scholarly journals Ruxolitinib for the prevention of thrombosis in polycythemia vera: a systematic review and meta-analysis

2020 ◽  
Vol 4 (2) ◽  
pp. 380-386 ◽  
Author(s):  
Arianna Masciulli ◽  
Alberto Ferrari ◽  
Alessandra Carobbio ◽  
Arianna Ghirardi ◽  
Tiziano Barbui
Keyword(s):  
Randomized Controlled Trials ◽  
Polycythemia Vera ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Prevention Of Thrombosis ◽  
Randomized Controlled ◽  
Thrombosis Risk ◽  
Hard Evidence ◽  
The Difference ◽  
American Society

Abstract Ruxolitinib is a recommended second-line treatment for the prevention of thrombosis in patients with polycythemia vera who become resistant or intolerant to hydroxyurea; however, evidence regarding its efficacy in terms of thrombosis reduction is uncertain. We searched Medline, Embase, and archives of abstracts from the European Hematology Association and the American Society of Hematology annual congresses from 2014 onward for randomized controlled trials comparing the treatment vs best available therapy (BAT). Our search retrieved 80 records; after screening of abstracts and full text, the total was reduced to 16. Evidence came from 4 randomized controlled trials, including 663 patients (1057 patients per year). We estimated a thrombosis risk ratio of 0.56 for ruxolitinib BAT, corresponding to an incidence of 3.09% and 5.51% patients per year, respectively. The number of thrombotic events reported with ruxolitinib was consistently lower than that with BAT in our sample, but, globally, the difference did not reach significance (P = .098). Hard evidence in favor of ruxolitinib is lacking; a clinical trial on selected patients at high risk of thrombosis would be warranted, but its feasibility is questionable.

Maintenance Therapies for Multiple Myeloma (MM): A Network Meta-Analysis

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 236-236
Author(s):  
Helen Mahony ◽  
Ambuj Kumar ◽  
Rahul Mhaskar ◽  
Branko Miladinovic ◽  
Keith Wheatley ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Phase Iii ◽  
Novel Agents ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
American Society ◽  
Novel Agent

Abstract Abstract 236 Background: There is little consensus on which maintenance therapy clinicians should choose for their patients. Since 1999, the three novel agents of bortezomib, lenalidomide, and thalidomide have been approved for use among patients with MM. These agents have been increasingly used as maintenance therapy. To date, only two randomized controlled trials of maintenance therapy have examined the efficacy of these novel agents head-to-head. Here, we conduct a network meta-analysis of bortezomib, lenalidomide, and thalidomide to determine which of these novel agents could potentially increase overall survival (OS) and progression-free survival (PFS). Methods: A comprehensive literature search of MEDLINE (PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), and meetings abstracts from American Society of Hematology, American Society of Clinical Oncology, European Society for Medical Oncology and European Hematology Association was undertaken to identify all phase III randomized controlled trials (RCTs) of maintenance therapy published until July 2012. We applied the Bayesian mixed treatment comparison (MTC) method under the random-effects model. The indirect comparisons were constructed from trials that have one treatment in common. For each included RCT, we calculated the hazard ratio (HR) and its corresponding standard error and used this to calculate the indirect estimates of HR and corresponding credible intervals (CrI). We also ranked the treatments according to the probability of best treatment and calculated the surface underneath the cumulative ranking curve (SUCRA). All analyses were conducted in WinBUGS 1.4.3 and Stata 11.2. Results: The network, number of trials for each comparison, and number of patients enrolled is shown in Figure 1. The network for OS was based on 12 RCTs enrolling 5542 patients and the network for PFS was constructed from 13 RCTs and 5784 patients. The MTC networks were consistent for both OS and PFS. For both OS and PFS, two comparisons were produced (Figure 2). For OS, the analysis showed that none of the treatments were superior. For PFS, lenalidomide was superior to thalidomide (HR = 0.58, 95% CrI [0.37, 0.94]). The estimates of SUCRA and rank probabilities (Figure 3) suggested that for OS bortezomib was best followed by lenalidomide and thalidomide. For PFS, lenalidomide was best followed by bortezomib and thalidomide. Conclusion: Using the MTC method, we found no evidence that any of the novel agents are superior to one another in terms of OS. Lenalidomide was the only novel agent which was superior to another active therapy (thalidomide). While these results provide preliminary evidence to which novel agent may be more beneficial as maintenance therapy, definitive conclusions cannot be reached until large, well designed RCTs evaluating these therapies head-to-head are conducted. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Comparison of the participation rate between CT colonography and colonoscopy in screening population: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 93 (1105) ◽  
pp. 20190240 ◽  
Author(s):  
He Zhu ◽  
Fudong Li ◽  
Ke Tao ◽  
Jing Wang ◽  
Carissa Scurlock ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Ct Colonography ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Participation Rate ◽  
Statistical Evidence ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Screening Population ◽  
The Difference

Objective: To compare the participation rate between CT colonography (CTC) and colonoscopy in screening population in randomized controlled trials (RCTs). Methods: A search was performed using the PubMed, Web of Science, and Cochrane databases. RCTs that included screening populations and reported participation number were assessed. Cochrane risk of bias tool was used to assess the bias and quality. Risk ratio (RR) was used to present the results. The non-participation rate was analyzed to verify the results of participation rate. Results: Five of 760 studies, with a total of 15,974 invitees, were included. The participation rate was higher at CTC (28.8%) than colonoscopy (20.8%), although the difference did not reach statistical significance (RR = 1.26; p = 0.070; I2 = 90.3%). The non-participation rate at CTC was significantly lower than colonoscopy (RR = 0.92; p = 0.012; I2 = 86.7%). Subgroup analysis suggested both the participation and non-participation rate were with significant difference between reduced/no cathartic preparation CTC and colonoscopy. Cumulative meta-analysis showed both the participation rate and non-participation rate exhibited a trend over time and sample size. Conclusion: The participation rate was higher at CTC than colonoscopy, although the difference did not reach statistical significance. But the non-participation rate was with statistical difference. Screening population seemed more likely to participate the reduced/no cathartic preparation CTC. Statistical evidence was provided for more large RCTs are needed in the future. Advances in knowledge: The screening populations seem more likely to participate in the CTC, especially the reduced/no cathartic preparation CTC. The statistical evidence was provided for more large RCTs are needed in the future.

scholarly journals BRCA1 Versus BRCA2 and PARP Inhibitors Efficacy in Solid Tumors:A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 11 ◽  
Author(s):  
Shan Li ◽  
Li Tao ◽  
Haiyun Dai ◽  
Xue Gong ◽  
Yuguo Zhuo ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Brca1 Mutation ◽  
Brca2 Mutation ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Substantial Impact ◽  
Randomized Controlled ◽  
Mutation Carriers ◽  
The Difference

BackgroundBRCA2 mutation has a more substantial impact on the homologous recombination and superior therapeutic response to platinum-based chemotherapy than BRCA1 mutation. Whether BRCA2-mutated patients could benefit more from PARPi than BRCA1-mutated patients remains unclear. We performed a meta-analysis to assess the efficacy difference of PARPi between BRCA1 mutation carriers and BRCA2 mutation carriers.MethodsPubmed, Embase, and Cochrane Library were comprehensively searched for randomized controlled trials (RCTs) of PARPi that had available hazard ratios (HRs) of progression-free survival (PFS) in both BRCA1-mutated population and BRCA2-mutated population. We calculated the pooled PFS HRs and 95%CI using randomized-effect models, and the difference between the two estimates was compared by interaction test.ResultsA total of 11 eligible RCTs of high quality were identified through search. Overall, 1544 BRCA1 mutation carriers and 1191 BRCA2 mutation carriers were included in the final analysis. The pooled PFS HR was 0.42 (95% CI: 0.35-0.50) in BRCA1-mutated patients who were treated with PARPi compared with patients in the control group. In BRCA2-mutated patients treated with PARPi, the pooled PFS HR compared with the control groups was 0.35 (95% CI: 0.24-0.51). The difference in efficacy of PARPi was not significant between the two subgroups (Pheterogeneity = 0.40, for interaction).ConclusionBRCA1-mutated patients and BRCA2-mutated patients could benefit from PARPi, and the efficacy is comparable. Currently, there is no evidence that BRCA2-mutated patients would benefit more from PARPi than BRCA1-mutated patients.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier CRD42020214582.

Comparing active immunotherapy efficacy of PD-L1 ≥ 50% NSCLC patients: A systematic review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21139-e21139
Author(s):  
Yi Hu ◽  
Xiaochen Zhao ◽  
Yuezong Bai ◽  
Longgang Cui ◽  
Fan Zhang
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Difference ◽  
Nsclc Patients

e21139 Background: Several therapies based on immune checkpoint inhibitors (ICIs) have been approved as the 1L standard of care for PD-L1≥ 50% advanced non-small cell lung cancer (NSCLC). However, little is known about the difference in efficacy between different strategies. We conducted a systematic review and meta-analysis to help clinicians choose more reasonable treatment options. Methods: We searched PubMed, Cochrane library, Embase and major conference proceedings from January 2010 to December 2020 for randomized controlled trials that had available subgroup hazard ratios (HRs) for overall survival according to PD-L1≥ 50%. Only drugs met primary outcome or approved by FDA were included for analysis. The primary outcome was the difference in overall survival (OS). HRs and 95% CI were calculated for the pooled OS using a random-effects model. p<0.05 was considered as statistical difference. Results: A total of 10 randomized controlled trials were included for this meta-analysis. The pooled HR and 95% CI for monotherapy, ICI plus chemotherapy and ICI plus ICI were 0.64 (0.55, 0.74), 0.64 (0.51, 0.79) and 0.70 (0.55, 0.90), respectively. There was no statistical differences between ICI monotherapy and ICI plus chemotherapy (HR 1.00, 95% CI 0.77- 1.30), between ICI monotherapy and ICI plus ICI (HR 0.91, 95% CI 0.69- 1.22) or between ICI plus chemotherapy and ICI plus ICI (HR 0.91, 95% CI 0.66- 1.27). Conclusions: For PD-L1≥ 50% NSCLC patients, active ICI monotherapies showed no different efficacy when compared with ICI combination therapies.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on the Effects of Oats and Oat Processing on Postprandial Blood Glucose and Insulin Responses

2020 ◽  
Author(s):  
Kathy Musa-Veloso ◽  
Daniel Noori ◽  
Carolina Venditti ◽  
Theresa Poon ◽  
Jodee Johnson ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Randomized Controlled Trials ◽  
Structural Integrity ◽  
Meta Analysis ◽  
Postprandial Blood Glucose ◽  
Controlled Trials ◽  
Study Objective ◽  
Randomized Controlled ◽  
The Difference ◽  
Insulin Responses

ABSTRACT Background Oats are a whole grain cereal with potentially favorable effects on the postprandial glycemic response; however, the effects of oat processing on these glycemic benefits are not well understood. Objectives The study objective was to determine the effects of differently processed oats on the postprandial blood glucose and insulin responses relative to refined grains. Methods Eleven electronic databases were systematically searched to identify studies published up to and including May 2019. Randomized controlled trials comparing the postprandial blood glucose and insulin responses to oats compared with any refined grain were included, so long as the available carbohydrate content of the test meals was similar. Pooled effect sizes were computed using the difference in incremental area under the curves for blood glucose and insulin following the consumption of oats compared with the refined grain control. Results Ten publications were included, with intact oat kernels studied in 3 comparisons, thick oat flakes (&gt;0.6 mm) in 7 comparisons, and thin/quick/instant oat flakes (≤0.6 mm) in 6 comparisons. Compared with the consumption of the refined grain control, the consumption of intact oat kernels was associated with significant reductions in postprandial blood glucose (−45.5 mmol x min/L; 95% CI: −80.1, −10.9 mmol x min/L; P = 0.010) and insulin (−4.5 nmol x min/L; 95% CI: −7.1, −1.8 nmol x min/L; P = 0.001) responses; the consumption of thick oat flakes was associated with significant reductions in postprandial blood glucose (−30.6 mmol x min/L; 95% CI: −40.4, −20.9 mmol x min/L; P &lt; 0.001) and insulin (−3.9 nmol x min/L; 95% CI: −5.3, −2.5 nmol x min/L; P &lt; 0.001) responses; but, the consumption of thin/quick/instant oat flakes was not associated with any effects on the postprandial blood glucose and insulin responses. Conclusions A disruption in the structural integrity of the oat kernel is likely associated with a loss in the glycemic benefits of oats.

scholarly journals Progression-free survival as a surrogate endpoint for overall survival in modern ovarian cancer trials: a meta-analysis

2018 ◽  
Vol 10 ◽  
pp. 175883591878850 ◽  
Author(s):  
Katrin M. Sjoquist ◽  
Sarah J. Lord ◽  
Michael L. Friedlander ◽  
Robert John Simes ◽  
Ian C. Marschner ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Surrogate Endpoint ◽  
Controlled Trials ◽  
First Line ◽  
Free Survival ◽  
Randomized Controlled ◽  
The Difference

Background: Progression-free survival (PFS) has been adopted as the primary endpoint in many randomized controlled trials, and can be determined much earlier than overall survival (OS). We investigated whether PFS is a good surrogate endpoint for OS in trials of first-line treatment for epithelial ovarian cancer (EOC), and whether this relationship has changed with the introduction of new treatment types. Methods: In a meta-analysis, we identified summary data [hazard ratio (HR) and median time] from published randomized controlled trials. Linear regression was used to assess the association between treatment effects on PFS and OS overall, and for subgroups defined by treatment type, postprogression survival (PPS) and established prognostic factors. Results: Correlation between HRs for PFS and OS, in 26 trials with 30 treatment comparisons comprising 24,870 patients, was modest ( r2 = 0.52, weighted by trial sample size). The correlation diminished with recency: preplatinum/paclitaxel era, r2 = 0.66; platinum/paclitaxel, r2 = 0.44; triplet combinations, r2 = 0.22; biologicals, r2 = 0.30. The median PPS increased over time for the experimental ( Ptrend = 0.03) and control arms ( Ptrend = 0.003). The difference in median PPS between treatment arms strongly correlated with the difference in median OS ( r2 = 0.83). In trials where the control therapy had median PPS of less than 18 months, correlation between PFS and OS was stronger ( r2 = 0.64) than where the median PPS was longer ( r2 = 0.48). Conclusions: In EOC, correlation in the relative treatment effect between PFS and OS in first-line platinum-based chemotherapy randomized controlled trials is moderate and has weakened with increasing availability of effective salvage therapies.

scholarly journals The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 10 (8) ◽  
pp. 1585
Author(s):  
Yi-Ting Chen ◽  
Cheuk-Kwan Sun ◽  
Kuan-Yu Wu ◽  
Ying-Jen Chang ◽  
Min-Hsien Chiang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Sleep Endoscopy ◽  
Drug Induced ◽  
Randomized Controlled ◽  
Drug Induced Sleep Endoscopy ◽  
Obstructive Sleep ◽  
Significant Difference ◽  
The Difference

The sedation outcomes associated with dexmedetomidine compared with those of propofol during drug-induced sleep endoscopy (DISE) remains unclear. Electronic databases (i.e., the Cochrane controlled trials register, Embase, Medline, and Scopus) were searched from inception to 25 December 2020 for randomized controlled trials (RCTs) that evaluated the sedation outcomes with dexmedetomidine or propofol in adult patients diagnosed with obstructive sleep apnea (OSA) receiving DISE. The primary outcome was the difference in minimum oxygen saturation (mSaO2). Five RCTs (270 participants) published between 2015 and 2020 were included for analysis. Compared with dexmedetomidine, propofol was associated with lower levels of mSaO2 (mean difference (MD) = −7.24, 95% confidence interval (CI) −12.04 to −2.44; 230 participants) and satisfaction among endoscopic performers (standardized MD = −2.43, 95% CI −3.61 to −1.26; 128 participants) as well as a higher risk of hypoxemia (relative ratios = 1.82, 95% CI 1.2 to 2.76; 82 participants). However, propofol provided a shorter time to fall asleep and a lower risk of failed sedation compared with dexmedetomidine. No significant difference was found in other outcomes. Compared with propofol, dexmedetomidine exhibited fewer adverse effects on respiratory function and provided a higher level of satisfaction among endoscopic performers but was associated with an elevated risk of failed sedation.

The difference between oats and beta-glucan extract intake in the management of HbA1c, fasting glucose and insulin sensitivity: a meta-analysis of randomized controlled trials

2016 ◽  
Vol 7 (3) ◽  
pp. 1413-1428 ◽  
Author(s):  
Li-xia He ◽  
Jian Zhao ◽  
Yuan-sheng Huang ◽  
Yong Li
Keyword(s):  
Insulin Sensitivity ◽  
Glycemic Control ◽  
Randomized Controlled Trials ◽  
Fasting Glucose ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Beta Glucan ◽  
Randomized Controlled ◽  
The Difference

This study aims to assess the different effects between oats (whole and bran) and beta-glucan extract intake on glycemic control and insulin sensitivity.

scholarly journals Comparison of general and aesthetic effects between flapless and flap techniques in dental implantation: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Xiaomeng Gao ◽  
Siyu Qin ◽  
He Cai ◽  
Qianbing Wan
Keyword(s):  
Randomized Controlled Trials ◽  
Subgroup Analysis ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Dental Implantation ◽  
Probing Depth ◽  
Significant Difference ◽  
The Difference ◽  
The Aesthetic

Abstract Background Information about the aesthetic effects of flapless in implant surgeries is scant. Differences of the survival rate (SR) and crestal bone loss (CBL) between the two techniques were also controversial. Thus, this review was aimed to compare the general and aesthetic effects of flapless and flap approaches in implant surgeries. Materials and methods Following the principals of PRISMA, literature databases were searched for the eligible randomized controlled trials (RCTs) comparing the clinical performances of flap and flapless techniques. After that, relevant data of selected studies were pooled and analyzed to compare SR, bleeding on probing (BOP), probing depth (PD), visual analogue scale (VAS), papillae presentation index (PPI), keratinized mucosa (KM) width and CBL between the two techniques. Results Fourteen RCTs were included. No significant difference was found in SR (RR = − 0.01, 95% confidence interval (CI) (− 0.05, 0.04)), BOP (OR = 0.40, 95% CI (0.15, 1.02)), KM width (WMD = − 0.42, 95% CI (− 1.02, 0.17)) between two groups. Subgroup analysis revealed that the difference of CBL was insignificant in two groups (WMD = − 0.13, 95% CI (− 0.63, 0.38)). However, flap techniques would lead more peri-implant PD (WMD = − 0.37, 95% CI (− 0.51, − 0.23)). Subgroup analysis also indicated lower VAS scores in flapless group after 1 day (WMD = − 1.66, 95% CI (− 2.16, − 1.16)) but comparable pain experience after 3 days (WMD = − 0.59, 95% CI (− 1.33, 0.16)). Mean difference of PPI (WMD = 0.32, 95% CI (0.28, 0.35)) between the two groups was significant. Conclusions The flapless procedure showed a superiority in preserving gingival papillae, reducing postoperative pain and peri-implant PD compared to the flap procedure, while exhibiting comparable effects on SR, BOP, KW width changes and CBL. Flapless technique is more recommended at the ideal soft and hard tissue implanting sites.

Efficacy Of Novel Agents As Maintenance Therapy For Multiple Myeloma: A Direct and Network Meta-Analysis

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1945-1945
Author(s):  
Tea Reljic ◽  
Ambuj Kumar ◽  
Helen Mahoney ◽  
Branko Miladinovic ◽  
Mohamed A Kharfan-Dabaja ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Maintenance Therapy ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Novel Agents ◽  
Cumulative Probability ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Mixed Treatment ◽  
American Society

Abstract Background Multiple myeloma (MM) accounts for 10% of all hematological malignancies. While MM remains incurable, several life-extending treatments are available including maintenance treatments. The goal of maintenance therapy is to modulate residual MM after an initial response, thereby prolonging progression-free and overall survival by adding additional therapy following induction treatment. The role of maintenance therapies in the management of multiple myeloma is unclear and evidence on efficacy of novel regimens (e.g. bortezomib, lenalidomide, or thalidomide) remains conflicting. We performed a systematic review and network meta-analysis of trials to assess the efficacy of novel agents used as maintenance therapy in management of multiple myeloma. Methods A comprehensive search of MEDLINE (PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), and meeting abstracts from American Society of Hematology, American Society of Clinical Oncology, European Society for Medical Oncology and European Hematology Association was conducted to identify all phase III randomized controlled trials (RCTs) of novel agents used as maintenance therapy for multiple myeloma published until May 2013. We extracted data on overall and progression-free survival (OS, PFS). Data were pooled using direct and network meta-analysis. Direct comparisons within trials were combined with indirect evidence from other trials using the Bayesian mixed treatment comparison method under the random-effects model. Indirect comparisons were constructed from trials which have one treatment in common. Results Of 2678 identified references, 23 randomized controlled trials met the inclusion criteria. Of these, 12 studies (4832 patients) contributed data to the network. The network of direct comparisons for all included studies for the outcome of PFS is shown in figure 1A. The results for meta-analysis of novel agents for PFS is shown in figure 1B. The combination of lenalidomide with prednisone was superior to no treatment as well as prednisone alone in addition to lenalidomide as single agent compared with no treatment. Furthermore, combination bortezomib plus thalidomide and dexamethasone plus lenalidomide was superior to no treatment. None of the novel agents except thalidomide plus prednisone compared with prednisone alone showed a significant improvement in OS and therefore an indirect comparison for OS was not conducted. The results of mixed treatment comparisons are illustrated in figure 1C which shows non-superiority of any novel agent. The cumulative probability rank for PFS is shown in Figure 1D. The area under the cumulative probability rank curve was highest for bortezomib+prednisone (0.73), followed by lenalidomide and lenalidomide+dexamethasone (both 0.71). Conclusion This analysis is an important addition to prior direct comparisons of novel agents for maintenance in multiple myeloma. Looking at PFS, use of bortezomib+prednisone, lenalidomide and lenalidomide+dexamethasone appears to be superior to other agents. However, provided the small number of trials between each comparison, current data do not allow for strong conclusions on superiority of any one treatment and direct comparison in a RCT is warranted for more conclusive results. Disclosures: No relevant conflicts of interest to declare.

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