• Title/Summary/Keyword: Adverse Event

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Endoscopic Treatment of Iatrogenic Perforation of Sigmoid Diverticulum: A Case Report of Multidisciplinary Management

  • Giacomo Emanuele Maria Rizzo;Giuseppina Ferro;Giovanna Rizzo;Giovanni Di Carlo;Alessandro Cantone;Gaetano Giuseppe Di Vita;Carmelo Sciume
    • Clinical Endoscopy
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    • v.55 no.2
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    • pp.292-296
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    • 2022
  • Iatrogenic perforations are severe complications of gastrointestinal endoscopy; therefore, their management should be adequately planned. A 77-year-old man with a history of diverticulosis underwent a colonoscopy for anemia. During the procedure, an iatrogenic perforation occurred suddenly in the sigmoid colon, near a severe angle among the numerous diverticula. Through-the-scope clips were immediately applied to treat it and close mucosal edges. Laboratory tests showed increased levels of inflammation and infection, and although there were no complaints of abdominal pain, the patient had an extremely distended abdomen. A multidisciplinary board began management based on a conservative approach. Pneumoperitoneum was treated with computed tomography-assisted drainage. After 72 hours, his intestinal canalization and laboratory tests were normal. Though this adverse event is rare, a multidisciplinary board should be promptly gathered upon occurrence, even if the patient appears clinically stable, to consider a conservative approach and avoid surgical treatment.

Characteristics of drought-flood abrupt alternation events using SWAP index in the Han River basin (SWAP 지수를 활용한 한강유역의 가뭄-홍수 급변사상 특성 분석)

  • Son, Ho Jun;Lee, Jin-Young;Yoo, Jiyoung;Kim, Tae-Woong
    • Journal of Korea Water Resources Association
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    • v.54 no.11
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    • pp.925-932
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    • 2021
  • A drought-flood abrupt alternation event is an overlapping extreme event that is harder to cope with than a single event of drought and flood. It is also expected to have a significant adverse impact on ecosystems as well as industries and agriculture. However, there has not yet been a comprehensive study that characterizes the drought-flood abrupt alternation events in Korea. Therefore, this study employed a standard weighted average precipitation (SWAP) index, which is efficient to analyze not only individual events of drought and flood but also the drought-flood abrupt alternation events considering various time scales. The SWAP standardized the weighted average precipitation (WAP) by adding temporal weights to the precipitation. The SWAP indices were calculated for middle-sized watersheds of the Han River basin using the area average precipitation during 1966 and 2018. The severity K was calculated to represent the relative regional severity considering normal rainfalls, and used to characterize the drought-flood abrupt alternation in the study areas. The results indicated that 20 of the 30 middle-sized watersheds in the Han River basin were confirmed to increase the severity of drought-flood abrupt alternation over time. Considering the frequency and severity of drought-flood abrupt alternation events in each watershed, vulnerable areas and dangerous areas due to drought-flood abrupt alternation were identified, for example, the Upstream Namhan River (#1001).

An Open-label, Randomized, Comparative Assessment of the Efficacy and Safety between Tofisopam and Lorazepam in Anxiety Disorder (Tofisopam과 lorazepam의 항불안효과와 안전성에 대한 비교 연구)

  • Lee, Min Soo;Kim, Yong-Ku;Kwak, Dong-Il
    • Korean Journal of Biological Psychiatry
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    • v.4 no.2
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    • pp.265-271
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    • 1997
  • Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

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Long-term Influence of Mild to Moderate Ischemic Mitral Regurgitation after Off-pump Coronary Artery Bypass Surgery (무심폐기하 관상동맥우회술에서의 중등도의 허혈성 승모판막부전증의 중요성)

  • Hong, Jong-Myeon;Cartier, Raymond
    • Journal of Chest Surgery
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    • v.43 no.3
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    • pp.246-253
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    • 2010
  • Background: Our objective was to review the long-term prognosis of patients with preoperative mild to moderate ischemic mitral regurgitation who underwent off-pump coronary artery bypass grafting. Material and Method: We prospectively followed 1,000 consecutive and systematic off-pump coronary artery bypass grafting patients who were operated on between September 1996 and March 2004; follow-up was achieved for 97%. Sixty-seven patients (6.7%) had mild to moderate ischemic mitral regurgitation at the time of surgery. Operative mortality, actuarial survival and major adverse cardiac event free survival were compared to assess the effect of ischemic mitral regurgitation. Result: Average follow-up was $66{\pm}22$ months. Patients with ischemic mitral regurgitation were older (p<0.001), had lower ejection fractions (p<0.001) and more comorbidities. Significantly more female patients presented with ischemic mitral regurgitation (p=0.002). There was no significant difference in operative mortality and perioperative myocardial infarction in ischemic mitral regurgitation patients (p=0.25). Eight-year survival was decreased in ischemic mitral regurgitation patients ($39.6{\pm}11.8%$ vs $76.7{\pm}2.2$, p<0.001). However, after correcting for risk factors, mild to moderate ischemic mitral regurgitation was not found to be a significant independent risk factor for long-term mortality (p=0.42). Major adverse cardiac event free survival at 8 years was significantly lower in ischemic mitral regurgitation patients ($53.12{\pm}12%$ vs $77{\pm}2%$, p<0.001). After correction for risk factors, ischemic mitral regurgitation remained a significant independent cause of major adverse cardiac events (HR: 2.31), especially congestive heart failure and recurrent myocardial infarction. Conclusion: In our series, patients with preoperative mild to moderate ischemic mitral regurgitation had a higher prevalence of preoperative risk factors than patients without ischemic mitral regurgitation. They had comparable perioperative mortality and morbidity, but, in the long term, were found to be at elevated risk for recurrent cardiac events.

Analysis of The Adverse Events Following Immunization of the National Compensation Program and the Surveillance System in Korea, 1995~2000 (1995~2000년 예방접종 후 이상반응 사례 분석 - 국가보상 신청 사례와 예방접종 후 이상반응 감시체계 보고 사례를 중심으로 -)

  • Lee, Hong Jue;Sohn, Young Mo;Kim, Joung Soon;Kim, Young Taek;Lee, Jong Gu;Choi, Bo Youl
    • Pediatric Infection and Vaccine
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    • v.8 no.2
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    • pp.135-149
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    • 2001
  • Purpose : To describe the characteristics of the claims for compensation and the methodology of investigations concerning adverse events following immunization(AEFI) and epidemiologic characteristics of the AEFI. From these results, to give a suggestion for improving AEFI surveillance system, consequently to stabilize National Immunization Program. Methods : Totally 61 cases were reported to the National Compensation Program and surveillance system of AEFI from 1995 to 2000. Documents from National Compensation Program, medical records and epidemiologic investigation reports of the cases were collected and analyzed. Results : The number of reported cases was 12 in 1995, 3 in 1996, 12 in 1998, 5 in 1999, and 29 in 2000, respectively. That of deaths was 24(39.3%) and 16 cases among them were autopsied(66.7%). That of claims for compensation was 36 and 17 cases among them were compensated(47.2%). The proportion of claim was lower in 1999~2000 than in 1995~1998, but proportion of compensation increased. Although proportion of investigation was lower in 1999~2000 than in 1995~1998, cases which were not epidemiologically investigated, decreased. The epidemiologic investigation launched within 24 hours after report increased from 25% in 1995~1998 to 48.3% in 1999~2000. Among reported cases, the number of boys was 31(50.8%), and 75.4% of subjects were from 2 months to 24 months old. 78.4% of adverse events occurred within one week after immunization. Conclusion : We can find that surveillance system of AEFI and quality of epidemiologic investigation has been somewhat improved. But, it seems that severe cases were more frequently reported than moderate or mild cases, and reporting rate was lower than that of other developed countries. We could not identify the detailed epidemiologic characteristics of AEFI due to these limitation of data. To achieve the stabilization of National Immunization Program, reporting rate and the quality of investigation should be improved.

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Treatment Adherence of Osmotic-Controlled Release Oral Delivery System Methylphenidate in Korean Children and Adolescents with Attention-Deficit Hyperactivity Disorder (주의력결핍 과잉행동장애 아동에서 Osmotic-Controlled Release Oral Delivery System Methylphenidate의 치료순응도)

  • Kim, Bongseog;Lee, Jeong-Seop;Kim, Eui-Jung;Sung, Hyung-Mo;Shin, Yun Mi;Hwang, Seong-Hye;Yoo, Hanik K.
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.25 no.2
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    • pp.65-72
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    • 2014
  • Objectives : The objective of this study was to evaluate the treatment duration and adherence of osmotic-controlled release oral delivery system (OROS) methylphenidate for treatment of attention-deficit hyperactivity disorder (ADHD). Methods : A total of 843 children with ADHD were recruited : 213 children (25.3%) who had previously taken medications for ADHD and 630 drug-na$\ddot{i}$ve children (74.7%) were recruited. The dosage was adjusted according to the clinician's judgment. The primary efficacy endpoint of this study was treatment retention rate, which was estimated at Week 12 and Week 20 using the Kaplan-Meier curve. The Swanson, Nolan and Pelham-IV (SNAP-IV), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement, and the side effect rating scale were measured at every visit. Remission rates were presented based on SNAP-IV and CGI-S, respectively. Results : The treatment retention rate at 12 weeks and at 20 weeks was 76.2% and 66.8%, respectively. Divided according to 6-8, 9-11, 12-14 and 15-18 years of age, younger children tended to show a statistically higher treatment retention rate (p=.02). Based on SNAP-IV and CGI scores, children with better response to medication showed tendencies of statistically higher treatment retention rate. The most common adverse events included loss of appetite (7.1%) and insomnia (3.3%). There was no serious adverse event related to the treatment, such as death. Conclusion : The use of OROS methylphenidate for treatment of ADHD was safe and tolerable for children. In this study, lower age and better treatment response showed a statistically significant relationship with higher treatment adherence. Boys showed a trend of high treatment adherence. The treatment adherence at 20 weeks was satisfactory, however, the treatment adherence after 20 weeks showed a sharp decrease. Therefore, treatment persistence for six months after the beginning of ADHD treatment is important. In addition, the positive role of psycho-education for children and parents is necessary for increasing treatment adherence.

Chest CT Parameters to Predict the Major Adverse Events in Acute Submassive Pulmonary Embolism (혈역학적으로 안정된 폐색전증 환자에서의 임상적 악화를 예측하는 전산화 단층촬영상 소견)

  • Jung, Sang-Ku;Kim, Won-Young;Lee, Choong-Wook;Seo, Dong-Woo;Lee, Youn-Sun;Lee, Jae-Ho;Oh, Bum-Jin;Kim, Won;Lim, Kyoung-Soo;Hong, Sang-Bum;Lim, Chae-Man;Koh, Youn-Suck
    • Tuberculosis and Respiratory Diseases
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    • v.69 no.3
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    • pp.184-190
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    • 2010
  • Background: The purpose of this study was to determine the prognostic significance of chest computed tomographic (CT) parameters in acute submassive pulmonary embolism (PE). Methods: Between January 2006 and December 2009, 268 consecutive patients with acute submassive PE that was confirmed by chest CT with pulmonary angiography in emergency room were studied. One experienced radiologist measured CT parameters and judged the presence of right ventricular dysfunction. CT parameters were analyzed to determine their ability to predict a major adverse event (MAE). Results: There were 220 patients included and 61 (27.7%) had MAE. Left ventricular and right ventricular maximum minor axis ($36.4{\pm}8.0$ vs. $41.7{\pm}7.4$, p<0.01; $45.7{\pm}9.4$ vs. $41.5{\pm}7.6$, p<0.01), superior vena cava diameter ($19.2{\pm}3.4$ vs. $18.0{\pm}3.4$, p=0.02), azygos vein diameter ($10.0{\pm}2.2$ vs. $9.2{\pm}2.3$, p=0.02), septal displacement (19 vs. 18, p<0.01) were significantly higher in MAE group than in no MAE group. Patients with MAE had high right ventricular/left ventricular dimension ratio (RV/LV ratio) compared to patients without MAE ($1.34{\pm}0.48$ vs. $1.03{\pm}0.28$, p<0.01). The most useful cut-off value of RV/LV ratio for MAE was 1.3 and the area under the curve was 0.71 (0.62~0.79). Conclusion: RV/LV ratio on chest CT was a significant predictor of submassive PE related shock, intubation, in-hospital mortality, thrombolysis, thrombectomy within 30 days.

Abiraterone for Treatment of Metastatic Castration-resistant Prostate Cancer: a Systematic Review and Meta-analysis

  • Zhou, Zhi-Rui;Liu, Shi-Xin;Zhang, Tian-Song;Xia, Jun;Li, Bo
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.3
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    • pp.1313-1320
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    • 2014
  • Introduction: Although most prostate cancers initially respond to castration with luteinizing hormonereleasing analogues or bilateral orchiectomy, progression eventually occurs. Based on the exciting results of several randomized controlled trials (RCTs), it seems that patients with metastatic castration-resistant prostate cancer (mCRPC) might benefit more from treatment withabiraterone. Therefore we conducted a systematic review to evaluate the efficacy and toxicity of abiraterone in the treatment of mCRPC. Methods: Literature was searched from Embase, PubMed, Web of Science, and Cochrane Library up to July, 2013. Quality of the study was evaluated according to the Cochrane's risk of bias of randomized controlled trial (RCT) tool, then the Grading of Recommendations Assessment, Development and Evaluation (GRADE) System was used to rate the level of evidence. Stata 12.0 was used for statistical analysis. Summary data from RCTs comparing abiraterone plus prednisone versus placebo plus prednisone for mCRPC were meta-analyzed. Pooled hazard ratios (HRs) for overall survival (OS), radiographic progression-free survival (RPFS) and time to PSA progression (TTPP); Pooled risk ratios (RR) for PSA response rate, objective response rate and adverse event were calculated. Results: Ten trials were included in the systematic review; Data of 2,283 patients (1,343 abiraterone; 940 placebo) from two phase 3 trials: COU-AA-301 and COU-AA-302 were meta-analyzed. Compared with placebo, abiraterone significantly prolonged OS (HR, 0.74; 95% confidence interval [CI], 0.66 to 0.84), RPFS (HR, 0.59; 95% CI, 0.48 to 0.74) and time to PSA progression (HR, 0.55; 95% CI, 0.43 to 0.70); it also significantly increased PSA response rate (RR, 3.63; 95% CI, 1.72 to 7.65) and objective response rate (RR, 3.05; 95% CI, 1.51 to 6.15). This meta-analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled. Conclutios: Abiraterone significantly prolonged OS, RPFS and time to progression patients with mCRPC, regardless of prior chemotherapy or whether chemotherapy-na$\ddot{i}$ve, and no unexpected toxicity was evident. Abiraterone can serve as a new standard therapy for mCRPC.

Efficacy and Safety of Herb Medication According to Cold-heat Tendency of Knee Osteoarthritis Patients (퇴행성 슬관절염 환자의 한열 성향에 따른 한약 제제의 유효성과 안전성 비교)

  • Song, Ji-Yeon;Kim, Min-Jung;Sung, Won-Seok;Kim, Pil-Kun;Goo, Bon-Hyuk;Kwak, Hyun-Young;Kim, Ji-Hye;Kim, Dong-Hyuk;Park, Yeon-Cheol;Seo, Byung-Kwan;Baek, Yong-Hyeon;Choi, Do-Young;Lee, Jae-Dong;Park, Dong-Suk
    • Journal of Acupuncture Research
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    • v.29 no.5
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    • pp.97-108
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    • 2012
  • Objectives : To demonstrate the importance of syndrome differentiation in clinical research of herb medication, through the comparative study on efficacy and safety of herb medication according to cold-heat tendency of OA knee patients. Methods : During December 2010 to July 2011, 138 knee OA patients were randomly assigned to WIN-34B 600mg(300mg, b.i.d.), 1,200mg(600mg, b.i.d.) and placebo b.i.d. for 8 weeks. Patient were re-classified into cold-heat tendency group according to cold-heat questionnaires. To investigate efficacy and safety, we assessed the 100mm pain VAS at baseline and 8 weeks later, and we monitored adverse event of patients during treatment period. Results : 1. Efficacy study : In WIN-34B 1,200mg group, VAS mean changes of heat tendency group showed slightly increase than those of cold tendency, but no significant difference within two groups. In heat tendency group, WIN-34B 1,200mg group showed a significant decrease of VAS compared to placebo group. but there were no significant difference in cold tendency group. 2. Safety study; In WIN-34B 600mg group, incidence of adverse events of cold tendency group was higher than those of heat tendency, but not in WIN-34B 1,200mg group. Conclusions : This study suggests that WIN-34B tend to have more efficacy in heat tendency-knee OA patients and WIN-34B is safe drug relatively, regardless of cold-heat tendency. In further clinical research on efficacy and safety of WIN-34B, stratification using syndrome differentiation is required.

Enzyme Replacement Therapy in Patients Who Have Mucopolysaccharidosis and Are younger than 5 years old (5세 미만 뮤코다당체침착증 환자에서의 효소 대체 요법)

  • Park, Seong-Won;Son, Yeong-Bae;Kim, Se-Hwa;Jo, Seong-Yun;Ji, Seon-Tae;Jin, Dong-Gyu
    • Journal of The Korean Society of Inherited Metabolic disease
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    • v.10 no.1
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    • pp.59-66
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    • 2010
  • Enzyme replacement of therapy (ERT) is one of the most promising therapeutic strategies for the treatment of lysosomal storage disorders. ERT is available in three types of Mucopolysaccharidosis (MPS): for MPS I (Aludrazyme$^{(R)}$), MPS II (Elaprase$^{(R)}$) and MPS VI (Naglazyme$^{(R)}$) patients who are over 5 years old. But recently, early diagnosis can be done by expert clinicians and even in prenatal case. We describe the case of ERT under 5 years old MPS patients. Up to June, 2010 in Samsung Medical Center, there are 6patients who were diagnosed as MPS and started ERT under 5 years old. 3 patients were MPS I, 3 patients were MPS II. 2 patient who was diagnosed as MPS I was female and others were male. Their age at diagnosis were 4 to 37month-old (4, 13, 16, 25, 27, 37 month-old) and they are now 9 to 60 month-old (9, 39, 32, 81, 60 month-old). The youngest patient was started ERT at 4 month-old and others were started at their 13 to 49 month-old (13, 29, 27, 28, 49 month-old). First manifested symptoms of patients were macrocephaly, kyphosis and coarse face appearance. Especially, in 2 of them, one was MPS I and the other was MPS II had elder brother with same disease. And the youngest one was diagnosed by the iduronate-2-sulfatase (IDS) gene analysis from chorionic villi sampling. His mother knew that she was a heterozygous carrier of IDS gene mutation because her younger brother died from MPS II. All of them confirmed as MPS by the enzyme assay in leukocytes and fibroblast skin culture. We started ERT with ${\alpha}$-L-iduronidase(Aldurazyme$^{(R)}$) to MPS I and did recombinant human iduronate-2-sulfatase (Elaprase$^{(R)}$) to MPS II patients as recommended dose as over 5 years old. But for MPS II patient who was 4 month old, we started ERT by recombinant human IDS (Elaprase$^{(R)}$) with reduced dose 0.1 mg/kg and increased dose every 2 weeks by 0.1mg/kg up to 0.5mg/kg IV infusion. During ERT, all patients had no adverse effects and the excretion of GAGs were decreased. We have evaluated other clinical symptoms such as liver/ spleen volume, heart function and neurologic evaluation. We describe a successful ERT to MPS I and MPS II patient under 5 years old without any adverse event. It indicates that ERT in young children are well tolerated and that it has several effects which may confer clinical benefits with long-term therapy.

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