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Monoclonal gammopathy of uncertain significance and apheresis donors
Gammapatía monoclonal de significado incierto y donantes de aféresis
Alicia Aranguren Azparrena,b, Mohamed Jatri Iusefa,b, José Antonio García Ercea,b,c,d,e,f,g,
Corresponding author
jagarciaerce@gmail.com

Corresponding author.
a Servicio Navarro de Salud-Osasunbidea, Pamplona, Spain
b Banco de Sangre y Tejidos de Navarra, Pamplona, Spain
c Grupo Español de Aféresis (GEA), Grupo de Trabajo de la SEHH y SETS, Madrid, Spain
d Grupo Español de Rehabilitación Multimodal (GERM), Zaragoza, Spain
e Instituto Aragonés de Ciencias de la Salud (IACS), Zaragoza, Spain
f Instituto de Investigación Sanitaria Aragón (IIS Aragón), Zaragoza, Spain
g Grupo de Investigación Gestión en el Paciente Sangrante-PBM del Instituto de Investigación Sanitaria del Hospital Universitaria La Paz (IdiPAZ), Madrid, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleDisplayedQuote" id="dsq0005"><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">One man come in the name of love</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">In the name of love</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">What more in the name of love&#63;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Pride &#40;In The Name Of Love&#41;&#44; U2</span></p></span></p><p id="par0010" class="elsevierStylePara elsevierViewall">A review of the literature reveals that there are no recent studies on the incidence or prevalence of monoclonal gammopathy of uncertain significance &#40;MGUS&#41; in Spain&#46; In Europe&#44; it may be as high as 4&#37; in men over 50 years of age&#44; with an annual risk of progression of 1&#37; when reviewing risk factors&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> There are also no published data in the voluntary non-remunerated blood donors &#40;VNRBD&#41; population&#46; We present the prevalence of MGUS in apheresis candidates and regular donors&#44; reviewed following the publication of a report by the committee on Improving Appropriateness of Care and Clinical Practice &#40;MAPAC&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">A retrospective study was conducted using the blood donor database of the region&#39;s blood donation and transfusion management software&#46; Recruitment of plasmapheresis donors was initiated in 2018&#44; starting from regular VNRBDs&#44; after screening and initial profiling &#40;&#8220;new apheresis donor&#8221; &#91;NAD&#93;&#41; including serum protein determination&#44; serum total protein and immunoglobulin &#40;Ig&#41; quantification &#40;IgA&#44; IgM and IgG&#41; plus a basic coagulation study&#46; After each cycle of six apheresis donations&#44; or at least once a year&#44; another profile &#40;&#8220;apheresis donor control&#8221; &#91;ADC&#93;&#41; was requested which focused exclusively on the determination of total protein and IgG levels &#40;Appendix <a class="elsevierStyleCrossRef" href="#sec0025">B</a> Annex&#41;&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">From baseline until 15 September 2023&#44; 4040 serum total protein tests were requested from 1822 different donors&#46; These analyses covered 1618 NAD studies &#40;1159 males &#91;M&#93; and 459 females &#91;F&#93;&#41;&#59; and 2127 ADCs&#44; from 1513 apheresis donors&#44; with at least one validated donation&#46; In the end&#44; a total of 12&#44;822 apheresis procedures were obtained&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">One hundred and forty-five &#40;3&#46;6&#37;&#41; serum total protein tests were recorded as &#8220;abnormal&#8221;&#58; 82 &#40;56&#46;5&#37;&#41; &#8220;polyclonal hypergammaglobulinaemia&#8221;&#44; 12 &#40;8&#46;3&#37;&#41; patterns compatible with inflammatory processes&#44; 28 &#40;19&#46;3&#37;&#41; &#8220;hypogammaglobulinaemia&#8221;&#59; and 19 &#40;13&#46;1&#37;&#41; reported as &#8220;monoclonal protein presence &#40;n&#8239;&#61;&#8239;16&#41;&#8221; or &#8220;monoclonal band in gamma region &#40;n&#8239;&#61;&#8239;3&#41;&#8221;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">These 19 monoclonal components &#40;MCs&#41; attributed to the centre corresponded to only 15 different donors&#46; Two of the individuals had previously been identified as MC carriers&#46; The first&#58; a 68-year-old female&#44; temporarily excluded due to a &#8220;clinical study&#8221; and diagnosed with breast cancer during follow-up&#46; The second&#58; a 47-year-old male&#44; later diagnosed with chronic lymphoproliferative syndrome&#46; Of the 14 active donors with MC &#40;12&#8239;M&#47;2&#8239;F&#41;&#44; seven were younger than 50 years&#44; mean age 54&#46;5&#46; Seven were IgG&#59; four IgA and three IgM&#59; nine kappa and five lambda&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The average value of the first MC result recorded is&#58; 1&#46;89&#8239;g&#47;L&#44; only two above 5&#8239;g&#47;L&#44; all below 30&#8239;g&#47;L&#46; Seven corresponded to NAD &#40;7&#47;1618&#8239;&#61;&#8239;0&#46;4&#37;&#41;&#44; and seven to ADC &#40;7&#47;2127&#8239;&#61;&#8239;0&#46;2&#37;&#41;&#46; The two F were NAD &#40;2&#47;456&#8239;&#61;&#8239;0&#46;4&#37;&#41;&#44; none in ADC&#46; In the 12&#8239;M&#58; five NAD &#40;5&#47;1159&#8239;&#61;&#8239;0&#46;4&#37;&#41; and seven ADC &#40;7&#47;2127&#8239;&#61;&#8239;0&#46;3&#37;&#41;&#46; A higher caseload in 2021 &#40;6&#47;14&#44; 1&#46;1&#37; &#8220;new&#8221;&#41; stands out &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; At the time of this review&#44; five remain temporarily excluded&#44; the rest have been discharged from the haematology department&#46; Of the nine cases reviewed deemed eligible for donation&#44; five made at least one donation&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">Although MGUS is of significant clinical importance due to its high prevalence&#44;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> the available data on a healthy population&#44; such as VNRBDs&#44; is limited&#46; Previous consecutive epidemiological studies in France analysed up to 36&#44;015 donors&#44; finding MC on agarose gel electrophoresis in 0&#46;14&#37;&#44; with 86&#37; considered as &#8220;benign&#8221;&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> In 3800 apheresis donors&#44; MC was found in only 13 &#40;0&#46;3&#37;&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> In 2012 in Trieste&#44; Italy&#44;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> a series of 8197 regular VNRBDs was analysed&#44; with MC being detected in 104 subjects &#40;1&#46;3&#37;&#41;&#58; two cases were found to have asymptomatic multiple myeloma within the following six months&#59; 14 &#8220;transient&#8221; MC&#59; and only 88 were classified as MGUS&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Although Italy incorporated this test for all VNRBDs in 2005&#44; since 2015 this procedure is not mandatory&#46; Additionally&#44; there are no public registries in place&#44; and local protocols vary considerably across the country&#46; &#40;Dr Ivo Beverina&#44; personal communication&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In our modest series we found a prevalence of 0&#46;4&#37; at baseline and 0&#46;2&#37; at annual follow-up&#46; Due to the small size&#44; we found no differences by gender or age&#46; Although our data would show a lower frequency than that described in the general population&#44; it does not allow us to state that donation is protective&#44; but at least it is safe against the occurrence of MGUS and possible transformation&#46; Prospective national registries are needed to answer this question that was already raised 50 years ago&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Ethical considerations</span><p id="par0050" class="elsevierStylePara elsevierViewall">Donors are required to sign a questionnaire consenting to the consultation of their data in the electronic medical records and the transfer of samples and records for research purposes&#46; The donation history and laboratory results recorded in the donation management programme have been reviewed&#44; based on the laboratory test numbers and anonymous donors&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Permission has not been sought from the Ethics and Research Committee as this is a review of our records with computer backups and is supported by the Ley Org&#225;nica de Protecci&#243;n de Datos &#40;Organic Law on Data Protection&#41;&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Funding</span><p id="par0060" class="elsevierStylePara elsevierViewall">This work has not received any funding&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflict of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest&#46;</p></span></span>"
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          "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">ADC&#58; apheresis donor control&#59; Inc&#58; incidence&#59; MGUS&#58; monoclonal gammopathy of uncertain significance&#59; NAD&#58; new apheresis donor&#46;</p>"
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
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                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " colspan="3" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Studies</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " colspan="3" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">GMSI</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Year&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Donors&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Apheresis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">NAD&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ADC&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Total&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">NAD&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ADC&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Total&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Inc&#46;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">418&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">1&#46;426&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">14&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">55&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#44;2&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">2019&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#46;881&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">392&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">342&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">734&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#44;3&#37;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2020&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">768&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">2&#46;636&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">330&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">443&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">773&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;3&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2021&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">792&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#46;891&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">376&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">495&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">871&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6&nbsp;\t\t\t\t\t\t\n
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Article information
ISSN: 23870206
Original language: English
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