasion, lymphovascular invasion, and involvement of the surgical margins and brought promising results for the association of bone invasion, tumor thickness, and pattern of invasion with increased risk for poor survival. Although with a small number of studies, the results also revealed a clinical significance of tumor budding and tumor-stroma ratio on predicted survival of patients with OSCC. Most of the studies were considered with low or moderate risk of bias, and the certainty in evidence varied from very low to high.ConclusionOur results confirm the potential prognostic usefulness of many histopathological features and highlight the promising results of others; however, further studies are advised to apply consistent designs, filling in the literature gaps to the pertinence of histopathological markers for OSCC prognosis.Systematic Review RegistrationInternational Prospective Register of Systematic Reviews (PROSPERO), identifier CRD42020219630.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Spezia ◽  
A Bonato ◽  
G De Fortunato ◽  
A Bossi ◽  
M Glauber

Abstract Funding Acknowledgements Type of funding sources: None. Background Patients with obesity present structural and functional changes in the heart and in the coronary circulation, which ultimately leads to an increased risk of cardiovascular disease. Obesity is associated with a low chronic state of inflammation which seems to be linked to a compromised coronary vasoreactivity, which is shown to be a forerunner and a long-term predictor of clinically relevant cardiovascular events. Methods A systematic review was performed by searching PubMed, Embase and Cochrane Library database. Selection criteria were applied leading to the inclusion of studies of any level of evidence published in peer-reviewed journals reporting clinical or preclinical results. Relative data were extracted and critically analysed. PRISMA guidelines were applied and risk of bias was assessed, as well as the methodological quality of the included studies. After this assessment, we excluded all the articles with serious risk of bias and/or low quality. Meta-analysis was conducted on the data collected regarding coronary blood flow (CFR) and hyperemic myocardial blood flow (MBF), while for the other parameters a descriptive analysis was performed. Results After applying the described criteria, we included 15 articles on human and animal literature assessed as medium or high quality. The data of 1399 patients were examined, 456 of which with obesity (BMI ≥ 30). A pooled effect size analysis shows that coronary flow reserve (CFR) is significantly reduced in patients with obesity [Random Effect (RE): -47.7%, 95% confidence interval (CI) -80.2% – -15.2%; n = 422]. Increased BMI is associated with reduced CFR. The same trend is found evaluating pharmacological induced stress MBF, which was reduced in patients with obesity [RE: -47.8%, 95% CI -73.7% – -21.8%; n = 409]. Nevertheless, MBF at rest did not show a significant difference in patients with obesity from our analysis [RE: 15%, 95% CI -24% - 53%; n = 409]. Pro-inflammatory adipokines secretion, as leptin and CRP, seems to correlate with a significant decrease of stress-induced MBF and reduced CFR. Conclusions Obesity is associated with a significant higher risk of coronary microvascular disfunction, which is reflected by diminished CFR and stress MBF. Systemic inflammation and the imbalance of adipokines related to obesity has been closely linked to a blunt coronary flow. CMD is a pre-clinical heart conditions that often remains undiagnosed. Further evidence is required to clear out the role of Obesity from a molecular point of view on the coronary endothelium.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048422
Author(s):  
Vaishali Adlakha ◽  
Leona Ramos ◽  
Abigail Smith ◽  
Olivia Tsistinas ◽  
Emily Tanner-Smith ◽  
...  

IntroductionDysphagia affects several children in USA and around the globe. Videofluoroscopic Swallow Study (VFSS) and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) are the most objective studies to define swallowing function. The presence of tracheal aspiration during VFSS or FEES in children with dysphagia is associated with an increased risk of aspiration pneumonia. However, the association of laryngeal penetration with aspiration pneumonia remains unclear. This systematic review aims to assess the risk of aspiration pneumonia in children with dysphagia with laryngeal penetration on VFSS/FEES and compare it with children with tracheal aspiration and children with neither tracheal aspiration nor laryngeal penetration.Methods and analysisThis study will be a systematic review and meta-analysis. Systematic electronic searches will be conducted on PubMed, EMBASE, Web of Science, CINHAL, Scopus, Cochrane CENTRAL, LILACS and WHO Global Index Medicus. We will include studies published through 6 October 2021. Primary outcome will be the incidence of aspiration pneumonia. Secondary outcomes will be incidence of hospitalisation, paediatric intensive care unit admission, enteral tube requirement, growth, symptoms improvement and mortality. The Cochrane Risk of Bias In Non-Randomised Studies of Interventions tool will be used to assess the risk of bias. Meta-analysis will be used to pool the studies. We will pool dichotomous outcomes to obtain an odd ratio (OR) and report with 95% CI. Continuous outcomes will be pooled to obtain mean difference and reported with 95% CI. Overall grade of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, and findings will be presented in a summary of findings table.Ethics and disseminationThis study is a systematic review without contact with patients. Therefore, IRB approval is not required. Authors consent to publishing this review. Data will be kept for review by editors and peer reviewers. Data will be available to general public on request.PROSPERO registration numberCRD42020222145.


Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2955 ◽  
Author(s):  
Daisy Vedder ◽  
Wendy Walrabenstein ◽  
Maaike Heslinga ◽  
Ralph de Vries ◽  
Michael Nurmohamed ◽  
...  

Gout is one of the most prevalent inflammatory rheumatic disease. It is preceded by hyperuricemia and associated with an increased risk for cardiovascular disease, both related to unhealthy diets. The objective of this systematic review is to better define the most appropriate diet addressing both disease activity and traditional cardiovascular risk factors in hyperuricemic patients. We included clinical trials with patients diagnosed with hyperuricemia or gout, investigating the effect of dietary interventions on serum uric acid (SUA) levels, gout flares and—if available—cardiovascular risk factors. Eighteen articles were included, which were too heterogeneous to perform a meta-analysis. Overall, the risk of bias of the studies was moderate to high. We distinguished four groups of dietary interventions: Calorie restriction and fasting, purine-low diets, Mediterranean-style diets, and supplements. Overall, fasting resulted in an increase of SUA, whilst small (SUA change +0.3 to −2.9 mg/dL) but significant effects were found after low-calorie, purine-low, and Mediterranean-style diets. Studies investigating the effect on cardiovascular risk factors were limited and inconclusive. Since Mediterranean-style diets/DASH (Dietary Approach to Stop Hypertension) have shown to be effective for the reduction of cardiovascular risk factors in other at-risk populations, we recommend further investigation of such diets for the treatment of gout.


2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Muhammad U. Siddiqui ◽  
David Scalzitti ◽  
Zunaira Naeem

Introduction. Atrial fibrillation leads to increased risk of systemic embolism and stroke. To decrease these adverse events, anticoagulation is routinely prescribed. Nonvitamin K anticoagulants like apixaban and rivaroxaban are becoming popular and being used more frequently nowadays. We here compare the efficacy and safety of apixaban with those of warfarin. Methods and Analysis. This systematic review aims to assess the efficacy and safety of apixaban compared to those of warfarin. Eligible participants were adults diagnosed with nonvalvular atrial fibrillation. The intervention was apixaban, and the comparator was warfarin. The primary efficacy endpoint is the first admission with systemic embolism or stroke, and the primary safety outcome is the occurrence of major bleeding. Relevant studies were searched in the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, and clinicaltrials.gov. After being independently reviewed by two authors, five articles were included in the systematic review. The risk of bias of included studies was assessed using the Cochrane risk of bias tool and SIGN methodology. The RevMan software was used to assess the effect size and perform meta-analysis. Results. Apixaban was found to be superior to warfarin in terms of safety (RR 0.58; CI 0.52–0.66) but not superior to warfarin in terms of efficacy (RR 0.93; CI 0.70–1.24). Conclusion. Apixaban is superior to warfarin in terms of safety, but no difference in efficacy is noted. The choice of anticoagulation should be individualized based on the risk factor profile of the patient.


Author(s):  
Elisabeth M. L. de Wijkerslooth ◽  
Jay M. Bakas ◽  
Joost van Rosmalen ◽  
Anne Loes van den Boom ◽  
Bas P. L. Wijnhoven

Abstract Purpose Patients presenting with acute appendicitis are usually hospitalized for a few days for appendectomy and postoperative recovery. Shortening length of stay may reduce costs and improve patient satisfaction. The purpose of this study was to assess the safety of same-day discharge after appendectomy for acute appendicitis. Methods A systematic review was performed according to PRISMA guidelines. A literature search of EMBASE, Ovid MEDLINE, Web of Science, Cochrane Central, and Google Scholar was conducted from inception to April 14, 2020. Two reviewers independently screened the literature and selected studies that addressed discharge on the same calendar day as the appendectomy. Risk of bias was assessed with the ROBINS-I tool. Main outcomes were hospital readmission, complications, and unplanned hospital visits in the postoperative course. A random effects model was used to pool risk ratios for the main outcomes. Results Of the 1912 articles screened, 17 comparative studies and 8 non-comparative studies met the inclusion criteria. Most only included laparoscopic procedure for uncomplicated appendicitis. Most studies were considered at moderate or serious risk of bias. In meta-analysis, same-day discharge (vs. overnight hospitalization) was not associated with increased rates of readmission, complication, and unplanned hospital visits. Non-comparative studies demonstrated low rates of readmission, complications, and unplanned hospital visits after same-day discharge. Conclusion This study suggests that same-day discharge after laparoscopic appendectomy for uncomplicated appendicitis is safe without an increased risk of readmission, complications, or unplanned hospital visits. Hence, same-day discharge may be further encouraged in selected patients. Trial registration PROSPERO registration no. CRD42018115948


2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Meilyn Muskus ◽  
Jorge Rojas ◽  
Camilo Gutiérrez ◽  
Juan Guio ◽  
Guillermo Bonilla ◽  
...  

Introduction. Patients with degenerative hip disease frequently present with bilateral involvement that requires surgical management. The main goal when treating these patients is to achieve the maximum efficiency without increasing risk of perioperative complications; therefore, the decision regarding the best moment to operate the second hip becomes relevant. Although studies have addressed this topic, whether a simultaneous or staged surgery should be performed remains controversial. The purpose of this study was to determine, based on available evidence, the optimum strategy in terms of safety to operate the second hip in patients with bilateral involvement. Materials and Methods. A meta-analysis was planned. A systematic review of the literature was performed including clinical trials or observational analytical studies comparing the safety of bilateral arthroplasty performed simultaneously or staged by measuring major and minor complications. The appropriateness of a meta-analysis was evaluated through the detailed analysis of the risk of bias and clinical heterogeneity of the included studies. Results. Thirteen studies were selected after the systematic review. A wide variability in the methodological designs was found with a critical risk of bias in most of them. Considerable heterogeneity was detected in defining staged surgery in the cointerventions and how the outcomes were defined and measured. In response to these findings, a meta-analysis was considered not appropriate. The results showed no differences in the risk of mortality or systemic complications in young and healthy patients between simultaneous or staged surgeries. However, increased risk of complications for staged surgeries performed during the same hospitalization was observed. Conclusions. Available evidence is very heterogeneous and the quality of evidence is low. The available evidence supports the performance of simultaneous hip arthroplasty in selected patients (not older than 65 years, ASA 1-2, without cardiovascular comorbidities) and suggests the avoidance of staged surgeries within the same hospitalization.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4894-4894
Author(s):  
Jameel Abdulrehman ◽  
Grace Tang ◽  
Michael Auerbach ◽  
Michelle Sholzberg

Abstract Background Iron deficiency (ID) is one of the most common nutritional deficiencies worldwide, with an increased prevalence in pathological states such as end stage renal disease and inflammatory bowel disorders. Iron stores can be replenished by either oral or intravenous (IV) formulations, however IV formulations are known to raise iron stores more quickly and reliably. Ferumoxytol is an IV iron formulation used in the treatment of ID that, advantageously, can be given in large doses over a short period of time. Despite the initial large quantity of post-marketing reports of serious adverse events (SAEs), multiple clinical trials have failed to demonstrate a significant safety signal. Objectives To determine the safety and efficacy of ferumoxytol in the treatment of ID compared to other IV and oral iron formulations, and placebo. Methods This systematic review and meta-analysis was conducted following the Cochrane Handbook, and was reported as per Preferred Reporting for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched the Cochrane Library, Medline, and EMBASE from inception until February 2018 as well as trial registries and reference lists of relevant articles. All randomized or quasi-randomized controlled trials comparing ferumoxytol to alternate IV iron, oral iron, or placebo were included. Outcomes included treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), SAEs, related serious adverse events (RSAEs), hypotension or hypersensitivity reactions (HHR) and composite cardiovascular outcomes (CCO). Two review authors independently extracted data and assessed included studies for risk of bias. If required, additional data was sought from trial authors. Meta-analysis was performed using the Review Manager 5.3. Data was pooled using random-effects models. Risk of bias was assessed using the Cochrane Collaboration tool Risk of Bias. The GRADE approach was used to assess quality of evidence. Results The review included nine studies, one of which was a cross-over trial. These included 5691 participants (mean age 54.3, study mean range 30 to 65.1 years). Ferumoxytol was compared to alternate IV iron in three studies, to oral iron in two, and to placebo in four. Overall, studies were at low risk of bias (see figure 1). There was high quality evidence that relative to other IV iron formulations, ferumoxytol has little to no increase in the achievement of a minimum 1g/dL increase in hemoglobin (Relative Risk [RR] 1.04, 95%Confidence Interval [CI] 0.96 to 1.12; 767 participants pooled (pp) from 2 trials)), low quality evidence that it has little to no decrease in TEAE (RR 0.88, 95%CI 0.80 to 0.97; 2764 pp from 3 trials), little to no decrease in TRAEs (RR 0.73, 95%CI 0.61 to 0.88; 2764 pp from 3 trials), little to no increase on SAEs (RR 1.13, 95%CI 0.77 to 1.67; 2764 pp from 3 trials), and little to no decrease in RSAEs (RR 0.58, 95%CI 0.13 to 2.55; 2764 pp from 3 trials), very low quality evidence that it has little to no decrease in HHR (RR 0.58, 95%CI 0.31 to 1.09; 2764 pp from 3 trials) and moderate quality evidence that it has little to no decrease on CCO (RR 0.56, 95% CI 0.24 to 1.29; 2602 pp from 2 trials). Compared to oral iron, ferumoxytol had less TEAEs (RR 0.78, 95%CI 0.61 to 0.98; 515 pp from 2 trials), but compared to placebo ferumoxytol had more (RR 1.62, 95%CI 1.01 to 2.61; 2348 pp from 3 trials). Publication bias was not assessed due to the limited number of studies included. Conclusions Upon review of the available evidence, ferumoxytol is probably as efficacious as alternative IV iron formulations with no clear safety concerns. In addition, ferumoxytol had less TEAEs compared to oral iron formulations, but more compared to placebo. Disclosures Auerbach: AMAG Pharmaceuticals: Research Funding; Pharmacosmos A/S: Research Funding.


2020 ◽  
pp. bjsports-2020-102525
Author(s):  
Stefanos Karanasios ◽  
Vasileios Korakakis ◽  
Rod Whiteley ◽  
Ioannis Vasilogeorgis ◽  
Sarah Woodbridge ◽  
...  

ObjectiveTo evaluate the effectiveness of exercise compared with other conservative interventions in the management of lateral elbow tendinopathy (LET) on pain and function.DesignSystematic review and meta-analysis.MethodsWe used the Cochrane risk-of-bias tool 2 for randomised controlled trials (RCTs) to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation methodology to grade the certainty of evidence. Self-perceived improvement, pain intensity, pain-free grip strength (PFGS) and elbow disability were used as primary outcome measures.Eligibility criteriaRCTs assessing the effectiveness of exercise alone or as an additive intervention compared with passive interventions, wait-and-see or injections in patients with LET.Results30 RCTs (2123 participants, 5 comparator interventions) were identified. Exercise outperformed (low certainty) corticosteroid injections in all outcomes at all time points except short-term pain reduction. Clinically significant differences were found in PFGS at short-term (mean difference (MD): 12.15, (95% CI) 1.69 to 22.6), mid-term (MD: 22.45, 95% CI 3.63 to 41.3) and long-term follow-up (MD: 18, 95% CI 11.17 to 24.84). Statistically significant differences (very low certainty) for exercise compared with wait-and-see were found only in self-perceived improvement at short-term, pain reduction and elbow disability at short-term and long-term follow-up. Substantial heterogeneity in descriptions of equipment, load, duration and frequency of exercise programmes were evident.ConclusionsLow and very low certainty evidence suggests exercise is effective compared with passive interventions with or without invasive treatment in LET, but the effect is small.PROSPERO registration numberCRD42018082703.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 401-401
Author(s):  
Yue-Heng Yin ◽  
Liu Yat Justina

Abstract Obesity has been shown to intensify the decline of physical function and lead to frailty. Nutrition is an important method in managing obesity and frailty, while seldom reviews have ever explored the effects of nutritional education interventions. We conducted a systematic review (PROSPERO: CRD42019142403) to explore the effectiveness of nutritional education interventions in managing body composition and physio-psychosocial parameters related to frailty. Randomized controlled trials and quasi-experimental studies were searched in CINAHL, Cochrane Library, EMBASE, MEDLINE, PsycINFO, PubMed and Scopus from 2001 to 2019. Hand search for the reference lists of included papers was conducted as well. We assessed the quality of included studies by Cochrane risk of bias tool. Meta-analyses and narrative synthesis were used to analyse the data. Two studies with low risk of bias were screened from 180 articles, which involved 177 older people with an average age of 69.69±4.08 years old. The results showed that nutritional education was significantly effective in reducing body weight and fat mass than exercises, and it was beneficial to enhancing physical function and psychosocial well-being. But the effects of nutritional education in increasing muscle strength were not better than exercises. The combined effects of nutritional education and exercises were superior than either exercises or nutritional education interventions solely in preventing the loss of lean mass and bone marrow density, and in improving physical function. Due to limited numbers of relevant studies, the strong evidence of effectiveness of nutritional education interventions on reversing frailty is still lacking.


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