A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum
This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Linn flower extract and extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subje...
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description | This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of
Linn flower extract and
extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0-9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (
= 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (
= 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (
= 0.0324), a statistically significant difference (
= 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (
= 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (
= 0.2187), a statistically significant difference between the administration groups (
= 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840. |
doi_str_mv | 10.3390/nu12123794 |
format | Article |
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Linn flower extract and
extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0-9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (
= 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (
= 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (
= 0.0324), a statistically significant difference (
= 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (
= 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (
= 0.2187), a statistically significant difference between the administration groups (
= 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu12123794</identifier><identifier>PMID: 33322063</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Adult ; Arthritis ; Asymptomatic ; Blood pressure ; C-reactive protein ; C-Reactive Protein - drug effects ; Cardiovascular disease ; Cellulose ; Chrysanthemum ; Cinnamomum aromaticum ; Clinical trials ; Complex Mixtures ; Consent ; Diabetes ; Diet ; Dietary Supplements ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Drug withdrawal ; EKG ; Electrocardiography ; Evaluation ; Exercise ; Fatty acids ; Female ; Food Ingredients - analysis ; Gout ; Hospitals ; Humans ; Hypertension ; Hyperuricemia ; Hyperuricemia - blood ; Hyperuricemia - therapy ; Ingestion ; Male ; Medicine ; Metabolism ; Middle Aged ; Physical fitness ; Plant Extracts - administration & dosage ; Review boards ; Rheumatism ; Safety ; Silica ; Statistical analysis ; Treatment Outcome ; Uric acid ; Uric Acid - blood</subject><ispartof>Nutrients, 2020-12, Vol.12 (12), p.3794</ispartof><rights>2020. This work is licensed under http://creativecommons.org/licenses/by/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2020 by the authors. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c406t-e99377d445cd126ae5982e0e961a093a56daade03aa2ef70c41712abb5463733</citedby><cites>FETCH-LOGICAL-c406t-e99377d445cd126ae5982e0e961a093a56daade03aa2ef70c41712abb5463733</cites><orcidid>0000-0001-7487-8973 ; 0000-0002-8076-1349 ; 0000-0002-4161-6798</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763673/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763673/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33322063$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Park, Yu Hwa</creatorcontrib><creatorcontrib>Kim, Do Hoon</creatorcontrib><creatorcontrib>Lee, Jung Suk</creatorcontrib><creatorcontrib>Jeong, Hyun Il</creatorcontrib><creatorcontrib>Lee, Kye Wan</creatorcontrib><creatorcontrib>Kang, Tong Ho</creatorcontrib><title>A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum</title><title>Nutrients</title><addtitle>Nutrients</addtitle><description>This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of
Linn flower extract and
extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0-9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (
= 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (
= 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (
= 0.0324), a statistically significant difference (
= 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (
= 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (
= 0.2187), a statistically significant difference between the administration groups (
= 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.</description><subject>Adult</subject><subject>Arthritis</subject><subject>Asymptomatic</subject><subject>Blood pressure</subject><subject>C-reactive protein</subject><subject>C-Reactive Protein - drug effects</subject><subject>Cardiovascular disease</subject><subject>Cellulose</subject><subject>Chrysanthemum</subject><subject>Cinnamomum aromaticum</subject><subject>Clinical trials</subject><subject>Complex Mixtures</subject><subject>Consent</subject><subject>Diabetes</subject><subject>Diet</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Drug withdrawal</subject><subject>EKG</subject><subject>Electrocardiography</subject><subject>Evaluation</subject><subject>Exercise</subject><subject>Fatty acids</subject><subject>Female</subject><subject>Food Ingredients - analysis</subject><subject>Gout</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hyperuricemia</subject><subject>Hyperuricemia - blood</subject><subject>Hyperuricemia - therapy</subject><subject>Ingestion</subject><subject>Male</subject><subject>Medicine</subject><subject>Metabolism</subject><subject>Middle Aged</subject><subject>Physical fitness</subject><subject>Plant Extracts - administration & dosage</subject><subject>Review boards</subject><subject>Rheumatism</subject><subject>Safety</subject><subject>Silica</subject><subject>Statistical analysis</subject><subject>Treatment Outcome</subject><subject>Uric acid</subject><subject>Uric Acid - blood</subject><issn>2072-6643</issn><issn>2072-6643</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdkttu1DAQhiMEolXpDQ-ALHGD0Kb4FJvcIG23C0UUgdpFXEaz9oS6OHZx4krLI_GUeOmBgi980P_Nr5nxVNVTRg-EaOmrkBlnXOhWPqh2OdW8VkqKh_fuO9X-OF7Q7dJUK_G42hFCcE6V2K1-zQnj9VfE7zPyMfvJGQwTphk5hWDj4H6inZGjmNce60PvQnl99mBwHetFDFOK3qMli6I4A56skit7HxNZXoHPMLkYSOzJdI5k2feFMRtSnMkZ9DhtttLRh0PGJCncKdpsbiO-JGfI3DhLXCBnmPLwpHrUgx9x_-bcq1Zvl6vFcX3y6d37xfykNpKqqca2FVpbKRtjGVeATfuaI8VWMaCtgEZZAItUAHDsNTWSacZhvW6kElqIverNte1lXg9ot_1I4LvL5AZImy6C6_5VgjvvvsWrTpfeqj8GL24MUvyRcZy6wY0GvYeAMY8dl5oqLmmjCvr8P_Qi5hRKdYVSpRDeNk2hXl5TJsVxTNjfJcNotx2C7u8QFPjZ_fTv0NsvF78BJZmrow</recordid><startdate>20201210</startdate><enddate>20201210</enddate><creator>Park, Yu Hwa</creator><creator>Kim, Do Hoon</creator><creator>Lee, Jung Suk</creator><creator>Jeong, Hyun Il</creator><creator>Lee, Kye Wan</creator><creator>Kang, Tong Ho</creator><general>MDPI AG</general><general>MDPI</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</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>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7487-8973</orcidid><orcidid>https://orcid.org/0000-0002-8076-1349</orcidid><orcidid>https://orcid.org/0000-0002-4161-6798</orcidid></search><sort><creationdate>20201210</creationdate><title>A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum</title><author>Park, Yu Hwa ; Kim, Do Hoon ; Lee, Jung Suk ; Jeong, Hyun Il ; Lee, Kye Wan ; Kang, Tong Ho</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c406t-e99377d445cd126ae5982e0e961a093a56daade03aa2ef70c41712abb5463733</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Arthritis</topic><topic>Asymptomatic</topic><topic>Blood pressure</topic><topic>C-reactive protein</topic><topic>C-Reactive Protein - drug effects</topic><topic>Cardiovascular disease</topic><topic>Cellulose</topic><topic>Chrysanthemum</topic><topic>Cinnamomum aromaticum</topic><topic>Clinical trials</topic><topic>Complex Mixtures</topic><topic>Consent</topic><topic>Diabetes</topic><topic>Diet</topic><topic>Dietary Supplements</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Drug dosages</topic><topic>Drug withdrawal</topic><topic>EKG</topic><topic>Electrocardiography</topic><topic>Evaluation</topic><topic>Exercise</topic><topic>Fatty acids</topic><topic>Female</topic><topic>Food Ingredients - analysis</topic><topic>Gout</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Hyperuricemia</topic><topic>Hyperuricemia - blood</topic><topic>Hyperuricemia - therapy</topic><topic>Ingestion</topic><topic>Male</topic><topic>Medicine</topic><topic>Metabolism</topic><topic>Middle Aged</topic><topic>Physical fitness</topic><topic>Plant Extracts - administration & dosage</topic><topic>Review boards</topic><topic>Rheumatism</topic><topic>Safety</topic><topic>Silica</topic><topic>Statistical analysis</topic><topic>Treatment Outcome</topic><topic>Uric acid</topic><topic>Uric Acid - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Park, Yu Hwa</creatorcontrib><creatorcontrib>Kim, Do Hoon</creatorcontrib><creatorcontrib>Lee, Jung Suk</creatorcontrib><creatorcontrib>Jeong, Hyun Il</creatorcontrib><creatorcontrib>Lee, Kye Wan</creatorcontrib><creatorcontrib>Kang, Tong Ho</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Physical Education Index</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</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>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Nutrients</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Park, Yu Hwa</au><au>Kim, Do Hoon</au><au>Lee, Jung Suk</au><au>Jeong, Hyun Il</au><au>Lee, Kye Wan</au><au>Kang, Tong Ho</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum</atitle><jtitle>Nutrients</jtitle><addtitle>Nutrients</addtitle><date>2020-12-10</date><risdate>2020</risdate><volume>12</volume><issue>12</issue><spage>3794</spage><pages>3794-</pages><issn>2072-6643</issn><eissn>2072-6643</eissn><abstract>This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of
Linn flower extract and
extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0-9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (
= 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (
= 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (
= 0.0324), a statistically significant difference (
= 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (
= 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (
= 0.2187), a statistically significant difference between the administration groups (
= 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>33322063</pmid><doi>10.3390/nu12123794</doi><orcidid>https://orcid.org/0000-0001-7487-8973</orcidid><orcidid>https://orcid.org/0000-0002-8076-1349</orcidid><orcidid>https://orcid.org/0000-0002-4161-6798</orcidid><oa>free_for_read</oa></addata></record> |
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source | MDPI - Multidisciplinary Digital Publishing Institute; MEDLINE; PubMed Central; EZB Electronic Journals Library; PubMed Central Open Access |
subjects | Adult Arthritis Asymptomatic Blood pressure C-reactive protein C-Reactive Protein - drug effects Cardiovascular disease Cellulose Chrysanthemum Cinnamomum aromaticum Clinical trials Complex Mixtures Consent Diabetes Diet Dietary Supplements Double-Blind Method Double-blind studies Drug dosages Drug withdrawal EKG Electrocardiography Evaluation Exercise Fatty acids Female Food Ingredients - analysis Gout Hospitals Humans Hypertension Hyperuricemia Hyperuricemia - blood Hyperuricemia - therapy Ingestion Male Medicine Metabolism Middle Aged Physical fitness Plant Extracts - administration & dosage Review boards Rheumatism Safety Silica Statistical analysis Treatment Outcome Uric acid Uric Acid - blood |
title | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-17T18%3A54%3A07IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%2012-Week,%20Multicenter,%20Randomized,%20Double-Blind,%20Placebo-Controlled%20Clinical%20Trial%20for%20Evaluation%20of%20the%20Efficacy%20and%20Safety%20of%20DKB114%20on%20Reduction%20of%20Uric%20Acid%20in%20Serum&rft.jtitle=Nutrients&rft.au=Park,%20Yu%20Hwa&rft.date=2020-12-10&rft.volume=12&rft.issue=12&rft.spage=3794&rft.pages=3794-&rft.issn=2072-6643&rft.eissn=2072-6643&rft_id=info:doi/10.3390/nu12123794&rft_dat=%3Cproquest_pubme%3E2469932955%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2469932955&rft_id=info:pmid/33322063&rfr_iscdi=true |