Orientadores: Ellen Hardy, Maria Jose Duarte Osis / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas / Made available in DSpace on 2018-11-09T13:16:09Z (GMT). No. of bitstreams: 1 Bassi_FabianaGuariglia_D.pdf: 1703561 bytes, checksum: 492a5b1b282e8a5db7051f9283374f80 (MD5) Previous issue date: 2009 / Resumo: As crianças estão sujeitas a muitas das doenças de que sofrem os adultos e, muitas vezes, são tratadas com os mesmos medicamentos. Nos últimos 30 anos foram realizadas poucas pesquisas para se desenvolver medicamentos pediátricos. A medicina baseada em evidências tem sido ponto de referência de uma boa prática clínica. Entretanto, as crianças são excluídas dessa prática, uma vez que os tratamentos não foram cientificamente avaliados nesse grupo etário. A ausência de estudos pediátricos representa um dilema ético para o profissional responsável pela saúde dos menores, os medicamentos acabam sendo ministrados sem a garantia de serem adequados às necessidades de cada grupo etário. Estes profissionais não têm orientação oficial a respeito do melhor para as crianças: expô-las ao risco de tomar medicamentos não adequados ou ao risco de participar de um ensaio clínico. Objetivo: Conhecer a experiência e a opinião de docentes de Departamentos de Pediatria e de Neonatologia de Faculdades de Medicina brasileiras a respeito do desenvolvimento de ensaios clínicos, para avaliar fármacos e formas de administração em crianças. Sujeitos e métodos: Este estudo foi realizado em duas etapas: a primeira foi quantitativa de corte transversal, descritiva utilizando um questionário autorrespondido A segunda foi qualitativa, utilizando entrevistas semi-estruturadas. Essa segunda etapa foi realizada para obter informações que permitissem a melhor compreensão do significado das informações obtidas inicialmente. Quantitativa: Os sujeitos do estudo foram docentes-pediatras das Faculdades de Medicina do Brasil. Foi enviada, por correio eletrônico, uma carta-convite personalizada explicando o objetivo do estudo e em anexo o questionário a ser autorrespondido. Realizouse análise descritiva univariada que consistiu de tabelas de distribuição de frequências de todas as variáveis consideradas. Qualitativa: Para esta etapa foram convidados os docentes-pesquisadores que responderam ao questionário na Etapa Quantitativa e relataram que foram pesquisadores principais, nos últimos 24 meses, de um de ensaio clínico que incluiu voluntários que o pesquisador considerou crianças. Todos os pesquisadores que aceitaram o convite foram entrevistados pessoalmente através de uma entrevista semi-estruturada de questões abertas. Realizou-se a análise de conteúdo. Resultados: Dos 89 docentes-pediatras que responderam ao questionário, 31 relataram que nos últimos 24 meses tinham sido pesquisador principal de um ensaio clínico pediátrico. Entretanto, apenas 58% das pesquisas referidas correspondiam a um ensaio clínico segundo definido para esta pesquisa. Foi detectado que as opiniões dos docentes-pediatras estavam em harmonia com as orientações internacionais existentes atualmente, apesar de ter sido identificado que dentre os docentes-pesquisadores não havia um conhecimento apurado das normas existentes no Brasil e das normas internacionais para a realização de ensaios clínicos na população pediátrica. Houve um consenso quanto à necessidade cada vez maior de se realizar ensaios clínicos para essa população e, consequentemente, da necessidade de se regulamentar esse tipo de pesquisa no Brasil. Conclusões: Com uma regulamentação nacional que as crianças e adolescentes do Brasil poderão ter uma possibilidade de garantir seus direitos, como a proteção de sua integridade física, emocional e social. Como também o acesso a novas tecnologias que atendam às suas reais necessidades. / Abstract: Children are subjected to many of the diseases adults suffer from, and most of the times they are treated with the same medication. In the past 30 years there have been conducted few researches to develop pediatric medication. The medicine based on evidence has been a reference point of a good clinical practice. However, children are excluded of this practice once the treatments haven't been scientifically tested in this age group. The lack of pediatric studies represent an ethical dilemma for the professional responsible for the children's health, because the medication ends up being administered without the guarantee that they are appropriate for the needs of each group. These professionals don't have professional official orientation in respect of the best for the children's: expose them to the risk of taking medicine that are not appropriate or to the risk of participating in a clinical study. Objective: To find out about the experience and opinion of professors from Neonatology and Pediatric Departments of Brazilian Medical Schools in respect of clinical trials developments to evaluate medicine and administration methods in children. Subjects and methods: this study was conducted in 2 stages: the first was quantitative and in a transversal cut and descriptive, using a self responded questionnaire. The second was qualitative, using semi-structured interviews. This second stage was developed to obtain information that permitted the best understanding of the information's meaning obtained initially. QUANTITATIVE: The study's subjects were pediatrics professors of Brazil's Medical School. A personalized invitation letter was sent, via -mail, explaining the objective of the study and the questionnaire was attached. The unvaried descriptive analysis consisted of frequency distribution tables of all the considered variants. QUALITATIVE: For this stage, the research professors were invited to respond to the questionnaire in the Quantitative Stage and they reported they had been the main researchers, over the past 24 months, of a clinical trial that included volunteers that the researcher took children into account. All the researchers who accepted the invitation were interviewed in person, through a semi-structured interview of open questions. The content analysis was performed. Results: From the 89 pediatrics professors who responded to the questionnaire, 31 reported that over the past 24 months they had been the main researchers of a pediatric clinical trial. However, only 58% of the reported surveys corresponded to a clinical trial according to the one defined for this survey. It has been detected that the pediatric professors opinions were in harmony with the international orientation that exists nowadays, even though it had been discovered that among the pediatric professors there was no accurate knowledge of the existing norms in Brazil and the international norms for the conduction of clinical trials in the pediatric population. There was an agreement concerning the increasing need of carrying out clinical trials for this population and consequently the need of regulating this kind of research in Brazil. Conclusions: With a national regulation that children and adolescents from Brazil will have a possibility of guaranteeing their rights, as well as their social, emotional and physical integrity protection. And also the access to new technologies that suit their real needs. / Doutorado / Ciencias Biomedicas / Doutor em Tocoginecologia

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Hepatitis (HCV) is a communicable disease that impacts many Americans. The scholarly literature lacked the knowledge pertaining to the relationships between poverty and HCV diagnosis and prescription for HCV medication. The purpose of the study was to measure the magnitude and statistical significance of these relationships, as modeled by the health belief model and public health surveillance and action framework. Specifically, the study was designed to determine whether there is a statistically significant relationship between living below the poverty line and being diagnosed with HCV, as well as living being below the poverty line and being prescribed HCV medication. A total of 78 records of HCV-positive individuals from the National Health and Nutrition Examination Survey dataset were evaluated by applying the statistical procedure of odds ratio (OR) analysis. The results of the analysis revealed that (a) there was not a statistically significant relationship between being below the poverty line and being diagnosed with HCV, OR = 0.99 (SE = 0.38, z = -0.03, p = .974); and (b) there was not a statistically significant relationship between being below the poverty line and being prescribed HCV medications, OR = 0.32 (SE = 0.55, z = -0.66, p = .507). Numerous recommendations for improving measurements of the relationship between poverty and HCV are provided. This study may promote positive social change by indicating the importance of poverty as an agenda item for public health policy and practice.

Of the plethora of social problems with which government has had to contend in recent history, few have generated more controversy than the non-therapeutic use of drugs. Many of those which are currently in common use did not exist fifty years ago; but the most dramatic growth in non-therapeutic use has been experienced with a drug that man has known for centuries: marijuana.1 Known generically as Cannabis sativa, internationally as Indian hemp, popularly as marijuana, and in American slang as "pot" or "grass," the drug was introduced to the United States as an intoxicant by itinerate Mexican farm workers in the early decades of this century. The acknowledged use of marijuana in the ghettos and communities of ethnic minorities for several decades stimulated no public outcry with the exception of the sensational press campaigns which led to the passage of the Marihuana Tax Act of 1937.

Many men who have sex with men (MSM) engage in alcohol and drug use. Drug use, particularly methamphetamines, amyl nitrates (poppers), and drugs used to treat erectile dysfunction among MSM may also contribute to risks such as unprotected sex, which leads to the possibility of contracting syphilis, Human immunodeficiency virus (HIV), and other Sexually Transmitted Infections (STIs). In the Metro Atlanta Area (Fulton and Dekalb Counties), primary and secondary syphilis rates among MSM are still rising and rank highest among the other counties in the area. Guided by the risk and protective factor theory, the purpose of this study was to determine if club drug use was a contributing factor in high-risk sexual behavior among MSM with syphilis. Data were collected from the State Electronic Notifiable Disease Surveillance System with permission from the State of Georgia's Division of Public Health's STD division and was tested by using hierarchical regression analyses. The findings were inconsistent with the reported literature; there was no association between drug use and risky sexual behavior in this sample of MSM infected with syphilis. However, there was an association between prior incarceration being predictive of engaging in sex with anonymous partners and having sex while high. Implications for positive social change include evidence for the need for public health interventions that target incarcerated MSM because they exhibit the highest-risk sexual behavior due to their time served in the correctional system. Further exploration of this topic could be used to develop health information and policies to meet the needs of those affected by high-risk sexual behavior while incarcerated and upon release, ultimately reducing the spread of HIV.

Behavior analysts have had much success in affecting behavior change with individuals diagnosed with intellectual disabilities as well as those who would be considered typically developing with a variety of intervention strategies; most of which involve affecting direct acting contingencies. However, the realm of language-based psychopathology has just begun to be addressed within the field through language based, or indirect acting strategies. Acceptance and Commitment Therapy (ACT) is based on the concept of derived stimulus relations and allows for a behavior analytic treatment of language-based psychopathology. The current study was intended to test the efficacy of a brief protocol-delivered ACT intervention with individuals who smoke marijuana. Oral swab drug screens were the primary dependent variable, along with the Acceptance and Action Questionnaire II (AAQ-II). All six ACT components were taught to each subject using a set list of metaphors and exercises and was assessed using a concurrent/non-concurrent multiple baseline across participants design. Results indicate that the brief protocol impacted levels of marijuana consumption with all three participants and that their self-reported levels of struggle (via the AAQ-II) lessened over the course of the training.

Does Nimbin have a drug problem? This tiny village in north-eastern NSW has an international reputation for its alternative community and its street drug market. Ever since the Aquarius Festival thirty years ago Nimbin has fascinated the media, and recurrent headlines about the village's (undefined) 'drug problem' suggested my research topic. My research aim was to investigate the meaning/s of Nimbin's 'drug problem' in the context of Nimbin's 'alternative' culture. Because the topic of illicit drugs is both ethically challenging and highly sensitive, my research design was strongly participant-focused, with an emphasis on confidentiality balanced by a mixed methodology to cross-validate results. My methods included an anonymous household (door-to-door) survey based on a national household survey; an anonymous mailed-back survey of Nimbin and Lismore drug injectors; taped interviews with health and legal professionals, cannabis activists and drug dealers; semi-structured interviews with 'professional' cannabis crop growers; and participant observation over several years. I found the multi-method research design to be particularly effective for investigating illegal drug marketing and use, and the design provided me with multiple perspectives on a complex issue. Superficially, there appeared to be two drug 'problems' in Nimbin — one was the (largely cannabis) street market, and the other revolved around heroin users, and included complaints about scruffy-looking people hanging around the main street, or overdosing in the public toilet. However, my research suggested that these issues, while immediately comprehensible as 'drug problems', obscured more complex issues. For example, the village's street drug market was intertwined with the local economy and with the alternative community's values and drug use, while close to half of the drug injectors lacked secure housing (which creates problems that are not related to heroin), and all heroin users were blamed for the actions of few. Many factors influence the creation and maintenance of what we might call 'problems', and drugs are frequently blamed for broader social problems. What is Nimbin’s drug problem? The answer depends, in part, on the drug of interest, but more importantly it depends on your definition of a ‘problem’. Some useful and meaningful perspectives on this important social issue include quantified indicators such as death, injury, arrest rates, the economics of black markets, the demographics of drug use, and estimates of ‘social costs’. Qualitative perspectives include people’s opinions about drugs, media-generated moral panics, the effects of social marginalisation, and the role of drug cultures. A number of ‘drug problems’ arise as a direct result of drug illegality. They include black markets, corruption, drug-related violence, theft, stronger forms of the drug, and more dangerous using practices (with the risk drug overdoses and HIV/AIDS), as well as public nuisance issues. Government policy, judicial sentencing and public opinion are moving towards the social reintegration of illicit drug users, but this is almost invariably counter-balanced by a toughening of legal sanctions against supply of the same drug. Most discussions about illicit drugs fail to consider the long-term implications of harsh penalties for, and elaborate and punitive police operations (such as occurred throughout my Nimbin research) against, small-scale independent growers and dealers. The only way to directly engage with drug markets and all the attendant problems, is to legitimise and regulate the supply of recreational drugs. I discuss several examples of the important role of the drug culture in mitigating problems caused by illegality. One example is the influence of Nimbin's alternative community on the style of the drug market. The village drug scene more closely resembles the many north coast village craft markets, than it does Kings Cross, Cabramatta or New York's Bronx. Buyers are north coast locals, along with national and international tourists (the small village is known to cannabis users world-wide, both through media attention and word-of-mouth). Nimbin offers a 'safe' village market ambience and competitive prices to a mainly cannabis using clientele. I suggest that there are two major underlying influences on the experience of a ‘drug problem’, regardless of the drug or the place. They are: 1. Political influences — specifically the effects of government policy on black markets, law enforcement practices, and access to services and resources; 2. Cultural influences — particularly the beneficial effects of norms and functional role models for the safe use of a drug, cultural effects on the drug market, and the role/s of the drug in the day-to-day life of the culture. These influences can operate with, or despite, each other, and can create or ameliorate many ‘drug problems’. In the case of Nimbin’s alternative culture, government policy has created a number of drug problems and the counter-culture has worked to minimise them. In my research into Nimbin’s ‘drug problem’ I have clarified some issues and raised a number of others. I have examined the notion of a ‘drug problem’ from several perspectives using a range of research tools, and discussed some key influences on the problem associated with drug use. Drawing from the Nimbin research and my reading, I suggest legalising the recreational drugs to bring them under the dual controls of supply legislation and social norms. In conclusion, I suggest that we need to be very clear about what ‘drug problem’ it is that we are talking about, and indeed, whether the problem is really about drugs at all.

Research Doctorate - Doctor of Philosphy (PhD) / A large body of population- and treatment-based evidence exists to indicate depression and alcohol/other drug (AOD) use are highly prevalent on a global scale, and co-occur with considerable frequency. Despite this evidence, significant gaps exist in treatment research and clinical services, as people with co-occurring depression and AOD use problems have typically been excluded from randomised controlled treatment trials, and also face many individual- and service-level barriers to accessing treatment. Consequently, a well-defined and adequately tested treatment strategy does not currently exist for people experiencing the complexities of concurrent depression and AOD use problems. A small body of evidence exists to suggest that co-occurring mental and AOD use disorders (“comorbidity”) leads to poorer treatment outcomes, increased risk of relapse, higher levels of problematic symptomatology, and poorer quality of life. However, little consistent information is currently available to suggest what additional impact comorbid depression and AOD misuse produces relative to the experience of a “single” condition (such as depression or AOD misuse in isolation). Studies 1 and 2 attempted to address this important gap in knowledge by examining the presenting characteristics of 246 people with AOD use problems, according to the presence of comorbid depressive symptoms. One hundred and thirty seven participants were drawn from AOD treatment services, and a further 109 were referred via mental health services and also met criteria for a psychotic disorder. Results indicated that the presence of depression was associated with a significantly higher severity of psychiatric symptoms and personality disorder, significantly decreased social and occupational functioning and significantly reduced quality of life. Current depression was also associated with a significant increase in the experience of cravings and self-reported dependence on amphetamines. These difficulties were over and above the already high rates of disability and distress reported by each sample as a whole. Furthermore, treatment for mental health problems was rare among the AOD treatment participants, as was AOD treatment among the mental health sample. This is despite the presence of moderate to severe levels of depression and AOD use reported by each sample. In particular, Studies 1 and 2 highlight the vulnerabilities for people with comorbid mental health and AOD use problems who present to treatment in the mental health or AOD use settings, and in particular how depression significantly increases the disability and other challenges experienced by these people. These results provide a strong rationale for the development of an appropriate treatment protocol for depression and AOD use comorbidity. No clear treatment model or evidence-based approach exists to suggest how depression and AOD use comorbidity is best managed. When people with this comorbidity do manage to access clinical treatment services, they typically receive treatment targeted at one aspect of their presentation (e.g. depression-focussed or AOD-focussed treatment). Yet, it is not known whether a singular focus of treatment is effective in producing sustainable change in the outcomes of people with comorbid problems, nor whether failure to treat all components of the comorbid presentation confers a worse outcome. Studies 3 and 4 reported on two randomised controlled clinical trials of psychologicaltreatment for AOD use problems among a sample of 246 people with AOD use problems, drawn from AOD treatment services (n=137) or mental health services (n=109). In doing so, these studies provide some of the first available data on these issues. Participants were categorised according to the presence of comorbid depression (as per Studies 1 and 2) and response to treatment was analysed over a six- to 12-month follow-up period. In spite of high levels of current depressive symptoms at entry to the studies, and equally hazardous use thresholds of a range of substance, people enrolled in Studies 3 and 4 reported some gains via their experiences with these single-focussed treatments. Attendance and retention rates were higher than reported in previous research, and the presence of depression did not adversely influence the motivation of project participants to change their current AOD use patterns. A treatment effect was generally not detected among the Study 3 and 4 participants, regardless of the presence of depression, with those receiving an assessment-only control treatment in both studies reporting similar patterns of change in outcome. Regardless of the magnitude of change reported by all study participants, people with depression reported significantly higher levels of depression, poly-drug use, amphetamine dependence, hazardous use of a range of substances, HIV risk taking and criminal activity and lower levels of functioning and self-concept across the follow-up assessment period. These residual symptoms were present at sufficiently high levels of severity to increase the risk of relapse to AOD use and continued morbidity. These results suggested the potential value of targeting depression in the context of comorbid AOD use problems. One previous study has examined the impact of an adjunctive psychological treatment of depression for people hospitalised for alcohol use disorder. Results indicated that people who received the additional depression treatment reported significantly greater improvements on depression- and alcohol-related outcomes over the short-term relative to people receiving a relaxation-only control treatment. These improvements were suggested to be enhanced if treatment had integrated depression- and alcohol-related approaches into the one treatment program. In the first study of its kind, Study 5 developed and evaluated the efficacy of an integrated psychological treatment program for comorbid depression and AOD use problems. Sixty-seven participants received integrated treatment delivered by a therapist, computer-delivered integrated treatment or a brief intervention (control) treatment delivered by a therapist. Depression scores, daily use of alcohol and cannabis, hazardous use of a range of substance and poly-drug use fell significantly over a 12-month follow-up period across the integrated treatments and brief intervention (control) conditions. The small sample size of Study 5 meant that very few treatment effects were detected at a statistically significant level, however important reductions in key outcomes for depression, AOD use, quality of life and general functioning were noted for people in the integrated treatment relative to controls over a 12-month period. The magnitude of change in Study 5 across these domains was comparable with the only other study of psychological treatment of depression and alcohol-use disorders described above. The integrated treatment in Study 5 was associated with higher levels of improvement in depression, alcohol use and cannabis use (where present) than did the AOD-focussed treatment examined in Studies 3 and 4. The results further suggest that a brief intervention targeting both depression and AOD drug use problems is associated with reductions in key outcomes in the short-term, withintegrated, lengthier psychological treatment potentially associated with longer-term changes on the same outcomes. No previous study has directly compared the outcomes for people completing psychological treatment delivered via a computer program with those completing treatment with a ‘live’ clinician over an extended follow-up period of 12-months. Given the barriers people with comorbid depression and AOD use problems face in accessing available treatment services, the consideration of alternative modes of delivery of evidence-based treatment to this group is timely. Study 6 expanded on the Study 5 results by presenting further analysis of the performance of the computer-delivered version of the integrated treatment relative to the clinician-delivered equivalent, matched for content. Given the small sample size of participants, Study 6 devised a four-point criterion which, if satisfied, would suggest that the computer-delivered and clinician-delivered integrated treatments were approximately equal. Based on these criteria, the results indicated that the outcome profiles for people engaged in the computer-delivered treatment were equivalent to those reported by people involved in clinician-delivered therapy over a 12¬month follow-up period. Additionally, computer-delivered integrated treatment was associated with similar rates of improvement as the therapist-equivalent on depression scores, risky drinking patterns, hazardous use of substances, poly-drug use, levels of daily cannabis use, suicidality, treatment retention and therapeutic alliance. This result requires further replication to test these assumptions, however it is promising that a treatment requiring an average of 12-minutes face-to-face of “generic” clinician time per weekproduces a similar pattern of improvement to a treatment requiring an average of 60 minutes of face-to-face specialist psychologist input over the same time period. Studies 1-6 resulted in the development of a menu of treatment options for people with depression and AOD use comorbidity, with each treatment approach providing evidence for at least some benefit among the study participants. While encouraging, these results again raise the issue of how treatment may be incorporated into existing services (mental health, AOD use, primary care, etc.), which typically remain segregated, with little opportunity for collaboration and cross-fertilisation of skills and expertise between service settings. Chapter 7 discusses a new model of treatment for comorbid depression and AOD use problems that incorporates the results of Studies 1-6, and involves a stepped care approach to developing a treatment plan tailored to the specific needs and levels of distress experienced by people with depression and AOD use comorbidity. The stepped care model of treatment could be incorporated into existing service settings and structures, with the potential for computer-based therapy to provide access to specialised treatment for depression and AOD use comorbidity that might otherwise be unavailable. As a result, stepped care treatment could foster earlier engagement with treatment services and encourage motivation and optimism among people with comorbid depression and AOD use problems. These are important issues for service development and delivery of appropriate treatments to this underserved population.

The consequences of drug use and benefits of methadone maintenance therapy (MMT) were investigated in a random sample of Maori and non- Maori injecting drug users in Christchurch, Aotearoa New Zealand. Eighty- five injecting drug users (IDUs) who had been on MMT for a mean time of 57 months were interviewed and followed up over an average 18 month period. Markov models were used to model cohorts of IDUs, changes in their health states and the effects of MMT and anti-viral therapy on morbidity and mortality. The savings in life from reductions in drug overdoses were used as the main outcome measure in cost-effectiveness analysis. Cost-utility and cost-benefit analysis were also used to provide additional information on the costs and outcomes of treatment. Comparisons were made between: (a) MMT alone; (b) MMT provided with conventional combination therapy for hepatitis C virus (HCV); and (c) MMT provided with anti-viral therapy with pegylated interferon. The monetary costs of drug use and benefits of MMT were similar for Maori and non-Maori. However, Markov modelling indicated that MMT is associated with greater savings in life for Maori than for non-Maori. Further, Maori IDUs identified the main personal costs of drug use as being loss of their children and loss of marriage or partners. Large reductions in use of opioids and benzodiazipines were reported at interview, compared with before starting MMT. The participants also reported large reductions in crime and stabilisation of their lifestyles. Improvements in the general health of IDUs om MMT were reported. However, 89% were positive for HCV infection, which was identified as the major physical health problem affecting IDUs in New Zealand. Few IDUs had received anti-viral therapy for HCV infections, despite having stabilised on MMT. This study investigated the benefits of providing anti-viral therapy for HCV to all patients meeting treatment criteria. The cost-effectiveness of MMT alone was estimated at $25,397 per life year saved (LYS) for non- Maori men and $25,035 for non-Maori women IDUs (costs and benefits discounted at 3%). The incremental effects of providing anti-viral therapy for HCV to all eligible patients were to save extra years of life, as well as to involve additional costs. The net effect was that anti-viral therapy could be provided, at a similar level of cost-effectiveness, to all patients who meet HCV treatment criteria. Cost-effectiveness could be improved if IDUs could be stabilised on MMT five years earlier at an average age of 26 instead of the current age of 31 years. The cost-effectiveness of treatment with pegylated interferon was similar to that for conventional combination therapy because there were incremental savings in life as well as increased treatment costs. Costs per LYS were estimated to be lower for Maori than for non-Maori, reflecting ethnic differences in mortality. Sensitivity analysis revealed that provision of MMT with anti-viral treatment remained cost-effective under varying assumptions of mortality, disease progression and compliance with treatment. the main problems that were not improved during MMT were continuing use of tobacco and cannabis, low participation in paid employment, only three participants had received specific treatment for their HCV infections. Cost-benefit analysis using a conservative approach showed a ratio of the benefits to the costs of MMT of 8:1. Benefits were demonstrated in terms of large reductions in crime. Benefit to cost ratios were similar for the different policy examined, as well as for both Maori and non-Maori IDUs.