Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial
CONTEXT Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics, mucolytics, and anti-inflammatory therapies. Increasing evidence suggests that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE To determine if an association between azithromycin use and...
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creator | Saiman, Lisa Marshall, Bruce C Mayer-Hamblett, Nicole Burns, Jane L Quittner, Alexandra L Cibene, Debra A Coquillette, Sarah Fieberg, Ann Yunker Accurso, Frank J Campbell III, Preston W for the Macrolide Study Group |
description | CONTEXT Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics,
mucolytics, and anti-inflammatory therapies. Increasing evidence suggests
that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE To determine if an association between azithromycin use and pulmonary
function exists in patients with CF. DESIGN AND SETTING A multicenter, randomized, double-blind, placebo-controlled trial conducted
from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United
States. PARTICIPANTS Of the 251 screened participants with a diagnosis of CF, 185 (74%) were
randomized. Eligibility criteria included age 6 years or older, infection
with Pseudomonas aeruginosa for 1 or more years,
and a forced expiratory volume in 1 second (FEV1) of 30% or more.
Participants were stratified by FEV1 (≥60% predicted vs |
doi_str_mv | 10.1001/jama.290.13.1749 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_75722155</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>197393</ama_id><sourcerecordid>75722155</sourcerecordid><originalsourceid>FETCH-LOGICAL-a313t-94210a5d58a580736ed168dd44979d9724756486fbd022ad88aa024d9e4b5d833</originalsourceid><addsrcrecordid>eNqF0c1rFDEUAPAgit1W73qRIOht1rx8TBJvy2BroWCRisfh7SSrWWaSmswctuD_bmBXCl4MD5KX9-NBXgh5BWwNjMGHPU645rZmYg1a2idkBUqYRihrnpIVY9Y0Whp5Rs5L2bO6QOjn5AykAquZXZHfm4cw_8xpOgwh0hq3OAcf50K_13vaHcocBnoZtjmVUGhXaQwDjuOBXsedH2bvjvK2-MWlKUUsFH1efoSYCn6kG_oVYy2Ehyq7FOecxrEe73LA8QV5tsOx-Jen_YJ8u_x0131ubr5cXXebmwYFiLmxkgND5ZRBZZgWrXfQGuektNo6q7nUqpWm3W0d4xydMYiMS2e93CpnhLgg749973P6tfgy91Mogx9HjD4tpddKcw5K_ReCYa1UzFT49h-4T0uO9RE9BxDCQMsrenNCy3byrr_PYcJ86P-Ov4J3J4ClDnWXMQ6hPDoF0gomq3t9dPW_H6tWCyvEH4rvnIw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>211338162</pqid></control><display><type>article</type><title>Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>Saiman, Lisa ; Marshall, Bruce C ; Mayer-Hamblett, Nicole ; Burns, Jane L ; Quittner, Alexandra L ; Cibene, Debra A ; Coquillette, Sarah ; Fieberg, Ann Yunker ; Accurso, Frank J ; Campbell III, Preston W ; for the Macrolide Study Group</creator><creatorcontrib>Saiman, Lisa ; Marshall, Bruce C ; Mayer-Hamblett, Nicole ; Burns, Jane L ; Quittner, Alexandra L ; Cibene, Debra A ; Coquillette, Sarah ; Fieberg, Ann Yunker ; Accurso, Frank J ; Campbell III, Preston W ; for the Macrolide Study Group ; Macrolide Study Group</creatorcontrib><description>CONTEXT Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics,
mucolytics, and anti-inflammatory therapies. Increasing evidence suggests
that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE To determine if an association between azithromycin use and pulmonary
function exists in patients with CF. DESIGN AND SETTING A multicenter, randomized, double-blind, placebo-controlled trial conducted
from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United
States. PARTICIPANTS Of the 251 screened participants with a diagnosis of CF, 185 (74%) were
randomized. Eligibility criteria included age 6 years or older, infection
with Pseudomonas aeruginosa for 1 or more years,
and a forced expiratory volume in 1 second (FEV1) of 30% or more.
Participants were stratified by FEV1 (≥60% predicted vs <60%
predicted), weight of less than 40 kg vs 40 kg or more, and CF center. INTERVENTION The active group (n = 87) received 250 mg (weight <40 kg) or 500
mg (weight ≥40 kg) of oral azithromycin 3 days a week for 168 days; placebo
group (n = 98) received identically packaged tablets. MAIN OUTCOME MEASURES Change in FEV1 from day 0 to completion of therapy at day
168 and determination of safety. Secondary outcomes included pulmonary exacerbations
and weight gain. RESULTS The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV1 at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean
difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P = .009). Nausea occurred in 17% more participatns in the azithromycin
group (P = .01), diarrhea in 15% more (P = .009), and wheezing in 13% more (P = .007).
Participants in the azithromycin group had less risk of experiencing an exacerbation
than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = .03) and weighed at the end of the study an average
0.7 kg more than participants receiving placebo (95% CI, 0.1-1.4 kg; P = .02). CONCLUSION Azithromycin treatment was associated with improvement in clinically
relevant end points and should be considered for patients with CF who are
6 years or older and chronically infected with P aeruginosa.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.290.13.1749</identifier><identifier>PMID: 14519709</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Adolescent ; Anti-Bacterial Agents - therapeutic use ; Antibacterial agents ; Antibiotics ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Azithromycin - therapeutic use ; Biological and medical sciences ; Child ; Chronic Disease ; Cystic fibrosis ; Cystic Fibrosis - complications ; Cystic Fibrosis - drug therapy ; Double-Blind Method ; Drug therapy ; Female ; Forced Expiratory Flow Rates ; Hospitalization ; Humans ; Interleukin-8 - blood ; Male ; Medical sciences ; Pancreatic Elastase - blood ; Pathology ; Pharmacology ; Pharmacology. Drug treatments ; Proportional Hazards Models ; Pseudomonas aeruginosa ; Pseudomonas Infections - complications ; Pseudomonas Infections - drug therapy ; Quality of Life ; Respiratory system ; Treatment Outcome</subject><ispartof>JAMA : the journal of the American Medical Association, 2003-10, Vol.290 (13), p.1749-1756</ispartof><rights>2004 INIST-CNRS</rights><rights>Copyright American Medical Association Oct 1, 2003</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.290.13.1749$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.290.13.1749$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,780,784,3340,27924,27925,76489,76492</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15149304$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14519709$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Saiman, Lisa</creatorcontrib><creatorcontrib>Marshall, Bruce C</creatorcontrib><creatorcontrib>Mayer-Hamblett, Nicole</creatorcontrib><creatorcontrib>Burns, Jane L</creatorcontrib><creatorcontrib>Quittner, Alexandra L</creatorcontrib><creatorcontrib>Cibene, Debra A</creatorcontrib><creatorcontrib>Coquillette, Sarah</creatorcontrib><creatorcontrib>Fieberg, Ann Yunker</creatorcontrib><creatorcontrib>Accurso, Frank J</creatorcontrib><creatorcontrib>Campbell III, Preston W</creatorcontrib><creatorcontrib>for the Macrolide Study Group</creatorcontrib><creatorcontrib>Macrolide Study Group</creatorcontrib><title>Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics,
mucolytics, and anti-inflammatory therapies. Increasing evidence suggests
that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE To determine if an association between azithromycin use and pulmonary
function exists in patients with CF. DESIGN AND SETTING A multicenter, randomized, double-blind, placebo-controlled trial conducted
from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United
States. PARTICIPANTS Of the 251 screened participants with a diagnosis of CF, 185 (74%) were
randomized. Eligibility criteria included age 6 years or older, infection
with Pseudomonas aeruginosa for 1 or more years,
and a forced expiratory volume in 1 second (FEV1) of 30% or more.
Participants were stratified by FEV1 (≥60% predicted vs <60%
predicted), weight of less than 40 kg vs 40 kg or more, and CF center. INTERVENTION The active group (n = 87) received 250 mg (weight <40 kg) or 500
mg (weight ≥40 kg) of oral azithromycin 3 days a week for 168 days; placebo
group (n = 98) received identically packaged tablets. MAIN OUTCOME MEASURES Change in FEV1 from day 0 to completion of therapy at day
168 and determination of safety. Secondary outcomes included pulmonary exacerbations
and weight gain. RESULTS The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV1 at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean
difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P = .009). Nausea occurred in 17% more participatns in the azithromycin
group (P = .01), diarrhea in 15% more (P = .009), and wheezing in 13% more (P = .007).
Participants in the azithromycin group had less risk of experiencing an exacerbation
than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = .03) and weighed at the end of the study an average
0.7 kg more than participants receiving placebo (95% CI, 0.1-1.4 kg; P = .02). CONCLUSION Azithromycin treatment was associated with improvement in clinically
relevant end points and should be considered for patients with CF who are
6 years or older and chronically infected with P aeruginosa.</description><subject>Adolescent</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibacterial agents</subject><subject>Antibiotics</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Azithromycin - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Chronic Disease</subject><subject>Cystic fibrosis</subject><subject>Cystic Fibrosis - complications</subject><subject>Cystic Fibrosis - drug therapy</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Forced Expiratory Flow Rates</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>Interleukin-8 - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pancreatic Elastase - blood</subject><subject>Pathology</subject><subject>Pharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Proportional Hazards Models</subject><subject>Pseudomonas aeruginosa</subject><subject>Pseudomonas Infections - complications</subject><subject>Pseudomonas Infections - drug therapy</subject><subject>Quality of Life</subject><subject>Respiratory system</subject><subject>Treatment Outcome</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0c1rFDEUAPAgit1W73qRIOht1rx8TBJvy2BroWCRisfh7SSrWWaSmswctuD_bmBXCl4MD5KX9-NBXgh5BWwNjMGHPU645rZmYg1a2idkBUqYRihrnpIVY9Y0Whp5Rs5L2bO6QOjn5AykAquZXZHfm4cw_8xpOgwh0hq3OAcf50K_13vaHcocBnoZtjmVUGhXaQwDjuOBXsedH2bvjvK2-MWlKUUsFH1efoSYCn6kG_oVYy2Ehyq7FOecxrEe73LA8QV5tsOx-Jen_YJ8u_x0131ubr5cXXebmwYFiLmxkgND5ZRBZZgWrXfQGuektNo6q7nUqpWm3W0d4xydMYiMS2e93CpnhLgg749973P6tfgy91Mogx9HjD4tpddKcw5K_ReCYa1UzFT49h-4T0uO9RE9BxDCQMsrenNCy3byrr_PYcJ86P-Ov4J3J4ClDnWXMQ6hPDoF0gomq3t9dPW_H6tWCyvEH4rvnIw</recordid><startdate>20031001</startdate><enddate>20031001</enddate><creator>Saiman, Lisa</creator><creator>Marshall, Bruce C</creator><creator>Mayer-Hamblett, Nicole</creator><creator>Burns, Jane L</creator><creator>Quittner, Alexandra L</creator><creator>Cibene, Debra A</creator><creator>Coquillette, Sarah</creator><creator>Fieberg, Ann Yunker</creator><creator>Accurso, Frank J</creator><creator>Campbell III, Preston W</creator><creator>for the Macrolide Study Group</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20031001</creationdate><title>Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial</title><author>Saiman, Lisa ; Marshall, Bruce C ; Mayer-Hamblett, Nicole ; Burns, Jane L ; Quittner, Alexandra L ; Cibene, Debra A ; Coquillette, Sarah ; Fieberg, Ann Yunker ; Accurso, Frank J ; Campbell III, Preston W ; for the Macrolide Study Group</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a313t-94210a5d58a580736ed168dd44979d9724756486fbd022ad88aa024d9e4b5d833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Adolescent</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antibacterial agents</topic><topic>Antibiotics</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Azithromycin - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Chronic Disease</topic><topic>Cystic fibrosis</topic><topic>Cystic Fibrosis - complications</topic><topic>Cystic Fibrosis - drug therapy</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Forced Expiratory Flow Rates</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Interleukin-8 - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pancreatic Elastase - blood</topic><topic>Pathology</topic><topic>Pharmacology</topic><topic>Pharmacology. Drug treatments</topic><topic>Proportional Hazards Models</topic><topic>Pseudomonas aeruginosa</topic><topic>Pseudomonas Infections - complications</topic><topic>Pseudomonas Infections - drug therapy</topic><topic>Quality of Life</topic><topic>Respiratory system</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Saiman, Lisa</creatorcontrib><creatorcontrib>Marshall, Bruce C</creatorcontrib><creatorcontrib>Mayer-Hamblett, Nicole</creatorcontrib><creatorcontrib>Burns, Jane L</creatorcontrib><creatorcontrib>Quittner, Alexandra L</creatorcontrib><creatorcontrib>Cibene, Debra A</creatorcontrib><creatorcontrib>Coquillette, Sarah</creatorcontrib><creatorcontrib>Fieberg, Ann Yunker</creatorcontrib><creatorcontrib>Accurso, Frank J</creatorcontrib><creatorcontrib>Campbell III, Preston W</creatorcontrib><creatorcontrib>for the Macrolide Study Group</creatorcontrib><creatorcontrib>Macrolide Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Saiman, Lisa</au><au>Marshall, Bruce C</au><au>Mayer-Hamblett, Nicole</au><au>Burns, Jane L</au><au>Quittner, Alexandra L</au><au>Cibene, Debra A</au><au>Coquillette, Sarah</au><au>Fieberg, Ann Yunker</au><au>Accurso, Frank J</au><au>Campbell III, Preston W</au><au>for the Macrolide Study Group</au><aucorp>Macrolide Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2003-10-01</date><risdate>2003</risdate><volume>290</volume><issue>13</issue><spage>1749</spage><epage>1756</epage><pages>1749-1756</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics,
mucolytics, and anti-inflammatory therapies. Increasing evidence suggests
that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE To determine if an association between azithromycin use and pulmonary
function exists in patients with CF. DESIGN AND SETTING A multicenter, randomized, double-blind, placebo-controlled trial conducted
from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United
States. PARTICIPANTS Of the 251 screened participants with a diagnosis of CF, 185 (74%) were
randomized. Eligibility criteria included age 6 years or older, infection
with Pseudomonas aeruginosa for 1 or more years,
and a forced expiratory volume in 1 second (FEV1) of 30% or more.
Participants were stratified by FEV1 (≥60% predicted vs <60%
predicted), weight of less than 40 kg vs 40 kg or more, and CF center. INTERVENTION The active group (n = 87) received 250 mg (weight <40 kg) or 500
mg (weight ≥40 kg) of oral azithromycin 3 days a week for 168 days; placebo
group (n = 98) received identically packaged tablets. MAIN OUTCOME MEASURES Change in FEV1 from day 0 to completion of therapy at day
168 and determination of safety. Secondary outcomes included pulmonary exacerbations
and weight gain. RESULTS The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV1 at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean
difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P = .009). Nausea occurred in 17% more participatns in the azithromycin
group (P = .01), diarrhea in 15% more (P = .009), and wheezing in 13% more (P = .007).
Participants in the azithromycin group had less risk of experiencing an exacerbation
than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = .03) and weighed at the end of the study an average
0.7 kg more than participants receiving placebo (95% CI, 0.1-1.4 kg; P = .02). CONCLUSION Azithromycin treatment was associated with improvement in clinically
relevant end points and should be considered for patients with CF who are
6 years or older and chronically infected with P aeruginosa.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>14519709</pmid><doi>10.1001/jama.290.13.1749</doi><tpages>8</tpages></addata></record> |
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source | MEDLINE; American Medical Association Journals |
subjects | Adolescent Anti-Bacterial Agents - therapeutic use Antibacterial agents Antibiotics Antibiotics. Antiinfectious agents. Antiparasitic agents Azithromycin - therapeutic use Biological and medical sciences Child Chronic Disease Cystic fibrosis Cystic Fibrosis - complications Cystic Fibrosis - drug therapy Double-Blind Method Drug therapy Female Forced Expiratory Flow Rates Hospitalization Humans Interleukin-8 - blood Male Medical sciences Pancreatic Elastase - blood Pathology Pharmacology Pharmacology. Drug treatments Proportional Hazards Models Pseudomonas aeruginosa Pseudomonas Infections - complications Pseudomonas Infections - drug therapy Quality of Life Respiratory system Treatment Outcome |
title | Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial |
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