• Title/Summary/Keyword: drug safety

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The Tumor Control According to Radiation Dose of Gamma Knife Radiosurgery for Small and Medium-Sized Brain Metastases from Non-Small Cell Lung Cancer

  • Park, Sue Jee;Lim, Sa-Hoe;Kim, Young-Jin;Moon, Kyung-Sub;Kim, In-Young;Jung, Shin;Kim, Seul-Kee;Oh, In-Jae;Hong, Jong-Hwan;Jung, Tae-Young
    • Journal of Korean Neurosurgical Society
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    • v.64 no.6
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    • pp.983-994
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    • 2021
  • Objective : The effectiveness of gamma knife radiosurgery (GKR) in the treatment of brain metastases is well established. The aim of this study was to evaluate the efficacy and safety of maximizing the radiation dose in GKR and the factors influencing tumor control in cases of small and medium-sized brain metastases from non-small cell lung cancer (NSCLC). Methods : We analyzed 230 metastatic brain tumors less than 5 mL in volume in 146 patients with NSCLC who underwent GKR. The patients had no previous radiation therapy for brain metastases. The pathologies of the tumors were adenocarcinoma (n=207), squamous cell carcinoma (n=18), and others (n=5). The radiation doses were classified as 18, 20, 22, and 24 Gy, and based on the tumor volume, the tumors were categorized as follows : small-sized (less than 1 mL) and medium-sized (1-3 and 3-5 mL). The progression-free survival (PFS) of the individual 230 tumors and 146 brain metastases was evaluated after GKR depending on the pathology, Eastern Cooperative Oncology Group (ECOG) performance score (PS), tumor volume, radiation dose, and anti-cancer regimens. The radiotoxicity after GKR was also evaluated. Results : After GKR, the restricted mean PFS of individual 230 tumors at 24 months was 15.6 months (14.0-17.1). In small-sized tumors, as the dose of radiation increased, the tumor control rates tended to increase (p=0.072). In medium-sized tumors, there was no statistically difference in PFS with an increase of radiation dose (p=0.783). On univariate analyses, a statistically significant increase in PFS was associated with adenocarcinomas (p=0.001), tumors with ECOG PS 0 (p=0.005), small-sized tumors (p=0.003), radiation dose of 24 Gy (p=0.014), synchronous lesions (p=0.002), and targeted therapy (p=0.004). On multivariate analyses, an improved PFS was seen with targeted therapy (hazard ratio, 0.356; 95% confidence interval, 0.150-0.842; p=0.019). After GKR, the restricted mean PFS of brain at 24 months was 9.8 months (8.5-11.1) in 146 patients, and the pattern of recurrence was mostly distant within the brain (66.4%). The small and medium-sized tumors treated with GKR showed radiotoxicitiy in five out of 230 tumors (2.2%), which were controlled with medical treatment. Conclusion : The small-sized tumors were effectively controlled without symptomatic radiation necrosis as the radiation dose was increased up to 24 Gy. The medium-sized tumors showed potential for symptomatic radiation necrosis without signifcant tumor control rate, when greater than 18 Gy. GKR combined targeted therapy improved the tumor control of GKR-treated tumors.

Study on relationship between caffeine intake level and metabolic syndrome and related diseases in Korean adults: 2013 ~ 2016 Korea National Health and Nutrition Examination Survey (한국 성인의 카페인 섭취 수준이 대사증후군 및 관련 질환과의 관련성 연구 : 2013~2016 국민건강영양조사 자료 활용)

  • Lee, Jung-Sug;Park, Hyoung-Seop;Han, Sanghoon;Tana, Gegen;Chang, Moon-Jeong
    • Journal of Nutrition and Health
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    • v.52 no.2
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    • pp.227-241
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    • 2019
  • Purpose: This study examined the relationship between caffeine intake and metabolic syndrome in Korean adults using the 2013 ~ 2016 Korea National Health and Nutrition Examination Survey data (KNHANES). Methods: The caffeine database (DB) developed by Food and Drug Safety Assessment Agency in 2014 was used to estimate the caffeine consumption. The food and beverage consumption of the 24 hr recall data of 2013 ~ 2016 KNHANES were matched to items in the caffeine DB and the daily caffeine intakes of the individuals were calculated. The sample was limited to non-pregnant healthy adults aged 19 years and older, who were not taking any medication for disease treatment. Results: The average daily caffeine intake was 41.97 mg, and the daily intake of caffeine of 97% of the participants was from coffee, teas, soft drinks, and other beverages. Multivariate analysis showed that the caffeine intake did not affect metabolic syndrome, hypertension, low HDL-cholesterol, and abdominal obesity. Diabetes and hypertriglyceridemia, however, were 0.76 (95% CI: 0.63 ~ 0.93), and 0.87 (95% CI: 0.77 ~ 0.98) in third quintile (Q3), and 0.66 (95% CI: 0.53 ~ 0.82) and 0.83 (95% CI: 0.73 ~ 0.94) in fourth quintile (Q4) compared to Q1, respectively. Therefore, caffeine intake of 3.66 ~ 45.81 mg per day is related to a lower risk of diabetes and hypertriglyceridemia. Conclusion: The study showed that adequate caffeine intake (approximately 45 mg) was associated with a lower prevalence of diabetes and hypertriglyceridemia. Therefore, it can be used as a guideline for the adequate level of caffeine intake for maintaining health.

Exposure and Risk Assessments of Multimedia of Arsenic in the Environment (환경 중 비소의 매체통합 노출평가 및 위해성평가 연구)

  • Sim, Ki-Tae;Kim, Dong-Hoon;Lee, Jaewoo;Lee, Chae-Hong;Park, Soyeon;Seok, Kwang-Seol;Kim, Younghee
    • Journal of Environmental Impact Assessment
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    • v.28 no.2
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    • pp.152-168
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    • 2019
  • The element arsenic, which is abundant in the Earth's crust, is used for various industrial purposes including materials for disease treatment and household goods. Various human activities, such as the disposal of soil waste, metal mining and smelting, and combustion of fossil fuels, have caused the pollution of the environment with arsenic. Recently, guidelines for arsenic in rice have been adopted by the Korean ministry of food and drug safety to prevent health risks based on rice consumption. Because of the exposure to arsenic and its accumulation in the human body through various channels, such as air inhalation, skin contact, ingestion of drinking water, and food consumption, integrated multimedia risk assessment is required to adopt appropriate risk management policies. Therefore, integrated human health risk assessment was carried out in this study using integrated exposure assessment based on multimedia (e.g., air, water, and soil) and multi-route (e.g., oral, inhalation, and dermal) scenarios. The results show that oral uptake via drinking water is the most common pathway of arsenic into the human body, accounting for 57%-96% of the total arsenic exposure. Among various age groups, the highest exposures to arsenic were observed in infants because the body weight of infants is low and the surface areas of infant bodies are large. Based on the results of the exposure assessment, the cancer and non-cancer risks were calculated. The cancer risk for CTE and RME is in the range of 2.3E-05 to 6.7E-05 and thus is negligible because it does not exceed the cancer probability of 1.0E-04 for all age groups. On the other hand, the cancer risk for RME varies from 6.4E-05 to 1.8E-04 and from 1.3E-04 to 1.8E-04 for infants and preschool children, exceeding the excess cancer risk of 1.0E-04. The non-cancer risks range from 5.4E-02 to 1.9E-01 and from 1.5E-01 to 6.8E-01, respectively. They do not exceed the hazard index 1 for all scenarios and all ages.

Improvement of analytical method for pymetrozine in citrus fruits (감귤류 과일의 피메트로진 정량을 위한 분석법 개선)

  • Jeon, Jun-Ho;Chun, Su-Hyun;Kim, Min-Hyuk;Kim, Mi-Ok;Lee, Kwang-Won
    • Korean Journal of Food Science and Technology
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    • v.51 no.4
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    • pp.316-323
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    • 2019
  • It is difficult to analyze pymetrozine in citrus fruits using the hydromatrix method because of its low efficiency of purification and overlap of matrix and pymetrozine peaks. Liquid-liquid extraction can analyze pymetrozine in citrus fruits using dichloromethane. Since low pH interferes with the extraction of pymetrozine, the extracts of citrus fruits were maintained over pH 7.0 by adding borax buffer and 1 N NaOH in the improved method. According to the improved method, citrus fruits (such as lemon, lime, orange, tangerine, and grapefruit) were extracted and purified for HPLC-photo diode array analysis. The results of validation were as follows: $4.360{\mu}g/kg$ of limit of detection, $14.533{\mu}g/kg$ of limit of quantitation, and 0.007 mg/kg of method quantitative limit. Citrus fruits spiked with pymetrozine showed a recovery range from 71.8 to 83.7% and a coefficient of variation below 6%. Thus, the improved method can efficiently analyze pymetrozine in citrus fruits.

New Functional Properties of Passion Fruit Extract on Skin (패션 프룻 추출물이 피부에 미치는 새로운 기능적 효과)

  • Jeong, Mi Suk;Kim, Soon-Rae;Han, Chang Woo;Kim, Hyeon Jin;Jang, Se Bok
    • Journal of Life Science
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    • v.32 no.2
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    • pp.101-107
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    • 2022
  • In this research, the anti-inflammatory, antioxidant, antiaging, and skin whitening properties of pulp and seed extracts of passion fruit were studied. The result of the primary skin irritation test using a skin-attached patch determined the skin irritation index to be 0.00 for the passion fruit extract. In addition, RAW 264.7 macrophages produce NO by stimulation of lipopolysaccharides, and the application of extracts to this resulted in significantly lower NOs, confirming the excellent anti-inflammatory properties of passion fruit extracts. The 2,2-diphenyl-1-picrylhydrazyl test further confirmed that the passion fruit extract exhibits a good 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonate radical scavenging ability of 5.11% and strong antioxidant properties. The presence of collagen type I in the skin is a measure of aging and various skin diseases. The results obtained from the analysis of the activity of human procollagen I alpha 1 confirmed that the passion fruit extract reduces the synthesis of procollagen. In addition, the skin whitening property of the passion fruit extract was confirmed by the melanin inhibition test, and a sample was obtained that contained more than 2% of arbutin, a whitening agent approved by the Ministry of Food and Drug Safety, which is generally present in the form of a white powder and is used as a functional ingredient. This confirms that the whitening efficacy of the passion fruit extract obtained from nature contributes to the development of functional raw materials for cosmetics and food.

Preparation of an Inactivated Influenza Vaccine Using the Ethanol Extracts of Medical Herbs (한약재 식물 에탄올추출물을 이용한 인플루엔자 불활화백신 제작)

  • Cho, Sehee;Lee, Seung-Hoon;Kim, Seonjeong;Cheong, Yucheol;Kim, Yewon;Kim, Ju Won;Kim, Su Jeong;Seo, Seungin;Seo, Dong-Won;Lim, Jae-Hwan;Jeon, Sejin;Jang, Yo Han
    • Journal of Life Science
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    • v.32 no.12
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    • pp.919-928
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    • 2022
  • As seen in the COVID-19 pandemic, unexpected emergence of new viruses presents serious concern on public health. Especially, the absence of effective vaccines or antiviral drugs against emerging viruses significantly increases the severity of disease and duration of viral circulation among population. Natural products have served as a major source for safe and effective antiviral drugs. In this study, we examined the virucidal activity of medical herb extracts with a view to discover novel antiviral agents with desired levels of safety and antiviral efficacy. Ethanol extracts of ten selected medical herbs were tested for antioxidant activity and in-vitro cytotoxicity in various animal cell lines. Of note, the herbal extracts showed broad and potent virucidal activities against rotavirus, hepatitis A virus, and influenza A virus. The extracts of Sorbus commixta and Glycyrrhiza uralensis showed strong virucidal activities against influenza A virus. We also examined whether the extracts of Sorbus commixta and Glycyrrhiza uralensis can be used as inactivating agents to prepare an inactivated viral vaccine. In a mouse model, influenza A virus inactivated by the extracts elicited high levels of neutralizing antibodies, and the vaccination provided complete protection against lethal challenge. These results suggest that herb-derived natural products can be developed to antiviral drugs as well as inactivating agents for preparation of inactivated viral vaccines.

Analyze Technologies and Trends in Commercialized Radiology Artificial Intelligence Medical Device (상용화된 영상의학 인공지능 의료기기의 기술 및 동향 분석)

  • Chang-Hwa Han
    • Journal of the Korean Society of Radiology
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    • v.17 no.6
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    • pp.881-887
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    • 2023
  • This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.

Development of smart education-based teaching and learning plans and a smart textbook for 'healthy diet and meal plans' unit in 「Technology·Home Economics」 (중학교 「기술·가정」의 '건강한 식생활과 식사 구성' 단원에 적용한 스마트 교수·학습 과정안과 교재 개발)

  • Choi, Song Eun;Chae, Jung-Hyun
    • Journal of Korean Home Economics Education Association
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    • v.26 no.4
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    • pp.85-114
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    • 2014
  • The main purpose of this study was to develop teaching and learning plans and a smart textbook for food and nutrition education in Home Economics focusing on 'healthy diet and meal plans' unit in "Technology home Economics" textbooks for 7th graders to evaluate the effectiveness of the instruction conducted with the smart textbook. The content of the study to achieve the purpose is as follows: First, design a smart education-based teaching and learning curriculum for food and nutrition education in Home Economics, focusing on 'healthy diet and meal plans' unit. Second, develop a smart textbook for food and nutrition education based on the teaching and learning curriculum, using a smart content authoring tool. Third, evaluate the effectiveness of the instruction after applying the curriculum in real classroom situations. The results of this study were as follows: First, teaching and learning plans and materials were developed for two units, 'issues regarding teenagers' diet' and 'implementation of a healthy and balanced diet', under 'teenagers' life'. The first unit, 'issues regarding teenagers' diet', dealt with topics such as teenagers' dietary behaviors, nutrition, and health. Learning objectives for this unit were to help students identify and evaluate their own dietary behaviors. The second unit, 'implementation of a healthy and balanced diet', encouraged students to diagnose problems with their diet and plan nutrient rich meals. The objectives for this unit were to help students implement a healthy and balanced diet by providing them with nutrition and dietary guidelines for Koreans, sample meal plans, and guidelines for developing healthy eating habits for teenagers. In order to develop a teaching and learning plans to achieve these objectives, teaching and learning materials including inquiry tasks, materials for group activities, multimedia, applications and various pop-up learning materials were developed. Second, a smart textbook using DocZoom, which was a smart content authoring tool was developed. The textbook dealt with issues regarding teenagers' diet and implementation of a healthy and balanced diet. Multimedia material used in the textbook come from the Ministry of Food and Drug Safety's food and nutrition education web sites and other sources. To develop student-oriented material, relevant video clips were added to the smart textbook to motivate students and enhance their interest in the course. Third, the outcome of this study indicated that the instruction using teaching and learning plans and learning materials with the smart textbook was effective for enhancing students' interest in Home Economics classes (t-value=-3.99, p<.001), creating enthusiasm for learning(t-value = -2.61, p<.05), encouraging self-directed and independent learning(t-value = -4.77, p<.001), and improving students' interest in food and nutrition courses(t-value = -3.83, p<.001). The students' evaluation of the instruction were as follows: the instruction using teaching and learning plans and learning materials with smart textbooks, instead of paper textbooks, helped them save time looking for learning materials; students evaluated that it was easier for them to see and understand video clips and charts. In addition, most students answered that instruction with smart textbooks were more fun and convenient, and they agreed that the courses enhanced their learning experience.

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The Comparison of Results Among Hepatitis B Test Reagents Using National Standard Substance (국가 표준물질을 이용한 B형 간염 검사 시약 간의 결과 비교)

  • Lee, Young-Ji;Sim, Seong-Jae;Back, Song-Ran;Seo, Mee-Hye;Yoo, Seon-Hee;Cho, Shee-Man
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.203-207
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    • 2010
  • Purpose: Hepatitis B is infection caused by Hepatitis B virus (HBV). Currently, there are several methods, Kits and equipments for conducting Hepatitis B test. Due to ununiformed methods, it would cause some differences. To manage these differences, it needs process evaluating function of test system and reagent using particular standard substance. The aim of this study is to investigate tendency of RIA method's reagent used in Asan Medical Center through comparing several other test reagents using national standard substance. Materials and Methods: The standard substance in National Institute of Food and Drug Safety Evaluation's biology medicine consists of 5 things, 4 antigens and 1 antibody. We tested reagents using A, B company's Kits according to each test method. All tests are measured repeatedly to obtain accurate results. Results: Test result of "HBs Ag Mixed titer Performance panel" is obtained match rate compared S/CO unit standard with RIA method and EIA 3 reagents, CIA 2 reagents is that company A's reagent is 94.4% (17/18), 83.3% (15/18), B is 88.9% (16/18), 77.8% (14/18). Test result of "HBs Ag Low titer Performance panel" is obtain that EIA 2 reagents is shown 7 posive results, CIA 3 reagents is 11, and RIA method's company A's reagent is 3, B is 2 of 13 in low panel. "HBV surface antigen 86.76 IU/vial" tested dilution. A is obtain positive results to 600 times(0.14 IU/mL), B is 300 times (0.29 IU/mL). Case of "HBV human immunoglobulin 95.45 IU/vial", A is shown positive result to 10,000 times (9.5 mIU/mL) and B is 4,000 times (24 mIU/mL). Test result of "HBs Ag Working Standards 0.02~11.52 IU/mL" is shown that Company A's kit concentration level was 0.38IU/mL, company B was 2.23 IU/mL and higher level of concentration was positive results. Conclusion: When comparing various test reagents and RIA method according to National Standard substances for Hepatitis B test, we recognized that there were no significant trends between reagents. For hepatitis B virus antigen-antibody titers even in parts of the test up to 600 times the antigen, antibodies to 10,000 times the maximum positive results could be obtained. Therefore, we confirmed that results from Asan Medical Center are performed smoothly by reagents and system for hepatitis B virus test.

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Global Cosmetics Trends and Cosmceuticals for 21st Century Asia (화장품의 세계적인 개발동향과 21세기 아시아인을 위한 기능성 화장품)

  • T.Joseph Lin
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.23 no.1
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    • pp.5-20
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    • 1997
  • War and poverty depress the consumption of cosmetics, while peace and prosperity encourage their proliferation. With the end of World War II, the US, Europe and Japan witnessed rapid growth of their cosmetic industries. The ending of the Cold War has stimulated the growth of the industry in Eastern Europe. Improved economies, and mass communication are also responsible for the fast growth of the cosmetic industries in many Asian nations. The rapid development of the cosmetic industry in mainland China over the past decade proves that changing economies and political climates can deeply affect the health of our business. In addition to war, economy, political climate and mass communication, factors such as lifestyle, religion, morality and value concepts, can also affect the growth of our industry. Cosmetics are the product of the society. As society and the needs of its people change, cosmetics also evolve with respect to their contents, packaging, distribution, marketing concepts, and emphasis. In many ways, cosmetics mirror our society, reflecting social changes. Until the early 70's, cosmetics in the US were primarily developed for white women. The civil rights movement of the 60's gave birth to ethnic cosmetics, and products designed for African-Americans became popular in the 70's and 80's. The consumerism of the 70's led the FDA to tighten cosmetic regulations, forcing manufacturers to disclose ingredients on their labels. The result was the spread of safety-oriented, "hypoallergenic" cosmetics and more selective use of ingredients. The new ingredient labeling law in Europe is also likely to affect the manner in which development chemists choose ingredients for new products. Environmental pollution, too, can affect cosmetics trends. For example, the concern over ozone depletion in the stratosphere has promoted the consumption of suncare products. Similarly, the popularity of natural cosmetic ingredients, the search of non-animal testing methods, and ecology-conscious cosmetic packaging seen in recent years all reflect the profound influences of our changing world. In the 1980's, a class of efficacy-oriented skin-care products, which the New York Times dubbed "serious" cosmetics, emerged in the US. "Cosmeceuticals" refer to hybrids of cosmetics and pharmaceuticals which have gained importance in the US in the 90's and are quickly spreading world-wide. In spite of regulatory problems, consumer demand and new technologies continue to encourage their development. New classes of cosmeceuticals are emerging to meet the demands of increasingly affluent Asian consumers as we enter the 21st century. as we enter the 21st century.

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