<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.147103.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>A Comparative Study between Intermittent Smead Jones Rectus Closure and Continuous Rectus Closure in Midline Laparotomy Wound</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: awaiting peer review]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Maheshwari</surname>
                        <given-names>Maulik</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0007-4578-2279</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>khan</surname>
                        <given-names>Imran Ali</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>surgery, Datta Meghe Institue of Higher Education And Research, Wardha, Maharashtra, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:maulik.maheshwari@gmail.com">maulik.maheshwari@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>25</day>
                <month>4</month>
                <year>2024</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2024</year>
            </pub-date>
            <volume>13</volume>
            <elocation-id>391</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>8</day>
                    <month>4</month>
                    <year>2024</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2024 Maheshwari M and khan IA</copyright-statement>
                <copyright-year>2024</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/13-391/pdf"/>
            <abstract>
                <p>This comparative study delves into the efficacy and impact of two primary closure techniques, intermittent Smead Jones rectus closure, and continuous rectus closure, on midline laparotomy wound management. Aimed at offering evidence-based guidance to surgeons, this investigation encompasses a prospective observational study involving 98 patients aged &#x2265;18 undergoing midline exploratory laparotomy at Acharya Vinoba Bhave Rural Hospital Sawangi. Divided into two groups&#x2014;intermittent S-J closure and continuous closure&#x2014;the study will meticulously assess wound parameters and complications, notably focusing on wound dehiscence, burst abdomen, and incisional hernia repair rates. Spanning from February 2023 to May 2025, the research aims to scrutinize statistical outcomes using SPSS and MS Excel, seeking to provide critical insights into these closure techniques&#x2019; comparative effectiveness. Despite its limitations, including a relatively small sample size and an observational nature without interventions, this study aspires to contribute valuable data that can aid surgeons in optimizing closure methods for midline laparotomy wounds, thereby enhancing postoperative outcomes and patient care.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Intermittent Smead Jones closure</kwd>
                <kwd>continuous rectus closure</kwd>
                <kwd>midline laparotomy</kwd>
                <kwd>wound dehiscence</kwd>
                <kwd>burst abdomen</kwd>
                <kwd>incisional hernia</kwd>
                <kwd>surgical techniques</kwd>
                <kwd>postoperative outcomes</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Surgical techniques for midline laparotomy wound closure play a pivotal role in postoperative outcomes, particularly concerning wound complications and recovery. Amid the diverse closure methods, the debate continues regarding the optimal technique to reduce complications and enhance patient recovery.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup> This thesis presents a comprehensive investigation into two primary closure approaches: intermittent Smead Jones rectus closure and continuous rectus closure, aiming to provide a comparative analysis of their efficacy, safety, and impact on midline laparotomy wound healing.</p>
            <p>Midline laparotomy incisions are extensively utilized in various abdominal surgeries, yet complications such as wound dehiscence, incisional hernias, and burst abdomen remain significant concerns post-surgery.
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup> The closure technique employed can profoundly influence the incidence of these complications, prompting an ongoing quest for an optimal closure method that minimizes such risks and contributes to better patient outcomes.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup>
            </p>
            <p>The intermittent Smead Jones rectus closure technique, characterized by its interrupted sutures pattern, and the continuous rectus closure technique, marked by uninterrupted closure, stand as two prominent approaches in abdominal wound closure strategies.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> The continuous method of closure has various benefits, including rapid closure with fewer knots, which lowers the likelihood of sinus formation. This studyendeavors to scrutinize and juxtapose these methods, examining their respective advantages, disadvantages, and overall impact on midline laparotomy wound management.</p>
            <p>This investigation aims to provide critical insights into the comparative effectiveness of these closure techniques in midline laparotomy wounds, contributing valuable data to the existing body of surgical knowledge. By analyzing clinical outcomes, wound healing parameters, and the incidence of complications associated with each closure method, this study endeavors to offer evidence-based recommendations that may guide surgeons in selecting the most optimal closure technique for midline laparotomy wounds.</p>
            <sec id="sec2">
                <title>Aim</title>
                <p>To compare the efficacy and outcomes of intermittent Smead-Jones rectus closure versus continuous rectus closure techniques in managing midline laparotomy wounds.</p>
            </sec>
            <sec id="sec3">
                <title>Objective</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>To evaluate the effectiveness of the Smead-Jones closure technique concerning wound dehiscence and burst abdomen.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>To examine the effectiveness of the continuous closure technique concerning incisional hernia repair.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <sec id="sec4" sec-type="methods">
            <title>Methods</title>
            <sec id="sec5">
                <title>Study design</title>
                <p>This research will employ a prospective cross-sectional observational study design, allowing for the collection of data and observation of naturally occurring phenomena without intervention.</p>
            </sec>
            <sec id="sec6">
                <title>Study population</title>
                <p>The study will include 96 patients aged &#x2265; 18 years who require midline exploratory laparotomy.</p>
            </sec>
            <sec id="sec7">
                <title>Study setting</title>
                <p>The study will be conducted at Acharya Vinoba Bhave Rural Hospital Sawangi, Wardha, which offers well-equipped facilities, providing an ideal environment for the investigation.</p>
            </sec>
            <sec id="sec8">
                <title>Duration of study</title>
                <p>The study, spanning from February 2023 to May 2025, will provide a two-year duration allowing for comprehensive data analysis and a thorough exploration of the research objectives.</p>
            </sec>
            <sec id="sec9">
                <title>Inclusion criteria</title>
                <p>
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Patients more than 18 years of age.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>All patients that require midline exploratory laparotomy; either emergency or elective.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec10">
                <title>Exclusion criteria</title>
                <p>
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Pregnancy</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Patients not willing for the study</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Patients requiring 2 ormoresurgeries through the same incision withinthe period initial 30 postoperative days.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec11">
                <title>Sample size
                    <sup>
                        <xref ref-type="bibr" rid="ref5">5</xref>
                    </sup>
                </title>
                <p>
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mi mathvariant="normal">n</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mfrac>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mrow>
                                            <mml:mo stretchy="true">{</mml:mo>
                                            <mml:mi mathvariant="normal">z</mml:mi>
                                            <mml:mn>1</mml:mn>
                                            <mml:mo>,</mml:mo>
                                            <mml:mo>&#x221a;</mml:mo>
                                            <mml:mrow>
                                                <mml:mo stretchy="true">[</mml:mo>
                                                <mml:mn>2</mml:mn>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mrow>
                                                    <mml:mo stretchy="true">(</mml:mo>
                                                    <mml:mn>1</mml:mn>
                                                    <mml:mo>&#x2212;</mml:mo>
                                                    <mml:mi mathvariant="normal">P</mml:mi>
                                                    <mml:mo stretchy="true">)</mml:mo>
                                                </mml:mrow>
                                                <mml:mo stretchy="true">]</mml:mo>
                                            </mml:mrow>
                                            <mml:mo>+</mml:mo>
                                            <mml:mi mathvariant="normal">z</mml:mi>
                                            <mml:mn>2</mml:mn>
                                            <mml:mo>,</mml:mo>
                                            <mml:mo>&#x221a;</mml:mo>
                                            <mml:mrow>
                                                <mml:mo stretchy="true">[</mml:mo>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mn>1</mml:mn>
                                                <mml:mrow>
                                                    <mml:mo stretchy="true">(</mml:mo>
                                                    <mml:mn>1</mml:mn>
                                                    <mml:mo>&#x2212;</mml:mo>
                                                    <mml:mi mathvariant="normal">P</mml:mi>
                                                    <mml:mn>1</mml:mn>
                                                    <mml:mo stretchy="true">)</mml:mo>
                                                </mml:mrow>
                                                <mml:mo>+</mml:mo>
                                                <mml:mi mathvariant="normal">P</mml:mi>
                                                <mml:mn>2</mml:mn>
                                                <mml:mrow>
                                                    <mml:mo stretchy="true">(</mml:mo>
                                                    <mml:mn>1</mml:mn>
                                                    <mml:mo>&#x2212;</mml:mo>
                                                    <mml:mi mathvariant="normal">P</mml:mi>
                                                    <mml:mn>2</mml:mn>
                                                    <mml:mo stretchy="true">)</mml:mo>
                                                </mml:mrow>
                                                <mml:mo stretchy="true">]</mml:mo>
                                            </mml:mrow>
                                            <mml:mo stretchy="true">}</mml:mo>
                                        </mml:mrow>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                </mml:mrow>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mrow>
                                            <mml:mo stretchy="true">(</mml:mo>
                                            <mml:mi mathvariant="normal">P</mml:mi>
                                            <mml:mn>1</mml:mn>
                                            <mml:mo>&#x2013;</mml:mo>
                                            <mml:mi mathvariant="normal">P</mml:mi>
                                            <mml:mn>2</mml:mn>
                                            <mml:mo stretchy="true">)</mml:mo>
                                        </mml:mrow>
                                        <mml:mn>2</mml:mn>
                                    </mml:msup>
                                </mml:mrow>
                            </mml:mfrac>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Building on the investigation led by Chirag B. Aghara, et al.,
                    <sup>
                        <xref ref-type="bibr" rid="ref6">6</xref>
                    </sup> the determination of the required sample size in our study centered on postoperative outcomes and wound infection, recognized as crucial elements. The ratio was observed to be 24% in the case group and 56% in the control group. In our present analysis, determining the minimum sample size involved two primary criteria: patients aged &gt;18 years and those who underwent emergency laparotomy through a midline incision with subsequent wound infection.</p>
                <p>Utilizing the aforementioned formula, for the entirety of our study, we will include a total of 96 patients. These 96 samples will be randomly divided into two groups, resulting in the collection of 48 samples in each group (
                    <xref ref-type="table" rid="T1">Table 1</xref>).</p>
                <table-wrap id="T1" orientation="portrait" position="float">
                    <label>Table 1. </label>
                    <caption>
                        <title>Sample size calculation parameters.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">P1</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Probability of variable in sample-1 (Value &lt;1.0)</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">0.24</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">P2</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Probability of variable in sample-2 (Value &lt;1.0)</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">0.56</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">P</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Arthmetic average of P1 &amp; P2</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">0.4</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">AH</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Alternate hypothesis ONE sided (1), or TWO sided? (2)</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">2</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">1-&#x03b1;</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Set level of confidence (value&lt;1.0). Usual values 0.95;0.99</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">0.95</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">1-&#x03b2;</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Set level of power of test (value&lt;1.0). Usual values 0.8;0.9</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">0.9</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Z1</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Z value associated with set level of alpha (One sided)</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">1.959963985</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Z2</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Z value associated with set level of beta</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">1.281551566</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">
                                    <bold>n1</bold>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Minimum sample size</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">48</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="middle">
                                    <bold>n2</bold>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">Minimum sample size</td>
                                <td align="left" colspan="1" rowspan="1" valign="middle">48</td>
                            </tr>
                        </tbody>
                    </table>
                </table-wrap>
                <p>
                    <bold>Sample size -</bold> 96 patients</p>
                <p>Group A - intermittent S-J closure 48 TEST</p>
                <p>Group B - continuous closure 48 CONTROL</p>
                <p>All patients will be included following the inclusion and exclusion criteria.</p>
                <p>Data documentation and statistical analysis will done with JASP is released under a 
                    <ext-link ext-link-type="uri" xlink:href="https://www.gnu.org/licenses/agpl.html">GNU Affero GPL v3 license</ext-link>, which is an open-source license that free and MS Excel.</p>
            </sec>
            <sec id="sec12">
                <title>Data collection process and method</title>
                <p>Patients will be randomly allotted into two groups and will alternatively be undergoing Smead Jones intermittent closure and continuous rectus closure.</p>
                <p>Postoperatively patients will be accessed for 7-10 days as an inpatient and watched for any burst abdomen.</p>
                <p>The patient will be followed up after 6 weeks, 3 months, and watched for incisional hernia.</p>
            </sec>
            <sec id="sec13">
                <title>Plan for analysis</title>
                <p>This Cross-sectional, comparative study will be conducted after the approval of the Ethics Committee Department of Medical Education, Jawaharlal Nehru Medical Sciences, Deemed University, Sawangi (Meghe). The outcomes will be recorded and analyzed at the end of the study using a statistical package for social science (SPSS).</p>
            </sec>
        </sec>
        <sec id="sec14" sec-type="discussion">
            <title>Discussion</title>
            <p>The investigation into intermittent Smead Jones rectus closure and continuous rectus closure techniques in midline laparotomy wounds serves as a critical endeavor toward evaluating the efficacy of these closure methods. The findings of this study contribute to the existing body of knowledge regarding abdominal wound closure strategies, particularly focusing on midline laparotomy incisions and their associated complications.</p>
            <p>The comparative analysis between intermittent Smead Jones and continuous rectus closures revealed valuable insights into their respective advantages and disadvantages. The intermittent closure technique, characterized by interrupted sutures, offers a distinct pattern compared to the uninterrupted closure of the continuous technique. Notably, the continuous closure showed benefits including rapid closure with fewer knots, potentially reducing the risk of sinus formation. However, it&#x2019;s essential to acknowledge that each method has its unique features, and the choice of closure technique may depend on various patient-specific factors and surgeon preferences.</p>
            <p>The study&#x2019;s focus on wound complications such as wound dehiscence, incisional hernias, and burst abdomen post-surgery sheds light on the critical importance of selecting an appropriate closure method. Abdominal wound dehiscence or a burst abdomen is a significant concern after emergency midline laparotomy, causing considerable sickness and death. Preventive actions are necessary as this condition can result in severe consequences such as pain, mental distress, infections, financial burdens, and the need for additional surgeries (reoperation) due to organ protrusion through the wound (evisceration). Addressing wound dehiscence is crucial to reducing patient suffering and complications, emphasizing the importance of finding effective measures to prevent such occurrences following midline laparotomy.
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>
                </sup>
                <sup>&#x2013;</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>
                </sup>
            </p>
            <p>The study has several limitations that warrant consideration. The relatively small sample size of 96 patients might restrict the generalizability of findings to a broader population. Its observational nature without intervention limits establishing direct cause-and-effect relationships between closure techniques and postoperative complications. Moreover, the possibility of unaccounted confounding variables influencing outcomes highlights the necessity for further research and analysis. Caution is advised when extending these findings to broader clinical practice or different patient groups due to these limitations.</p>
            <sec id="sec15">
                <title>Implications and generalizability</title>
                <p>The study&#x2019;s findings offer valuable insights into choosing optimal closure techniques for midline laparotomy wounds, potentially reducing complications and improving patient recovery. However, caution is needed when applying these findings widely due to the study&#x2019;s limited sample size and observational nature. Further research involving larger and diverse patient groups is necessary to strengthen the applicability of these findings to different surgical scenarios and improve their real-world impact in clinical practice.</p>
            </sec>
            <sec id="sec16">
                <title>Ethical considerations</title>
                <p>The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has approved the study protocol with approval number DMIHER (DU)/IEC/2024/182 on date 01/02/2024. Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study&#x2019;s objectives.</p>
            </sec>
            <sec id="sec17">
                <title>Dissemination</title>
                <p>This study protocol will be published in an indexed journal.</p>
            </sec>
            <sec id="sec18">
                <title>Study status</title>
                <p>The study has yet to start.</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec21" sec-type="data-availability">
            <title>Data availability</title>
            <p>No data are associated with this article.</p>
            <sec id="sec22">
                <title>Extended data</title>
                <p>Figshare: STROBE checklist for A COMPARATIVE STUDY BETWEEN INTERMITTENT SMEAD JONES RECTUS CLOSURE AND CONTINUOUS RECTUS CLOSURE IN MIDLINE LAPAROTOMY WOUND. 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.6084/m9.figshare.24972075.v1">https://doi.org/10.6084/m9.figshare.24972075.v1</ext-link>.
                    <sup>

                        <xref ref-type="bibr" rid="ref10">10</xref>
</sup>
                </p>
                <p>Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution 4.0 International license</ext-link> (CC-BY 4.0).</p>
            </sec>
        </sec>
        <ref-list>
            <title>References</title>
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                        <etal/>
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                    <article-title>Abdominal fascia closure following elective midline laparotomy: a surgical experience at a tertiary care hospital in Tanzania.</article-title>
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