validation

验证
  • 文章类型: Journal Article
    连续肾脏替代治疗(CRRT)已成为危重患者肾脏替代治疗(RRT)的标准方式。然而,关于停止CRRT的标准缺乏共识。在这里,我们验证了多中心回顾性队列中成功停止CRRT的预测模型的有用性。
    一个时间队列和四个外部队列包括1,517例急性肾损伤患者,他们在2018年至2020年接受了CRRT>2天。该模型由四个变量组成:尿量,血尿素氮,血清钾,和平均动脉压。CRRT的成功停止被定义为此后7天没有RRT要求。
    受试者工作特征曲线下面积(AUROC)为0.74(95%置信区间,0.71-0.76)。成功停药的概率约为17%,35%,70%在低分中,中级分数,和高分组,分别。四个队列的模型性能良好(AUROC,0.73-0.75),但在一个队列中较差(AUROC,0.56)。在一个表现不佳的队列中,主治医生主要控制CRRT处方和停药,而在其他四个队列中,肾脏病学家确定了CRRT手术的所有重要步骤,包括CRRT停药的筛查。
    我们的预测模型使用四个简单变量成功停止CRRT的总体性能良好,除了一个肾脏科医师没有积极参与CRRT手术的队列.这些结果表明,需要积极参与肾脏病学家和对CRRT停药的规范化管理。
    UNASSIGNED: Continuous renal replacement therapy (CRRT) has become the standard modality of renal replacement therapy (RRT) in critically ill patients. However, consensus is lacking regarding the criteria for discontinuing CRRT. Here we validated the usefulness of the prediction model for successful discontinuation of CRRT in a multicenter retrospective cohort.
    UNASSIGNED: One temporal cohort and four external cohorts included 1,517 patients with acute kidney injury who underwent CRRT for >2 days in 2018 to 2020. The model was composed of four variables: urine output, blood urea nitrogen, serum potassium, and mean arterial pressure. Successful discontinuation of CRRT was defined as the absence of an RRT requirement for 7 days thereafter.
    UNASSIGNED: The area under the receiver operating characteristic curve (AUROC) was 0.74 (95% confidence interval, 0.71-0.76). The probabilities of successful discontinuation were approximately 17%, 35%, and 70% in the low-score, intermediate-score, and high-score groups, respectively. The model performance was good in four cohorts (AUROC, 0.73-0.75) but poor in one cohort (AUROC, 0.56). In one cohort with poor performance, attending physicians primarily controlled CRRT prescription and discontinuation, while in the other four cohorts, nephrologists determined all important steps in CRRT operation, including screening for CRRT discontinuation.
    UNASSIGNED: The overall performance of our prediction model using four simple variables for successful discontinuation of CRRT was good, except for one cohort where nephrologists did not actively engage in CRRT operation. These results suggest the need for active engagement of nephrologists and protocolized management for CRRT discontinuation.
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  • 文章类型: Journal Article
    目标:尽管研究表明,语音的数字测量检测到ALS语音障碍,并与ALSFRS-R语音项目相关,尚未有研究比较他们在检测语音变化方面的表现。在这项研究中,我们比较了ALSFRS-R语音项和算法语音测量在检测临床重要语音变化方面的表现.重要的是,该研究是FDA提交的报告的一部分,该报告获得了用于ALS监测的突破性设备名称;我们提供本文作为验证用于监测疾病进展的其他语音措施的路线图.方法:我们从ALS患者中获得ALSFRS-R语音子分数和语音样本。我们计算了两种测量的最小可检测变化(MDC);使用临床医生报告的听众努力和严重程度的感知评级,我们计算了两组临床评分的各项指标的最小临床重要差异(MCID).结果:对于关节精度,MDC(.85)低于两个MCID指标(2.74和2.28),对于ALSFRS-R语音项目,MDC(.86)大于两个MCID度量(.82和.72),这表明,虽然发音精度测量检测到最小的临床上重要的语音差异,ALSFRS-R语音项目没有。结论:结果表明,发音精度的数字测量有效地检测出语音评分的临床重要差异,优于ALSFRS-R语音项。一起来看,本文的结果表明,这种语音结果是一种有临床意义的语音变化量度。
    Objective: Although studies have shown that digital measures of speech detected ALS speech impairment and correlated with the ALSFRS-R speech item, no study has yet compared their performance in detecting speech changes. In this study, we compared the performances of the ALSFRS-R speech item and an algorithmic speech measure in detecting clinically important changes in speech. Importantly, the study was part of a FDA submission which received the breakthrough device designation for monitoring ALS; we provide this paper as a roadmap for validating other speech measures for monitoring disease progression. Methods: We obtained ALSFRS-R speech subscores and speech samples from participants with ALS. We computed the minimum detectable change (MDC) of both measures; using clinician-reported listener effort and a perceptual ratings of severity, we calculated the minimal clinically important difference (MCID) of each measure with respect to both sets of clinical ratings. Results: For articulatory precision, the MDC (.85) was lower than both MCID measures (2.74 and 2.28), and for the ALSFRS-R speech item, MDC (.86) was greater than both MCID measures (.82 and .72), indicating that while the articulatory precision measure detected minimal clinically important differences in speech, the ALSFRS-R speech item did not. Conclusion: The results demonstrate that the digital measure of articulatory precision effectively detects clinically important differences in speech ratings, outperforming the ALSFRS-R speech item. Taken together, the results herein suggest that this speech outcome is a clinically meaningful measure of speech change.
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  • 文章类型: Journal Article
    本文介绍了一种全自动实验装置,用于评估增强和虚拟现实技术在医疗保健环境中的有效性,以达到监管目的。专注于深度传感器的表征。该设置构造为模块化台式平台,可对深度相机进行定量分析,这对于受控环境中的扩展现实技术至关重要。我们详细介绍了旨在模拟头戴式显示器的现实场景的实验配置的设计概念和注意事项。该系统包括配备有三自由度机动化系统的观察平台和测试对象台。为了准确地复制现实世界的场景,我们使用了一系列传感器,包括常用的范围感应摄像头和商用增强现实耳机,特别是英特尔实感L515激光雷达摄像头,集成到运动控制系统中。论文详细阐述了系统架构和自动化数据采集过程。我们讨论了使用此设置进行的几项评估研究,检查空间分辨率等因素,Z精度,和像素到像素的相关性。这些研究为模拟医疗环境中这些技术的精度和可靠性提供了宝贵的见解。
    This paper presents a fully automated experimental setup tailored for evaluating the effectiveness of augmented and virtual reality technologies in healthcare settings for regulatory purposes, with a focus on the characterization of depth sensors. The setup is constructed as a modular benchtop platform that enables quantitative analysis of depth cameras essential for extended reality technologies in a controlled environment. We detail a design concept and considerations for an experimental configuration aimed at simulating realistic scenarios for head-mounted displays. The system includes an observation platform equipped with a three-degree-of-freedom motorized system and a test object stage. To accurately replicate real-world scenarios, we utilized an array of sensors, including commonly available range-sensing cameras and commercial augmented reality headsets, notably the Intel RealSense L515 LiDAR camera, integrated into the motion control system. The paper elaborates on the system architecture and the automated data collection process. We discuss several evaluation studies performed with this setup, examining factors such as spatial resolution, Z-accuracy, and pixel-to-pixel correlation. These studies provide valuable insights into the precision and reliability of these technologies in simulated healthcare environments.
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  • 文章类型: Journal Article
    2019年冠状病毒病(COVID-19)疫苗免疫原性的评估仍然至关重要,因为严重的急性呼吸道合胞病毒2(SARS-CoV-2)大流行继续演变,并且随着其他变体的出现。中和抗体是SARS-CoV-2疫苗的保护的已知关联。在Novavax临床免疫学实验室开发并验证了假病毒中和(PNT)测定法,以允许检测疫苗临床试验血清中的中和抗体。PNT测定是精确的,准确,线性,并且在测量祖先菌株和Omicron亚变体BA.5和XBB.1.5的人血清中SARS-CoV-2中和滴度方面具有特异性,总体几何变异系数≤43.4%,在-60%至150%的预期范围内的百分比相对偏差,所有三个菌株的线性值R2>0.98。该假病毒测定可用于分析疫苗临床试验样品以评估疫苗免疫原性。未来的工作将集中在修改新出现的变体的测定,包括XBB.1.16、EG.5.1、BA.2.86以及正在进行的大流行中出现的任何其他变体。
    The evaluation of coronavirus disease 2019 (COVID-19) vaccine immunogenicity remains essential as the severe acute respiratory syncytial virus 2 (SARS-CoV-2) pandemic continues to evolve and as additional variants emerge. Neutralizing antibodies are a known correlate of protection for SARS-CoV-2 vaccines. A pseudovirus neutralization (PNT) assay was developed and validated at Novavax Clinical Immunology Laboratories to allow for the detection of neutralizing antibodies in vaccine clinical trial sera. The PNT assay was precise, accurate, linear, and specific in measuring SARS-CoV-2 neutralization titers in human serum for ancestral strain and the Omicron subvariants BA.5 and XBB.1.5, with an overall geometric coefficient of variation of ≤43.4%, a percent relative bias within the expected range of -60% to 150%, and a linearity value of R2 > 0.98 for all three strains. This pseudovirus assay will be useful for the analysis of vaccine clinical trial samples to assess vaccine immunogenicity. Future work will focus on modifying the assay for emerging variants, including XBB.1.16, EG.5.1, BA.2.86, and any other variants that emerge in the ongoing pandemic.
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  • 文章类型: Journal Article
    脑雾是一种以注意力不集中为特征的疾病,记忆丧失,认知功能下降,和精神疲劳。虽然它通常被称为一种长期的COVID-19症状,据报道,脑雾也是由许多其他疾病引起的。因此,有必要在某些人群中评估这种情况。这项研究旨在评估土耳其人群脑雾量表的信度和效度。我们分两个阶段进行了研究。在一项包括125名参与者的试点研究中,我们确认量表适用于有效性分析,然后进行探索性(n=230)和验证性因素分析(n=343).23项脑雾量表的Cronbachα值为0.966。此外,分析结果证实了23项和三因素结构.这三个因素是精神疲劳,认知敏锐度受损,和困惑。我们还发现,先前被诊断患有COVID-19的参与者的脑雾评分更高。这一发现表明,脑雾是可能伴随COVID-19的重要疾病。此外,这个经过验证的结构具有可接受的拟合度,是土耳其人口的有效和有用的工具.
    Brain fog is a condition that is characterized by poor concentration, memory loss, decreased cognitive function, and mental fatigue. Although it is generally known as a long-term COVID-19 symptom, brain fog has also been reported to be caused by many other diseases. Thus, it is necessary to assess this condition in certain populations. This study aimed to evaluate the reliability and validity of the Brain Fog Scale in a Turkish population. We conducted the study in two phases. In a pilot study including 125 participants, we confirmed the suitability of the scale for validity analyses and then conducted exploratory (n = 230) and confirmatory factor analyses (n = 343). The Cronbach\'s alpha value of the 23-item Brain Fog Scale was 0.966. In addition, the 23-item and three-factor structure was confirmed as a result of the analyses. These three factors are mental fatigue, impaired cognitive acuity, and confusion. We also found that participants previously diagnosed with COVID-19 had higher brain fog scores. This finding indicates that brain fog is an important condition that can accompany COVID-19. Furthermore, this validated construct has an acceptable fit and is a valid and useful tool for the Turkish population.
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  • 文章类型: Journal Article
    背景:存在一种有效的工具来评估母亲在分娩过程中对医学伦理的遵守态度,可以导致采取适当的干预措施,以创造积极的态度。这项研究的目的是确定MEAVDQ(阴道分娩问卷中的医学伦理学态度)的结构效度。
    方法:研究对象为350名女性。主要研究仪器为MEAVDQ。这份59项问卷包括三个部分A,B,J.A部分涉及第一原则。B部分涉及第二和第三原则,J部分涉及医学伦理学的第四原则。结构方程模型(SEM)用于确定MEAVDQ的结构有效性。
    结果:SEM结果显示结构A和B之间呈正相关,结构B和J之间也呈正相关且显着。另一方面,结构A和结构J之间存在直接和间接的关系。结构A的一个单位增加导致结构J的直接增加0.16(95%CI:0.01,0.33)。结构A中的一个单位增加分数增加导致结构J中的0.39间接增加(95%CI:0.26,0.53),并具有结构B的中介作用。
    结论:可以建议助产政策制定者和助产士尊重医学伦理和自主权的第一原则是分娩中最重要的医学伦理原则。尊重母亲的自主权,可以为他们创造积极的出生体验。
    BACKGROUND: The existence of a valid instrument to evaluate the attitude of mothers towards compliance with medical ethics during childbirth can lead to appropriate interventions to create a positive attitude. The purpose of this study is to determine the construct validity of the MEAVDQ (Medical Ethics Attitude in Vaginal Delivery Questionnaire).
    METHODS: The study was carried out with 350 women. The main research instrument was MEAVDQ. This 59-item questionnaire comprises three parts A, B, J. Part A is concerned with the first principles. Part B deals with the second and third principles and part J addresses the fourth principle of medical ethics. Structural Equations Modeling (SEM) was used to determine the construct validity of MEAVDQ.
    RESULTS: The results of SEM revealed that there was a positive correlation between structures A and B. The relationship between structures B and J was also positive and significant. On the other hand, there was a direct and indirect relationship between structures A and J. One-unit increase in structure A led to 0.16 (95% CI: 0.01, 0.33) direct increase in structure J. Also, one-unit increase score increases in structure A caused 0.39 indirect rise (95% CI: 0.26, 0.53) in structure J with the mediating role of the structure B.
    CONCLUSIONS: It can be suggested to midwifery policy maker and midwives that respect for the first principle of medical ethics and autonomy is the most important principle of medical ethics in childbirth. By respecting the autonomy of mothers, a positive birth experience can be created for them.
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  • 文章类型: Journal Article
    目的:建立并验证预测肾切除术后临床T1/2(cT1/2)透明细胞肾细胞癌(ccRCC)患者无复发生存期(RFS)的列线图。
    方法:纳入2017-2020年天津医科大学第二医院1289例cT1/2ccRCC患者的临床病理和生存资料。Cox回归分析用于确定训练和验证队列中902和387例ccRCC患者的独立危险因素。分别,并构造列线图。通过校准图评估列线图的性能,随时间变化的接收机工作特性(ROC)曲线,C指数(一致性指数),和决策曲线分析(DCA)。采用Kaplan-Meier曲线评价不同复发风险患者发生RFS的概率。
    结果:年龄,肿瘤大小,手术方法,Fuhrman年级,pT3a上升阶段被确定为RFS的独立预测因子。训练队列中3年和5年RFSROC曲线的曲线下面积(AUC)分别为0.791和0.835,验证队列中的0.860和0.880。DCA和校准图证明了列线图在预测3年和5年RFS方面的最佳应用和出色的准确性。Kaplan-Meier曲线显示了训练和验证队列中三个风险组之间RFS的显着差异。临床上,开发的列线图为风险分层提供了更精确的工具,实现量身定制的术后管理和监测策略,最终旨在改善患者预后。
    结论:我们开发了一个列线图,用于预测cT1/2ccRCC患者肾切除术后的RFS,具有很高的准确性。此列线图的临床实施可以显着提高临床决策,改善患者预后,优化ccRCC管理资源利用。
    OBJECTIVE: To develop and validate a nomogram for predicting recurrence-free survival (RFS) for clinical T1/2 (cT1/2) clear cell renal cell carcinoma (ccRCC) patients after nephrectomy.
    METHODS: Clinicopathological and survival data from 1289 cT1/2 ccRCC patients treated at the Second Hospital of Tianjin Medical University between 2017 and 2020 were included. Cox regression analysis was used to identify independent risk factors in 902 and 387 ccRCC patients in the training and validation cohorts, respectively, and construct the nomogram. The performance of the nomogram was assessed through calibration plots, time-dependent receiver operating characteristic (ROC) curves, C-index (concordance-index), and decision curve analysis (DCA). Kaplan-Meier curves were used to evaluate the probability of RFS in patients with different recurrence risks.
    RESULTS: Age, tumor size, surgical approach, Fuhrman grade, and pT3a upstage were identified as independent predictors of RFS. The area under the curve (AUC) for the 3-year and 5-year RFS ROC curves were 0.791 and 0.835 in the training cohort, and 0.860 and 0.880 in the validation cohort. The DCA and calibration plots demonstrated the optimal application and excellent accuracy of the nomogram for predicting 3-year and 5-year RFS. Kaplan-Meier curves revealed significant differences in RFS among the three risk groups in both the training and validation cohorts. Clinically, the developed nomogram provides a more precise tool for risk stratification, enabling tailored postoperative management and surveillance strategies, ultimately aiming to improve patient outcomes.
    CONCLUSIONS: We developed a nomogram for predicting RFS in cT1/2 ccRCC patients after nephrectomy with high accuracy. The clinical implementation of this nomogram can significantly enhance clinical decision-making, leading to improved patient outcomes and optimized resource utilization in the management of ccRCC.
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  • 文章类型: Journal Article
    背景:该研究旨在验证Wooley问题在社区环境中筛查中国女性产后抑郁症。
    方法:按照Beaton的跨文化调试指南将Whooley问题翻译成中文。2020年12月1日至2021年6月30日,长沙市开福区、长沙县基层妇幼保健工作者在出院七天内进行家访时,招募了近期分娩的18岁及以上妇女。参与者妇女在线完成了Wooley问题,并在访问后7天内接受了DSM-IV的诊断性访谈。我们评估了克朗巴赫的阿尔法,半分割可靠性,ROC曲线下面积(AUC),灵敏度,特异性,阳性预测值(PPV),负预测值(NPV),和Wooley问题的最优截止值。
    结果:在3,004名合格女性中,1,862人完成了Wooley问题和诊断性访谈。62名妇女(3.3%)被诊断患有抑郁症。Cronbach的α系数为0.64,分裂半可靠性为0.64。最佳截止值是当至少一个问题被回答为“是”时,AUC为0.84(SE=0.03,95CI0.78-0.90,P<0.001),灵敏度为0.77(95CI0.65-0.87),特异性为0.89(95CI0.88-0.90),PPV为0.20(95CI0.15-0.25),净现值为0.99(95CI0.98-1.00)。
    结论:这项研究表明,Wooley问题的中文版是筛查社区产后抑郁症的可靠工具,但它可能会导致许多假阳性病例。
    BACKGROUND: The study aims to validate the Whooley questions for screening postpartum depression in Chinese women in a community setting.
    METHODS: The Whooley questions was translated into Chinese following Beaton\'s intercultural debugging guidelines. From December 1, 2020 to June 30, 2021, primary maternal and child health workers in Kaifu District and Changsha County in Changsha City recruited women aged 18 years or older who had recently given birth during home visits within seven days of discharge from hospital. Participants women completed the Whooley questions online and underwent a diagnostic interview for DSM-IV within 7 days of the visit. We evaluated Cronbach\'s alpha, split-half reliability, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and optimal cut-off value of the Whooley questions.
    RESULTS: Of the 3,004 eligible women, 1,862 completed the Whooley questions and diagnostic interviews. Sixty-two women (3.3%) were diagnosed with depressive disorders. The Cronbach\'s alpha coefficient was 0.64, the split-half reliability was 0.64. The optimal cut-off value was when at least one questions was answered \"yes\", with an AUC of 0.84 (SE=0.03, 95%CI 0.78-0.90, P<0.001), sensitivity of 0.77 (95%CI 0.65-0.87), specificity of 0.89 (95%CI 0.88-0.90), PPV of 0.20 (95%CI 0.15-0.25) and NPV of 0.99 (95%CI 0.98-1.00).
    CONCLUSIONS: This study shows that the Chinese version of the Whooley questions is a reliable tool for screening postpartum depression in the community, but it may lead to many false positive cases.
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  • 文章类型: Journal Article
    估算生物流体和食物中锌(Zn)的灵敏而精确的方法是了解与Zn营养有关的各个方面的重要工具。建议估算血清/血浆Zn,以评估种群的Zn状况,同时评估水稻等作物品种的模拟胃肠道消化后生物可利用的Zn,有助于对作物进行排名。原子吸收光谱法(AAS)或电感耦合等离子体质谱法(ICP-MS)广泛用于Zn估算。Zinquin,锌荧光团,已用于以极高的灵敏度定位生物流体中的细胞Zn和不稳定Zn库。然而,未对其在血清/血浆中的锌估算或从食物中评估锌的生物可利用性进行测试。在目前的研究中,我们展示了一种用于人体血浆中锌估算的灵敏方法,并通过比较相同样品的成对测量结果来验证其与参考方法(AAS)。zinquin与AAS之间与方法相关的偏差可以忽略不计(0.48µg/dL),在不同的Zn浓度下,测定的精确度(CV)<5%。此外,我们还证明了zinquin测定法在估算水稻品种中锌的生物可及性方面的实用性,并表明该方法再次与AAS相当。zinquin方法能够区分精米和非精米品种之间锌生物可及性的差异。在所需的低血浆体积(100微升对400微升)的情况下,结果与参考方法的优异可比性和分析简单性可能特别有用。
    Sensitive and precise methods for the estimation of zinc (Zn) in biological fluids and foods are important tools in understanding the various aspects related to Zn nutrition. Estimation of serum/plasma Zn was suggested for assessing the population Zn status while assessing the bioaccessible Zn following simulated gastrointestinal digestion of crop varieties such as rice helps in ranking the crops. Atomic absorption spectrometry (AAS) or inductively coupled plasma-mass spectrometry (ICP-MS) are widely used for Zn estimation. Zinquin, a Zn fluorophore, has been used for the localization of cellular Zn and labile Zn pools in biological fluids with extremely high sensitivity. However, it was not tested for its use in Zn estimation in serum/plasma or in assessing the Zn bioaccessibility from foods. In the current study, we demonstrate a sensitive method for Zn estimation in human plasma and validate it against the reference method (AAS) by comparing the paired measurements on the same samples. The method-related bias between zinquin with AAS was negligible (0.48 µg/dL), and the precision (CV) of the assay was < 5% across different Zn concentrations. In addition, we also demonstrated the utility of zinquin assay in estimating the bioaccessibility of Zn from rice varieties and showed that the method is again comparable to AAS. The zinquin method is capable of discriminating the differences in zinc bioaccessibility between polished and unpolished rice varieties. In the context of required low plasma volume (100 µL Vs 400 µL), excellent comparability of the results with the reference method and analytical simplicity could be particularly useful.
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  • 文章类型: Journal Article
    在这篇文章中,我们概念化了一种名为“延展性”的新结构,并提出了一种测量仪器。我们检查了心理测量特性-意大利延性量表的因子效度和信度。探索性因素分析结果表明,该量表具有双因素结构,即,个人和组织的延展性。两个维度的量表可靠性都很好(个体ω=0.82;组织ω=0.85)。参与者是来自私人和公共组织的员工(n=466)。我们测试了延性量表的结构效度。通过多组确认因子分析测试的测量模型的不变性表明,延性量表在性别之间是不变的。此外,我们发现延展性与积极主动的人格和工作投入呈正相关。这些初步结果表明,延性量表是一种可靠而有效的措施。此外,我们的发现通过新开发的量表说明了延性结构的潜在有用性。
    In this article, we conceptualize a new construct named \"ductility\" and propose a measurement instrument. We examine psychometric properties-the factorial validity and reliability of the Ductility Scale in Italy. The results of exploratory factor analysis showed that the scale has a two-factor structure, namely, individual and organizational ductility. The scale reliability was excellent for both dimensions (individual ω = 0.82; organizational ω = 0.85). The participants were employees from private and public organizations (n = 466). We tested the construct validity of the Ductility Scale. The invariance of the measurement model tested via multigroup confirmative factor analysis showed that the Ductility Scale was invariant across gender. In addition, we found ductility to be positively related to proactive personality and work engagement. These preliminary results show that the Ductility Scale is a reliable and valid measure. In addition, our findings illustrate the potential usefulness of the ductility construct via the newly developed scale.
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