Burden Profile Research Articles

Simulation of particle flow in a bell-less type charging system of a blast furnace using the discrete element method

A three-dimensional model was established by the discrete element method (DEM) to analyze the flow and segregation of particles in a charging process in detail. The simulation results of the burden falling trajectory obtained by the model were compared with the industrial charging measurements to validate the applicability of the model. The flow behavior of particles from the weighing hopper to the top layer of a blast furnace and the heaping behavior were analyzed using this model. A radial segregation index (RSI) was used to evaluate the extent of the size segregation in the charging process. In addition, the influence of the chute inclination angle on the size segregation and burden profile during the charging process was investigated.

Changing profile of rotavirus genotypes in Bangladesh, 2006–2012

BackgroundRotavirus is the leading cause of severe diarrhea in infants and young children worldwide including Bangladesh. Unlike what was seen in high-income countries, the licensed rotavirus vaccines did not show high efficacy in Bangladeshi trials. We assessed rotavirus prevalence and genotypes in Bangladesh over six-year period to provide baseline information on the rotavirus burden and changing profile in the country.MethodsThis study was conducted from June 2006 to May 2012 in Matlab, Bangladesh. Group A rotaviruses were detected in stools collected from diarrhea patients by ELISA and genotyped using multiplex reverse transcription PCR followed by nucleotide sequencing.ResultsOf the 9678 stool samples, 20.3% were positive for rotavirus. The most predominant genotype was G1P[8] (22.4%), followed by G9P[8] (20.8%), G2P[4] (16.9%) and G12P[8] (10.4%). Mixed infections were detected in 14.2% of the samples. Emergence of an unusual strain, G9P[4] was documented during 2011–12. Several amino acid mismatches in the antigenic epitopes of VP7 and VP4 between Bangladeshi and the vaccine strains were identified.ConclusionsOur study provides important information on rotavirus genotypes that should be considered for the selection and introduction of rotavirus vaccines in Bangladesh.

EFFECTS OF WORKING ENVIRONMENT ON ISCHEMIC HEART DISEASE BURDEN PROFILE IN YOUNG EGYPTIAN MALES

Introduction: Ischemic Heart Diseases (IHD) are mostly attributed to increased exposure to traditional risk factors. Few studies were directed to understand the environmental and occupational determinants as potentially modifiable risk factors. Aim of work: To evaluate the impact of various working environments on the ischemic heart disease burden profile in young Egyptian male workers. Materials and Methods: Three years follow up of ischemic events in three groups of workers based on the type of industry was performed. Group I (Motor industry) which included 4779 individuals, group II (Construction industry) which included 6230 individuals & group III (Food industry) which included 2613 individuals. Main risk factors analysis were collected from out-patient visits and investigations results, followed by multicenter in time on site monitoring on groups records of in-patient admissions and different interventional coronary procedures performed. Results: Mean age in motor industry group was 34.6 ± 9, in construction group was 35.8 ± 9 while in food industry group was 31.6 ± 7. Total incidence of coronary artery disease in the three groups was 1.5%; of hypertension 4.3 %; of diabetes mellitus 3.5 % and that of dyslipidemia was 2.3 %. Incidence of coronary events in motor industry was significantly higher than the other two industries. Highly significant increase in number of total in-patient and critical care admissions due to acute coronary syndromes and myocardial infarction in addition to number of interventional coronary procedures was observed in motor and construction industries when compared to food industry. Conclusion: Different working environmental hazards might increase the incidence of coronary artery diseases in young Egyptian male workers either directly or through augmenting known risk factors. Morbidity due to IHD might be affected by the type of industry. Cooperation between general practitioners, occupational diseases specialists and cardiologists may improve the efficiency of prevention programs.

Burden Distribution Calculation of Bell-Less Top of Blast Furnace Based on Multi-Radar Data

The burden distribution real-time estimation problem of multi-loop charging based on the real multi-radar data is resolved. Firstly, an iterative algorithm is introduced to calculate the radial coordinate of the pile-top. Then, based on the multi-radar data, the burden profile is estimated by a cubic-curve equation at the end of the multi-loop charging. Furthermore, the burden profile before the next multi-loop charging is calculated based on multi-radar data by considering the impact of burden descent. On the basis of these burden profiles, a more accurate thickness ratio of ore to coke (Ro/c) at the radial direction of blast furnace can be obtained. Finally, an example is given to calculate the burden profiles and Ro/c by using the real multi-radar data sampled from Baosteel, which shows the effectiveness of the method introduced.

PWE-161 Sessile Serrated Adenomas, Under-Recognised Endoscopically and Under Diagnosed Pathologically

IntroductionThe serrated pathway of colorectal carcinogenesis is a distinct and important pathway leading to CpG island methylated phenotype (CIMP) carcinomas. These lesions are over-represented in interval cancers and may explain...

The role of Notch signaling in host defenses to Cryptococcus neoformans (P3310)

Abstract Cryptococcus neoformans (C. neoformans) is a major opportunistic fungal pathogen in individuals with impaired T cell-mediated immunity. Notch pathway is an important signaling component of immunological synapse during APC/T-cell engagement. Little is known about the role of Notch signaling in fungal infections. We sought to determine the role of Notch signaling in C. neoformans infection. Wild-type C57BL/6 (WT) and CD4-Cre+×ROSA DNMAML (DNMAML) mice were infected intratracheally infected with C. neoformans. The fungal burden, leukocyte recruitment, and cytokine profile were assessed at 3 and 6 weeks post-infection (wpi). A 50-fold greater fungal burden was detected in both lungs and brains of DNMAML mice compared to those in the WT mice at 6 wpi. Although, equivalent fungal burdens were found at 3 wpi in WT and DNMAML groups, the production of IFN-γ, IL-4, and IL-13 was significantly decreased in lung leukocytes of DNMAML mice. In contrast, an equivalent induction of IL-17 was observed in both WT and DNMAML mice at this time. Notch signaling plays a crucial role in the host defense against C. neoformans. Notch signaling contributes to control of pulmonary fungal growth and inhibition of CNS dissemination by promoting cytokine induction. This is the first demonstration of the importance of Notch signaling in cryptococcal infection. The mechanisms by which Notch signaling regulate the immune response against cryptococcal infection are under investigation.

Cancer pain and opioid use--a global issue

Living with inadequately controlled cancer pain is a sad and avoidable daily reality for many patients across the globe. Despite all of the accumulated knowledge and experience, cancer pain remains undertreated with 70–80% of patients with advanced disease experiencing uncontrolled pain of moderate-to-severe intensity.1 The World Health Organization (WHO) estimates that every year 5.5 million terminal cancer patients still suffer moderate-to-severe pain.2 It is an appalling indictment of health care professionals, regulatory agencies and governments that this unacceptable situation is allowed to continue. We have a plethora of policy documents, declarations and guidelines but the stark reality is that far too many patients continue to suffer unnecessarily. For a variety of reasons, there is an evident and consistent failure to address this major public health issue. The various statistics reliably quoted throughout the literature fail to adequately portray the level of individual human misery and suffering associated with chronic uncontrolled cancer pain. In addition to having a high pain and symptom burden profile, these patients are also coping with the ravages of progressive disease, treatment-related toxicities, major disruptions to their personal and professional lives, multiple losses across a variety of domains and for some, the loss of life itself. The human cost to these patients and to those close to them is incalculable. The scale of this obscenity is brought into sharp focus by the fact that cancer pain can be adequately controlled in the vast majority of cases by the rational application of well-established guidelines.3 It is acknowledged that we lack robust scientific evidence to support aspects of current clinical practice.4 Nevertheless, what we lack in terms of ‘evidence-based practice’, we compensate for in abundance by ‘practice-based evidence’. Inspired by the pioneering work of Dame Cicely Saunders and greatly assisted …

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Introduction: Current culture-based techniques may be inadequate for identifying causative agents in patients with ventilator-associated pneumonia (VAP). We used a culture-independent molecular approach to assess the bacterial species colonizing the aerodigestive tract of mechanically ventilated children. Hypothesis: We hypothesized that culture-independent methods would identify phylotypes and difficult-to-grow species that are not detected by routine culture. These data may shed new light on the differences in the oral microbiome between age groups and might uncover novel VAP-associated pathogens. Methods: Oral swabs as well as tracheal and gastric aspirates were obtained sequentially from mechanically ventilated children (<18 years) in the ICU following elective surgery. Samples were sent for routine bacterial culture and DNA isolation for PCR amplification of 16S rRNA genes followed by analysis using a previously validated microarray (HOMIM). Results: We analyzed 97 clinical samples from 14 subjects (50% female, mean 5.6 years) following cardiac (n=10) and spinal fusion surgery (n=4). Routine cultures revealed 4 potential bacterial pathogens in 6 samples from 2 subjects. PCR amplification of 16S rRNA genes was successful in 28 samples (29%). Over 100 distinct taxa were detected on microarray analysis. The oral microbiome burden was significantly higher in older children compared to infants <12 months (p<0.05 by Wilcoxon rank sum test). Microbial profiles were also distinct between the 2 groups. One subject had VAP, and growth of Pseudomonas aeruginosa from tracheal aspirate was mirrored by molecular detection of the organism first in oral and then tracheal samples during the study. Conclusions: Culture-independent molecular methods using 16S rRNA gene sequences allowed identification of known VAP-associated pathogens and a variety of unculturable microbes in oral, tracheal and gastric samples. The clinical significance of these taxa warrants further investigation. Edentulate infants have a lower microbiome burden and distinct profile compared to older children. Microbiome identification may guide bedside practices in the ICU, such as oral hygiene, and enhance our understanding of VAP pathogenesis.

Recognizing Global Burden of Cardiovascular Disease and Related Chronic Diseases

Cardiovascular disease is the leading cause of death worldwide, affecting not only high-income but also low- and middle-income countries. Nearly 80 percent of all estimated cardiovascular disease-related deaths worldwide now occur in low- and middle-income countries, where nearly 30 percent of all deaths are attributable to cardiovascular disease. The health burden of cardiovascular disease and other chronic diseases is also accompanied by a significant deleterious economic impact at the level of both national economies and households. The global trends in the health and economic burden of cardiovascular disease provide a compelling argument in support of prioritizing urgent yet carefully planned efforts to prevent and control cardiovascular disease worldwide-and especially in low- and middle-income countries. After decades of escalating efforts to draw attention to the high burden of cardiovascular disease and other chronic diseases, this critically important issue is now emerging as a more central part of the global health and development agenda. The breadth of behavioral, biological, social, environmental, and systems-level factors that contribute to cardiovascular disease necessitates multisectoral approaches across the lifecourse that promote healthful lifestyles, reduce risk, and reduce cardiovascular-disease morbidity and mortality through the delivery of quality health care services. Given that the complex interactions among the determinants of cardiovascular disease vary in different contexts, real progress in control efforts will come through approaches that are driven by a country's disease burden and risk profile, capacities, resources, and priorities-approaches that are led by a country's key decision-makers and stakeholders, including governments, civil society, the private sector, and communities. Many countries are already establishing efforts to address chronic diseases. In addition to these locally driven efforts, success will require active engagement and sustained action from a wide array of stakeholders operating at global and regional levels.

Status of epidemiology in the WHO South-East Asia region: burden of disease, determinants of health and epidemiological research, workforce and training capacity.

The South-East Asia region (SEAR) accounts for one-quarter of the world's population, 40% of the global poor and ∼30% of the global disease burden, with a disproportionately large share of tuberculosis (35%), injuries (30%), maternal (33%) and <5-year-old mortality (30%). In this article, we describe the disease burden and status of epidemiological research and capacity in the SEAR to understand, analyse and develop capacity in response to the diverse burdens of diseases in the region. Data on morbidity, mortality, risk factors, social determinants, research capacity, health education, workforce and systems in the SEAR were obtained using global data on burden of disease, peer-reviewed journals, World Health Organization (WHO) technical and advisory reports, and where available, validated country reports and key informants from the region. SEAR countries are afflicted with a triple burden of disease-infectious diseases, non-communicable diseases and injuries. Of the seven WHO regions, SEAR countries account for the highest proportion of global mortality (26%) and due to relatively younger ages at death, the second highest percentage of total years of life lost (30%). The SEAR exceeds the global average annual mortality rate for all three broad cause groupings-communicable, maternal, perinatal and nutritional conditions (334 vs 230 per 100 000); non-communicable diseases (676 vs 573 per 100 000); and injuries (101 vs 78 per 100 000). Poverty, education and other social determinants of health are strongly linked to inequities in health among SEAR countries and within socio-economic subgroups. India, Thailand and Bangladesh produce two-thirds of epidemiology publications in the region. Significant efforts to increase health workforce capacity, research and training have been undertaken in the region, yet considerable heterogeneity in resources and capacity remains. Health systems, statistics and surveillance programmes must respond to the demographic, economic and epidemiological transitions that define the current disease burden and risk profile of SEAR populations. Inequities in health must be critically analysed, documented and addressed through multi-sectoral approaches. There is a critical need to improve public health intelligence by building epidemiological capacity in the region.

Pegloticase: A Novel Agent for Treatment-Refractory Gout

To evaluate efficacy and safety of pegloticase, approved by the Food and Drug Administration in September 2010 for treatment of patients with chronic treatment-refractory gout. Literature searches were conducted using PubMed (1948-January 2012), TOXLINE, International Pharmaceutical Abstracts (1970-January 2012), and Google Scholar using the terms pegloticase, puricase, PEG-uricase, gout, uricase, and Krystexxa. Results were limited to English-language publications. References from selected articles were reviewed to identify additional citations. Studies evaluating the pharmacology, pharmacokinetics, safety, and efficacy of pegloticase for the treatment of chronic treatment-refractory gout were included. Pegloticase represents a novel intravenous treatment option for patients who have chronic gout refractory to other available treatments. Pegloticase is a recombinant uricase and achieves therapeutic effects by catalyzing oxidation of uric acid to allantoin, resulting in decreased uric acid concentrations. Results of published trials demonstrate the ability of pegloticase to maintain uric acid concentrations below 7 mg/dL in patients with chronic gout. Data supporting reduction of gout flares are limited. Pegloticase is well tolerated but associated with gout flares and infusion reactions. Other adverse events include nausea, dizziness, and back pain. During Phase 3 trials, 2 patients in the pegloticase biweekly group and 1 in the monthly group experienced heart failure exacerbation; another patient in the monthly group experienced a nonfatal myocardial infarction. Providers should exercise caution before administering pegloticase to patients with cardiovascular disease. The cost burden and safety profile may limit its use in practice, in addition to limited data available to support decreases in patient-centered outcomes (eg, gouty attacks). Pegloticase is an effective option for patients with symptomatic gout for whom current uric acid-lowering therapies are ineffective or contraindicated.

Coke Collapse Model and Collapse Profile Variation Law for Bell-Less Top BF

The mathematical model of minimum safety factor that investigated the collapse trends of coke layer under different charging parameters was established firstly on the basis of the slope stabilization theory in soil mechanics, and then the model of burden profile after coke collapse was improved by adopting the predetermination of quadratic curve and energy correction methods. The research will provide theoretical evidences for describing the coke profile more accurately and technical direction for choosing suitable charging parameters of blast furnace. The results show that: it is helpful to improve the stability of coke layer with increasing chute inclining angle and length of the coke flat; when the main falling point of ore moves toward furnace wall or the coke flat is wider, the curve radian of burden profile after coke collapse becomes smaller; the ore to coke ratio distribution agrees with the gas top temperature measurement well under considering coke collapse comparing with the result of ignoring coke collapse.

16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008

We analyzed the infection burden associated with the implantation of cardiac implantable electrophysiological devices (CIEDs) in the United States for the years 1993 to 2008. Recent data suggest that the rate of infection following CIED implantation may be increasing. The Nationwide Inpatient Sample (NIS) discharge records were queried between 1993 and 2008 using the 9th Revision of the International Classification of Diseases (ICD-9-CM). CIED infection was defined as either: 1) ICD-9 code for device-related infection (996.61) and any CIED procedure or removal code; or 2) CIED procedure code along with systemic infection. Patient health profile was evaluated by coding for renal failure, heart failure, respiratory failure, and diabetes mellitus. The infection burden and patient health profile were calculated for each year, and linear regression was used to test for changes over time. During the study period (1993 to 2008), the incidence of CIED infection was 1.61%. The annual rate of infections remained constant until 2004, when a marked increase was observed, which coincided with an increase in the incidence of major comorbidities. This was associated with a marked increase in mortality and in-hospital financial charges. The infection burden associated with CIED implantation is increasing over time and is associated with prolonged hospital stays and high financial costs.

Mathematical modeling of the burden distribution in the blast furnace shaft

Process efficiency in the blast furnace is influenced by the gas flow pattern, which is dictated by the burden profile. Therefore, it is important to control the burden distribution so as to achieve reasonable gas flow in the blast furnace operation. Additionally, the charging pattern selection is important as it affects the burden trajectory and stock profile. For analysis of the burden distribution, a new analysis model was developed by use of the spreadsheet program, Microsoft® Office Excel, based on visual basic. This model is composed of the falling burden trajectory and a stock model. The burden trajectory is determined by the burden type, batch weight, rotating velocity of the chute, tilting angle, and friction coefficient. After falling, stock lines are formed by the angle of repose, which is affected by the burden trajectory and the falling velocity. The mathematical formulas for developing this model were modified by a scaled model experiment and DEM simulation.

Burden of Stroke in Indigenous Western Australians

Despite the disproportionate burden of cardiovascular disease among indigenous Australians, information on stroke is sparse. This article documents the incidence and burden of stroke (in disability-adjusted life years) in indigenous and non-indigenous people in Western Australia (1997-2002), a state resident to 15% of indigenous Australians comprising 3.4% of the population of Western Australia. Indigenous and non-indigenous stroke incidence and excess mortality rates were estimated from linked hospital and mortality data, with adjustment for nonadmitted events. Nonfatal burden was calculated from nonfatal incidence, duration (modeled from incidence, excess mortality, and remission), and disability weights. Stroke death counts formed the basis of fatal burden. Nonfatal and fatal burden were summed to obtain disability-adjusted life years, by indigenous status. The total burden was 55 099 and 2134 disability-adjusted life years in non-indigenous and indigenous Western Australians, respectively. The indigenous to non-indigenous age-standardized stroke incidence rate ratio (≥15 years) was 2.6 in males (95% CI, 2.3-3.0) and 3.0 (95% CI, 2.6-3.5) in females, with similar rate ratios of disability-adjusted life years. The burden profile differed substantially between populations, with rate ratios being highest at younger ages. The differential between indigenous and non-indigenous stroke burden is considerable, highlighting the need for comprehensive intersectoral interventions to reduce indigenous stroke incidence and improve outcomes. Programs to reduce risk factors and increase access to culturally appropriate stroke services are required. The results here provide the quantitative basis for policy development and monitoring of stroke outcomes.

Numerical Simulation of Gas Flow Field in the Moving Bed of Corex Melter-Gasifier

The Corex process, which consists of the upper reduction shaft and the melter-gasifier is an alternative ironmaking process to the blast furnace. The Corex melter-gasifier is a countercurrent reactor to produce liquid iron. Directly reduced iron(DRI), noncoking coal, and other additives are charged to the melter-gasifier at their respective temperature, and O2 is blown through the tuyeres. Moving bed of melter-gasifier is an important zone for reduction of iron oxide and melting of DRI, in which lump coal is a function as skeleton of moving bed replacing coke. A two-dimensional mathematical model was developed for describing gas flowing in the moving bed of Corex melter-gasifier. The gas velocity and pressure distribution were obtained. Further more, the effects of deadman porosity and cohesive zone, burden profile and height of moving bed above tuyere on the gas velocity and pressure distribution were studied.

Development of the Burden Distribution and Gas Flow Model in the Blast Furnace Shaft

It is important to control the burden distribution, which affects the gas flow pattern in the blast furnace. Therefore, a burden distribution analysis model is needed to predict the burden profile. In this study, the burden descent and gas flow models were developed to complete a blast furnace analysis model. A previous study reported two models based on the burden trajectory and stock model. The burden profile that is due to the burden trajectory was calculated using stock model in the upper part of shaft. The entire burden profile, which is classified into five burden types calculated using the descent model, was used for a gas flow calculation as the initial conditions in the gas flow model. The analysis models were developed using a visual basic based spread sheet, and compared with the 1/12 scaled model experiment. In addition, a GUI (Graphic User Interface) was added for the convenience of the operators.

Pathogen burden and cortisol profiles over the day

Hypothalamic-pituitary-adrenocortical (HPA) regulation in adults is influenced by early psychosocial adversity, but the role of infectious disease history is poorly understood. We studied the association between cumulative pathogen burden and cortisol profile over the day in a sample of 317 healthy men and women aged 51-72 years. Cumulative pathogen burden was defined as positive serostatus for Chlamydia pneumoniae, cytomegalovirus (CMV) and herpes simplex virus 1 (HSV-1). Salivary cortisol was sampled repeatedly over the day. The cortisol slope was defined as the decrease across the day and evening. Age, gender, grade of employment, body mass index, smoking status, self-rated health, cardiovascular medication, depressed mood and time of waking were included as covariates. The pathogen burden averaged 1.76 (s.d.=0.92). The cortisol slope was inversely associated with pathogen burden after controlling for covariates. When individual pathogens were studied, only CMV was associated with flatter cortisol rhythms in isolation. We conclude that pathogen burden is independently associated with flatter cortisol slopes over the day, and may contribute to disturbed neuroendocrine regulation.

T1200 Long-Term Safety of Once-Daily 1.5-G Mesalamine Granules in Patients in Remission from Ulcerative Colitis

Mesalamine granules (MG) are the first 5-aminosalicylate (5-ASA) formulation to use an innovative delivery system that combines delayedand extended-release mechanisms to release mesalamine directly in the ileum and colon. Agents with a low pill burden and favorable safety profile are more likely to enhance patient compliance in the long-term maintenance of UC remission. Two similarly designed multicenter, randomized, doubleblind, placebo-controlled, phase 3 trials (RCTs) have individually demonstrated significant efficacy of MG (1.5 g, q. d.) for the long-term maintenance of ulcerative colitis (UC). Additionally, an open-label extension trial (OLT) with new and rollover subjects from the two phase 3 trials was conducted to study the long term safety of MG for maintenance of UC remission. The integrated safety data in the expanded population of subjects who received MG from all three trials are presented here (All MG population). Methods: Data for the All MG analyses (n=557) included subjects who received MG in the two RCTs (n=367) and the OLT. The OLT included 197 MGtreated patients who rolled over from the RCTs; and 190 MG naive patients (83 placebo-treated patients from the RCTs, and 107 new patients) all in UC remission. Results: Of 557 patients included in the analysis, 250 patients were exposed for >1 year and 354 were exposed to MG (1.5 g, q.d.) for >6 months. Incidence of treatment-emergent adverse events (TEAEs) was 69.7% in the All MG group. Majority of TEAEs were mild or moderate in intensity, with a profile similar to that during the 6month RCTs. The notably lower incidence of UC flare observed in the RCTs for MG (10.9%) versus placebo (24.3%) was maintained (10.4%) in the OLT. Other common TEAEs in the All MG group were headache (13.8%), diarrhea (9.7%), nasopharyngitis (8.8%), abdominal pain (7.7%), sinusitis (5.4%), and nausea (5.2%). Incidences of serious adverse events and TEAEs leading to study discontinuation were comparable between the 6-month RCT group and the All MG population in the open label study. Occurrences of renal, hepatic, and pancreatic adverse events in patients in the open-label study were ≤1%. Long term compliance for the once-daily treatment regimen was high: mean compliance was ≥ 95% in each treatment group in the RCT population, and 88% for the All MG population. Conclusions: The favorable safety profile of MG when combined with a high compliance of once-daily dosing may support its dispensation as first-line therapy for long-term maintenance of UC remission.

T1202 Once-Daily Mesalamine Granules Effectively Maintain Remission from Ulcerative Colitis: Data from 2 Phase 3 Trials

Mesalamine granules (MG) are the first 5-aminosalicylate (5-ASA) formulation to use an innovative delivery system that combines delayedand extended-release mechanisms to release mesalamine directly in the ileum and colon. Agents with a low pill burden and favorable safety profile are more likely to enhance patient compliance in the long-term maintenance of UC remission. Two similarly designed multicenter, randomized, doubleblind, placebo-controlled, phase 3 trials (RCTs) have individually demonstrated significant efficacy of MG (1.5 g, q. d.) for the long-term maintenance of ulcerative colitis (UC). Additionally, an open-label extension trial (OLT) with new and rollover subjects from the two phase 3 trials was conducted to study the long term safety of MG for maintenance of UC remission. The integrated safety data in the expanded population of subjects who received MG from all three trials are presented here (All MG population). Methods: Data for the All MG analyses (n=557) included subjects who received MG in the two RCTs (n=367) and the OLT. The OLT included 197 MGtreated patients who rolled over from the RCTs; and 190 MG naive patients (83 placebo-treated patients from the RCTs, and 107 new patients) all in UC remission. Results: Of 557 patients included in the analysis, 250 patients were exposed for >1 year and 354 were exposed to MG (1.5 g, q.d.) for >6 months. Incidence of treatment-emergent adverse events (TEAEs) was 69.7% in the All MG group. Majority of TEAEs were mild or moderate in intensity, with a profile similar to that during the 6month RCTs. The notably lower incidence of UC flare observed in the RCTs for MG (10.9%) versus placebo (24.3%) was maintained (10.4%) in the OLT. Other common TEAEs in the All MG group were headache (13.8%), diarrhea (9.7%), nasopharyngitis (8.8%), abdominal pain (7.7%), sinusitis (5.4%), and nausea (5.2%). Incidences of serious adverse events and TEAEs leading to study discontinuation were comparable between the 6-month RCT group and the All MG population in the open label study. Occurrences of renal, hepatic, and pancreatic adverse events in patients in the open-label study were ≤1%. Long term compliance for the once-daily treatment regimen was high: mean compliance was ≥ 95% in each treatment group in the RCT population, and 88% for the All MG population. Conclusions: The favorable safety profile of MG when combined with a high compliance of once-daily dosing may support its dispensation as first-line therapy for long-term maintenance of UC remission.