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id="mco-b2-hero-block-block_dcc7170d3f59a1bd0e72cb14115d063f" class="mco-b2-hero-block full mccberg-block pl-2"> <div class="mco-b2-hero-block-wrapper"> <div class="mco-b2-hero-block-image-section "> <div class="mco-b2-hero-block-image-container mco-b2-hero-block-toggle-btn"> <picture> <source media="(max-width: 767px)" data-srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17425285_Labor-2048x1365px.jpg?resize=348,324"> <source media="(min-width: 768px) and (max-width: 1279px)" data-srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17425285_Labor-2048x1365px.jpg?resize=341,524"> <source media="(min-width: 1280px)" data-srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17425285_Labor-2048x1365px.jpg?resize=666,664"> <img data-src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17425285_Labor-2048x1365px.jpg?resize=666,664" alt="Hero Image" class="eager" loading="eager" /> </picture> <div class='mco-b2-hero-block-play-button btn-play'></div><div class='mco-b2-hero-block-video-type' style='display: none;'>youtube</div><div class='mco-b2-hero-block-youtube-url' style='display: none;'></div><div class='mco-b2-hero-block-brightcove-info' style='display: none;'>:</div> </div> <div class="mco-b2-hero-block-image-container-two"> <div class='mco-b2-hero-block-green-box'></div> </div> </div> <div class="mco-b2-hero-block-content-section"> <div class="breadcrumbs wrapper text-descriptive"><span><span><a href="https://www.msd.de/forschung-und-arzneimittel/">Forschung und Arzneimittel</a></span> > <span class="breadcrumb_last" aria-current="page">Hintergrundwissen</span></span></div> <h1>Der lange Weg zum Medikament</h1> <div class="mco-b2-hero-block-description"><p>Unsere Arbeit dreht sich um das höchste Gut des Menschen: die Gesundheit. Wir forschen weiter an neuen Medikamenten und Impfstoffen, um immer mehr Menschen weltweit helfen zu können. Bevor es jedoch so weit ist, wird ein Arzneimittel in mehreren Studienphasen umfassend auf Sicherheit und Wirksamkeit geprüft.</p> </div> </div> </div> </div> <div class="mco-b2-hero-block-modal popup" style="display: none;"> <div class="popup-wrapper"> <div class="mco-b2-hero-block-modal-content popup-content"> </div> </div> </div> <script> let b2_hero_block_modal_triggers = document.getElementsByClassName('mco-b2-hero-block-toggle-btn'); let b2_hero_block_video_type = document.getElementsByClassName('mco-b2-hero-block-video-type'); let b2_hero_block_youtube_url = document.getElementsByClassName('mco-b2-hero-block-youtube-url'); let b2_hero_block_brightcove_info = document.getElementsByClassName('mco-b2-hero-block-brightcove-info'); let b2_hero_block_modals = document.getElementsByClassName('mco-b2-hero-block-modal'); for (let i = 0; i < b2_hero_block_modal_triggers.length; i++) { let trigger = b2_hero_block_modal_triggers[i]; let video_type = b2_hero_block_video_type[i].textContent; let youtube_url = b2_hero_block_youtube_url[i].textContent; let brightcove_info = b2_hero_block_brightcove_info[i].textContent; let modal = b2_hero_block_modals[i]; let modal_content_div = modal.getElementsByClassName('mco-b2-hero-block-modal-content')[0]; trigger.addEventListener('click', function () { if (modal.style.display === 'none') { // Load Video Content if (video_type === 'youtube') { // Insert YouTube Iframe into Div let youtube_video_id = youtube_url.split('=')[1].split('&')[0] modal_content_div.innerHTML = `<iframe width='933' height='525' src='https://www.youtube.com/embed/${youtube_video_id}' frameborder='0' allow='accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture' allowfullscreen></iframe>`; } else { // Insert Brightcove Video Info Into Div let account_id = brightcove_info.split(":")[0]; let video_id = brightcove_info.split(":")[1]; modal_content_div.innerHTML = `<video class='video-js vjs-fluid mco-featured-stories-e1-video' data-account='${account_id}' data-player='default' data-embed='default' controls='' data-video-id='${video_id}' data-playlist-id='' data-application-id='' width='960' height='540'></video>`; let brightcove_videos = document.getElementsByClassName("mco-featured-stories-e1-video"); for (let i = 0; i < brightcove_videos.length; i++) { let video = brightcove_videos[i]; let script = document.createElement("script"); script.async = true; script.src = "https://players.brightcove.net/" + account_id + "/default_default/index.min.js"; video.parentNode.insertBefore(script, video.nextSibling); } } } modal.style.display = modal.style.display === "none" ? "block" : "none"; }); modal.addEventListener('click', function (e) { if (e.target.classList.contains("mco-b2-hero-block-modal") || e.target.classList.contains('popup-wrapper')) { modal.setAttribute('style', 'display: none;'); if (video_type === "youtube") { var iframe = modal_content_div.getElementsByTagName("iframe")[0]; var video_src = iframe.getAttribute('src'); iframe.setAttribute("src", " "); iframe.setAttribute("src", video_src); } else { var videoPlayer = modal_content_div.firstChild.getElementsByTagName("video")[0]; videoPlayer.pause(); } } }); } </script> <div class="wp-block-group is-layout-flow"><div class="wp-block-group__inner-container"> <h3 class="wp-block-heading has-text-align-center">Präklinische Phase</h3> <p class="has-text-align-center">Mithilfe modernster Wissenschaft analysieren wir Erkrankungen aus verschiedensten Blickwinkeln, um so einen Ansatzpunkt für Medikamente zu finden. Im Labor entwickeln Wissenschaftler:innen tausende Moleküle und testen diese z.B. an Zellkulturen, um herauszufinden, ob diese wirksam und sicher sein können.</p> <div style="height:46px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-layout-flex wp-container-3"> <div class="wp-block-column pl-2 pr-2 pt-2 pb-2 is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/family2.png?w=313" alt="Icon with family" class="wp-image-9977" width="157" height="143"/></figure></div> <h4 class="wp-block-heading">1. Medizinischen Bedarf erkennen</h4> <p>Am Anfang steht die Entscheidung, ein neues Medikament für Patient:innen zu entwickeln, die zum Beispiel an einer bisher nicht gut behandelbaren Krankheit leiden.</p> </div> <div class="wp-block-column pl-2 pr-2 pt-2 pb-2 is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/cell-korr.png?w=286" alt="Icon with cell" class="wp-image-9686" width="143" height="143"/></figure></div> <h4 class="wp-block-heading">2. Wirkansatz finden</h4> <p>Forscher:innen ermitteln, welche Moleküle in unserem Körper bei der Entwicklung einer Krankheit eine entscheidende Rolle spielen. Mit diesem Wissen identifizieren sie therapeutische Ansatzpunkte, um das Krankheitsgeschehen zu beeinflussen.</p> </div> </div> <div class="wp-block-columns is-layout-flex wp-container-6"> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/three-test-tubes.png?w=325" alt="Icon with laboratory tubes" class="wp-image-9695" width="163" height="143"/></figure></div> <h4 class="wp-block-heading">3. Erkennen von geeigneten möglichen Wirkstoffen</h4> <p>Wissenschaftler:innen identifizieren Substanzen, die in ein Krankheitsgeschehen eingreifen könnten. Zielsetzungen können die Heilung oder Linderung der Krankheit sein. Auch eine verbesserte Lebensqualität von Patient:innnen ist ein mögliches, sehr wichtiges Forschungsziel.</p> </div> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/syringe.png?w=286" alt="Icon with syringe" class="wp-image-9696" width="143" height="143"/></figure></div> <h4 class="wp-block-heading">4. Erste Prüfung auf Wirksamkeit und Verträglichkeit außerhalb des Menschen</h4> <p>Die erfolgversprechendsten Substanzen werden zunächst in Zellkulturen und/oder Tieren geprüft, ob sie wirksam, nicht giftig oder anderweitig schädlich sind. Wirkstoffe, die in dieser präklinischen Phase erfolgreich sind, können in weiteren klinischen Phasen untersucht werden.</p> </div> </div> </div></div> <div style="height:46px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-group is-layout-flow"><div class="wp-block-group__inner-container"> <h3 class="wp-block-heading has-text-align-center">Klinische Phase</h3> <p class="has-text-align-center">Erst wenn ein Wirkstoffkandidat alle Tests der präklinischen Phase positiv abgeschlossen hat, kann er in der klinischen Phase erstmals an Menschen angewandt werden. Für klinische Studien ist die Zustimmung der zuständigen nationalen Behörden und der Ethikkommissionen nötig. In allen Phasen der Studie müssen die Teilnehmenden umfassend aufgeklärt und über mögliche Risiken informiert werden. Die Studienteilnahme ist zu jeder Zeit freiwillig.</p> <div style="height:46px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-layout-flex wp-container-10"> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/diploma.png?w=268" alt="Icon with certificate" class="wp-image-9720" width="134" height="143"/></figure></div> <h4 class="wp-block-heading">5. Begutachtung durch Zulassungsbehörden und Ethikkommissionen</h4> <p>Vor jeder Phase klinischer Studien prüfen ausgewählte Gremien die Studienprotokolle. Sie bewerten aus ethischer, medizinischer und rechtlicher Sicht, ob eine Studie durchgeführt werden darf. Auch während der klinischen Prüfung werden die Daten kontinuierlich überwacht.</p> </div> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/parents2.png?w=303" alt="Icon with family" class="wp-image-9684" width="152" height="143"/></figure></div> <h4 class="wp-block-heading">6. Phase I: Studie mit wenigen gesunden Erwachsenen</h4> <p>In Phase I wird ein neuer Wirkstoff an einer kleinen Gruppe freiwilliger gesunder Erwachsener (Probanden) geprüft. Die Phase-I-Studie dient u.a. dazu, die Aufnahme und den Abbau der Substanz im Körper engmaschig zu überwachen. Zusätzlich werden alle Symptome, Nebenwirkungen und das allgemeine Wohlbefinden der Probanden beobachtet.</p> </div> </div> <div class="wp-block-columns is-layout-flex wp-container-13"> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/parents2.png?w=303" alt="Icon with family" class="wp-image-9684" width="152" height="143"/></figure></div> <h4 class="wp-block-heading">7. Phase II: Studie mit wenigen kranken Erwachsenen.</h4> <p>In einer Phase-II-Studie erhalten Erkrankte entweder das neue Medikament oder eine Vergleichsbehandlung. Die Zahl der Teilnehmenden ist höher als in Phase I. In Phase II werden Wirksamkeit und Verträglichkeit sowie die ideale Dosierung bei realen Patient:innen ermittelt.<br></p> </div> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/team1.png?w=334" alt="Icon with many people" class="wp-image-9723" width="167" height="143"/></figure></div> <h4 class="wp-block-heading">8. Phase III: Studien mit vielen kranken Erwachsenen</h4> <p>In Phase-III-Studien wird eine große Anzahl Patient:innen aufgenommen, die möglichst repräsentativ für das spätere Patientenklientel sein sollen. Wirksamkeit und Sicherheit werden untersucht. Wegen der großen Patientenzahl können auch seltenere Neben- und Wechselwirkungen erkannt werden. Zusätzlich werden besondere Kriterien für das Krankheitsbild untersucht wie zum Beispiel die Lebensqualität.</p> </div> </div> </div></div> <div style="height:46px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-group is-layout-flow"><div class="wp-block-group__inner-container"> <h3 class="wp-block-heading has-text-align-center">Zulassung und Beobachtung in der Praxis</h3> <p class="has-text-align-center">Nach Abschluss der klinischen Studien entscheiden die Zulassungsbehörden darüber, ob ein Medikament eingeführt und eingesetzt werden darf. Außerdem überwachen Behörden, Hersteller und Ärzt:innen das Medikament auch weiterhin.</p> <div style="height:46px" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-columns is-layout-flex wp-container-17"> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/search2.png?w=288" alt="icons with certificates" class="wp-image-9742" width="144" height="143"/></figure></div> <h4 class="wp-block-heading">9. Zulassung des Medikaments</h4> <p>Die Ergebnisse der durchgeführten Studien, der Labor- und Tierversuche sowie derjenigen aus technischen Qualitätstests werden von Fachleuten der jeweiligen Zulassungsbehörde geprüft. Bei positiver Bewertung dieser Daten für die Patient:innen kann es zu einer Zulassung des Medikaments für eine bestimmte Erkrankung kommen. Erst wenn ein Medikament zugelassen ist, kann es auf den Markt gebracht werden.</p> </div> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/rocking-horse.png?w=291" alt="icon with horse" class="wp-image-9741" width="146" height="143"/></figure></div> <h4 class="wp-block-heading">10. Festlegung eines möglichen Kinderstudienplans</h4> <p>Die Zulassungsbehörde legt fest, ob das Medikament für Kinder oder besondere Patientengruppen wie zum Beispiel Schwangere zusätzlich erprobt werden soll. Kinderstudien beginnen in der Regel erst nach Zulassung des Arzneimittels für Erwachsene, manchmal aber auch zeitgleich.</p> </div> </div> <div class="wp-block-columns is-layout-flex wp-container-20"> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/medicines_blue.png?w=286" alt="icon with medicamentes" class="wp-image-9740" width="143" height="143"/></figure></div> <h4 class="wp-block-heading">11. Entwicklung zusätzlicher Darreichungsformen</h4> <p>Bei Bedarf können noch zusätzliche Darreichungsformen entwickelt werden, zum Beispiel eine Tablette oder Injektionslösung.<br></p> </div> <div class="wp-block-column is-layout-flow"><div class="wp-block-image"> <figure class="aligncenter size-large is-resized"><img decoding="async" loading="lazy" src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/bar-chart.png?w=291" alt="icon with graph" class="wp-image-9743" width="146" height="143"/></figure></div> <h4 class="wp-block-heading">12. Weitere Beobachtung und mögliche Phase IV Studien</h4> <p>Ärzt:innen, Behörden und Hersteller überwachen das Medikament nach erfolgter Zulassung. In möglichen Phase-IV-Studien wird der Einsatz unter realen Bedingungen erforscht, u.a. zur Beobachtung, wie es mit anderen Arzneimitteln zusammenwirkt oder ob es auch für weitere Krankheiten in Betracht gezogen werden könnte.</p> </div> </div> </div></div> <div style="height:100px" aria-hidden="true" class="wp-block-spacer"></div> <div class="text-hero-block mccberg-block"> <div class="breadcrumbs wrapper text-descriptive"><span><span><a href="https://www.msd.de/forschung-und-arzneimittel/">Forschung und Arzneimittel</a></span> > <span class="breadcrumb_last" aria-current="page">Hintergrundwissen</span></span></div> <h1>Das MSD Portal für klinische Studien</h1> <p>Auf unserem Studienportal finden Sie Kurzinformationen zu den einzelnen klinischen Studien von MSD, in die Patient:innen aufgenommen werden. Wenn Sie an einer Studienteilnahme interessiert sind, sprechen Sie bitte mit Ihrer behandelnden Ärztin bzw. Ihrem behandelnden Arzt, bevor Sie in Kontakt mit einem der beteiligten Studienzentren treten. Ihre Ärztin bzw. Ihr Arzt wird mit Ihnen eine erste Einschätzung vornehmen können, ob eine klinische Studie für Ihre Erkrankung infrage kommen könnte.</p> <a class="btn" href="https://www.msd.de/forschung-und-arzneimittel/klinische-studien/" title="Klinische Studien von MSD in Deutschland" target="_blank">Klinische Studien von MSD in Deutschland</a> </div> <div style="height:100px" aria-hidden="true" class="wp-block-spacer"></div> <div id="mco-title-block-block_1d779c86ae829eb1e762711550bb971e" class="mco-title-block mccberg-block pull-up-stats negative no-mt mb-2 aligncenter" > <div class="wrapper"> <div class="mco-title-block-content"> <h2 class="mco-title-block-title">Arzneimittel-Entwicklung in Zahlen</h2> </div> </div> </div> <div class="wp-block-group is-layout-flow"><div class="wp-block-group__inner-container"><div id="stat-block-block_87ab99222ed91bb83166e0bbda5614c2" class="stat-block mccberg-block"> <div class="stat-block-content "> <div class="stat-block-statistic">13 Jahre</div> <div class="stat-block-tablet-wrapper"> <p class="stat-block-description">vergehen durchschnittlich von der Idee bis zum zugelassenen Medikament.</p> </div> </div> </div> <div id="stat-block-block_bd614af762dbc8be21ff1c961996ac58" class="stat-block mccberg-block"> <div class="stat-block-content "> <div class="stat-block-statistic">1-1,6Mrd</div> <div class="stat-block-tablet-wrapper"> <p class="stat-block-description">US-Dollar Budget müssen forschende Arzneimittelhersteller für jedes neue Medikament einplanen.</p> </div> </div> </div> <div id="stat-block-block_9fc0a437d247322df7bca035bb4acf42" class="stat-block mccberg-block"> <div class="stat-block-content "> <div class="stat-block-statistic">5-10Tsd</div> <div class="stat-block-tablet-wrapper"> <p class="stat-block-description">Substanzen werden untersucht bis 1 Medikament zugelassen wird.</p> </div> </div> </div></div></div> </div><!-- .entry-content --> </article><!-- #post-1396 --> </main><!-- #main --> </div><!-- #primary --> </div><!-- #content --> <div class="related-content-container" id="related-content-main"> <h2>Weiterführende Links</h2> <div class="related-content-section"> <div class="related-content-item"> <a href="https://www.msd.de/politik-und-verantwortung/transparenz-bei-msd/" target="" title="Transparenz bei MSD"> <div class="related-content-item-image-contianer"> <picture> <source media="(max-width: 767px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374243_Besprechung_im_Buero_2048x1365px.jpg?resize=321,196"> <source media="(min-width: 768px) and (max-width: 1279px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374243_Besprechung_im_Buero_2048x1365px.jpg?resize=314,280"> <source media="(min-width: 1280px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374243_Besprechung_im_Buero_2048x1365px.jpg?resize=404,268"> <img class="lazyload" loading="lazy" data-src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374243_Besprechung_im_Buero_2048x1365px.jpg?resize=404,268" alt="related content image #1"> </picture> </div> <div class="related-content-content-container"> <p><strong>Transparenz bei MSD</strong></p> <p class="realted-content-excerpt">Volle Transparenz – Wir bei MSD sind stolz auf das, was wir tun und für wen wir etwas tun. Diese Informationen teilen wir gerne.</p> </div> </a> </div> <div class="related-content-item"> <a href="https://www.msd.de/forschung-und-arzneimittel/klinische-studien/" target="" title="Klinische Studien von MSD"> <div class="related-content-item-image-contianer"> <picture> <source media="(max-width: 767px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2022/05/Bild_Digital-Archives_Getty-Images_106002250_22_Teal_65x43-1.png?resize=321,196"> <source media="(min-width: 768px) and (max-width: 1279px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2022/05/Bild_Digital-Archives_Getty-Images_106002250_22_Teal_65x43-1.png?resize=314,280"> <source media="(min-width: 1280px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2022/05/Bild_Digital-Archives_Getty-Images_106002250_22_Teal_65x43-1.png?resize=404,268"> <img class="lazyload" loading="lazy" data-src="https://www.msd.de/wp-content/uploads/sites/33/2022/05/Bild_Digital-Archives_Getty-Images_106002250_22_Teal_65x43-1.png?resize=404,268" alt="related content image #2"> </picture> </div> <div class="related-content-content-container"> <p><strong>Klinische Studien von MSD</strong></p> <p class="realted-content-excerpt">MSD führt kontinuierlich klinische Studien durch, für die Patient:innen rekrutiert werden.</p> </div> </a> </div> <div class="related-content-item"> <a href="https://www.msd.de/?page_id=40" target="" title="Unsere Partnerschaften"> <div class="related-content-item-image-contianer"> <picture> <source media="(max-width: 767px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374316_Labor_Arzt_2048x1365px.jpg?resize=321,196"> <source media="(min-width: 768px) and (max-width: 1279px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374316_Labor_Arzt_2048x1365px.jpg?resize=314,280"> <source media="(min-width: 1280px)" srcset="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374316_Labor_Arzt_2048x1365px.jpg?resize=404,268"> <img class="lazyload" loading="lazy" data-src="https://www.msd.de/wp-content/uploads/sites/33/2021/10/17374316_Labor_Arzt_2048x1365px.jpg?resize=404,268" alt="related content image #3"> </picture> </div> <div class="related-content-content-container"> <p><strong>Unsere Partnerschaften</strong></p> <p class="realted-content-excerpt">MSD pflegt den Austausch mit Wissenschaftler:innen, Patient:innen und Patientenvertreter:innen sowie Vertreter:innen aus Politik und anderen Pharmaunternehmen.</p> </div> </a> </div> </div> </div> <footer id="footerMain" class="footer"> <div id="footerSocial"> <div class="wrapper"> <h3>Folgen Sie uns auf Social Media! 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