• Title/Summary/Keyword: Re-examination system

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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

A Study on the Factors of the school health Teachers' Self-confidence Affecting the School Nursing Activities in Jeonbuk Province (전북지역 양호교사의 업무수행과 자신감과 그에 영향하는 요인에 관한 연구)

  • Yang, Koung-Hee
    • Research in Community and Public Health Nursing
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    • v.1 no.1
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    • pp.582-594
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    • 1989
  • The purpose of this study is to analyze the factors affecting the school health teachers' self-confidence. This study was conducted with 87 school health teachers working in Jeonbuk province, from September to December, 1986, The results are follows; 1. Demographic characteristics of school health teachers 1) Age mean ; 34, range; 23-54 2) School Nursing experience mean; 11 years, range; 0-24 3) Clinical experience mean; 1.5 years, range: 0-13 2. Status of school health resources & nursing activities 1) Personnel resource school health teacher: pupils : 1 : 1,436 'classes=1:31 'general teacher=1:39 2) Budget Total school operating budget: School health budget : 100 : 4.2 (52.2 thousand Won) Half of the school health budget expend on medicine. 3) Clinic 80% of all schools have health clinic seperately. 71.32 of all schools have less than $35m^2$, 23.9%, $36-66m^2$. 4) Only 20% of all schools have organization for health 5) Average of clinic visitor for 1 year; 2,084 Major problem is on digestive system. And other problem: respiratory, skin, musculo - skeletal system, dental problem, etc... 6) Literal message for 1 year; 12 times. For health education (4), vaccination (3), examination of parasites (2), etc... 3. The degrees of the school health teachers' self-confidence 1) Program planning & evaluation; 2.9. 2) Clinic management; 2.8 3) Health education; 2.8 4) Management of school environment; 2.7 5) Health care services; 2.5. 6) Operating of school health organization; 2.3 4. Significances to self-confidence on school health nursing activities 1) Program planning & evaluation: home message (r=.228, p<.05) No. of clinic visitor (r=.220, p<.05) expending time for clinic management (r=.229, p<.05) religion (t: 2.5, p<.05) level of school (F=6.3, p<.005) 2) Clinic management: age of school health teacher (r=-.202, p<.05) school health experience (r=-.211, p<.05) salary step (r=.187, p<.05) expending time for clinic management (r=.315, p<0.1) marital status (t=3.97, p<.005) level of school (F=3,139, p<0.5) 3) Management of school environment: level of school (F=3.899, p<.05) expending time for clinic management (r=-,216, p<0.5) 4) Health care service: age of school health teacher (r=-.186, p<.05) marital status (t= 3.67, pH.005) 5) Health education: expending times for clinic management (r=-.252, p<05) level of school (F=5.343, p<.01) 6) Operating of health organization; age of school health teacher (r=-.258, p<.01)salary step (r=.188, p<.05) Based on the above results, the suggestions are as follows; 1. Need to raise ,appointment rate school health teacher. 2. Need to raise self-confidence on school health nursing activities through the inservice education or re-inforcement. 3. Need to secure adequate budget for school health. 4. Participation of school health teacher and support of school master for school health services are required. 5. Need for use the health clinic seperately, adequate facilities and free utilization by visitors.

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Multi-locus Phylogeny Analysis of Korean Isolates of Phytophthora Species Based on Sequence of Ribosomal and Mitochondrial DNA (핵 및 미토콘드리아 DNA 염기서열을 이용한 국내 Phytophthora 속의 Multi-locus phylogeny 분석)

  • Seo, Mun-Won;Song, Jeong-Young;Kim, Hong-Gi
    • The Korean Journal of Mycology
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    • v.38 no.1
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    • pp.40-47
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    • 2010
  • To investigate genetic relationships either interspecies or intraspecies of 14 Korean Phytophthora species, sequence analyses of nuclear DNA (ypt gene and rDNA-IGS region) and mitochondrial DNA (Cox gene, $\beta$-tubuline gene, and EF1A gene) were performed. All of 14 Korean Phytophthora species clearly clustered into foreign isolates of each species. These Korean isolates in Phytophthora species also showed no correlation between molecular classification and morphological classification like as in case of foreigners. P. palmivora KACC 40167 reported previously from genetic groups of Phytophthora species in Korea was not consistent with the classification system, and therefore was required re-examination for the genetic group analysis. Korean isolates of P. drechsleri KACC 40195 showed very close relationship with P. cryptogea KACC 40161 above 94% bootstrap value in P. cryptogea-P. drechsleri complex group. Identification of these isolates is still unclear, because P. cryptogea and P. drechsleri were not differentiated in this study. On the other hand, it was required to unify species for these two species, since P. parasitica and P. nicotianae were clustered into a group on the level of 99 to 100% sequence homology. Comparing to the sequences of foreigners, Korean isolates were newly divided to ten groups in the phylogenic system. These results could be prepared useful informations to understand genetic diversity of Phytophthora species in Korea.

A Study on tradition of Nihonbuyo(日本舞踊) and the Imoto(家元) system (니혼부요(日本舞踊)의 전승과 이에모토(家元) 제도)

  • Nam, Sung-Ho
    • (The) Research of the performance art and culture
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    • no.40
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    • pp.71-109
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    • 2020
  • Nihonbuyo(日本舞踊), a typical traditional Japanese dance, began with kabuki dancing and formed many schools, and was managed by Iemoto system. Iemoto(家元) is the head family of a school of a traditional Japanese art. Iemoto(家元) existed after the establishment of the ancient family system, and it was established as a system during the modern feudal period. Especially in Nihon Buyo, the Iemoto system has developed greatly since the modern era. Iemoto System has has contributed greatly to the succession of traditional arts and has been considered one of the characteristics of Japanese society. Basically, Iemoto system considers it the best authority to pass on the skills of excellent teachers without any distortion. It has various forms depending on the field and the school, but it is an organization with a family structure similar to that of a family with Iemoto at the top. In this article, I examined the establishment and background of the Nihonbuyo and considered the succession of the fame and authority of Iemoto through the system of succession. There are so many schools in the Nihonbuyo world that it is said to be a school kingdom. These schools were divided into kabuki actors, choreographers, female entertainers, ChiutaMai dance(地唄舞) and new dance styles, and the aspect of the Iemoto system was examined through the background and characteristics of each school. While Iemoto system has a positive aspect of inheriting the tradition, there are also many negative criticisms in the art world, such as rigid organizational management, the products of feudal society, the power of Iemoto, and the stalemate of arts. Nevertheless, in a Japanese society that places importance on tradition, the landlady system will not disappear easily. In fact, today, when there are many different art genres in common, young dancers are starting to challenge themselves along with self-examination of Iemoto in order to make the best use of traditional art. We hope that through consideration of the Japanese housekeeping system, it will become a place where intangible cultural properties will be re-acknowledged.

Policy suggestions to educate and produce outstanding paramedics in Korea (우수한 1급 응급구조사 인력 양성 및 배출을 위한 정책 제안)

  • Choi, Eun-Sook;Koh, Bong-Yeun;Park, Hee-Jin;Kim, Hyo-Sik;Kwon, Hay-Rran;Choi, Hea-Kyung;Lee, Kyoung-Youl;Yun, Jong-Geun;Hong, Sung-Gi;Cho, Keun-Ja
    • The Korean Journal of Emergency Medical Services
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    • v.22 no.1
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    • pp.7-19
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    • 2018
  • Purpose: With the purpose of educating and producing outstanding paramedics by enhancing their competencies, this study aimed to make policy suggestions to re-establish the education system and improve the national examination and the certification scheme. Methods: This study used focus group interviews and questionnaires to collect data. Totally, there were 277 subjects, including experts from the education and field. Data were collected from September 9 to 20, 2016, and analyzed using SPSS 22.0. Results: To strengthen the curriculum of paramedics, this study suggested 27 courses with 94 credits as the standardized curriculum and derived 9 core competencies of paramedics. For the national examination, this study suggested consolidating written test subjects, adding scenario questions to practical tests, and applying critical criteria to simple practical tests that performs a procedure, grading these tests on a pass/fail basis. In addition, this study suggested converting certification into license, reflecting paramedics' healthcare job characteristics. Conclusion: The quality of emergency medical services in Korea will improve when those with core competencies that originated from the standardized curriculum based on the results of this study acquire their certification through the national test scheme, and the certification management system creates a virtuous cycle to further enhance paramedics' professionalism.

The Achievements and Limitations of Petit Bourgeois Desires in "Oksosun Story" (<옥소선 이야기> 속 소시민적 욕망의 성취와 한계)

  • Lee, Won-young
    • Journal of Korean Classical Literature and Education
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    • no.32
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    • pp.327-355
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    • 2016
  • This study aims to identify petit bourgeois desires through the characters in "Oksosun Stories" from Cheonyerok, an eighteenth-century Yadam anthology. The desires and motivations of the characters are quite secular and egocentric. Because of this, their shared characteristics are similar to those of the petit bourgeois, as neutral existence begins to emerge during the transition from feudal to modern society. The concept of petit bourgeois generally means the public and the working class of modern society. The main character's behavior in the story differs little from general petit bourgeois attitudes. An important belief in petit bourgeois is not the ruling ideology in society but the achievement and stability of realistic and ordinary desires to fulfill their lives' satisfaction. Also selfish or antisocial attitudes and boundary characteristics appear in the process, depending on whether subject having any desire. However, the character's actions are limited in the governance system of a huge reality. And It is characterized by end goal being to meet their upward mobility and stability. This corresponds with Seang's (書生) actions of turning his back on his family and country as well as promising Jaran his love; and, he redeems himself with his family and society by acquiring stability after he passed the state examination. Furthermore, the contemporary significance of this work demonstrates Seang (書生) discovering his desires for human love; therefore, in order to affirm and gratify this desire, he endures the societal state of semi-feudalism against filial duty (不孝), disloyalty (不忠), and non-chastity (不烈), and he acts independently. In addition, on the strength of his pursuit of his desires, Oksosun frees herself from the caste restraint called gisaeng (妓生) and affirms her desire to become a subject of love, but she then deviates from the social system. Moreover, the limitations and achievements of the petit bourgeois are indicated in the actions of recognizing the social threshold of their past in the process, making independent efforts using their capabilities, fulfilling success in the state examination with their intellectual capacity, and re-entering society. From the late Chosun Dynasty to modern times, there is not only the type of contemporary people who hunger for fulfillment of their personal desire and live in free will, but there is also the feudal type that is still lacking in the understanding of independent life. This is not as different as in these present times. This literature asserts the meaning of awakening one's self-existence and assigning great value to the fulfillment of self-desires against the odds that are created by socio-political, cultural, economic norms of the era. "Oksosun Story" affirms the small efforts and successes of private individuals in reality. It also validates the search for life happiness through positivity. In this sense, even the contemporary reader would derive valid meaningfulness from this literature.

A Study of the Major Courses Operation on National Competence Standards(NCS) at Department of Library and Information Science: Focusing on Educational Experience of Instructor (문헌정보학 전공에서의 국가직무능력표준(NCS)을 활용한 교과목 운영에 관한 연구 - 교수자의 교육경험을 중심으로 -)

  • Kwon, Sun-Young;Cha, Sung-Jong
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.27 no.3
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    • pp.129-149
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    • 2016
  • The purpose of this study is to examine in depth the personal experience of Instructor during National Competence Standards (NCS) Curriculum at Department of Library and Information Science. We conducted in depth interview (FGI) with participants who had recently experienced and data analysis was undertaken. We hope this study that an application of NCS would be activated fully in Library, educational institutes and qualifying examination institutes and that diverse feedbacks from related parties would makes leading to a better updated version of NCS development. As a result, First, The instructor had generally familiar with the background and purpose of the NCS. and they issued the inadequacies of job elements, non-reflection of the opinion on field education, the problems of classification of NCS. second, In the experience of NCS curriculum operating, There were the paperwork burden, Problems of methods of evaluation, evaluation period discrimination, the need to well communication with students. Third, In the problems on the NCS Curriculum operating, we found that there were The need on the proper Class size/hour, additional education, re-evaluation, Support system for NCS Curriculum operation, tools for practice, discrimination between relative evaluation and NCS evaluation, Enhancement for Competence/Standards. Fourth, On The ways of improving for NCS curriculum, We found that There were Class size, Support tools for practice, The improvement Competence/elements/standards based on LIS characteristic. The result of this study may contribute for improving the overall environment Based upon FGI analysis, several new directions for NCS education in the filed LIS curriculum are suggested.

A Case of Mitochondrial Myopathy Showing Severe Hypoxemia during REM Sleep (렘수면중 심한 저산소혈증을 보인 사립체근병증 1례)

  • Kim, Ju-Sang;Kim, Sung-Kyung;Lee, Sang-Haak;Ahn, Joong-Hyun;Kim, Chi-Hong;Moon, Hwa-Sik
    • Sleep Medicine and Psychophysiology
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    • v.14 no.1
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    • pp.49-53
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    • 2007
  • Mitochondrial myopathy is characterized by variable clinical manifestations from mild limb weakness to fatal respiratory failure and central nervous system sequela. But it is a rare event that sleep disordered breathing become a clue of diagnosis for mitochondrial myopathy. We report a case of a 21 year-old man who was diagnosed as mitochondrial myopathy during the investigation for the possible cause of chronic hypoventilation syndrome. Before being admitted to our hospital, he was suspected as having sleep apnea syndrome in another hospital. We re-evaluated the history, physical examination, laboratoy findings and polysomnography in detail. Severe hypoxemia was noted during REM sleep on nocturnal polysomnography and the diagnosis of mitochondrial myopathy was made by muscle biopsy in rectus abdominis muscle. We treated him with bilevel positive airway pressure therapy during sleep and it could reverse the hypoxemia during REM sleep. He could be discharged with improved condition and is being well with the use of this ventilatory assistance.

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Physicochemical Characteristics and Nutrient Release from Sediment in an Urban Stream (도심하천 퇴적물의 이화학적 특성과 영양염 용출)

  • Kim, Tae Hoon;Jung, Jae Hoon;Choi, Sun Hwa;Choi, I Song;Oh, Jong Min
    • Ecology and Resilient Infrastructure
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    • v.2 no.2
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    • pp.167-176
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    • 2015
  • The water quality of the Gulpo Stream flowing through Incheon, Bucheon, Seoul, and Kimpo is getting worse due to a slow flow rate and bank constructions by stream channelization as well as an inflow of pollutants from living-sewages and factory-sewages. Besides, a dry stream phenomenon caused by a lack of maintenance water upstream makes a self-purification system worse, and the water quality of the Gulpo Stream is currently at its lowest level. The accumulated sludge of the streambed is mostly formed by the deposition of particle pollutants due to the slow flow rate and an artificially straightened stream channel. This accumulated sludge adsorbs a great quantity of organic materials and heavy metals. Because of the internal contamination possibility by a re-gushing, even after the pollution source is removed, it can cause future water pollution. Without a total examination as previously recommended, it is considered difficult to accomplish practical efficiency. In conclusion, the management of periodic sediment management such as dredging would be necessary in the Gulpo Stream because sediment could be an internal pollution source of stream water under anaerobic conditions.

Study on Hospital Environmental Causes Affected the Mother′s Comfort After Her Child Birth (산욕부 안위에 영향을 미치는 병원환경 요인에 관한 연구)

  • 변수자
    • Journal of Korean Academy of Nursing
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    • v.8 no.1
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    • pp.1-15
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    • 1978
  • The Purpose of this study is to examine closely the causes influenced upon the comfort and recovery of the woman delivered of a child in the hospital at the same time to understand environmental status of hospitals in order to promote mother's health recovery, and to improve hospital environment by emphasizing the meaning of environment and health before the medical staff and hospital administrative authority. In the method of servery of the research, 165 post paestum patients have been randomly selected who were accommodated and delivered their babies at OB(obstetric ) & GY (Gynecologic) unit the 7 general hospitals for the period of 6 December 1976 through 17 December 1976. As for the survey, it has been used of Questionnaire where we have 65 items in the respect of personal environment in the hospital such as trusting nurse, ability, reliability, kindness and etiquette of nurse and tile character of nurse the relationship with patients the other respect of physical environment included 9f temperature, moisture. air-ventilation lightening noise, cleanness. facilities, and the third realm being of mother's hearth ground to have the following conclusion 1. The feature of the collected personnel they are from OB or GY sects of from OB unit of the other 5 hospitals except the two general hospitals of the college or school Otherwise the rate of the patients to nurses would be 9 : 1. As for the nurses'ground it would be appeared of 20-25 years of age as the 76%. either 3 year course or 4 year course in the education would be each 50% and less than 2 year experience case would record as of 60 %. In the respect of hospital physical environmental status, there we have two hospitals without any thermometers, on the other han4 nowhere there's hygrometer, otherwise, the lightening is normal or over than normal As for the structure of noise protection the corridors're, generally speaking worse than rooms, nerver hueless, there's no ventilating system in the hospitals. The rooms'repainted in white and yellow, light green white, or green color. The patient's clothing were in green pink blue, light green or in white co for. There're not anything special in both decoration and equipments. Most of them used tall beds except in one hospital 2. To the extent of perception of patient's hatch 9round and hospital environment it is presented that they perceived nurse's ability in highest in total human variable, though perceived kindness or etiquette in the lowest otherwise, comparatively high in total average. 3. In the respect of physical environment it is highest perceived of lightening terms, otherwise, lowest perceived of air ventilation and total average became lowest than the one of the original record 4. To ages, in the respect of hatch ground rather old aged mother than the younger one has perceived that nurse would be trusting, in good service character, able, at the same time, liable, Otherwise, in physical environment regardless of age, they perceived lightening in high and remarkably lower in ventilation As a result of the examination of the difference in hospital environment to each age it is appeared of statistical difference at 5% level of ability in the personal environment otherwise little difference as for physical environment 5. In the respect of perceiving level to educational standard it is highly perceived of personal environment for higher ranking group rather than lower group in the educational standard. In case of physical environment it is highly perceived for lower level group rather than higher level group in educational background. The variables which have statistical significance at 5% level are from trusting kindness, etiquette and total kindness, etiquette and total all significance at 5% level are from trusting, kindness, etiquette and total human environment variable in personal environment, otherwise, there's little difference in the physical environment. 6. The perceiving level due to times of admission and accommodation at the hospital would be cleared out as gradual higher perception both physical and personal environment in the hospital. At 5% significant level of the ventilation condition in physical environmental variable it is presented of meaningful difference otherwise, there we have little difference both in Personal variable and other one. 7. In accordance with living standard, the perception degree of personal environment in tee hospital would be inclined to increase to higher living standard on the other hand, in case of the physical environment, the perception level world increase to lower living standard At 5 % level, the trustuariable and total scores in the personal eicuironmectal variable there appeared a meaningful/ significant difference otherwise, there presented little difference both in physical environmental and other variable to the living standard 8. Pertaining to family unit, the mother of an independent family unit perceived highly in all respect of the personal and the physical environment in the hospital rather than the woman of succeeding family unit. At 5 % level there appeared a difference in the respect of kindness and etiquette both in personal environment variable, on the other hand, there hardly marked a difference between other variable and physical environmental one. 9. The degree of perception to comforting level has little connection with a statistical difference the age, educational level hospital admitting times, living standard or family unit. 10. The most effective variable to mother's comforting level will be nurse's ability, reliability, trusting manner, and total physical environment variable in order.

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