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Original article
Clinical study of the effectiveness of the “3-sulphates solution” on balanitis and balanoposthitis
Estudio clínico de la eficacia del «agua de 3 sulfatos» en la balanitis y la balanopostitis
V. Gonzalvoa,
Corresponding author
gonzalvoperez@gmail.com

Corresponding author.
, A. Poloa, F. Serrallachb, A. Gutiérrezb, E. Peyric
a Servei d’Urología Hospital Lluis Alcanyís de Xàtiva, Xàtiva, Spain
b Servei d’Urología, Hospital Universitari Sagrat Cor, Barcelona, Spain
c Clinica Urológica Dr. Peyri, Barcelona, Spain
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along with proper hygiene and removing of irritants&#44; to use astringent solutions &#40;antiexudative&#41; with antiseptic capacity&#46; The local use of topical sulfates as non-specific treatment of balanitis is collected in multiple treaties of dermatology and urology<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">2&#44;5&#44;6</span></a>&#59; however&#44; we found no prospective study that it does&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">With this study&#44; we aim to evaluate the efficacy of a classic topical astringent formula &#8220;3-sulfate water&#8221; based on zinc sulfate&#44; copper&#44; and aluminum&#8211;potassium in the treatment of patients with acute irritative and non-specific balanitis&#47;balanoposthitis&#46; We have compared it with a control group&#44; treated with saline solution&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">This study followed a double-blind design&#44; with randomized distribution of the treatments&#44; comparing the effectiveness of a solution of &#8220;3-sulfate water&#8221; &#40;experimental treatment&#41; and a physiological saline solution &#40;control group&#41;&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Three health centers took part&#58; the &#8220;Lluis Alcany&#237;s&#8217; hospital in X&#224;tiva &#40;Servei d&#8217;Urolog&#237;a&#41;&#44; the &#8220;Sagrat Cor&#8221; hospital in Barcelona &#40;Servei d&#8217; Urolog&#237;a&#41;&#44; and the urological clinic of Dr&#46; Peyri&#46; The inclusion of patients was conducted from June 2012 to December 2013 &#40;19 months&#41;&#46; 50 adult patients diagnosed with non-specific or irritative balanitis or balanoposthitis were selected&#44; who were randomized so that 30 patients received the solution of the &#8220;3-sulfate water&#8221; and another 20 patients saline solution as a control&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">We excluded infectious or other-cause balanitis&#44; patients with severe systemic diseases&#44; those treated with other therapies that could interfere&#44; and those who presented with other skin lesions in the genital area &#40;herpes&#44; syphilis&#44; chancroid&#41; or allergic dermatitis&#46; The treatment consisted of the application of the solution 2 times a day &#40;morning and evening&#41; either by immersing the penis for 5&#8211;6<span class="elsevierStyleHsp" style=""></span>min in an aliquot of the solution using a small plastic cup or by fomentation with a soaked gauze applied on the penis for 5 or 6<span class="elsevierStyleHsp" style=""></span>min &#40;in this case the operation was repeated 2 times&#41;&#46; The composition of the &#8220;3-sulfate water&#8221; was&#58; 2<span class="elsevierStyleHsp" style=""></span>&#8240; zinc sulphate&#44; 2<span class="elsevierStyleHsp" style=""></span>&#8240; aluminum&#8211;potassium sulphate&#44; and 1<span class="elsevierStyleHsp" style=""></span>&#8240; copper sulfate&#46; The duration of the treatment was 10 days&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Each patient underwent 2 controls&#44; a baseline one &#40;day 0&#41; and a final one &#40;day 10&#41;&#46; In the baseline control&#44; assessment of the initial symptoms was collected and the treatment was handed&#44; and in the final control we evaluated the final symptoms and an overall assessment of both the physician and patient was issued on the efficacy and tolerability of the treatment&#46; The symptomatology assessed was&#58; exudate&#44; erythema&#44; edema&#44; stinging&#44; and itching according to the following score&#58; 0<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>absence&#59; 1<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>mild&#59; 2<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>moderate&#44; and 3<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>intense&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">During treatment the patient had to note any adverse events that might be perceived and the physician assessed their intensity &#40;mild&#44; moderate&#44; or severe&#41; and their causation &#40;probable&#44; possible&#44; unlikely&#44; unrelated&#41; with the treatment in the final control&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">For the statistical analysis of results&#44; we used the Chi-square test for qualitative characteristics&#44; and Student&#8211;Fisher&#39;s <span class="elsevierStyleItalic">T</span> to compare quantitative parameters&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0050" class="elsevierStylePara elsevierViewall">Of the 50 patients who started treatment&#44; 47 finished it&#59; one of the patients did not perform successful treatment and the other two did not return to the final control&#44; so they were excluded from the final analysis&#46; Of those who completed the treatment&#44; 27 received the &#8220;3-sulfate water&#8221; solution and the remaining 20 the physiological solution&#46; The groups have been homogeneous in terms of age &#40;54 years in the experimental group and 59 in the control&#41;&#44; diagnosis &#40;12 balanitis &#91;44&#37;&#93;&#41;&#44; and &#40;15 balanoposthitis &#91;56&#37;&#93; in the first group&#44; and 9 &#91;45&#37;&#93; and 11 &#91;55&#37;&#93; in the control group&#41; and in the method of treatment &#40;immersion or fomentation&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0055" class="elsevierStylePara elsevierViewall">After the treatment&#44; there was a clear overall symptomatic improvement in both groups&#44; as reflected in <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#40;a&#8211;e&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">When comparing the symptoms&#44; we observed a trend to a better evolution of the group treated with the &#8220;3-sulfate water&#8221; in all clinical parameters&#44; and in one of them the differences were statistically significant&#58; in the evolution of the exudate&#46; This sign improved or disappeared in 25 of the 27 patients treated with the &#8220;3-sulfate water&#8221; and in the remaining 2 it remained constant&#44; while in the control one 13 of the 20 improved or were cured&#44; 3 remained constant&#44; and 4 worsened&#46; This difference is statistically significant &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;025&#41; and favorable to &#8220;3-sulfate water&#8221;&#46; In terms of overall judgments of doctor and patient&#44; favorable differences are observed in the treatment with the &#8220;3-sulfate water&#8221;&#44; although they did not reach significant differences compared to control&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Finally&#44; tolerability was excellent in 96&#37; of the &#8216;3-sulfate water&#8217; group and in 89&#37; of the control group&#46; In the first one&#44; there was a case of moderate tolerability without the patient referring any adverse event&#44; and in the second one&#44; a case of increased secretion &#40;probably related&#41;&#44; another of pruritus &#40;probably related&#41;&#44; and another of itching &#40;possibly related&#41; were recorded&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0070" class="elsevierStylePara elsevierViewall">The study shows that both the &#8220;3-sulfate water&#8221; and the saline solution are effective in the treatment of balanitis&#47;balanoposthitis&#44; with favorable overall results&#46; This is logical&#44; since poor hygiene favors the emergence of balanitis and balanoposthitis&#46;<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">2&#44;4</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The &#8220;3-sulfate water&#8221; has proven significantly more effective than the control in the removal of the exudate&#44; confirming the well-known astringent and drying capacity of this classic formula&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">5&#8211;7</span></a> The antiexudative effectiveness is important to eliminate this possible element&#44; the exudate&#44; which favors bacterial&#47;fungal growth and chronification of the process&#44;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">4&#44;7</span></a> and this has been evident in our study&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The remaining parameters studied evolved more favorably with the &#8220;3-sulfate water&#8221; and perhaps they could have achieved significant differences with a larger sample size&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusions</span><p id="par0085" class="elsevierStylePara elsevierViewall">The &#8220;3-sulphate water&#8221; has proven significantly more effective than the saline solution in removing the exudate from the acute balanitis and balanoposthitis in our study&#46; The tolerability of the treatments has been excellent&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Conflict of interest</span><p id="par0090" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflict of interest&#46;</p></span></span>"
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    "fechaRecibido" => "2014-05-06"
    "fechaAceptado" => "2014-05-14"
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          "clase" => "keyword"
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            0 => "Balanitis"
            1 => "Balanoposthitis"
            2 => "&#8220;3 sulphates solution&#8221;"
            3 => "Copper sulphate"
            4 => "Zinc sulphate"
            5 => "Potassium aluminum sulphate"
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          "palabras" => array:6 [
            0 => "Balanitis"
            1 => "Balanopostitis"
            2 => "&#171;Agua de 3 sulfatos&#187;"
            3 => "Sulfato de cobre"
            4 => "Sulfato de cinc"
            5 => "Sulfato alum&#237;nico-pot&#225;sico"
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    "resumen" => array:2 [
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Despite scientific literature mentions the application of&#8220;&#8216;3 sulphates solution&#8221; &#40;copper sulphate&#44; zinc sulphate and alum&#41; as a treatment for acute balanitis and balanoposthitis&#44; no clinical trials evaluating its efficacy have been found&#46; In our study we evaluate the efficacy of this solution in acute balanitis and balanoposthitis&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A double-blind randomized study was designed to compare the efficacy of &#8220;3 sulphates solution&#8221; &#40;intervention&#41; with saline solution &#40;control&#41; in 50 patients &#40;30 patients and 20 patients&#44; respectively&#41; who suffer from acute balanitis or balanoposthitis&#46; Exudate&#44; erythema&#44; edema&#44; burning&#44; and itching were the clinical parameters assessed&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">For all clinical parameters assessed&#44; the outcomes obtained with &#8220;3 sulphates solution&#8221; are higher than control&#44; although significant differences only have been found for exudate&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">In our study&#44; the &#8220;3 sulphates solution&#8221; is significantly more effective than saline solution for removing exudates in acute balanitis and balanoposthitis&#46; Tolerability was excellent in both treatments&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
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            "titulo" => "Objectives"
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            "identificador" => "abst0010"
            "titulo" => "Materials and methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La utilizaci&#243;n del &#171;agua de 3 sulfatos&#187; &#40;sulfato de cinc&#44; cobre y alum&#237;nico-pot&#225;sico&#41; se cita en la literatura como un posible tratamiento para la balanitis y balanopostitis&#59; ahora bien&#44; no existen trabajos prospectivos que documenten su eficacia cl&#237;nica&#46; Pretendemos estudiar dicha eficacia&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Material y m&#233;todo</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Presentamos un estudio aleatorizado doble ciego sobre 50 pacientes con balanitis o balanopostitis en el que se comparan los resultados cl&#237;nicos del &#171;agua de 3 sulfatos&#187; &#40;30 pacientes&#41; frente a una soluci&#243;n salina &#40;20 pacientes&#41;&#46; Los par&#225;metros cl&#237;nicos estudiados han sido&#58; exudado&#44; eritema&#44; edema&#44; escozor y prurito&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Una vez aplicados los test estad&#237;sticos&#44; hemos observado que el &#171;agua de 3 sulfatos&#187; ha sido superior al suero salino en todos los par&#225;metros cl&#237;nicos estudiados&#44; aunque las diferencias solo han sido significativas para el par&#225;metro exudado&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El &#171;agua de los 3 sulfatos&#187; se ha mostrado significativamente m&#225;s eficaz que el suero fisiol&#243;gico en la eliminaci&#243;n del exudado de las balanitis y balanopostitis agudas de nuestro estudio&#46; La tolerabilidad de los tratamientos ha sido excelente&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Gonzalvo V&#44; Polo A&#44; Serrallach F&#44; Guti&#233;rrez A&#44; Peyri E&#46; Estudio cl&#237;nico de la eficacia del &#171;agua de 3 sulfatos&#187; en la balanitis y la balanopostitis&#46; Actas Urol Esp&#46; 2015&#59;39&#58;118&#8211;121&#46;</p>"
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Evolution of symptoms after treatment&#46; &#40;a&#41; Erythema&#44; &#40;b&#41; edema&#44; &#40;c&#41; stinging&#44; &#40;d&#41; itching&#44; and &#40;e&#41; exudate&#46;</p>"
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          "leyenda" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>NS for all comparisons&#46;</p>"
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                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Control &#40;Saline solution&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Water 3 &#40;Sulfates&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Age &#40;mean</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#177;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">SD&#44; years&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">59<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>14&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">54<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>14&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleItalic">Diagnosis&#44; n</span> &#40;&#37;&#41;</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Balanitis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">9 &#40;45&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">12 &#40;44&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Balanoposthitis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">11 &#40;55&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">15 &#40;56&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleItalic">Type</span></td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Non-specific&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">11 &#40;55&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">17 &#40;63&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Irritative&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7 &#40;35&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8 &#40;30&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Other &#40;atrophic&#44; diabetic&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2 &#40;10&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2 &#40;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="3" align="left" valign="top"><span class="elsevierStyleItalic">Application method&#44; n</span> &#40;&#37;&#41;</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Inmersion&nbsp;\t\t\t\t\t\t\n
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ISSN: 21735786
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

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