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Therapeutic efficacy and effects of artesunate-amodiaquine and artemether-lumefantrine on malaria-associated anaemia in Nigerian children aged two years and under | Infectious Diseases of Poverty | Full Text

<!DOCTYPE html> <html lang="en" class="no-js"> <head> <meta charset="UTF-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge"> <meta name="applicable-device" content="pc,mobile"> <meta name="viewport" content="width=device-width, initial-scale=1"> <title>Therapeutic efficacy and effects of artesunate-amodiaquine and artemether-lumefantrine on malaria-associated anaemia in Nigerian children aged two years and under | Infectious Diseases of Poverty | Full Text</title> <meta name="citation_abstract" content="Artemisinin-based combination therapies are recommended as first-line treatments for uncomplicated falciparum malaria, but there is little evaluation of their efficacy and effects on uncomplicated malaria-associated anaemia in children aged 2&#160;years and under. Parasitological efficacy and effects on malaria-associated anaemia were evaluated in 250 malarious children aged 2&#160;years and under, and efficacy was evaluated in 603 malarious children older than two but younger than 5&#160;years of age following treatment with artesunate-amodiaquine (AA) or artemether-lumefantrine (AL). Kinetics of the disposition of parasitaemia following treatment were evaluated using a non-compartment model. Late-appearing anaemia (LAA) was diagnosed using the following criteria: clearance of parasitaemia, fever and other symptoms occurring within 7&#160;days of starting treatment, adequate clinical and parasitological response on days 28&#8211;42, haematocrit (HCT)&#8201;&#8805;&#8201;30&#160;% at 1 and/or 2&#160;weeks, a fall in HCT to&#8201;&lt;&#8201;30&#160;% occurring at 3&#8211;6 weeks, absence of concomitant illness at 1&#8211;6 weeks, and absence of asexual parasitaemia detected using both microscopy and polymerase chain reaction (PCR) at 1&#8211;6 weeks. Overall, in children aged 2&#160;years and under, the PCR-corrected parasitological efficacy was 97.2&#160;% (95&#160;% CI 92.8&#8211;101.6), which was similar for both treatments. In children older than 2&#160;years, parasitological efficacy was also similar for both treatments, but parasite prevalence 1&#160;day after treatment began was significantly higher, and fever and parasite clearance times were significantly faster in the AA-treated children compared with the AL-treated children. Declines in parasitaemia were monoexponential with an estimated elimination half-time of 1&#160;h. Elimination half-times were similar for both treatments. In children aged 2&#160;years and under who were anaemic at presentation, the mean anaemia recovery time was 12.1&#160;days (95&#160;% CI 10.6&#8211;13.6, n&#8201;=&#8201;127), which was similar for both treatments. Relatively asymptomatic LAA occurred in 11 children (4.4&#160;%) aged 2&#160;years and under, the recovery from which was uneventful. This study showed that AA and AL are efficacious treatments for uncomplicated falciparum malaria in Nigerian children aged 2&#160;years and under, and that AA clears parasitaemia and fever significantly faster than AL in children older than 2&#160;years. Both treatments may cause a relatively asymptomatic LAA with uneventful recovery in a small proportion of children aged 2&#160;years and under. Pan African Clinical Trial Registry PACTR201508001188143, 3 July 2015; PACTR201510001189370, 3 July 2015; PACTR201508001191898, 7 July 2015 and PACTR201508001193368, 8 July 2015&#160; http://www.pactr.org ."/> <meta name="journal_id" content="40249"/> <meta name="dc.title" content="Therapeutic efficacy and effects of artesunate-amodiaquine and artemether-lumefantrine on malaria-associated anaemia in Nigerian children aged two years and under"/> <meta name="dc.source" content="Infectious Diseases of Poverty 2016 5:1"/> <meta name="dc.format" content="text/html"/> <meta name="dc.publisher" content="BioMed Central"/> <meta name="dc.date" content="2016-07-06"/> <meta name="dc.type" content="OriginalPaper"/> <meta name="dc.language" content="En"/> <meta name="dc.copyright" content="2016 The Author(s)."/> <meta name="dc.rights" content="2016 The Author(s)."/> <meta name="dc.rightsAgent" content="reprints@biomedcentral.com"/> <meta name="dc.description" content="Artemisinin-based combination therapies are recommended as first-line treatments for uncomplicated falciparum malaria, but there is little evaluation of their efficacy and effects on uncomplicated malaria-associated anaemia in children aged 2&amp;nbsp;years and under. Parasitological efficacy and effects on malaria-associated anaemia were evaluated in 250 malarious children aged 2&amp;nbsp;years and under, and efficacy was evaluated in 603 malarious children older than two but younger than 5&amp;nbsp;years of age following treatment with artesunate-amodiaquine (AA) or artemether-lumefantrine (AL). Kinetics of the disposition of parasitaemia following treatment were evaluated using a non-compartment model. Late-appearing anaemia (LAA) was diagnosed using the following criteria: clearance of parasitaemia, fever and other symptoms occurring within 7&amp;nbsp;days of starting treatment, adequate clinical and parasitological response on days 28&#8211;42, haematocrit (HCT)&#8201;&#8805;&#8201;30&amp;nbsp;% at 1 and/or 2&amp;nbsp;weeks, a fall in HCT to&#8201;&amp;lt;&#8201;30&amp;nbsp;% occurring at 3&#8211;6 weeks, absence of concomitant illness at 1&#8211;6 weeks, and absence of asexual parasitaemia detected using both microscopy and polymerase chain reaction (PCR) at 1&#8211;6 weeks. Overall, in children aged 2&amp;nbsp;years and under, the PCR-corrected parasitological efficacy was 97.2&amp;nbsp;% (95&amp;nbsp;% CI 92.8&#8211;101.6), which was similar for both treatments. In children older than 2&amp;nbsp;years, parasitological efficacy was also similar for both treatments, but parasite prevalence 1&amp;nbsp;day after treatment began was significantly higher, and fever and parasite clearance times were significantly faster in the AA-treated children compared with the AL-treated children. Declines in parasitaemia were monoexponential with an estimated elimination half-time of 1&amp;nbsp;h. Elimination half-times were similar for both treatments. In children aged 2&amp;nbsp;years and under who were anaemic at presentation, the mean anaemia recovery time was 12.1&amp;nbsp;days (95&amp;nbsp;% CI 10.6&#8211;13.6, n&#8201;=&#8201;127), which was similar for both treatments. Relatively asymptomatic LAA occurred in 11 children (4.4&amp;nbsp;%) aged 2&amp;nbsp;years and under, the recovery from which was uneventful. This study showed that AA and AL are efficacious treatments for uncomplicated falciparum malaria in Nigerian children aged 2&amp;nbsp;years and under, and that AA clears parasitaemia and fever significantly faster than AL in children older than 2&amp;nbsp;years. Both treatments may cause a relatively asymptomatic LAA with uneventful recovery in a small proportion of children aged 2&amp;nbsp;years and under. Pan African Clinical Trial Registry PACTR201508001188143, 3 July 2015; PACTR201510001189370, 3 July 2015; PACTR201508001191898, 7 July 2015 and PACTR201508001193368, 8 July 2015&amp;nbsp; http://www.pactr.org ."/> <meta name="prism.issn" content="2049-9957"/> <meta name="prism.publicationName" content="Infectious Diseases of Poverty"/> <meta name="prism.publicationDate" content="2016-07-06"/> <meta name="prism.volume" content="5"/> <meta name="prism.number" content="1"/> <meta name="prism.section" content="OriginalPaper"/> <meta name="prism.startingPage" content="1"/> <meta name="prism.endingPage" content="14"/> <meta name="prism.copyright" content="2016 The Author(s)."/> <meta name="prism.rightsAgent" content="reprints@biomedcentral.com"/> <meta name="prism.url" content="https://idpjournal.biomedcentral.com/articles/10.1186/s40249-016-0165-2"/> <meta name="prism.doi" content="doi:10.1186/s40249-016-0165-2"/> <meta name="citation_pdf_url" content="https://idpjournal.biomedcentral.com/counter/pdf/10.1186/s40249-016-0165-2"/> <meta name="citation_fulltext_html_url" content="https://idpjournal.biomedcentral.com/articles/10.1186/s40249-016-0165-2"/> <meta name="citation_journal_title" content="Infectious Diseases of Poverty"/> <meta name="citation_journal_abbrev" content="Infect Dis Poverty"/> <meta name="citation_publisher" content="BioMed Central"/> <meta name="citation_issn" content="2049-9957"/> <meta name="citation_title" content="Therapeutic efficacy and effects of artesunate-amodiaquine and artemether-lumefantrine on malaria-associated anaemia in Nigerian children aged two years and under"/> <meta name="citation_volume" content="5"/> <meta name="citation_issue" content="1"/> <meta name="citation_publication_date" content="2016/12"/> <meta name="citation_online_date" content="2016/07/06"/> <meta name="citation_firstpage" content="1"/> <meta name="citation_lastpage" content="14"/> <meta name="citation_article_type" content="Research Article"/> <meta name="citation_fulltext_world_readable" content=""/> <meta name="citation_language" content="en"/> <meta name="dc.identifier" content="doi:10.1186/s40249-016-0165-2"/> <meta name="DOI" content="10.1186/s40249-016-0165-2"/> <meta name="size" content="312059"/> <meta name="citation_doi" content="10.1186/s40249-016-0165-2"/> <meta name="citation_springer_api_url" content="http://api.springer.com/xmldata/jats?q=doi:10.1186/s40249-016-0165-2&amp;api_key="/> <meta name="description" content="Artemisinin-based combination therapies are recommended as first-line treatments for uncomplicated falciparum malaria, but there is little evaluation of their efficacy and effects on uncomplicated malaria-associated anaemia in children aged 2&amp;nbsp;years and under. Parasitological efficacy and effects on malaria-associated anaemia were evaluated in 250 malarious children aged 2&amp;nbsp;years and under, and efficacy was evaluated in 603 malarious children older than two but younger than 5&amp;nbsp;years of age following treatment with artesunate-amodiaquine (AA) or artemether-lumefantrine (AL). Kinetics of the disposition of parasitaemia following treatment were evaluated using a non-compartment model. Late-appearing anaemia (LAA) was diagnosed using the following criteria: clearance of parasitaemia, fever and other symptoms occurring within 7&amp;nbsp;days of starting treatment, adequate clinical and parasitological response on days 28&#8211;42, haematocrit (HCT)&#8201;&#8805;&#8201;30&amp;nbsp;% at 1 and/or 2&amp;nbsp;weeks, a fall in HCT to&#8201;&amp;lt;&#8201;30&amp;nbsp;% occurring at 3&#8211;6 weeks, absence of concomitant illness at 1&#8211;6 weeks, and absence of asexual parasitaemia detected using both microscopy and polymerase chain reaction (PCR) at 1&#8211;6 weeks. Overall, in children aged 2&amp;nbsp;years and under, the PCR-corrected parasitological efficacy was 97.2&amp;nbsp;% (95&amp;nbsp;% CI 92.8&#8211;101.6), which was similar for both treatments. In children older than 2&amp;nbsp;years, parasitological efficacy was also similar for both treatments, but parasite prevalence 1&amp;nbsp;day after treatment began was significantly higher, and fever and parasite clearance times were significantly faster in the AA-treated children compared with the AL-treated children. Declines in parasitaemia were monoexponential with an estimated elimination half-time of 1&amp;nbsp;h. Elimination half-times were similar for both treatments. In children aged 2&amp;nbsp;years and under who were anaemic at presentation, the mean anaemia recovery time was 12.1&amp;nbsp;days (95&amp;nbsp;% CI 10.6&#8211;13.6, n&#8201;=&#8201;127), which was similar for both treatments. Relatively asymptomatic LAA occurred in 11 children (4.4&amp;nbsp;%) aged 2&amp;nbsp;years and under, the recovery from which was uneventful. This study showed that AA and AL are efficacious treatments for uncomplicated falciparum malaria in Nigerian children aged 2&amp;nbsp;years and under, and that AA clears parasitaemia and fever significantly faster than AL in children older than 2&amp;nbsp;years. Both treatments may cause a relatively asymptomatic LAA with uneventful recovery in a small proportion of children aged 2&amp;nbsp;years and under. Pan African Clinical Trial Registry PACTR201508001188143, 3 July 2015; PACTR201510001189370, 3 July 2015; PACTR201508001191898, 7 July 2015 and PACTR201508001193368, 8 July 2015&amp;nbsp; http://www.pactr.org ."/> <meta name="dc.creator" content="Sowunmi, Akintunde"/> <meta name="dc.creator" content="Akano, Kazeem"/> <meta name="dc.creator" content="Ayede, Adejumoke I."/> <meta name="dc.creator" content="Ntadom, Godwin"/> <meta name="dc.creator" content="Adewoye, Elsie O."/> <meta name="dc.creator" content="Fatunmbi, Bayo"/> <meta name="dc.creator" content="Aderoyeje, Temitope"/> <meta name="dc.subject" content="Infectious Diseases"/> <meta name="dc.subject" content="Tropical Medicine"/> <meta name="dc.subject" content="Public Health"/> <meta name="citation_reference" content="citation_title=World malaria report 2014; citation_publication_date=2014; citation_id=CR1; citation_publisher=WHO"/> <meta name="citation_reference" content="Federal Ministry of Health. 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Methods Parasitological efficacy and effects on malaria-associated anaemia were evaluated in 250 malarious children aged 2 years and under, and efficacy was evaluated in 603 malarious children older than two but younger than 5 years of age following treatment with artesunate-amodiaquine (AA) or artemether-lumefantrine (AL). Kinetics of the disposition of parasitaemia following treatment were evaluated using a non-compartment model. Late-appearing anaemia (LAA) was diagnosed using the following criteria: clearance of parasitaemia, fever and other symptoms occurring within 7 days of starting treatment, adequate clinical and parasitological response on days 28&#8211;42, haematocrit (HCT)&#8201;&#8805;&#8201;30 % at 1 and/or 2 weeks, a fall in HCT to&#8201;&lt;&#8201;30 % occurring at 3&#8211;6 weeks, absence of concomitant illness at 1&#8211;6 weeks, and absence of asexual parasitaemia detected using both microscopy and polymerase chain reaction (PCR) at 1&#8211;6 weeks. Results Overall, in children aged 2 years and under, the PCR-corrected parasitological efficacy was 97.2 % (95 % CI 92.8&#8211;101.6), which was similar for both treatments. In children older than 2 years, parasitological efficacy was also similar for both treatments, but parasite prevalence 1 day after treatment began was significantly higher, and fever and parasite clearance times were significantly faster in the AA-treated children compared with the AL-treated children. Declines in parasitaemia were monoexponential with an estimated elimination half-time of 1 h. Elimination half-times were similar for both treatments. In children aged 2 years and under who were anaemic at presentation, the mean anaemia recovery time was 12.1 days (95 % CI 10.6&#8211;13.6, n&#8201;=&#8201;127), which was similar for both treatments. Relatively asymptomatic LAA occurred in 11 children (4.4 %) aged 2 years and under, the recovery from which was uneventful. Conclusion This study showed that AA and AL are efficacious treatments for uncomplicated falciparum malaria in Nigerian children aged 2 years and under, and that AA clears parasitaemia and fever significantly faster than AL in children older than 2 years. Both treatments may cause a relatively asymptomatic LAA with uneventful recovery in a small proportion of children aged 2 years and under. Trials registration Pan African Clinical Trial Registry PACTR201508001188143, 3 July 2015; PACTR201510001189370, 3 July 2015; PACTR201508001191898, 7 July 2015 and PACTR201508001193368, 8 July 2015 http://www.pactr.org ."/> <meta property="og:image" content="https://static-content.springer.com/image/art%3A10.1186%2Fs40249-016-0165-2/MediaObjects/40249_2016_165_Fig1_HTML.gif"/> <script type="application/ld+json">{"mainEntity":{"headline":"Therapeutic efficacy and effects of artesunate-amodiaquine and artemether-lumefantrine on malaria-associated anaemia in Nigerian children aged two years and under","description":"Artemisinin-based combination therapies are recommended as first-line treatments for uncomplicated falciparum malaria, but there is little evaluation of their efficacy and effects on uncomplicated malaria-associated anaemia in children aged 2 years and under. Parasitological efficacy and effects on malaria-associated anaemia were evaluated in 250 malarious children aged 2 years and under, and efficacy was evaluated in 603 malarious children older than two but younger than 5 years of age following treatment with artesunate-amodiaquine (AA) or artemether-lumefantrine (AL). Kinetics of the disposition of parasitaemia following treatment were evaluated using a non-compartment model. Late-appearing anaemia (LAA) was diagnosed using the following criteria: clearance of parasitaemia, fever and other symptoms occurring within 7 days of starting treatment, adequate clinical and parasitological response on days 28–42, haematocrit (HCT) ≥ 30 % at 1 and/or 2 weeks, a fall in HCT to < 30 % occurring at 3–6 weeks, absence of concomitant illness at 1–6 weeks, and absence of asexual parasitaemia detected using both microscopy and polymerase chain reaction (PCR) at 1–6 weeks. Overall, in children aged 2 years and under, the PCR-corrected parasitological efficacy was 97.2 % (95 % CI 92.8–101.6), which was similar for both treatments. In children older than 2 years, parasitological efficacy was also similar for both treatments, but parasite prevalence 1 day after treatment began was significantly higher, and fever and parasite clearance times were significantly faster in the AA-treated children compared with the AL-treated children. Declines in parasitaemia were monoexponential with an estimated elimination half-time of 1 h. Elimination half-times were similar for both treatments. In children aged 2 years and under who were anaemic at presentation, the mean anaemia recovery time was 12.1 days (95 % CI 10.6–13.6, n = 127), which was similar for both treatments. Relatively asymptomatic LAA occurred in 11 children (4.4 %) aged 2 years and under, the recovery from which was uneventful. This study showed that AA and AL are efficacious treatments for uncomplicated falciparum malaria in Nigerian children aged 2 years and under, and that AA clears parasitaemia and fever significantly faster than AL in children older than 2 years. Both treatments may cause a relatively asymptomatic LAA with uneventful recovery in a small proportion of children aged 2 years and under. Pan African Clinical Trial Registry PACTR201508001188143, 3 July 2015; PACTR201510001189370, 3 July 2015; PACTR201508001191898, 7 July 2015 and PACTR201508001193368, 8 July 2015 \n http://www.pactr.org\n \n .","datePublished":"2016-07-06T00:00:00Z","dateModified":"2016-07-06T00:00:00Z","pageStart":"1","pageEnd":"14","license":"http://creativecommons.org/publicdomain/zero/1.0/","sameAs":"https://doi.org/10.1186/s40249-016-0165-2","keywords":["Falciparum malaria","Malaria-related anaemia","Young children","Artemisinin-based combination therapies","Nigeria","Infectious Diseases","Tropical Medicine","Public Health"],"image":["https://media.springernature.com/lw1200/springer-static/image/art%3A10.1186%2Fs40249-016-0165-2/MediaObjects/40249_2016_165_Fig1_HTML.gif","https://media.springernature.com/lw1200/springer-static/image/art%3A10.1186%2Fs40249-016-0165-2/MediaObjects/40249_2016_165_Fig2_HTML.gif","https://media.springernature.com/lw1200/springer-static/image/art%3A10.1186%2Fs40249-016-0165-2/MediaObjects/40249_2016_165_Fig3_HTML.gif"],"isPartOf":{"name":"Infectious Diseases of Poverty","issn":["2049-9957"],"volumeNumber":"5","@type":["Periodical","PublicationVolume"]},"publisher":{"name":"BioMed Central","logo":{"url":"https://www.springernature.com/app-sn/public/images/logo-springernature.png","@type":"ImageObject"},"@type":"Organization"},"author":[{"name":"Akintunde Sowunmi","affiliation":[{"name":"University of Ibadan","address":{"name":"Department of Pharmacology and Therapeutics, University of Ibadan, Ibadan, Nigeria","@type":"PostalAddress"},"@type":"Organization"},{"name":"University of Ibadan","address":{"name":"Institute for Medical Research and Training, University of Ibadan, Ibadan, Nigeria","@type":"PostalAddress"},"@type":"Organization"}],"email":"akinsowunmi@hotmail.com","@type":"Person"},{"name":"Kazeem Akano","affiliation":[{"name":"University of Ibadan","address":{"name":"Department of Pharmacology and Therapeutics, University of Ibadan, Ibadan, Nigeria","@type":"PostalAddress"},"@type":"Organization"}],"@type":"Person"},{"name":"Adejumoke I. 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u-list-reset u-mb-24"> <li> <dl class="c-article-metrics__access-citation"> <dt> 2181 </dt> <dd>Article Accesses</dd> </dl> </li> <li> <dl class="c-article-metrics__access-citation"> <dt> 7 </dt> <dd><a href="https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=sn-citations&SrcAuth=WosAPI&KeyUT=WOS:000381046400001&DestLinkType=FullRecord&DestApp=WOS_CPL" data-track="click" data-track-action="view citations" data-track-label="link" data-track-category="metrics">Web of Science</a></dd> </dl> </li> <li> <dl class="c-article-metrics__access-citation"> <dt> 6 </dt> <dd><a href="http://citations.springer.com/item?doi=10.1186/s40249-016-0165-2" data-track="click" data-track-action="view citations" data-track-label="link" data-track-category="metrics">CrossRef</a></dd> </dl> </li> </ul> </div> <div class="c-article-metrics__section--right"> <p class="c-article-metrics__explanation">Citation counts are provided from Web of Science and CrossRef. The counts may vary by service, and are reliant on the availability of their data. Counts will update daily once available.</p> </div> </div> </div> <div class="c-article-metrics__section c-box c-box--shadowed u-mb-24"> <h2 class="c-article-metrics__section-heading">Online attention</h2> <div class="c-article-metrics__body" data-test="altmetric-score"> <div class="c-article-metrics__section--left"> <div class="c-article-metrics__altmetric-donut"> <div class="c-article-metrics__image"> <img alt="Altmetric score 1" src="https://badges.altmetric.com/?size&#x3D;180&amp;score&#x3D;1&amp;types&#x3D;tttttttt"> </div> <div class="c-article-metrics__legend"> <ul class="u-list-reset" data-altmetric-key data-test="metrics-counts"> <li class="u-list-reset"> <span class="c-article-metrics__altmetric-key c-article-metrics__altmetric-key--twitter"></span> <span>2 tweeters</span> </li> </ul> <ul class="u-list-reset" data-altmetric-key data-test="metrics-readers"> <li class="u-list-reset"> <span class="c-article-metrics__altmetric-key c-article-metrics__altmetric-key--mendeley"></span> <span>54 Mendeley</span> </li> </ul> </div> </div> <div class="c-article-metrics__altmetric-context-score"> <p> This article is in the 11<sup>th</sup> percentile (ranked 289,835<sup>th</sup>) of the 373,021 tracked articles of a similar age in all journals and the 1<sup>st</sup> percentile (ranked 5<sup>th</sup>) of the 6 tracked articles of a similar age in <i>Infectious Diseases of Poverty</i> </p> <p>View more on <a href="https://bmc.altmetric.com/details/9507799" data-track="click" data-track-action="view altmetric" data-track-label="link" data-track-category="metrics">Altmetric</a></p> </div> </div> <div class="c-article-metrics__section--right"> <p class="c-article-metrics__explanation">Altmetric calculates a score based on the online attention an article receives. Each coloured thread in the circle represents a different type of online attention. The number in the centre is the Altmetric score. Social media and mainstream news media are the main sources that calculate the score. Reference managers such as Mendeley are also tracked but do not contribute to the score. Older articles often score higher because they have had more time to get noticed. To account for this, Altmetric has included the context data for other articles of a similar age. </p> </div> </div> </div> </div> <div class="c-journal-footer"> <div class="c-journal-footer__inner"> <div class="c-journal-footer__summary"> <h4 class="c-journal-title c-journal-title--footer"> <span class="c-journal-title__text">Infectious Diseases of Poverty</span> </h4> <p class="c-journal-footer__issn">ISSN: 2049-9957</p> </div> <div class="c-journal-footer__contact"> <h4 class="c-journal-footer__contact-title ">Contact us</h4> <ul class="c-journal-footer__contact-list"> <li class="c-journal-footer__contact-item">Submission enquiries: <a href="https://www.editorialmanager.com/idop/" target="_blank">Access here and click Contact Us</a></li> <li class="c-journal-footer__contact-item">General enquiries: <a href="mailto:journalsubmissions@springernature.com">journalsubmissions@springernature.com</a></li> </ul> </div> </div> </div> <img rel="nofollow" class='tracker' style='display:none' 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