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Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019
Introduction The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev ® ) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profi...
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| Published in: | Infectious diseases and therapy 2020-09, Vol.9 (3), p.589-598 |
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| creator | Kim, Hee Soo Oh, Yongho Korejwo, Joanna Castells, Valérie Bosch Yang, Kuhyun |
| description | Introduction
The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev
®
) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.
Methods
An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination.
Results
Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0–3 days (80.4%; 144/179), were of 1–3 days’ duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to |
| doi_str_mv | 10.1007/s40121-020-00305-6 |
| format | article |
| fullrecord | <record><control><sourceid>gale_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_7683186216694933bdabb7f5cb6c4757</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A633790861</galeid><doaj_id>oai_doaj_org_article_7683186216694933bdabb7f5cb6c4757</doaj_id><sourcerecordid>A633790861</sourcerecordid><originalsourceid>FETCH-LOGICAL-c607t-7c124d20eb0ada937d219b0c4d4ba431464e6863906cb9827af70fdeca77d5863</originalsourceid><addsrcrecordid>eNp9ks9u1DAQxiMEolXpC3BAlrgUiRT_ix1fkFZVC4VFIBV6tRxnsuslGy92shU33oH3QDwDj8KT4HSXlkUI-WBr5pufPeMvyx4SfEwwls8ix4SSHFOcY8xwkYs72T4liuWClfTu9lxSqvaywxgXGCd9yYmS97M9RrnkpaL72fd3Pvb5GxM-Qu-6GboYwhpc25rOAvINmtRrCBHQ6Rq6PqIz37b-ahReGmtdZ3rnO3Tl-jnq54Cmbg35pO-hG0wPNXplVqaDsTzhVnPTut5FdDJ3SwjOoksXhrglATo6X_oFrH98e4Jchy78kKCvfQDzFFFMip9fvqZNPcjuNaaNcLjdD7IPZ6fvT17m07cvzk8m09wKLPtcWkJ5TTFU2NRGMVmneVTY8ppXhjPCBQdRCqawsJUqqTSNxE0N1khZFylxkJ1vuLU3C70KbmnCZ-2N09cBH2bahN7ZFrQUJSOloEQIxRVjVW2qSjaFrYTlspCJ9XzDWg3VEmqbRhlMuwPdzXRurmd-rSUvqCpVAhxtAcF_GiD2eumihfGbwA9RU47Lgkkqx3c__ku68EPo0qg0LYUkpGRc3apmJjXgusane-0I1RPBmFS4FCSpjv-hSquGpbO-g8al-E4B3RTY4GMM0Nz0SLAebas3ttXJtvratnp88aM_p3NT8tukScA2gphS3QzCbUv_wf4Cqp74WA</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2867118349</pqid></control><display><type>article</type><title>Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019</title><source>Springer Nature - SpringerLink Journals - Fully Open Access </source><source>Publicly Available Content (ProQuest)</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Kim, Hee Soo ; Oh, Yongho ; Korejwo, Joanna ; Castells, Valérie Bosch ; Yang, Kuhyun</creator><creatorcontrib>Kim, Hee Soo ; Oh, Yongho ; Korejwo, Joanna ; Castells, Valérie Bosch ; Yang, Kuhyun</creatorcontrib><description>Introduction
The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev
®
) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.
Methods
An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination.
Results
Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0–3 days (80.4%; 144/179), were of 1–3 days’ duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to < 24 months (34.7% [52/150] subjects; 107 events) and 2 to < 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events.
Conclusion
JE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified.
Trial registration
ClinicalTrials.gov identifier, NCT02933710</description><identifier>ISSN: 2193-8229</identifier><identifier>EISSN: 2193-6382</identifier><identifier>DOI: 10.1007/s40121-020-00305-6</identifier><identifier>PMID: 32474892</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Encephalitis ; Health aspects ; Immunization ; Infectious Diseases ; Internal Medicine ; Japanese encephalitis ; Live-attenuated Japanese encephalitis chimeric virus vaccine ; Marketing ; Medicine ; Medicine & Public Health ; Original Research ; Safety ; Side effects ; Surveillance ; Vaccination ; Vaccine ; Vaccines ; Vector-borne diseases</subject><ispartof>Infectious diseases and therapy, 2020-09, Vol.9 (3), p.589-598</ispartof><rights>The Author(s) 2020</rights><rights>COPYRIGHT 2020 Springer</rights><rights>The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c607t-7c124d20eb0ada937d219b0c4d4ba431464e6863906cb9827af70fdeca77d5863</citedby><cites>FETCH-LOGICAL-c607t-7c124d20eb0ada937d219b0c4d4ba431464e6863906cb9827af70fdeca77d5863</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2867118349/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2867118349?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32474892$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Hee Soo</creatorcontrib><creatorcontrib>Oh, Yongho</creatorcontrib><creatorcontrib>Korejwo, Joanna</creatorcontrib><creatorcontrib>Castells, Valérie Bosch</creatorcontrib><creatorcontrib>Yang, Kuhyun</creatorcontrib><title>Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019</title><title>Infectious diseases and therapy</title><addtitle>Infect Dis Ther</addtitle><addtitle>Infect Dis Ther</addtitle><description>Introduction
The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev
®
) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.
Methods
An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination.
Results
Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0–3 days (80.4%; 144/179), were of 1–3 days’ duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to < 24 months (34.7% [52/150] subjects; 107 events) and 2 to < 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events.
Conclusion
JE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified.
Trial registration
ClinicalTrials.gov identifier, NCT02933710</description><subject>Encephalitis</subject><subject>Health aspects</subject><subject>Immunization</subject><subject>Infectious Diseases</subject><subject>Internal Medicine</subject><subject>Japanese encephalitis</subject><subject>Live-attenuated Japanese encephalitis chimeric virus vaccine</subject><subject>Marketing</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research</subject><subject>Safety</subject><subject>Side effects</subject><subject>Surveillance</subject><subject>Vaccination</subject><subject>Vaccine</subject><subject>Vaccines</subject><subject>Vector-borne diseases</subject><issn>2193-8229</issn><issn>2193-6382</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp9ks9u1DAQxiMEolXpC3BAlrgUiRT_ix1fkFZVC4VFIBV6tRxnsuslGy92shU33oH3QDwDj8KT4HSXlkUI-WBr5pufPeMvyx4SfEwwls8ix4SSHFOcY8xwkYs72T4liuWClfTu9lxSqvaywxgXGCd9yYmS97M9RrnkpaL72fd3Pvb5GxM-Qu-6GboYwhpc25rOAvINmtRrCBHQ6Rq6PqIz37b-ahReGmtdZ3rnO3Tl-jnq54Cmbg35pO-hG0wPNXplVqaDsTzhVnPTut5FdDJ3SwjOoksXhrglATo6X_oFrH98e4Jchy78kKCvfQDzFFFMip9fvqZNPcjuNaaNcLjdD7IPZ6fvT17m07cvzk8m09wKLPtcWkJ5TTFU2NRGMVmneVTY8ppXhjPCBQdRCqawsJUqqTSNxE0N1khZFylxkJ1vuLU3C70KbmnCZ-2N09cBH2bahN7ZFrQUJSOloEQIxRVjVW2qSjaFrYTlspCJ9XzDWg3VEmqbRhlMuwPdzXRurmd-rSUvqCpVAhxtAcF_GiD2eumihfGbwA9RU47Lgkkqx3c__ku68EPo0qg0LYUkpGRc3apmJjXgusane-0I1RPBmFS4FCSpjv-hSquGpbO-g8al-E4B3RTY4GMM0Nz0SLAebas3ttXJtvratnp88aM_p3NT8tukScA2gphS3QzCbUv_wf4Cqp74WA</recordid><startdate>20200901</startdate><enddate>20200901</enddate><creator>Kim, Hee Soo</creator><creator>Oh, Yongho</creator><creator>Korejwo, Joanna</creator><creator>Castells, Valérie Bosch</creator><creator>Yang, Kuhyun</creator><general>Springer Healthcare</general><general>Springer</general><general>Springer Nature B.V</general><general>Adis, Springer Healthcare</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20200901</creationdate><title>Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019</title><author>Kim, Hee Soo ; Oh, Yongho ; Korejwo, Joanna ; Castells, Valérie Bosch ; Yang, Kuhyun</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c607t-7c124d20eb0ada937d219b0c4d4ba431464e6863906cb9827af70fdeca77d5863</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Encephalitis</topic><topic>Health aspects</topic><topic>Immunization</topic><topic>Infectious Diseases</topic><topic>Internal Medicine</topic><topic>Japanese encephalitis</topic><topic>Live-attenuated Japanese encephalitis chimeric virus vaccine</topic><topic>Marketing</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research</topic><topic>Safety</topic><topic>Side effects</topic><topic>Surveillance</topic><topic>Vaccination</topic><topic>Vaccine</topic><topic>Vaccines</topic><topic>Vector-borne diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Hee Soo</creatorcontrib><creatorcontrib>Oh, Yongho</creatorcontrib><creatorcontrib>Korejwo, Joanna</creatorcontrib><creatorcontrib>Castells, Valérie Bosch</creatorcontrib><creatorcontrib>Yang, Kuhyun</creatorcontrib><collection>Springer Nature OA/Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Infectious diseases and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Hee Soo</au><au>Oh, Yongho</au><au>Korejwo, Joanna</au><au>Castells, Valérie Bosch</au><au>Yang, Kuhyun</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019</atitle><jtitle>Infectious diseases and therapy</jtitle><stitle>Infect Dis Ther</stitle><addtitle>Infect Dis Ther</addtitle><date>2020-09-01</date><risdate>2020</risdate><volume>9</volume><issue>3</issue><spage>589</spage><epage>598</epage><pages>589-598</pages><issn>2193-8229</issn><eissn>2193-6382</eissn><abstract>Introduction
The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev
®
) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.
Methods
An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination.
Results
Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0–3 days (80.4%; 144/179), were of 1–3 days’ duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to < 24 months (34.7% [52/150] subjects; 107 events) and 2 to < 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events.
Conclusion
JE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified.
Trial registration
ClinicalTrials.gov identifier, NCT02933710</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>32474892</pmid><doi>10.1007/s40121-020-00305-6</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Infectious diseases and therapy, 2020-09, Vol.9 (3), p.589-598 |
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| subjects | Encephalitis Health aspects Immunization Infectious Diseases Internal Medicine Japanese encephalitis Live-attenuated Japanese encephalitis chimeric virus vaccine Marketing Medicine Medicine & Public Health Original Research Safety Side effects Surveillance Vaccination Vaccine Vaccines Vector-borne diseases |
| title | Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019 |
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