• 제목/요약/키워드: interval criteria

검색결과 433건 처리시간 0.033초

A Phase I/II Trial of $DCVac/IR^{(R)}$ Dendritic Cell Immunotherapy Combined with Irradiation in Cases of Refractory Colorectal Cancer with Multiple Liver Metastases (기존의 치료에 반응하지 않는 다발성 간전이 대장암 환자에서 방사선조사와 병합한 수지상세포 면역치료의 1, 2상 임상시험)

  • Choi, Young-Min;Lee, Hyung-Sik;Kwon, Hyuk-Chan;Han, Sang-Young;Choi, Jong-Cheol;Chung, Ju-Seop;Kim, Chang-Won;Kim, Dong-Won;Kang, Chi-Duk
    • Radiation Oncology Journal
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    • 제26권2호
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    • pp.104-112
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    • 2008
  • Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.

Suitability Grouping System of Paddy Soils for Multiple Cropping -Part II : Criteria of the Suitability Grouping (다모작(多毛作)을 위한 답토양(畓土壤) 적성등급(適性等級) 구분(區分) -제(第)2보(報) : 적성등급(適性等級) 구분기준(區分基準))

  • Jung, Yeun-Tae;Park, Eun-Ho;No, Yeong-Pal;Um, Ki-Tae
    • Korean Journal of Soil Science and Fertilizer
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    • 제19권4호
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    • pp.283-289
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    • 1986
  • To establish a suitability grouping system of paddy soils for multiple cropping of rice with other upland crops, the study was carried out after a few basic experiments. In succession to the results on basic experiment prior, the suitability system proposed and the results of application mentioned in this report were summarized as follows; 1. The factors of soil properties in the system were productivities represented by soil texture and drainage class, as well as salinity of surface and sub-soil pH of chemical properties were considered together with slope, warmth index, ground water table, parent materials etc. of soil physical or environmental conditions. The weights of the factors were combined with multiplicatively and additively so as the total marks of ideal soil to be 100. The system was composed with 5 suitability classes; over 91 mark is class I, under 60 mark class V, and each 10 point interval between classes. The limiting factors "P" (in the case that Physical properties or Productivity marks under 24), "S" (Surface slope less than 15) and "C" (Chemical condition below 15) etc. were appended up to two kinds to the classes except a part of soils in class I. 2. The areas where the warmth index exceed 110 in Yeongnam were 19% for class I, 22.7% for class II, 44.7% for class III, 11.5% for class IV, and 2.1% for class V. The rates in class I and II were slightly more than those of the whole country. 3. The points of each soil gained by the system had a positive correlation ($r=.922^{**}$) with the potential productivities.

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Comparison of Enalapril Maleate Tablets on Bioavailability and the Time Course of Inhibition of Plasma Angiotensin-Converting Enzyme (Enalapril Maleate 정제의 동등성에 관한 연구 ; 약동학적 성상 및 혈장 ACE 활성도 억제 효과)

  • Jang, In-Jin;Jang, Byung-Soo;Shin, Sang-Goo;Shin, Jae-Gook;Rho, Il-Kun;Lee, Kyeong-Hun;Park, Chan-Woong
    • The Korean Journal of Pharmacology
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    • 제26권2호
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    • pp.219-226
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    • 1990
  • Enalapril maleate tablets of two different producers were tested for bioequivalence. Enalapril is rapidly metabolized to an active metabolite, enalaprilat which inhibits angiotensin-converting enzyme (ACE). The pharmacokinetics of enalapril maleate and the time course of inhibition of plasma ACE activity after administration of the drugs were studied. Two single doses of 10mg each of enalapril maleate were administered orally to twelve male volunteers in a balanced, randomized, two-way crossover investigation. Plasma enalaprilat concentrations were determined over a 23-hour after the dose by enzyme inhibition assay and enalapril by the same method following in vitro hydrolysis. Urinary recoveries of enalapril and enalaprilat were determined for the calculation of renal clearance. Plasma ACE activity was determined by an enzyme assay. Peak plasma levels of enalapril were observed about 1 hour after the doses, and practically all enalapril had disappeared from plasma within 6 hour. Peak enalapril concentrations of both formulations were almost identical ($Vasotec^{\circledR}$, 61.38 ng/ml; $Beartec^{\circledR}$, 64.27 ng/ml). The values of the pharmacokinetic parameters of enalaprilat computed for $Vasotec^{\circledR}$ and $Beartec^{\circledR}$ tablets are presented in that order; area under the curve=330.63:320.96 $ng{\cdot}hr/ml$; peak concentration=38.63:39.43 ng/ml; time to peak=3.83:4.08 hour; elimination half-life=3.95:3.92 hours. No statistically significant difference was detected when area under the curve and all other parameters were compared. Using criteria of 95% confidence interval for the comparison of these parameters, only the upper limits of area under the curve and time to peak of enalapril were over 120%. All the parameters of enalaprilat were acceptable. Percent inhibition of plasma ACE to plasma enalaprilat concentration showed the sigmoid concentration-inhibition relationship. Time courses of plasma ACE inhibition after the administration of both formulations were quite similar. The formulations were found to be equivalent when compared on the premise that no significant difference was detected when pharmacokientic parameters and inhibition of ACE activity were compared, based on the confidence limits analysis.

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Depression, Anxiety, Alexithymia, Stress Response in Caregivers of Attention Deficit Hyperactivity Disorder Patient (주의력결핍 과잉행동장애 환아 보호자의 우울, 불안, 감정표현불능, 스트레스반응)

  • Jeong, Jong-Hyun;Hong, Seung-Chul;Han, Jin-Hee;Lee, Sung-Pil
    • Korean Journal of Psychosomatic Medicine
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    • 제13권2호
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    • pp.95-101
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    • 2005
  • Objectives : This study was designed to investigate depression, anxiety, alexithymia, stress res ponses in caregivers of patients with attention deficit hyperactivity disorder. Methods : The subjects were 38 attention deficit hyperactivity disorder patients caregivers(38 women, mean age $37.5{\pm}6.5$). Patients were diagnosed with DSM-IV ADHD criteria. Korean version of Beck Depression Inventory(BDI), State and Trait Anxiety Inventory(STAI), Toronto Alexithymia Scale(TAS) and Stress Response Inventory(SRI) were used for assessment. Results 1) The BDI scores of ADHD patients caregiver group were significantly higher than control group$(16.4{\pm}7.1\;vs.\;10.9{\pm}5.5)(p=0.011)$. 7 of the 38 caregivers(18.4%) and none of control group(0%) had BDI scores over 20 points(p=0.021). Calculated relative risk for ADHD in the presence of caregivers' depression was 1.516 overall(95% confidence interval, 1.234-1.862). 2) In ADHD patient's caregiver group, the scores of Stress Response Inventory were significantly higher than control group$(44.2{\pm}20.2\;vs.\;26.5{\pm}16.8)(p=0.006)$. 3) No significant differences were found in the score of STAI, SIAIS, SIAI-T, TAS between caregiver and control group. Conclusion : This study suggest that ADHD patients' caregivers are likely to have more depressive symptoms and higher stress response level than control group. We propose that physicians should consider integrated approaches for caregiver's psychopathology in the management of ADHD.

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Diagnosis of Irrigation Time Based on Microchange of Stem Diameter in Greenhouse Tomato (온실재배 토마토의 농직경 변화에 의한 관개시기 진단)

  • 이변우
    • Journal of Bio-Environment Control
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    • 제6권4호
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    • pp.250-257
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    • 1997
  • Stem diameter and shoot fresh weight of tomato grown in greenhouse were measured non-destructively at 10 minutes interval from 1 to 16 July, 1996 with displacement detector using strain gauges and with suspension-type load cell, respectively, and simultaneously were measured soil water potential, transpiration and solar radiation. Ample water was irrigated before experiment, and thereafter, irrigations were made on the next morning when visual symptoms of wilting appeared. Shoot fresh weight and stem diameter showed very similar patterns in diurnal changes which are characterized by predawn maximum and afternoon minimum and in long- term evolutions, suggesting that stem diameter shrinkage and expansion are closely related to plant water content and growth, respectively, Shoot weight and stem diameter reached minimum values a little later than the time on which transpiration showed maximum. The daily net gains of fresh weight(DG) and stem diameter(DI) showed significantly Positive correlations with solar radiation in those days on which plants were not water-stressed. However, Dl and DG on those days of water stress showed much lower values than expected from the relationships between solar radiation and them. Transpiration was much lower than the expected potential transpiration on 10 July, implying that plants were water-stressed. In this case water stress was not detected from visual symptom of wilting and/or soil water potential, but was able to be identified by the lower DI and DG than the expected. The maximum contraction of stem diameter(MC) and the maximum loss of fresh weight(ML) during daytime showed significantly positive correlations with solar radiation in those days on which plants were not water-stressed and were observed greater than expected from the relationships on severely water-stressed days. But mild water stress could not be discernable by ML and MC. It would be concluded that the daily net gains of fresh weight and/or stem diameter could be used as criteria for diagnosing the water status of tomato and for triggoring the onset of irrigation in automatic system.

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Golf activity after total knee arthroplasty (슬관절 전치환술 후 골프활동)

  • Kim, Hyung-Jun;Cha, Seung-Han;Nam, Kyoung-Mo;Kim, Dong-Heon
    • Journal of Korean Orthopaedic Sports Medicine
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    • 제11권1호
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    • pp.51-56
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    • 2012
  • Purpose: Golf is a popular sports activity after total knee arthroplasty in old age patients. We evaluated golf and implant loosening through the radiologic method. We also evaluated correlation of patterns of golf activity and clinical outcome to suggest guidelines to the patients. Materials and Methods: We carried out a retrospective case-control study of 80 patients (80 knees) who underwent TKR between 2005 and 2008, and followed up more than 3 years. We divided patients who played golf after TKR as a study group and who did not participate sports activities as a control group. We calculated the sum of width of radiolucent line in 7 sections around femoral component, 7 sections around tibial components and 5 sections in patella component using American Knee Society Roentgenographic Evaluation and Scoring system respectively. The inclusion criteria, was BMI (body mass index) was between 25 and $30kg/m^2$, and UCLA activity-level rating System score was between 5 and 8. We also got the information of patients' patterns of golf activities such as 1. the interval from surgery to return to golf activity. 2. the frequency of golf activities 3. using spike or cart. We obtained the information from patient's questionnaire and telephone interview. We compared with the VAS (visual analogue scale) respectively. And handicaps and driving distance was evaluated as well. Results: The study group's mean sum of radiologic score was 0.84 mm and 0.69 mm in control group. This is not statistically significant (p=0.22). Too early returning to golf (p=0.01) and left knee replacement (p<0.01) were statistically significant factors affecting clinical outcomes of golf activities after total knee arthroplasty. Conclusion: We concluded that golf activities after total knee arthroplasty is not correlated with radiographic loosening, and we need to give an explanation to the patients about increased pain when returing to golf too early and left side arthroplasties.

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Software Reliability Growth Modeling in the Testing Phase with an Outlier Stage (하나의 이상구간을 가지는 테스팅 단계에서의 소프트웨어 신뢰도 성장 모형화)

  • Park, Man-Gon;Jung, Eun-Yi
    • The Transactions of the Korea Information Processing Society
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    • 제5권10호
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    • pp.2575-2583
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    • 1998
  • The productionof the highly relible softwae systems and theirs performance evaluation hae become important interests in the software industry. The software evaluation has been mainly carried out in ternns of both reliability and performance of software system. Software reliability is the probability that no software error occurs for a fixed time interval during software testing phase. These theoretical software reliability models are sometimes unsuitable for the practical testing phase in which a software error at a certain testing stage occurs by causes of the imperfect debugging, abnornal software correction, and so on. Such a certatin software testing stage needs to be considered as an outlying stage. And we can assume that the software reliability does not improve by means of muisance factor in this outlying testing stage. In this paper, we discuss Bavesian software reliability growth modeling and estimation procedure in the presence of an imidentitied outlying software testing stage by the modification of Jehnski Moranda. Also we derive the Bayes estimaters of the software reliability panmeters by the assumption of prior information under the squared error los function. In addition, we evaluate the proposed software reliability growth model with an unidentified outlying stage in an exchangeable model according to the values of nuisance paramether using the accuracy, bias, trend, noise metries as the quantilative evaluation criteria through the compater simulation.

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Antithrombin-III as an early prognostic factor in children with acute lung injury (급성 폐손상 소아 환자에서 조기 예후 인자로서의 antithrombin-III)

  • Lee, Young Seung;Kim, Seonguk;Kang, Eun Kyeong;Park, June Dong
    • Clinical and Experimental Pediatrics
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    • 제50권5호
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    • pp.443-448
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    • 2007
  • Purpose : To evaluate the potential prognostic value of the antithrombin-III (AT-III) level in the children with acute lung injury (ALI), we analyzed several early predictive factors of death including AT-III level at the onset of ALI and compared the relative risk of them for mortality. Methods : Over a 18-month period, a total of 198 children were admitted to our pediatric intensive care unit and 21 mechanically ventilated patients met ALI criteria, as defined by American-European consensus conference, i.e., bilateral pulmonary infiltrates and $PaO_2/FiO_2$ lower than 300 without left atrial hypertension. Demographic variables, hemodynamic and respiratory parameters, underlying diseases, as well as Pediatric Risk of Mortality-III (PRISM-III) scores and Lung Injury Score (LIS) at admission were collected. AT-III levels were measured within 3 hours after admission. These variables were compared between survivors and non-survivors and entered into a multiple logistic regression analysis to evaluate their independent prognostic roles. Results : The overall mortality rate was 38.1% (8/21). Non-survivors showed lower age, lower lung compliance, higher PEEP, higher oxygenation index (OI), lower arterial pH, lower $PaO_2/FiO_2$, higher PRISM-III score and LIS, and lower AT-III level. PRISM-III score, LIS, OI and decreased AT-III level (less than 70%) were independently associated with a risk of death and the odds ratio of decreased AT-III level for mortality is 2.75 (95% confidence interval; 1.28-4.12) Conclusion : These results suggest that the decreased level of AT-III is an important prognostic factor in children with ALI and the replacement of AT-III may be considered as an early therapeutic trial.

Residue Studies of Difenoconazole and Thiamethoxam during Cultivation of Sweet Persimmon for Export (수출용 단감에 대한 Difenoconazole과 Thiamethoxam의 잔류특성 연구)

  • Chang, Hee-Ra;Kang, Hae-Rim;Do, Jung-A;Oh, Jae-Ho;Hwang, In-Kyun;Kwon, Ki-Sung;Im, Moo-Hyeog;Kim, Kyun
    • Korean Journal of Environmental Agriculture
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    • 제31권3호
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    • pp.248-254
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    • 2012
  • BACKGROUND: In order to elucidate residual characteristics of difenoconazole and thiamethoxam by treatment to sweet persimmons for one year and to generate the data for the maximum residue limit (MRL) establishment for those pesticides in or on sweet persimmon. METHODS AND RESULTS: Systemic fungicide difenoconazole WP (10% a.i.) and systemic insecticide thiamethoxam WG (10% a.i.) were sprayed onto 12~25-years-old sweet persimmons according to its preharvest interval (PHI), respectively, and then fresh sweet persimmons were harvested at 0, 1, 3, 7, 14, 21 days after treatment from pesticide-sprayed plots at each 3 sites. The analytical methods were evaluated to limit of quantification, linearity, specificity, reproducibility and recoveries. The crop samples were extracted with acetone and performed dichloromethane partition process. The extracted samples of difenoconazole were analyzed by GC-ECD and the thiamethoxam extracted samples were analyzed by HPLC with good sensitivity and selectivity of the method. The average recoveries of difenoconazole ranged from 87.5 to 99.5% with the percentage of coefficient variation in the range 4.1~7.6% at three different spiking levels(0.02, 0.2 and 2.0 mg/kg). And the average recoveries of thiamethoxam and clothianidin ranged from 88.8 to 98.9% and 83.2 to 96.6% with the percentage of coefficient variation in the range 3.6~5.0% and 3.8~9.4% at three different spiking levels(0.02, 0.2 and 2.0 mg/kg), respectively. The residue amounts ranges of difenoconazole were 0.2~0.56 mg/kg and the residue amount was decreased below the MRL level, 1.0 mg/kg, after 1 day harvest. The residue amounts ranges of thiamethoxam were 0.08~0.28 mg/kg and the residue amount was decreased below the MRL level, 0.5 mg/kg, after 1 day harvest. And the residue amount of clothianidin was below then 0.03 mg/kg for only one test site of 14 and 28 day samples. CONCLUSION: As a result, the residual amounts of difenoconazole and thiamethoxam were not exceeded the MRL of established criteria for sweet persimmon. The biological half-lives of difenoconazole and thiamethoxam were 13.6, 19.4, 16.3 and 10.0, 15.3, 14.0 days at each three test sites, respectively.

The Study of Normal Tissue Complication Probability(NTCP) for Radiation Pneumonitis by Effective Volume Method (유효체적 방법과 임상분석을 통한 방사선에 의한 정상 폐조직의 부작용 확률에 관한 연구)

  • Ahn Seung Do;Choi Eun Kyung;Yi Byong Yong;Chang Hyesook
    • Radiation Oncology Journal
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    • 제15권3호
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    • pp.243-249
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    • 1997
  • Purpose : In radiation therapy, NTCF is very importart indicator of selecting the optimal treatment plan. In our study, we tried to find out usefullness of NTCP in lung cancer by comparng the incidence of radiation pneumonitis with NTCP. Materials and Methods : From August 1993 to December 1994, thirty six patients with locally advanced non=small cell lung cancer were treated by concurrent chemoradiation therapy. Total dose of radiation therapy was 6480cGy (120cGy, bid) and chemotherapeutlc agents were mitomycin C. vinblastion, cisplatin (2 cycles, 4 weeks interval). We evaluated the development of raniation pneumonitis by CT scan, chest x-rar and clinical symptoms. We used grading system of South Western Oncology Group (SWOG) for radiation pneumanitis. Dose Volume Histograms (DVH) were analyzed for ipsilateral and whole lung, Non uniform DVH was translated to uniform DVH by effective volume method. With these data, we calculated NTCP for ipsilateral and whole lung. Finally we compared the clinical results to NTCP. Results : Eight of thrity six patients developed radiation pneumonitis. Of these 8 patients , 6 had grade I severity and 2 had grade II. The average NTCP value cf the patients who showed radiation pneumonitis was significantly higher than that uf the patients without pneumonitis $(66\%\;vs.\;26.4\%)$. But the results of pulmonary function test was not correlated with NTCP. Conclusion : NTCP of lung is very good indicator for selecting rival treatment planning in lung cancer. According to the results of NTCP, it may be possible to adjust target volume and optimize target dose. In the near future, we are going to anaiyze the effect of hyperfractionation and concurrent chemotherapy in addition to NTCP.

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