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1.
BackgroundPregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers.MethodsBANSAR is a pragmatic randomised controlled trial conducted in antenatal clinic in seven public hospitals in Hong Kong, China. An estimated 1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking will be randomised (1:1) to receive brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care). Outcome will be assessed at 3 and 6 months after treatment initiation. The primary outcome is carbon monoxide-verified (<4 part per million) abstinence at 6 months post-treatment initiation. Secondary outcomes include self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers.CommentThis trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population. The findings may be particularly relevant to low and middle-income countries, where male-to-female smoking ratios and birth rates tend to be higher than higher-income countries.Trial registrationClinicalTrials.gov, number NCT03671707.  相似文献   

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Tobacco cessation counseling by health care professionals has been associated with increased tobacco cessation rates. In this study we compare the effectiveness of two smoking cessation approaches administered by nurse practitioners--a stepped care approach (n = 34) and a routine care approach (n = 41), using a pre- and post-test control group study design. Additionally, this study was guided by the "stages of change" construct of the transtheoretical model. Study results indicated that nurse practitioners delivered consistent office-based advice about tobacco use. In addition, nurse practitioner smoking cessation interventions contributed to positive shifts in stage of change for smoking cessation.  相似文献   

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This randomized clinical trial was designed to test the efficacy of intensive versus brief smoking cessation interventions for hospital patients. The interventions included advice and pamphlets for Brief and bedside counselling, take-home materials, and 7 post-discharge telephone counselling calls over 2 months for Intensive. Confirmed 1-year abstinence was 28% for Intensive (85/301) and 24% for Brief (76/315). Abstinence was significantly higher for patients who did not use pharmacotherapy (36%) versus those who did (16%) and for patients with CVD (40%) versus other diagnoses (20%). Because this was a replication trial, benchmarks for planning can be suggested: 12% to 15% recruitment of identified smokers, 90% plus completion for Intensive, 15% drop-out, and 75% abstinence corroboration. The results consolidate findings for general inpatients, including expected absolute abstinence and treatment outcomes, the effect of CVD patients on outcomes, the reproducibility of high abstinence in a universal health-care system, and the need for more research to inform practice.  相似文献   

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BackgroundNovel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g., WhatsApp, Facebook Messenger) are widely used but under-studied as a mobile health modality for delivering smoking cessation support. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a chat-based intervention using mobile instant messaging combined with brief interventions for community smokers.MethodsThis is a two-arm, parallel, accessor-blinded, pragmatic cluster-randomized controlled trial on an estimated 1172 daily cigarette smokers aged ≥18 years proactively recruited from 68 community sites (cluster) throughout Hong Kong. Subjects in intervention group received three months of chat-based, instant messaging support guided by acceptance and commitment therapy and other behavioural change techniques, integrated with brief advice and active referral to a smoking cessation service using the AWARD (Ask, Warn, Advise, Refer, Do-it-again) intervention model. Control group received brief advice to quit plus a self-help booklet at baseline. Outcomes were assessed at 1-, 2-, 3- and 6-month after baseline. The primary outcome is abstinence validated by exhaled carbon monoxide (<4 ppm) and salivary cotinine (<10 ng/mL) at 6-month after baseline. Primary analyses will be based on intention-to-treat.CommentsThis is the first trial examining the effectiveness of a chat-based cessation support programme combined with brief interventions in promoting abstinence. The intervention model can be adapted for other behavioural change treatments and more advanced digital smoking cessation intervention.  相似文献   

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IntroductionMost smokers see a physician each year, but few use any assistance when they try to quit. Text messaging programs improve smoking cessation in community and school settings; however, their efficacy in a primary care setting is unclear. The current trial assesses the feasibility and preliminary clinical outcomes of text messaging and mailed nicotine replacement therapy (NRT) among smokers in primary care.MethodsIn this single-center pilot randomized trial, eligible smokers in primary care are offered brief advice by phone and randomly assigned to one of four interventions: (1) Brief advice only, (2) text messages targeted to primary care patients and tailored to quit readiness, (3) a 2-week supply of nicotine patches and/or lozenges (NRT), and (4) both text messaging and NRT. Randomization is stratified by practice and intention to quit. The text messages (up to 5/day) encourage those not ready to quit to practice a quit attempt, assist those with a quit date through a quit attempt, and promote NRT use. The 2-week supply of NRT is mailed to patients' homes.ResultsFeasibility outcomes include recruitment rates, study retention, and treatment adherence. Clinical outcomes are assessed at 1, 2, 6, and 12-weeks post-enrollment. The primary outcome is ≥1self-reported quit attempt(s). Secondary clinical outcomes include self-reported past 7- and 30-day abstinence, days not smoked, NRT adherence, and exhaled carbon monoxide.ConclusionsThis pilot assesses text messaging plus NRT, as a proactively offered intervention for smoking cessation support in smokers receiving primary care and will inform full-scale randomized trial planning.Trial registrationClinicalTrials.govNCT03174158.  相似文献   

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BackgroundVarenicline was designed to relieve symptoms of nicotine withdrawal, including cigarette craving, and to block the reinforcing effects of continued nicotine use. The cost-effectiveness of varenicline in some countries has not been studied.ObjectiveThe aim of this study was to compare the cost-effectiveness of varenicline to that of bupropion, nicotine-replacement therapy (NRT), and unaided cessation in the Greek health care setting. The analysis takes into account a societal security (third-party payer) perspective.MethodsTo perform the analyses of the benefits of smoking cessation in terms of smoking-related morbidity, mortality, and associated medical costs, a Markov model was used that simulated the progress of a hypothetical cohort of current smokers making a single attempt to quit smoking at the beginning of the timeframe of the analysis. The robustness of the results was assessed using a series of 1-way sensitivity analyses.ResultsVarenicline was associated with the potential prevention of 14.1, 14.2, and 35.1 additional cases of the 4 smoking-related diseases incorporated into the model, per 1000 smokers willing to quit, versus bupropion, NRT, and unaided cessation, respectively. Potentially avoided smoking-related deaths with varenicline were estimated at 3.24, 3.26, and 7.5 per 1000 quitters versus the 3 comparators. Varenicline led to a potential gain of 33.78, 33.91, and 83.97 QALYs per 1000 persons willing to make a quit attempt versus the 3 comparators. Varenicline was associated with cost-savings against both active comparators for the lifetime horizon. Overall, the cost per additional quitter with varenicline, considering only the costs of the smoking-cessation strategy, was €2659 (€1015) for a lifetime horizon compared with bupropion (NRT); however, when all direct costs were incorporated into the analysis, varenicline was cost-saving.ConclusionThe findings from the present study suggest that, compared with the widely used treatment options bupropion and NRT, as well as unaided cessation, varenicline may enhance smoking-cessation treatment outcomes while substantially reducing the overall costs of smoking to the health care system.  相似文献   

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BackgroundDespite the well-established risks of persistent smoking, 10–30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers.Methods/designA two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST.DiscussionThis trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.  相似文献   

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Quitting smoking is the single most effective strategy to reduce morbidity and premature mortality in smokers. Research has demonstrated the effectiveness of pharmacotherapy in smoking cessation, but few studies have directly compared varenicline and monotherapy nicotine replacement therapy (NRT) and none have examined varenicline and combinations of NRT products. The majority of smoking cessation trials involve carefully circumscribed populations, making their results less generalizable to those with severe medical conditions or psychiatric comorbidities. This paper reports on the rationale, methodology and participant characteristics of a randomized controlled trial designed to: (1) determine which pharmacotherapy – NRT, long term combinations of NRT, or varenicline – is most effective in achieving abstinence; (2) investigate the incidence of neuropsychiatric symptoms among participants over the course of their quit attempt; and (3) assess whether there is a significant difference in the incidence of neuropsychiatric symptoms in those receiving differing pharmacotherapies, and between those with and without psychiatric illnesses. The primary outcome was carbon monoxide confirmed abstinence from weeks 5–52 following a target quit date. Secondary outcomes included neuropsychiatric (i.e., depression, suicidal ideation, anxiety, anger) and withdrawal symptoms. Smokers (N = 737) were randomly assigned to one of three treatment conditions, and were scheduled to attend 8 follow-up appointments over 12 months. All participants received 6–15 minute practical counseling sessions with nurse counselors experienced in treating tobacco dependence. We expect that the results will lead to an enhanced understanding of the efficacy of these pharmacotherapies, including those with a history of psychiatric illness.  相似文献   

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Preclinical research and learning theory suggest that a longer duration of varenicline treatment prior to the target quit date (TQD) would reduce smoking rates before cessation and improve abstinence outcomes. A double-blind randomized controlled trial tested this hypothesis in 60 smokers randomized to either an Extended run-in group (4 weeks of pre-TQD varenicline) or a Standard run-in group (3 weeks of placebo, 1 week of pre-TQD varenicline); all the participants received 11 weeks of post-TQD varenicline and brief counseling. During the pre-quit run-in, the reduction in smoking rates was greater in the Extended run-in group than in the Standard run-in group (42% vs. 24%, P < 0.01), and this effect was greater in women than in men (57% vs. 26%, P = 0.001). The rate of continuous abstinence during the final 4 weeks of treatment was higher among women in the Extended group compared to women in the Standard run-in group (67% vs. 35%). Although these data suggest that extension of varenicline treatment reduces smoking during the pre-quit period and may further enhance cessation rates, confirmatory evidence is needed from phase III clinical trials.  相似文献   

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Although identified as a clinical priority, smoking cessation has been addressed minimally in the literature in the context of physical therapy practice. Smoking cessation advice delivered by a health professional can help smokers quit. The salient components of such advice however warranted elucidation to enable physical therapists to integrate this clinical competence into their practices. Therefore, we conducted a systematic review to elucidate the effectiveness of advice by a health professional and its components to optimize smoking cessation instituted in the context of physical therapy practice. Thirty source articles were identified. A random-effects model meta-analysis was used to assess the effectiveness of the advice parameters. Risk ratios (RRs) were used to estimate pooled treatment effects. RRs for brief, intermediate, and intensive advice were 1.74 (95% CI=1.37, 2.22), 1.71 (95% CI=1.39, 2.09), and 1.60 (95% CI=1.13, 2.27), respectively. Self-help materials, follow-up, and interventions based on psychological or motivational frameworks were particularly effective components of intermediate and intensive advice interventions. Advice can be readily integrated into physical therapy practice and used to initiate or support ongoing smoking cessation in clients irrespective of reason for referral. Incorporating smoking cessation as a physical therapy goal is consistent with the contemporary definition of the profession and the mandates of physical therapy professional associations to promote health and wellness, including smoking cessation for both primary health benefit and to minimize secondary effects (e.g., delayed healing and recovery, and medical and surgical complications). Thus, advice is an evidence-based strategy to effect smoking cessation that can be exploited in physical therapy practice. Further research to refine how best to assess smokers and, in turn, individualize brief smoking cessation advice could augment positive smoking cessation outcomes.  相似文献   

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IntroductionIn rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiveness and cost-effectiveness of integrated telemedicine counseling delivered by 2-way webcams mounted on desktop computers in participant's physician office examining rooms (ITM) versus quitline counseling delivered by telephone in participant's homes (Phone) for helping rural smokers quit.Methods/designC2Q was implemented in twenty primary care and safety net clinics. Integrated telemedicine consisted of real-time video counseling, delivered to patients in their primary care physician's (PCP) office. Phone counseling, was delivered to patients in their homes. All participants received educational materials and guidance in selecting cessation medications.ResultsThe 566 participants were predominantly Caucasian (92%); 9% were Latino. Most (65%) earned < 200% of Federal Poverty Level. One out of three lacked home internet access, 40% were not comfortable using computers, and only 4% had been seen by a doctor via telemedicine in the past. Hypertension, chronic lung disease, and diabetes were highly prevalent. Participants smoked nearly a pack a day and were highly motivated to quit.DiscussionC2Q is reaching a rural low-income population, with comorbid chronic diseases, that would benefit greatly from quitting smoking. ITM is a good delivery model, which integrates care by holding counseling sessions in the patient's PCP office and keeps the primary care team updated on patients' progress.Trial registrationClinical trials registration: NCT00843505  相似文献   

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BackgroundIndividuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25–32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully quit smoking with adequate support. Further evidence shows that using technology to deliver sustained care interventions to hospitalized smokers can lead to smoking cessation up to 6 months after discharge. The current comparative effectiveness trial adapts a technology-assisted sustained care intervention designed for smokers admitted to a general hospital and tests whether this approach can produce higher cessation rates compared to usual care for smokers admitted to a psychiatric inpatient unit.MethodsA total of 353 eligible patients hospitalized for psychiatric illness are randomized by cohort into one of two conditions, Sustained Care (SusC) or Usual Care (UC), and are followed for six months after discharge. Participants assigned to UC receive brief tobacco education delivered by a hospital nurse during or soon after admission. Those assigned to SusC receive a 40-min, in-hospital motivational counseling intervention. Upon discharge, they also receive up to 8 weeks of free nicotine patches, automated interactive voice response (IVR) telephone and text messaging, and access to cessation counseling resources lasting 3 months post discharge. Smoking cessation outcomes are measured at 1-, 3- and 6-months post hospital discharge.ConclusionResults from this comparative effectiveness trial will add to our understanding of acceptable and effective smoking cessation approaches for patients hospitalized with SMI.  相似文献   

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Aims: Nicotine addiction is a complex, chronic condition with physiological and psychological/behavioural aspects that make smoking cessation extremely difficult. This paper reviews current recommendations for smoking cessation and the efficacy of pharmacotherapy and behavioural modification techniques, used either alone or in combination, for smoking cessation. Results: Abstinence rates for pharmacotherapies range from ~16% to ~30% at 1‐year follow‐up, with efficacy odds ratios (ORs) compared with placebo of ~1.7 for nicotine replacement therapy (NRT), ~1.9 for bupropion sustained release and ~3.0 for varenicline. Behaviour modification therapies have achieved quit rates of between 8% and 43% for up to 1 year, with ORs in comparison to no treatment of between ~1.2 and ~2.2. No direct comparisons have been made between pharmacotherapy alone and psychological behaviour strategies alone. However, combining physiological approaches with counselling significantly increases the odds of quitting compared with either technique alone. Conclusions: Applying multimodal techniques for the treatment of nicotine addiction is the recommended approach and has demonstrated the potential to improve rates of permanent abstinence in smokers attempting cessation. While the numbers of patients receiving help and advice regarding smoking cessation is increasing, the multimodal approach appears to be currently underutilised by clinicians and therefore smoking cessation strategies are not being optimised.  相似文献   

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BackgroundAfrican-Americans smoke fewer cigarettes per day than Whites but experience greater smoking attributable morbidity and mortality. African-American–White differences may also exist in cessation but rigorously designed studies have not been conducted to empirically answer this question.Methods/designQuit2Live is, to our knowledge, the first head-to-head trial designed with the primary aim of examining African-American–White disparities in quitting smoking. Secondary aims are to identify mechanisms that mediate and/or moderate the relationship between race and quitting. The study is ongoing. Study aims are accomplished through a 5-year prospective cohort intervention study designed to recruit equal numbers of African-Americans (n = 224) and Whites (n = 224) stratified on age (< 40, ≥ 40) and gender, key factors known to impact cessation, and all within a restricted income range (≤ 400% federal poverty level). All participants will receive 12 weeks of varenicline in combination with smoking cessation counseling. The primary outcome is cotinine-verified 7-day point prevalence abstinence from smoking at week 26. Secondary outcomes are cotinine-verified 7-day point prevalence abstinence from smoking at weeks 4 and 12.DiscussionFindings from Quit2Live will not only address if African-American–White disparities in quitting smoking exist but, more importantly, will examine mechanisms underlying the difference. Attention to proximal, modifiable mechanisms (e.g., adherence, response to treatment, depression, stress) maximizes Quit2Live's potential to inform practice. Findings will provide an empirically-derived approach that will guide researchers and clinicians in identifying specific factors to address to improve cessation outcomes and reduce tobacco-related morbidity and mortality in African-American and White smokers.Trial registration numberClinicalTrials.gov: NCT01836276  相似文献   

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AIM: This paper reports an evaluation of the effectiveness and cost-effectiveness of nurse-led screening and brief intervention in reducing excessive alcohol consumption among patients in primary health care. BACKGROUND: Excessive alcohol consumption is a major source of social, economic and health problems. However, such consumption is responsive to brief alcohol intervention. To date, brief intervention research in primary health care has focused on general practitioner-led interventions, and there is only circumstantial evidence of effectiveness in nurse-led interventions. However, nurses are increasingly taking a lead in health promotion work in primary care. METHODS: A pragmatic cluster-randomized controlled trial was carried out between August 2000 and June 2003 to evaluate the effects of a brief intervention compared with standard advice (control condition). A total of 40 general practice clusters (intervention = 21 and control = 19) recruited 127 patients (intervention = 67 and control = 60) to the trial. Excessive consumption was identified opportunistically via the Alcohol Use Disorders Identification Test. After baseline assessment, patients received either a 5-10 minutes brief intervention using the 'Drink-Less' protocol or standard advice (control condition). Follow-up occurred at 6 and 12 months postintervention. RESULTS: Analysis of variance weighted for cluster size revealed no statistically significant differences between intervention and control patients at follow up. A majority of patients in both conditions reduced their alcohol consumption between assessment and subsequent measurement. Economic analysis suggested that the brief intervention led to no statistically significant changes in subsequent health service resource use relative to standard treatment. CONCLUSION: The brief intervention evaluated in this trial had no effect over standard advice delivered by nurses in primary health care. However, there was a reduction in excessive drinking across both arms of the trial over time. Due to nurse drop-out, this trial was significantly underpowered. Future research should explore barriers to nurses' involvement in research trials, particularly with an alcohol focus. A larger trial is required to evaluate the effectiveness of nurse-led screening and brief alcohol intervention in primary care.  相似文献   

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BackgroundDutch practice nurses sub-optimally adhere to evidence-based smoking cessation guidelines. Web-based computer-tailoring could be effective in improving their guideline adherence. Therefore, this paper aims to describe the development of a web-based computer-tailored program and the design of a randomized controlled trial testing its (cost-)effectiveness.MethodsTheoretically grounded in the I-Change Model and Self-Determination Theory, and based on the results of a qualitative needs assessment among practice nurses, a web-based computer-tailored program was developed including three modules with tailored advice, an online forum, modules with up-to-date information about smoking cessation, Frequently Asked Questions (FAQs) and project information, and a counseling checklist. The program's effects are assessed by comparing an intervention group (access to all modules) with a control group (access to FAQs, project information and counseling checklist only). Smoking cessation guideline adherence and behavioral predictors (i.e. intention, knowledge, attitude, self-efficacy, social influence, action and coping planning) are measured at baseline and at 6- and 12-month follow-up. Additionally, the program's indirect effects on smokers' quit rates and the number of quit attempts are assessed after 6 and 12 months.DiscussionThis paper describes the development of a web-based computer-tailored adherence support program for practice nurses and the study design of a randomized controlled trial testing its (cost-)effectiveness. This program potentially contributes to improving the quality of smoking cessation care in Dutch general practices. If proven effective, the program could be adapted for use by other healthcare professionals, increasing the public health benefits of improved smoking cessation counseling for smokers.  相似文献   

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IntroductionWhen the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.Methods and designOaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.DiscussionThe OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.  相似文献   

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