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Original Article
One-year effectiveness and safety of ustekinumab treatment in patients with ulcerative colitis: an Asan-Crohn’s and Colitis Association in Daegu-Gyeongbuk (CCAiD) multicenter real-world cohort study
Ji Eun Baek, Min Kyu Kim, Eun Soo Kim, Kyeong Ok Kim, Hyeong Ho Jo, Sung Wook Hwang, Sang Hyoung Park, Byung Ik Jang, Eun Young Kim, Sung Kook Kim, Suk-Kyun Yang, Byong Duk Ye
Received October 12, 2025  Accepted December 30, 2025  Published online April 20, 2026  
DOI: https://doi.org/10.5217/ir.2025.00258    [Epub ahead of print]
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Background/Aims
This study aimed to evaluate the 1-year effectiveness and safety of ustekinumab (UST) in Korean patients with ulcerative colitis (UC).
Methods
We conducted a multicenter retrospective study of UC patients who received UST between January 2021 and October 2023. The primary endpoint was clinical remission at week (W) 8. Secondary endpoints included clinical remission at W16–20 and W52–56; corticosteroid-free clinical remission at W8, W16–20, and W52–56; clinical response at the same time points; endoscopic remission at W16–20 and W52–56; UST interval shortening and persistence through W52–56; and adverse events (AEs).
Results
Sixty patients were included. After excluding one patient in clinical remission at baseline, 49.2% (29/59) achieved clinical remission at W8. Clinical remission rates were 59.3% (35/59) at W16–20 and 55.9% (33/59) at W52–56. Endoscopic remission was achieved in 15.3% (9/59) at W16–20 and 11.9% (7/59) at W52–56. The 12-month UST persistence rate was 84.9%. Multivariable analysis identified factors associated with clinical remission at W52–56: higher body mass index at baseline (adjusted odds ratio [aOR], 1.26; 95% confidence interval [CI], 1.00–1.57; P< 0.05), concomitant immunomodulator use (aOR, 4.69; 95% CI, 1.04–21.06; P= 0.04), and endoscopic improvement at W16–20 (aOR, 13.47; 95% CI, 2.87–63.30; P< 0.01), while prior exposure to advanced therapies was associated with lower remission (aOR, 0.20; 95% CI, 0.04–0.98; P< 0.05). AEs occurred in 24 patients (40.0%), with 1 serious AE (1.7%).
Conclusions
UST showed favorable 1-year effectiveness and an acceptable safety profile in Korean patients with UC.
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Review
IBD
Evolution of inflammatory bowel disease in Korea: a 60-year perspective on clinical and research development
Suk-Kyun Yang
Intest Res 2025;23(3):233-253.   Published online June 23, 2025
DOI: https://doi.org/10.5217/ir.2025.00073
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Inflammatory bowel disease (IBD) was once considered rare in Korea, with the first reported case documented in 1961. Since then, its incidence and prevalence have increased markedly, accompanied by significant progress in clinical care and research. This narrative review traces the historical evolution of IBD in Korea, dividing the timeline into 4 periods: 1960–1979, 1980–1999, 2000–2019, and 2020–2039. For each period, major developments in the research environment and trends, diagnostic process, patient population and characteristics, and treatment are outlined. Over the past 6 decades, diagnostic and therapeutic approaches in Korea have advanced markedly, transitioning from limited diagnostic capacity and symptom-based management to practices that align with global standards. Notably, Korean patients with IBD exhibit distinctive clinical features compared with Western counterparts, including a markedly higher proportion of proctitis and a lower long-term risk of colectomy in ulcerative colitis, and a substantially higher prevalence of perianal fistulas in Crohn’s disease, highlighting the need for population- specific strategies to advance personalized medicine. In parallel, the research landscape has evolved through multicenter collaborations, expanded research capacity, and growing international engagement, positioning Korea as an increasingly active contributor to the global IBD research community. Looking ahead, the future of IBD research in Korea is expected to be shaped by innovation-driven research, including advances in artificial intelligence, large-scale data integration, and deeper international collaboration. By tracing the clinical and research trajectory of IBD in Korea, this review offers insight into how the country has adapted to global trends and is preparing to meet future challenges.

Citations

Citations to this article as recorded by  
  • Rational design of nanotherapy for ulcerative colitis: New strategies, mechanistic approaches, and translational challenges
    Wenyuan Xu, Qiulin Deng, Liuhong Chen, Xishun Zhou, Yao Dong, Chenran Ren, Xi Zeng, Deliang Cao
    Nanomedicine: Nanotechnology, Biology and Medicine.2026; 71: 102894.     CrossRef
  • Endoscopic and pathologic findings of esophagogastroduodenal involvement in Crohn disease in Korea: a prospective single-center cohort study
    Ga Hee Kim, Jihun Kim, Ji Yong Ahn, Sang Hyoung Park, Sung Wook Hwang, Byong Duk Ye, Hwoon-Yong Jung, Suk-Kyun Yang
    Inflammatory Bowel Diseases.2026; 32(5): 963.     CrossRef
  • KASID and Intestinal Research journal: a central academic hub for research of intestinal diseases in the Asia-Pacific region
    Jae Hee Cheon, Hye Kyung Hyun, You Sun Kim, Dong Il Park, Tae Il Kim, Dong Soo Han
    Intestinal Research.2026; 24(1): 6.     CrossRef
  • Comparative analysis of strain-specific gut microbiota dynamics and disease progression in DSS-induced murine colitis
    Yeonsu Oh, Ho-Seong Cho
    Korean Journal of Veterinary Service.2026; 49(1): 1.     CrossRef
  • Can lifestyle restrictions prevent relapse in ulcerative colitis? A focus on quality of life
    Jihye Park
    Intestinal Research.2026; 24(2): 195.     CrossRef
  • 8,352 View
  • 163 Download
  • 5 Crossref
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Original Articles
IBD
Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study
Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye, on behalf of the Korean Association for the Study of Intestinal Diseases
Intest Res 2023;21(1):137-147.   Published online July 12, 2022
DOI: https://doi.org/10.5217/ir.2021.00173
Correction in: Intest Res 2023;21(2):273
AbstractAbstract PDFPubReaderePub
Background/Aims
We investigated the real-world effectiveness and safety of ustekinumab (UST) as induction treatment for Koreans with Crohn’s disease (CD).
Methods
CD patients who started UST were prospectively enrolled from 4 hospitals in Korea. All enrolled patients received intravenous UST infusion at week 0 and subcutaneous UST injection at week 8. Clinical outcomes were assessed using Crohn’s Disease Activity Index (CDAI) scores at weeks 8 and 20 among patients with active disease (CDAI ≥150) at baseline. Clinical remission was defined as a CDAI <150, and clinical response was defined as a reduction in CDAI ≥70 points from baseline. Safety and factors associated with clinical remission at week 20 were also analyzed.
Results
Sixty-five patients were enrolled between January 2019 and December 2020. Among 49 patients with active disease at baseline (CDAI ≥150), clinical remission and clinical response at week 8 were achieved in 26 (53.1%) and 30 (61.2%) patients, respectively. At week 20, 27 (55.1%) and 35 (71.4%) patients achieved clinical remission and clinical response, respectively. Twenty-seven patients (41.5%) experienced adverse events, with serious adverse events in 3 patients (4.6%). One patient (1.5%) stopped UST therapy due to poor response. Underweight (body mass index <18.5 kg/m2) (odds ratio [OR], 0.085; 95% confidence interval [CI], 0.014–0.498; P=0.006) and elevated C-reactive protein at baseline (OR, 0.133; 95% CI, 0.022–0.823; P=0.030) were inversely associated with clinical remission at week 20.
Conclusions
UST was effective and well-tolerated as induction therapy for Korean patients with CD.

Citations

Citations to this article as recorded by  
  • One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn’s Disease: The K-STAR Study
    Chang Kyun Lee, Won Moon, Jaeyoung Chun, Eun Soo Kim, Hyung Wook Kim, Hyuk Yoon, Hyun Soo Kim, Yoo Jin Lee, Chang Hwan Choi, Yunho Jung, Sung Chul Park, Geun Am Song, Jong Hun Lee, Eun Suk Jung, Youngdoe Kim, Su Young Jung, Jong Min Choi, Byong Duk Ye
    Inflammatory Bowel Diseases.2025; 31(5): 1306.     CrossRef
  • Characteristics and outcomes of portal vein thrombosis in patients with inflammatory bowel disease in Korea
    Ki Jin Kim, Su-Bin Song, Jung-Bin Park, June Hwa Bae, Ji Eun Baek, Ga Hee Kim, Min-Jun Kim, Seung Wook Hong, Sung Wook Hwang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Chang Sik Yu, Yong-Sik Yoon, Jong-Lyul Lee, Min Hy
    The Korean Journal of Internal Medicine.2025; 40(2): 243.     CrossRef
  • The ‘totality of evidence’ and ‘extrapolation’ of SB17, a ustekinumab biosimilar
    Jae Hee Cheon, Byong Duk Ye, Alessandro Armuzzi, Florian Rieder, Giampiero Girolomoni, Luis Puig, Hojung Jung, Steven R. Feldman
    Expert Opinion on Biological Therapy.2025; 25(6): 615.     CrossRef
  • Long-term real-world data of ustekinumab in Crohn’s disease: the Stockholm ustekinumab study
    Francesca Bello, Samer Muhsen, Haider Sabhan, Alexandra Borin, Fredrik Johansson, Charlotte Höög, Ole Forsberg, Christina Wennerström, Charlotte Söderman, Mikael Lördal, Sven Almer
    Therapeutic Advances in Gastroenterology.2024;[Epub]     CrossRef
  • Approach to loss of response to advanced therapies in inflammatory bowel disease
    Nikil Vootukuru, Abhinav Vasudevan
    World Journal of Gastroenterology.2024; 30(22): 2902.     CrossRef
  • Corrigendum: Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study
    Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye
    Intestinal Research.2023; 21(2): 273.     CrossRef
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  • 6 Crossref
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Inflammatory bowel diseases
Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study
Masayuki Saruta, Dong Il Park, Young-Ho Kim, Suk-Kyun Yang, Byung-Ik Jang, Jae Hee Cheon, Jong Pil Im, Takanori Kanai, Tatsuro Katsuno, Yoh Ishiguro, Makoto Nagaoka, Naoki Isogawa, Yinhua Li, Anindita Banerjee, Alaa Ahmad, Mina Hassan-Zahraee, Robert Clare, Kenneth J. Gorelick, Fabio Cataldi, Mamoru Watanabe, Toshifumi Hibi
Intest Res 2020;18(1):45-55.   Published online January 30, 2020
DOI: https://doi.org/10.5217/ir.2019.00039
AbstractAbstract PDFPubReaderePub
Background/Aims
PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD).
Methods
OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients.
Results
In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment.
Conclusions
In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)

Citations

Citations to this article as recorded by  
  • Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease
    Hiroshi Nakase
    Internal Medicine.2026; 65(2): 214.     CrossRef
  • Soluble mucosal addressin cell adhesion molecule 1 is a biomarker for pediatric ulcerative colitis
    Moritz Muschaweck, Christian Gutbier, Gernot Sellge, Angeliki Pappa, Tobias Wenzl, Karim Hamesch, Norbert Wagner, Angela Schippers
    Molecular and Cellular Pediatrics.2026;[Epub]     CrossRef
  • Novel Histone Deacetylase 6 Inhibitor Confers Anti-inflammatory Effects and Enhances Gut Barrier Function
    Jae-Young Lee, Hyun Woo Ma, Ji Hyung Kim, I Seul Park, Mijeong Son, Keun Ho Ryu, Jieun Shin, Seung Won Kim, Jae Hee Cheon
    Gut and Liver.2023; 17(5): 766.     CrossRef
  • Downregulation of Heat Shock Protein 72 Contributes to Fibrostenosis in Crohn’s Disease
    Seung Won Kim, Jae-Young Lee, Han Cheol Lee, Jae Bum Ahn, Ji Hyung Kim, I Seul Park, Jae Hee Cheon, Duk Hwan Kim
    Gut and Liver.2023; 17(6): 905.     CrossRef
  • Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
    Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
    Frontiers in Immunology.2021;[Epub]     CrossRef
  • Renin–angiotensin system in intestinal inflammation—Angiotensin inhibitors to treat inflammatory bowel diseases?
    Hanne Salmenkari, Riitta Korpela, Heikki Vapaatalo
    Basic & Clinical Pharmacology & Toxicology.2021; 129(3): 161.     CrossRef
  • Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
    Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
    Expert Opinion on Investigational Drugs.2021; 30(10): 1037.     CrossRef
  • Emerging therapeutic options in inflammatory bowel disease
    Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
    World Journal of Gastroenterology.2021; 27(48): 8242.     CrossRef
  • 19,092 View
  • 201 Download
  • 9 Web of Science
  • 8 Crossref
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Special Review
Inflammatory Bowel Disease Cohort Studies in Korea: Present and Future
Jung Won Lee, Jong Pil Im, Jae Hee Cheon, You Sun Kim, Joo Sung Kim, Dong Soo Han
Intest Res 2015;13(3):213-218.   Published online June 9, 2015
DOI: https://doi.org/10.5217/ir.2015.13.3.213
AbstractAbstract PDFPubReader

Inflammatory bowel disease (IBD) is defined as a chronic and relapsing inflammatory disorder of the intestine. Intestinal inflammation in IBD has been proposed to be attributable to the interplay between microbial, genetic, environmental, and immunological factors. The incidence and prevalence rates of IBD are rapidly increasing apparently in other parts of the world, with dramatic increases especially in East Asia. Generally, cohort studies are useful for estimating the incidence, prevalence, natural course, prognosis, and risk factors of diseases. In particular, cohort studies performed in Western countries have well described the prevalence, risk factors, and natural course of IBD and investigated its genetic pathophysiology. However, the outcomes of IBD cohort studies performed in Korea are not as persuasive as those of Western studies because of the relatively low prevalence of IBD and short follow-up periods of the cohorts in Korea. Despite this critical limitation, members of the Korean Association for the Study of Intestinal Diseases have demonstrated outstanding results. Some unique features of IBD patients in Korea are well demonstrated, such as thiopurine-induced leukopenia or risks of opportunistic tuberculosis infection in patients receiving tumor necrosis factor-α inhibitors. In this review, the present authors summarized the key points of the results of the cohort studies performed in Korea and explored future perspectives.

Citations

Citations to this article as recorded by  
  • Inflammatory bowel disease and metabolic reprogramming: From pathological mechanisms to targeted interventions
    Zemin Tian, Yinde Huang, Ying Wang, Chenyu Zhao, Zhaokai Zhou, Hua Yang, Yuan Qiu
    Interdisciplinary Medicine.2026;[Epub]     CrossRef
  • CXCL10 as a shared specific marker in rheumatoid arthritis and inflammatory bowel disease and a clue involved in the mechanism of intestinal flora in rheumatoid arthritis
    Yin Guan, Yue Zhang, Yifan Zhu, Yue Wang
    Scientific Reports.2023;[Epub]     CrossRef
  • Plasma miRNA Profile of Crohn’s Disease and Rheumatoid Arthritis Patients
    Tatiana D. Saccon, Joseph M. Dhahbi, Augusto Schneider, Yury O. Nunez Lopez, Ahmad Qasem, Marcelo B. Cavalcante, Lauren K. Sing, Saleh A. Naser, Michal M. Masternak
    Biology.2022; 11(4): 508.     CrossRef
  • Inflammatory bowel disease in Korea: epidemiology and pathophysiology
    Jung Won Lee, Chang Soo Eun
    The Korean Journal of Internal Medicine.2022; 37(5): 885.     CrossRef
  • Effect of Age on the Initiation of Biologic Agent Therapy in Patients With Inflammatory Bowel Disease: Korean Common Data Model Cohort Study
    Youn I Choi, Yoon Jae Kim, Jun-Won Chung, Kyoung Oh Kim, Hakki Kim, Rae Woong Park, Dong Kyun Park
    JMIR Medical Informatics.2020; 8(4): e15124.     CrossRef
  • Patterns of Ulcerative Colitis Treatments and Factors Affecting the Prescribing of Systemic Corticosteroid using Health Insurance Claims Database
    Jiyool Kim, So-Hee Park, Ju-Young Shin
    Korean Journal of Clinical Pharmacy.2020; 30(2): 102.     CrossRef
  • Association study between two polymorphisms of tumor necrosis factor ligand superfamily member 15 (TNFSF15) gene and ulcerative colitis in south‐west of Iran
    Marzieh Taheri, Pegah Ghandil, Seyyed Jalal Hashemi, Mehri Ghafourian, Abdol Rahim Masjedi Zadeh, Ata Allah Ghadiri
    Journal of Cellular Biochemistry.2019; 120(5): 8784.     CrossRef
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    Chang Kyun Lee, Kang-Moon Lee, Dong Il Park, Sung-Ae Jung, Yoon Tae Jeen, Young Sook Park, Hyo Jong Kim
    Intestinal Research.2019; 17(1): 1.     CrossRef
  • Dermatologic Manifestations in Inflammatory Bowel Disease
    Hyun Yi Suh, Woo Jin Lee, Soo-Young Na
    The Korean Journal of Gastroenterology.2019; 73(5): 285.     CrossRef
  • Depressive Symptoms and Quality of Life in the Patients of Inflammatory Bowel Disease
    Jung Won Lee
    Gut and Liver.2017; 11(4): 449.     CrossRef
  • Association of inflammatory bowel disease with ankylosing spondylitis and rheumatoid arthritis: A nationwide population-based study
    Jung Min Bae, Ji Yoon Choo, Ki-Jo Kim, Kyung-Su Park
    Modern Rheumatology.2017; 27(3): 435.     CrossRef
  • Ophthalmologic manifestations in patients with inflammatory bowel disease
    Hye Jin Lee, Hyun Joo Song, Jin Ho Jeong, Heung Up Kim, Sun-Jin Boo, Soo-Young Na
    Intestinal Research.2017; 15(3): 380.     CrossRef
  • Hydrogen-rich water protects against inflammatory bowel disease in mice by inhibiting endoplasmic reticulum stress and promoting heme oxygenase-1 expression
    Nai-Ying Shen, Jian-Bin Bi, Jing-Yao Zhang, Si-Min Zhang, Jing-Xian Gu, Kai Qu, Chang Liu
    World Journal of Gastroenterology.2017; 23(8): 1375.     CrossRef
  • Impact of inflammatory bowel disease on daily life: an online survey by the Korean Association for the Study of Intestinal Diseases
    Young Sun Kim, Sung-Ae Jung, Kang-Moon Lee, Soo Jung Park, Tae Oh Kim, Chang Hwan Choi, Hyun Gun Kim, Won Moon, Chang Mo Moon, Hye Kyoung Song, Soo-Young Na, Suk-Kyun Yang
    Intestinal Research.2017; 15(3): 338.     CrossRef
  • Disease Phenotype, Activity and Clinical Course Prediction Based on C-Reactive Protein Levels at Diagnosis in Patients with Crohn’s Disease: Results from the CONNECT Study
    Jee Hye Kwon, Jong Pil Im, Byong Duk Ye, Jae Hee Cheon, Hyun Joo Jang, Kang Moon Lee, You Sun Kim, Sang Wook Kim, Young Ho Kim, Geun Am Song, Dong Soo Han, Won Ho Kim, Joo Sung Kim
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    Dong Jin Song, Il Soon Whang, Hyung Wook Choi, Cheol Yun Jeong, Sung Hoon Jung
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  • Importance of Patients’ Knowledge of Their Prescribed Medication in Improving Treatment Adherence in Inflammatory Bowel Disease
    Chung Hyun Tae, Sung-Ae Jung, Hye Sung Moon, Jung-A Seo, Hye Kyung Song, Chang Mo Moon, Seong-Eun Kim, Ki-Nam Shim, Hye-Kyung Jung
    Journal of Clinical Gastroenterology.2016; 50(2): 157.     CrossRef
  • Fusobacterium Isolates Recovered From Colonic Biopsies of Inflammatory Bowel Disease Patients in Korea
    Yangsoon Lee, Chang Soo Eun, A Reum Lee, Chan Hyuk Park, Dong Soo Han
    Annals of Laboratory Medicine.2016; 36(4): 387.     CrossRef
  • Crohn's disease prognosis and early immunomodulator therapy: Results from the CONNECT study
    Bun Kim, Jae Hee Cheon, Hyun Jin Moon, Yi Rang Park, Byong Duk Ye, Suk‐Kyun Yang, Geom Seog Seo, Byung Ik Jang, You Sun Kim, Joo Sung Kim, Dong Soo Han, Young‐Ho Kim, Won Ho Kim
    Journal of Gastroenterology and Hepatology.2016; 31(1): 126.     CrossRef
  • 9,184 View
  • 59 Download
  • 18 Web of Science
  • 19 Crossref
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