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<title>Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study - PubMed</title>
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<meta name="description" content="Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. 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effects, PubMed Abstract, NIH, NLM, NCBI, National Institutes of Health, National Center for Biotechnology Information, National Library of Medicine, MEDLINE"><meta name="robots" content="index,nofollow,noarchive"><meta property="og:title" content="Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study - PubMed"><meta property="og:url" content="https://pubmed.ncbi.nlm.nih.gov/37386786/"><meta property="og:description" content="Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. 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<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Saving..."
data-ga-category="save_share"
data-ga-action="save"
data-ga-label="save">
Create file
</button>
<button class="action-panel-cancel"
aria-label="Close 'Save citations to file' panel"
ref="linksrc=close_save_panel"
aria-controls="save-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="save"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="email-action-panel"
class="email-action-panel action-panel"
aria-hidden="true"
data-recaptcha-script-url="https://www.recaptcha.net/recaptcha/enterprise.js?render=explicit&onload=onloadCaptchaCallback"
data-recaptcha-enabled="true">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Email citation
</h2>
<form id="email-action-panel-form"
class="action-panel-content action-form"
action="/send-email/"
data-by-search-action="/results-export-email-by-search-data/"
data-by-ids-action="/send-email/"
data-by-search-method="post"
data-by-ids-method="post"
method="post"
>
<input type="hidden" name="csrfmiddlewaretoken" value="mIdbAfU3YIO04g9tu8dItcIKVAEcNFQxDvXgd5npyjBuYHfj7rQKXkeotEmoGgoR">
<div class="action-panel-control-wrap">
<span class="action-panel-label">
Subject:
</span>
<span class="email-subject" id="email-subject" aria-label="Email subject">1 selected item: 37386786 - PubMed</span>
<input type="hidden" name="email-subject" value="1 selected item: 37386786"/>
<input type="hidden" name="email-subject-hash" value="2211cd1599cfa9c302925c690a6e41760e01313af92041cec765b753c6f0bdff"/>
</div>
<div class="action-panel-control-wrap">
<label for="email-to" class="action-panel-label required-field-asterisk">
To:
</label>
<input type="email" aria-label="Recipient Email Address" placeholder="email@example.com" id="email-to" class="email-to" pattern="^[a-zA-Z0-9_.+-]+@[a-zA-Z0-9-]+\.[a-zA-Z0-9-.]+$" maxlength="100" required>
</div>
<div class="action-panel-control-wrap">
<label for="email-from" class="action-panel-label">
From:
</label>
<input type="email" aria-label="Sender Email Address" placeholder="email@example.com" id="email-from" class="email-from" pattern="^[a-zA-Z0-9_.+-]+@[a-zA-Z0-9-]+\.[a-zA-Z0-9-.]+$" maxlength="256">
</div>
<div class="action-panel-control-wrap">
<label for="email-citation-format" class="action-panel-label">
Format:
</label>
<select id="email-citation-format" name="citation-format" class="action-panel-selector email-citation-format">
<option selected="selected" value="summary">Summary</option>
<option value="summary-text">Summary (text)</option>
<option value="abstract">Abstract</option>
<option value="abstract-text">Abstract (text)</option>
</select>
</div>
<div class="include-supplemental-container">
<input type="checkbox" aria-label="Include MeSH and other data" name="include-supplemental" id="email-include-supplemental" class="email-include-supplemental">
<label for="email-include-supplemental" class="email-include-supplemental-label">MeSH and other data</label>
</div>
<div class="form-field recaptcha ">
<div class="g-recaptcha" id="id-recaptcha" data-sitekey="6LfsWHMdAAAAAClKbtOpjQ2pMjgsGxvv7NdZW9uI"></div>
</div>
<div id="captcha-error-message" class="usa-input-error-message captcha-validation-message" role="alert"></div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Sending..."
data-ga-category="save_share"
data-ga-action="email"
data-ga-label="send">
Send email
</button>
<button class="action-panel-cancel"
aria-label="Close 'Email citations' panel"
ref="linksrc=close_email_panel"
aria-controls="email-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="email"
data-ga-label="cancel">
Cancel
</button>
</div>
<input type="hidden" name="email-search-details" value="" />
<input type="hidden" name="email-search-details-hash" value="0e42663a6c3bd85498fcb88798998fed7bfdc45d457db35281e41afe13cc0524" />
</form>
</div>
</div>
<div id="collections-action-panel"
class="collections-action-panel action-panel in-progress-dots-panel"
aria-hidden="true"
data-collections-open-panel-enabled="false"
data-collections-open-panel-url-hash="#open-collections-panel">
<div class="inner-wrap">
<h3 class="action-panel-heading">
Add to Collections
</h3>
<form id="collections-action-panel-form"
class="collections-action-panel-form action-panel-content action-form action-panel-smaller-selectors"
data-existing-collections-url="/list-existing-collections/"
data-add-to-existing-collection-url="/add-to-existing-collection/"
data-create-and-add-to-new-collection-url="/create-and-add-to-new-collection/"
data-get-article-ids-by-search-url="/get-article-ids-by-search/"
data-myncbi-max-collection-name-length="100"
data-add-to-collection-max-amount="1000"
data-collections-root-url="https://www.ncbi.nlm.nih.gov/myncbi/collections/">
<input type="hidden" name="csrfmiddlewaretoken" value="mIdbAfU3YIO04g9tu8dItcIKVAEcNFQxDvXgd5npyjBuYHfj7rQKXkeotEmoGgoR">
<div class="choice-group" role="radiogroup">
<ul class="radio-group-items">
<li>
<input type="radio"
id="collections-action-panel-new"
class="collections-new"
name="collections"
value="new"
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="collections_radio_new">
<label for="collections-action-panel-new">Create a new collection</label>
</li>
<li>
<input type="radio"
id="collections-action-panel-existing"
class="collections-existing"
name="collections"
value="existing"
checked="true"
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="collections_radio_existing">
<label for="collections-action-panel-existing">Add to an existing collection</label>
</li>
</ul>
</div>
<div class="controls-wrapper">
<div class="action-panel-control-wrap new-collections-controls">
<label for="collections-action-panel-add-to-new" class="action-panel-label required-field-asterisk">
Name your collection:
</label>
<input
type="text"
name="add-to-new-collection"
id="collections-action-panel-add-to-new"
class="collections-action-add-to-new"
pattern="[^&quot;&amp;=&lt;&gt;\/]*" title="The following characters are not allowed in the Name field: &quot;&amp;=&lt;&gt;/"
maxlength="100"
data-ga-category="save_share"
data-ga-action="create_collection"
data-ga-label="non_favorties_collection">
<div class="collections-new-name-too-long usa-input-error-message selection-validation-message">
Name must be less than 100 characters
</div>
</div>
<div class="action-panel-control-wrap existing-collections-controls">
<label for="collections-action-panel-add-to-existing" class="action-panel-label">
Choose a collection:
</label>
<select id="collections-action-panel-add-to-existing"
class="action-panel-selector collections-action-add-to-existing"
data-ga-category="save_share"
data-ga-action="select_collection"
data-ga-label="($('#collections-action-add-to-existing').val() === 'Favorites') ? 'Favorites' : 'non_favorites_collection'">
</select>
<div class="collections-retry-load-on-error usa-input-error-message selection-validation-message">
Unable to load your collection due to an error<br>
<a href="#">Please try again</a>
</div>
</div>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Adding..."
data-pinger-ignore
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="add">
Add
</button>
<button class="action-panel-cancel"
aria-label="Close 'Add to Collections' panel"
ref="linksrc=close_collections_panel"
aria-controls="collections-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="bibliography-action-panel"
class="bibliography-action-panel action-panel in-progress-dots-panel"
aria-hidden="true"
data-bibliography-open-panel-enabled="false"
data-bibliography-open-panel-url-hash="#open-bibliography-panel">
<div class="inner-wrap">
<h3 class="action-panel-heading">
Add to My Bibliography
</h3>
<form id="bibliography-action-panel-form"
class="bibliography-action-panel-form action-panel-content action-form action-panel-smaller-selectors"
data-add-to-bibliography-max-amount="100"
data-add-to-bibliography-batch-size="10"
data-bibliography-delegates-url="/list-bibliography-delegates/"
data-add-to-bibliography-url="/add-to-bibliography/"
data-get-article-ids-by-search-url="/get-article-ids-by-search/"
data-mybib-root-url="https://www.ncbi.nlm.nih.gov/myncbi/collections/mybibliography/">
<input type="hidden" name="csrfmiddlewaretoken" value="mIdbAfU3YIO04g9tu8dItcIKVAEcNFQxDvXgd5npyjBuYHfj7rQKXkeotEmoGgoR">
<div class="action-panel-control-wrap bibliographies-controls">
<div class="choice-group">
<ul class="bibliographies-action-add radio-group-items">
<li>
<input name="bibliography" id="my-bibliography" class="my-bibliography" type="radio" checked/>
<label for="my-bibliography">My Bibliography</label>
</li>
</ul>
</div>
</div>
<div class="bibliographies-retry-load-on-error usa-input-error-message selection-validation-message">
Unable to load your delegates due to an error<br>
<a href="#">Please try again</a>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Adding..."
data-pinger-ignore>
Add
</button>
<button class="action-panel-cancel"
aria-label="Close 'Add to bibliography' panel"
ref="linksrc=close_bibliography_panel"
aria-controls="bibliography-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="mybib"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="saved-search-action-panel" class="saved-search-action-panel action-panel " aria-hidden="true"
data-saved-search-open-panel-enabled="false"
data-saved-search-open-panel-url-hash="#open-saved-search-panel">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Your saved search
</h2>
<form id="saved-search-action-panel-form"
class="saved-search-action-panel-form action-panel-content action-form"
data-create-saved-search-url="/create-saved-search/"
data-try-search-terms-url="/try-search-term/"
data-saved-search-root-url="https://www.ncbi.nlm.nih.gov/myncbi/searches/">
<input type="hidden" name="csrfmiddlewaretoken" value="mIdbAfU3YIO04g9tu8dItcIKVAEcNFQxDvXgd5npyjBuYHfj7rQKXkeotEmoGgoR">
<div class="action-panel-control-wrap">
<label for="saved-search-name" class="action-panel-label saved-search-name-label required-field-asterisk">
Name of saved search:
</label>
<input maxlength="200"
type="text"
name="saved-search-name"
id="saved-search-name"
class="saved-search-name"
value=""
required
pattern="[^&quot;&amp;=&lt;&gt;\/]*" title="The following characters are not allowed in the Name field: &quot;&amp;=&lt;&gt;/">
</div>
<div class="action-panel-control-wrap">
<label for="saved-search-term" class="action-panel-label required-field-asterisk">
Search terms:
</label>
<textarea name="saved-search-term" id="saved-search-term" class="saved-search-term" required></textarea>
</div>
<div class="test-search-term-wrap">
<a href="#" class="try-search-term">Test search terms</a>
</div>
<div class="choice-group action-panel-extra-margin-top">
<span class="action-panel-label" id="fieldset-label">
Would you like email updates of new search results?
</span>
<fieldset id="saved-search-alert" aria-describedby="fieldset-label">
<legend class="usa-sr-only">Saved Search Alert Radio Buttons</legend>
<ul class="radio-group-items">
<li>
<input type="radio" id="saved-search-alert-yes" class="saved-search-alert-yes" name="saved-search-alert" value="yes" checked>
<label for="saved-search-alert-yes" class="action-panel-label">Yes</label>
</li>
<li>
<input aria-label="No radio input" type="radio" id="saved-search-alert-no" class="saved-search-alert-no" name="saved-search-alert" value="no">
<label for="saved-search-alert-no" class="action-panel-label">No</label>
</li>
</ul>
</fieldset>
</div>
<div class="alert-schedule-wrap">
<div class="action-panel-control-wrap">
<label class="action-panel-label">
Email:
</label>
<span aria-label="Email address" id="saved-search-email" class="action-panel-label"><span class="action-panel-label-bold"></span> (<a class="myncbi-account-settings" href="https://www.ncbi.nlm.nih.gov/account/settings/">change</a>)</span>
</div>
<div class="action-panel-control-wrap action-panel-extra-margin-top">
<label for="saved-search-frequency" class="action-panel-label">
Frequency:
</label>
<select id="saved-search-frequency" class="no-border-panel-selector saved-search-frequency">
<option value="monthly">Monthly</option>
<option value="weekly">Weekly</option>
<option value="daily">Daily</option>
</select>
</div>
<div class="action-panel-control-wrap saved-search-monthly-additional">
<label for="saved-search-monthly-on-day" class="action-panel-label">
Which day?
</label>
<select id="saved-search-monthly-on-day" class="no-border-panel-selector">
<option value="Sunday">The first Sunday</option>
<option value="Monday">The first Monday</option>
<option value="Tuesday">The first Tuesday</option>
<option value="Wednesday">The first Wednesday</option>
<option value="Thursday">The first Thursday</option>
<option value="Friday">The first Friday</option>
<option value="Saturday">The first Saturday</option>
<option value="day">The first day</option>
<option value="weekday">The first weekday</option>
</select>
</div>
<div class="action-panel-control-wrap saved-search-weekly-additional">
<label for="saved-search-weekly-on-day" class="action-panel-label">
Which day?
</label>
<select id="saved-search-weekly-on-day" class="no-border-panel-selector saved-search-weekly-on-day">
<option value="Sunday">Sunday</option>
<option value="Monday">Monday</option>
<option value="Tuesday">Tuesday</option>
<option value="Wednesday">Wednesday</option>
<option value="Thursday">Thursday</option>
<option value="Friday">Friday</option>
<option value="Saturday">Saturday</option>
</select>
</div>
<div class="action-panel-control-wrap">
<label for="saved-search-report" class="action-panel-label">
Report format:
</label>
<select id="saved-search-report" class="no-border-panel-selector saved-search-report">
<option value="DocSum">Summary</option>
<option value="DocSumText">Summary (text)</option>
<option value="Abstract">Abstract</option>
<option value="AbstractText">Abstract (text)</option>
<option value="MEDLINE">PubMed</option>
</select>
</div>
<div class="action-panel-control-wrap">
<label for="saved-search-amount" class="action-panel-label">
Send at most:
</label>
<select id="saved-search-amount" class="no-border-panel-selector saved-search-amount">
<option value="1">1 item</option>
<option value="5" selected>5 items</option>
<option value="10">10 items</option>
<option value="20">20 items</option>
<option value="50">50 items</option>
<option value="100">100 items</option>
<option value="200">200 items</option>
</select>
</div>
<div>
<input type="checkbox" id="saved-search-send-if-no-result" class="saved-search-send-if-no-result" name="saved-search-send-if-no-result">
<label for="saved-search-send-if-no-result" class="action-panel-label smaller-checkbox">
Send even when there aren't any new results
</label>
</div>
<div class="action-panel-control-wrap option-text-in-email-wrap">
<label for="saved-search-email-text" class="action-panel-label">
Optional text in email:
</label>
<textarea name="saved-search-email-text"
id="saved-search-email-text"
class="saved-search-email-text"></textarea>
</div>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Saving..."
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="save">
Save
</button>
<button class="action-panel-cancel"
aria-label="Close 'Your saved search' panel"
ref="linksrc=close_saved_search_panel"
aria-controls="saved-search-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="citation-manager-action-panel" class="citation-manager-action-panel action-panel" aria-hidden="true">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Create a file for external citation management software
</h2>
<form id="citation-manager-action-panel-form"
class="action-panel-content action-form"
action="/results-export-ids/"
data-by-search-action="/results-export-search-data/"
data-by-ids-action="/results-export-ids/"
method="post"
data-by-search-method="post"
data-by-ids-method="post">
<input type="hidden" name="csrfmiddlewaretoken" value="mIdbAfU3YIO04g9tu8dItcIKVAEcNFQxDvXgd5npyjBuYHfj7rQKXkeotEmoGgoR">
<input name="results-format" type="hidden" value="pubmed"/>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Sending..."
data-ga-category="save_share"
data-ga-action="citation_manager"
data-ga-label="save">
Create file
</button>
<button class="action-panel-cancel"
aria-label="Close 'Send citations to citation manager' panel"
ref="linksrc=close_citation_manager_panel"
aria-controls="citation-manager-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="citation_manager"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="rss-action-panel" class="rss-action-panel action-panel " aria-hidden="true">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Your RSS Feed
</h2>
<form id="rss-action-panel-form"
class="rss-action-panel-form action-panel-content action-form"
data-create-rss-feed-url="/create-rss-feed-url/"
data-search-form-term-value="">
<input type="hidden" name="csrfmiddlewaretoken" value="mIdbAfU3YIO04g9tu8dItcIKVAEcNFQxDvXgd5npyjBuYHfj7rQKXkeotEmoGgoR">
<div class="action-panel-control-wrap">
<label for="rss-name" class="action-panel-label required-field-asterisk">
Name of RSS Feed:
</label>
<input maxlength="200"
placeholder="Name"
type="text"
name="rss-name"
id="rss-name"
class="rss-name"
value=''
required
pattern="[^&quot;&amp;=&lt;&gt;\/]*" title="The following characters are not allowed in the Name field: &quot;&amp;=&lt;&gt;/">
</div>
<div class="rss-limit-wrap">
<div class="action-panel-control-wrap action-panel-extra-margin-top">
<label for="rss-limit" class="action-panel-label">
Number of items displayed:
</label>
<select id="rss-limit" class="no-border-panel-selector rss-limit">
<option value="5">5</option>
<option value="10">10</option>
<option value="15" selected="selected">15</option>
<option value="20">20</option>
<option value="50">50</option>
<option value="100">100</option>
</select>
</div>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Creating..."
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="save">
Create RSS
</button>
<button class="action-panel-cancel"
aria-label="Close 'Your RSS' panel"
ref="linksrc=close_rss_panel"
aria-controls="rss-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="cancel">
Cancel
</button>
</div>
<div class="action-panel-control-wrap rss-link-copy-wrap">
<label for="rss-link" class="usa-sr-only">RSS Link</label>
<input placeholder="Your RSS Feed Link" type="text" name="rss-link" id="rss-link" class="rss-link" title="RSS Link">
<button
type="button"
disabled
class="rss-link-copy-button disabled"
data-ga-category="save_share"
data-ga-action="rss"
data-ga-label="copy">
Copy
</button>
</div>
</form>
</div>
</div>
</div>
</div>
<div class="article-page" id="article-page" data-article-pmid="37386786">
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<div class="full-text-links">
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<h3 class="title">
Full text links
</h3>
<div class="full-text-links-list">
<a class="link-item
dialog-focus"
href="https://doi.org/10.1097/HEP.0000000000000395"
target="_blank"
rel="noopener"
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rel="noopener"
ref="linksrc=fulltextorjournal_fulltext&amp;is_pmc=True&amp;PrId=3494&amp;itool=Abstract-def&amp;log$=linkouticon&amp;uid=37386786&amp;db=pubmed&amp;nlmid=8302946"
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<a href="#" class="full-text-links-button full-text-links-dialog-trigger">
Full text links
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</div>
</div>
<div class="actions-buttons sidebar"><h3 class="title">Actions</h3><div class="inner-wrap"><button class="citation-button citation-dialog-trigger"
aria-label="Open dialog with citation text in different styles"
data-ga-category="save_share"
data-ga-action="cite"
data-ga-label="open"
data-all-citations-url="/37386786/citations/"
data-citation-style="nlm"
data-pubmed-format-link="/37386786/export/"><span class="button-label">Cite</span></button><link type="text/css" href="ncbi-overlay-block/src/overlay-block.css"><div class="collections-button-container" data-article-id="37386786" data-article-db="pubmed"><button class="collections-button collections-dialog-trigger"
aria-label="Save article in MyNCBI collections."
data-ga-category="collections_button"
data-ga-action="click"
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<h1 class="heading-title">
Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Ladr%C3%B3n+de+Guevara+AL&amp;cauthor_id=37386786"
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data-ga-label="Alma L Ladrón de Guevara">Alma L Ladrón de Guevara</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Center of Research and Gastroenterology, Mexico City, Mexico." href="#full-view-affiliation-22" ref="linksrc=author_aff">
22
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Marlyn J Mayo">Marlyn J Mayo</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, Texas, USA." href="#full-view-affiliation-23" ref="linksrc=author_aff">
23
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Dalekos+GN&amp;cauthor_id=37386786"
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data-ga-label="George N Dalekos">George N Dalekos</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece." href="#full-view-affiliation-24" ref="linksrc=author_aff">
24
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Joost P H Drenth">Joost P H Drenth</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands." href="#full-view-affiliation-25" ref="linksrc=author_aff">
25
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Janczewska+E&amp;cauthor_id=37386786"
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data-ga-label="Ewa Janczewska">Ewa Janczewska</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Basic Medical Sciences, Faculty of Health Sciences in Bytom, Medical University of Silesia, Katowice, Poland." href="#full-view-affiliation-26" ref="linksrc=author_aff">
26
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="ID Clinic, Myslowice, Poland." href="#full-view-affiliation-27" ref="linksrc=author_aff">
27
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Leggett+BA&amp;cauthor_id=37386786"
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data-ga-label="Barbara A Leggett">Barbara A Leggett</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="School of Medicine, University of Queensland, Herston, Queensland, Australia." href="#full-view-affiliation-28" ref="linksrc=author_aff">
28
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Nevens+F&amp;cauthor_id=37386786"
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data-ga-label="Frederik Nevens">Frederik Nevens</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="University Hospitals KU Leuven, Belgium." href="#full-view-affiliation-29" ref="linksrc=author_aff">
29
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Center of European Reference Network (ERN) RARE-LIVER, Leuven, Belgium." href="#full-view-affiliation-30" ref="linksrc=author_aff">
30
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Vargas+V&amp;cauthor_id=37386786"
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data-ga-label="Victor Vargas">Victor Vargas</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Liver Unit, Hospital Universitari Vall d&#x27;Hebron, Universitat Autònoma de Barcelona, Bellaterra, Spain." href="#full-view-affiliation-31" ref="linksrc=author_aff">
31
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain." href="#full-view-affiliation-32" ref="linksrc=author_aff">
32
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Zuckerman+E&amp;cauthor_id=37386786"
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data-ga-label="Eli Zuckerman">Eli Zuckerman</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Liver Unit, Carmel Medical Center, Technion, Faculty of Medicine, Israeli Association for the Study of the Liver, Haifa, Israel." href="#full-view-affiliation-33" ref="linksrc=author_aff">
33
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Corpechot+C&amp;cauthor_id=37386786"
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data-ga-label="Christophe Corpechot">Christophe Corpechot</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department (MIVB-H), Filière Maladies Rares: Maladies Rares du Foie de l&#x27;Adulte et de l&#x27;Enfant (FILFOIE), European Reference Network (ERN) RARE-LIVER, Inserm, Centre de Recherche Saint-Antoine (CRSA), Assistance Publique-Hopitaux of Paris (AP-HP), Saint-Antoine Hospital, Sorbonne Universités, Paris, France." href="#full-view-affiliation-34" ref="linksrc=author_aff">
34
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Fassio+E&amp;cauthor_id=37386786"
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data-ga-label="Eduardo Fassio">Eduardo Fassio</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="DIM Clínica Privada, Ramos Mejía, Buenos Aires province, Argentina." href="#full-view-affiliation-35" ref="linksrc=author_aff">
35
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Hinrichsen+H&amp;cauthor_id=37386786"
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data-ga-label="Holger Hinrichsen">Holger Hinrichsen</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Gastroenterology-Hepatology Center Kiel, Kiel, Germany." href="#full-view-affiliation-36" ref="linksrc=author_aff">
36
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Invernizzi+P&amp;cauthor_id=37386786"
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data-ga-label="Pietro Invernizzi">Pietro Invernizzi</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medicine and Surgery, Center for Autoimmune Liver Diseases, University of Milano-Bicocca, Monza, Italy." href="#full-view-affiliation-37" ref="linksrc=author_aff">
37
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Division of Gastroenterology, Fondazione IRCCS San Gerardo dei Tintori &amp; European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Monza, Italy." href="#full-view-affiliation-38" ref="linksrc=author_aff">
38
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Trivedi+PJ&amp;cauthor_id=37386786"
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data-ga-label="Palak J Trivedi">Palak J Trivedi</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Centre for Liver and Gastroenterology Research, University of Birmingham, UK." href="#full-view-affiliation-39" ref="linksrc=author_aff">
39
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Liver Unit, University Hospitals Birmingham Queen Elizabeth, Birmingham, UK." href="#full-view-affiliation-40" ref="linksrc=author_aff">
40
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Institute of Immunology and Immunotherapy, University of Birmingham, UK." href="#full-view-affiliation-41" ref="linksrc=author_aff">
41
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Institute of Applied Health Research, University of Birmingham, UK." href="#full-view-affiliation-42" ref="linksrc=author_aff">
42
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Forman+L&amp;cauthor_id=37386786"
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data-ga-label="Lisa Forman">Lisa Forman</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="University of Colorado, Aurora, Colorado, USA." href="#full-view-affiliation-43" ref="linksrc=author_aff">
43
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Jones+DEJ&amp;cauthor_id=37386786"
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data-ga-label="David E J Jones">David E J Jones</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Institute of Cellular Medicine and National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK." href="#full-view-affiliation-44" ref="linksrc=author_aff">
44
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Stephen D Ryder">Stephen D Ryder</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at Nottingham University Hospitals National Health Service (NHS) Trust and the University of Nottingham, Queens Medical Centre, Nottingham, UK." href="#full-view-affiliation-45" ref="linksrc=author_aff">
45
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Swain+MG&amp;cauthor_id=37386786"
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data-ga-label="Mark G Swain">Mark G Swain</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medicine, University of Calgary, Calgary, Alberta, Canada." href="#full-view-affiliation-46" ref="linksrc=author_aff">
46
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Alexandra Steinberg">Alexandra Steinberg</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#full-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Pol F Boudes">Pol F Boudes</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#full-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Yun-Jung Choi">Yun-Jung Choi</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#full-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Charles A McWherter">Charles A McWherter</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#full-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="semicolon">;&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="ENHANCE Study Group*">ENHANCE Study Group*</a></span>
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<strong class="title">ENHANCE Study Group*</strong>:
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data-ga-label="Alan Bonder">Alan Bonder</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Andrew Muir">Andrew Muir</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Jing Hieng Jeffrey Ngu">Jing Hieng Jeffrey Ngu</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Pavel Ogurtsov">Pavel Ogurtsov</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Pawel Pabjan">Pawel Pabjan</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Pagadala+M"
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data-ga-label="Mangesh Pagadala">Mangesh Pagadala</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Mária Papp">Mária Papp</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Albert Parés">Albert Parés</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Peskov+A"
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href="/?term=Peyton+A"
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data-ga-label="Adam Peyton">Adam Peyton</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Phillips+J"
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data-ga-label="John Phillips">John Phillips</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Porayko+M"
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data-ga-label="Michael Porayko">Michael Porayko</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Post+A"
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data-ga-label="David C Pound">David C Pound</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Rabinovitz+M"
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href="/?term=Rank+K"
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data-ga-label="Kevin Rank">Kevin Rank</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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href="/?term=Regula+J"
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data-ga-label="Thomas Riley">Thomas Riley</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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href="/?term=Safadi+R"
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href="/?term=Sheridan+DA"
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data-ga-label="David A Sheridan">David A Sheridan</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Silva+MO"
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href="/?term=Silveira+MG"
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data-ga-label="Marina G Silveira">Marina G Silveira</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Sood+S"
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data-ga-label="Siddarth Sood">Siddarth Sood</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Sporea+I"
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data-ga-label="Ioan Sporea">Ioan Sporea</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Stanca+C"
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data-ga-label="Carmen Stanca">Carmen Stanca</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Stauber+R"
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data-ga-label="Rudolf Stauber">Rudolf Stauber</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Svorcan+P"
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data-ga-label="Petar Svorcan">Petar Svorcan</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Tak+WY"
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data-ga-label="Won Young Tak">Won Young Tak</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Taylor+RM"
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data-ga-label="Ryan M Taylor">Ryan M Taylor</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Thorburn+D"
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<div class="affiliations">
<h3 class="title">
Affiliations
</h3>
<ul class="item-list">
<li data-affiliation-id="full-view-affiliation-1"
id="full-view-affiliation-1"
><sup class="key">1</sup> University Health Network and Division of Gastroenterology and Hepatology, Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada.</li>
<li data-affiliation-id="full-view-affiliation-2"
id="full-view-affiliation-2"
><sup class="key">2</sup> Liver Institute of Virginia, Bon Secours Mercy Health, Bon Secours Liver Institute of Richmond, Richmond, Virginia, USA.</li>
<li data-affiliation-id="full-view-affiliation-3"
id="full-view-affiliation-3"
><sup class="key">3</sup> Bon Secours Liver Institute of Hampton Roads, Newport News, Virginia, USA.</li>
<li data-affiliation-id="full-view-affiliation-4"
id="full-view-affiliation-4"
><sup class="key">4</sup> University Health Network and Department of Medicine, Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada.</li>
<li data-affiliation-id="full-view-affiliation-5"
id="full-view-affiliation-5"
><sup class="key">5</sup> Liver Institute Northwest, Seattle, Washington, USA.</li>
<li data-affiliation-id="full-view-affiliation-6"
id="full-view-affiliation-6"
><sup class="key">6</sup> Departments of Medicine and Surgery, Baylor College of Medicine, Houston, Texas, USA.</li>
<li data-affiliation-id="full-view-affiliation-7"
id="full-view-affiliation-7"
><sup class="key">7</sup> Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.</li>
<li data-affiliation-id="full-view-affiliation-8"
id="full-view-affiliation-8"
><sup class="key">8</sup> Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.</li>
<li data-affiliation-id="full-view-affiliation-9"
id="full-view-affiliation-9"
><sup class="key">9</sup> Center for Autoimmune Liver Diseases, Tel-Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.</li>
<li data-affiliation-id="full-view-affiliation-10"
id="full-view-affiliation-10"
><sup class="key">10</sup> Department of Medical and Surgical Sciences, Division of Internal Medicine, Maternal-Infantile and Adult, University of Modena and Reggio Emilia, Modena, Italy.</li>
<li data-affiliation-id="full-view-affiliation-11"
id="full-view-affiliation-11"
><sup class="key">11</sup> Postgraduate School of Allergy and Clinical Immunology, University of Modena and Reggio Emilia, Italy.</li>
<li data-affiliation-id="full-view-affiliation-12"
id="full-view-affiliation-12"
><sup class="key">12</sup> Division of Hepatology, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Michigan, USA.</li>
<li data-affiliation-id="full-view-affiliation-13"
id="full-view-affiliation-13"
><sup class="key">13</sup> Division of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, California, USA.</li>
<li data-affiliation-id="full-view-affiliation-14"
id="full-view-affiliation-14"
><sup class="key">14</sup> Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas, USA.</li>
<li data-affiliation-id="full-view-affiliation-15"
id="full-view-affiliation-15"
><sup class="key">15</sup> Department of Hepatology, Portsmouth Liver Centre, Portsmouth Hospitals National Health Service Trust, Queen Alexandra Hospital, Portsmouth, UK.</li>
<li data-affiliation-id="full-view-affiliation-16"
id="full-view-affiliation-16"
><sup class="key">16</sup> Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Massachusetts, USA.</li>
<li data-affiliation-id="full-view-affiliation-17"
id="full-view-affiliation-17"
><sup class="key">17</sup> Saint Petersburg State University, St. Petersburg, Russia.</li>
<li data-affiliation-id="full-view-affiliation-18"
id="full-view-affiliation-18"
><sup class="key">18</sup> City Hospital 31, St. Petersburg, Russia.</li>
<li data-affiliation-id="full-view-affiliation-19"
id="full-view-affiliation-19"
><sup class="key">19</sup> Metepec Edo Mex., Mexico.</li>
<li data-affiliation-id="full-view-affiliation-20"
id="full-view-affiliation-20"
><sup class="key">20</sup> King&#x27;s College Hospital National Health Service Foundation Trust, London, UK.</li>
<li data-affiliation-id="full-view-affiliation-21"
id="full-view-affiliation-21"
><sup class="key">21</sup> Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.</li>
<li data-affiliation-id="full-view-affiliation-22"
id="full-view-affiliation-22"
><sup class="key">22</sup> Center of Research and Gastroenterology, Mexico City, Mexico.</li>
<li data-affiliation-id="full-view-affiliation-23"
id="full-view-affiliation-23"
><sup class="key">23</sup> Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, Texas, USA.</li>
<li data-affiliation-id="full-view-affiliation-24"
id="full-view-affiliation-24"
><sup class="key">24</sup> Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece.</li>
<li data-affiliation-id="full-view-affiliation-25"
id="full-view-affiliation-25"
><sup class="key">25</sup> Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.</li>
<li data-affiliation-id="full-view-affiliation-26"
id="full-view-affiliation-26"
><sup class="key">26</sup> Department of Basic Medical Sciences, Faculty of Health Sciences in Bytom, Medical University of Silesia, Katowice, Poland.</li>
<li data-affiliation-id="full-view-affiliation-27"
id="full-view-affiliation-27"
><sup class="key">27</sup> ID Clinic, Myslowice, Poland.</li>
<li data-affiliation-id="full-view-affiliation-28"
id="full-view-affiliation-28"
><sup class="key">28</sup> School of Medicine, University of Queensland, Herston, Queensland, Australia.</li>
<li data-affiliation-id="full-view-affiliation-29"
id="full-view-affiliation-29"
><sup class="key">29</sup> University Hospitals KU Leuven, Belgium.</li>
<li data-affiliation-id="full-view-affiliation-30"
id="full-view-affiliation-30"
><sup class="key">30</sup> Center of European Reference Network (ERN) RARE-LIVER, Leuven, Belgium.</li>
<li data-affiliation-id="full-view-affiliation-31"
id="full-view-affiliation-31"
><sup class="key">31</sup> Liver Unit, Hospital Universitari Vall d&#x27;Hebron, Universitat Autònoma de Barcelona, Bellaterra, Spain.</li>
<li data-affiliation-id="full-view-affiliation-32"
id="full-view-affiliation-32"
><sup class="key">32</sup> Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain.</li>
<li data-affiliation-id="full-view-affiliation-33"
id="full-view-affiliation-33"
><sup class="key">33</sup> Liver Unit, Carmel Medical Center, Technion, Faculty of Medicine, Israeli Association for the Study of the Liver, Haifa, Israel.</li>
<li data-affiliation-id="full-view-affiliation-34"
id="full-view-affiliation-34"
><sup class="key">34</sup> Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department (MIVB-H), Filière Maladies Rares: Maladies Rares du Foie de l&#x27;Adulte et de l&#x27;Enfant (FILFOIE), European Reference Network (ERN) RARE-LIVER, Inserm, Centre de Recherche Saint-Antoine (CRSA), Assistance Publique-Hopitaux of Paris (AP-HP), Saint-Antoine Hospital, Sorbonne Universités, Paris, France.</li>
<li data-affiliation-id="full-view-affiliation-35"
id="full-view-affiliation-35"
><sup class="key">35</sup> DIM Clínica Privada, Ramos Mejía, Buenos Aires province, Argentina.</li>
<li data-affiliation-id="full-view-affiliation-36"
id="full-view-affiliation-36"
><sup class="key">36</sup> Gastroenterology-Hepatology Center Kiel, Kiel, Germany.</li>
<li data-affiliation-id="full-view-affiliation-37"
id="full-view-affiliation-37"
><sup class="key">37</sup> Department of Medicine and Surgery, Center for Autoimmune Liver Diseases, University of Milano-Bicocca, Monza, Italy.</li>
<li data-affiliation-id="full-view-affiliation-38"
id="full-view-affiliation-38"
><sup class="key">38</sup> Division of Gastroenterology, Fondazione IRCCS San Gerardo dei Tintori &amp; European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Monza, Italy.</li>
<li data-affiliation-id="full-view-affiliation-39"
id="full-view-affiliation-39"
><sup class="key">39</sup> National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Centre for Liver and Gastroenterology Research, University of Birmingham, UK.</li>
<li data-affiliation-id="full-view-affiliation-40"
id="full-view-affiliation-40"
><sup class="key">40</sup> Liver Unit, University Hospitals Birmingham Queen Elizabeth, Birmingham, UK.</li>
<li data-affiliation-id="full-view-affiliation-41"
id="full-view-affiliation-41"
><sup class="key">41</sup> Institute of Immunology and Immunotherapy, University of Birmingham, UK.</li>
<li data-affiliation-id="full-view-affiliation-42"
id="full-view-affiliation-42"
><sup class="key">42</sup> Institute of Applied Health Research, University of Birmingham, UK.</li>
<li data-affiliation-id="full-view-affiliation-43"
id="full-view-affiliation-43"
><sup class="key">43</sup> University of Colorado, Aurora, Colorado, USA.</li>
<li data-affiliation-id="full-view-affiliation-44"
id="full-view-affiliation-44"
><sup class="key">44</sup> Institute of Cellular Medicine and National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK.</li>
<li data-affiliation-id="full-view-affiliation-45"
id="full-view-affiliation-45"
><sup class="key">45</sup> National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at Nottingham University Hospitals National Health Service (NHS) Trust and the University of Nottingham, Queens Medical Centre, Nottingham, UK.</li>
<li data-affiliation-id="full-view-affiliation-46"
id="full-view-affiliation-46"
><sup class="key">46</sup> Department of Medicine, University of Calgary, Calgary, Alberta, Canada.</li>
<li data-affiliation-id="full-view-affiliation-47"
id="full-view-affiliation-47"
><sup class="key">47</sup> CymaBay Therapeutics, Newark, California, USA.</li>
</ul>
</div>
</div>
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<div class="publication-type" >Clinical Trial</div>
<h1 class="heading-title">
Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study
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<span class="authors-list-item "><span class="full-name">Gideon M Hirschfield</span><span class="citation-separator">&nbsp;et al.</span></span>
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Hepatology<span class="citation-separator">.</span>
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<span class="authors-list-item "><a class="full-name"
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1
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Bon Secours Liver Institute of Hampton Roads, Newport News, Virginia, USA." href="#short-view-affiliation-3" ref="linksrc=author_aff">
3
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Aliya Gulamhusein">Aliya Gulamhusein</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="University Health Network and Department of Medicine, Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada." href="#short-view-affiliation-4" ref="linksrc=author_aff">
4
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Cynthia Levy">Cynthia Levy</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA." href="#short-view-affiliation-7" ref="linksrc=author_aff">
7
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Kremer+AE&amp;cauthor_id=37386786"
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data-ga-label="Andreas E Kremer">Andreas E Kremer</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland." href="#short-view-affiliation-8" ref="linksrc=author_aff">
8
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Zigmond+E&amp;cauthor_id=37386786"
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data-ga-label="Ehud Zigmond">Ehud Zigmond</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Center for Autoimmune Liver Diseases, Tel-Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel." href="#short-view-affiliation-9" ref="linksrc=author_aff">
9
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Andreone+P&amp;cauthor_id=37386786"
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data-ga-label="Pietro Andreone">Pietro Andreone</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medical and Surgical Sciences, Division of Internal Medicine, Maternal-Infantile and Adult, University of Modena and Reggio Emilia, Modena, Italy." href="#short-view-affiliation-10" ref="linksrc=author_aff">
10
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Postgraduate School of Allergy and Clinical Immunology, University of Modena and Reggio Emilia, Italy." href="#short-view-affiliation-11" ref="linksrc=author_aff">
11
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Gordon+SC&amp;cauthor_id=37386786"
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data-ga-label="Stuart C Gordon">Stuart C Gordon</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Division of Hepatology, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Michigan, USA." href="#short-view-affiliation-12" ref="linksrc=author_aff">
12
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Bowlus+CL&amp;cauthor_id=37386786"
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data-ga-label="Christopher L Bowlus">Christopher L Bowlus</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Division of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, California, USA." href="#short-view-affiliation-13" ref="linksrc=author_aff">
13
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Lawitz+EJ&amp;cauthor_id=37386786"
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data-ga-label="Eric J Lawitz">Eric J Lawitz</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas, USA." href="#short-view-affiliation-14" ref="linksrc=author_aff">
14
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Aspinall+RJ&amp;cauthor_id=37386786"
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data-ga-label="Richard J Aspinall">Richard J Aspinall</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Hepatology, Portsmouth Liver Centre, Portsmouth Hospitals National Health Service Trust, Queen Alexandra Hospital, Portsmouth, UK." href="#short-view-affiliation-15" ref="linksrc=author_aff">
15
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Pratt+DS&amp;cauthor_id=37386786"
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data-ga-label="Daniel S Pratt">Daniel S Pratt</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Massachusetts, USA." href="#short-view-affiliation-16" ref="linksrc=author_aff">
16
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Raikhelson+K&amp;cauthor_id=37386786"
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data-ga-label="Karina Raikhelson">Karina Raikhelson</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Saint Petersburg State University, St. Petersburg, Russia." href="#short-view-affiliation-17" ref="linksrc=author_aff">
17
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="City Hospital 31, St. Petersburg, Russia." href="#short-view-affiliation-18" ref="linksrc=author_aff">
18
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Gonzalez-Huezo+MS&amp;cauthor_id=37386786"
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data-ga-label="Maria S Gonzalez-Huezo">Maria S Gonzalez-Huezo</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Metepec Edo Mex., Mexico." href="#short-view-affiliation-19" ref="linksrc=author_aff">
19
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Heneghan+MA&amp;cauthor_id=37386786"
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data-ga-label="Michael A Heneghan">Michael A Heneghan</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="King&#x27;s College Hospital National Health Service Foundation Trust, London, UK." href="#short-view-affiliation-20" ref="linksrc=author_aff">
20
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Jeong+SH&amp;cauthor_id=37386786"
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data-ga-label="Sook-Hyang Jeong">Sook-Hyang Jeong</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea." href="#short-view-affiliation-21" ref="linksrc=author_aff">
21
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Ladr%C3%B3n+de+Guevara+AL&amp;cauthor_id=37386786"
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data-ga-label="Alma L Ladrón de Guevara">Alma L Ladrón de Guevara</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Center of Research and Gastroenterology, Mexico City, Mexico." href="#short-view-affiliation-22" ref="linksrc=author_aff">
22
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Mayo+MJ&amp;cauthor_id=37386786"
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data-ga-label="Marlyn J Mayo">Marlyn J Mayo</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, Texas, USA." href="#short-view-affiliation-23" ref="linksrc=author_aff">
23
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Dalekos+GN&amp;cauthor_id=37386786"
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data-ga-label="George N Dalekos">George N Dalekos</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece." href="#short-view-affiliation-24" ref="linksrc=author_aff">
24
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Drenth+JPH&amp;cauthor_id=37386786"
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data-ga-label="Joost P H Drenth">Joost P H Drenth</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands." href="#short-view-affiliation-25" ref="linksrc=author_aff">
25
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Janczewska+E&amp;cauthor_id=37386786"
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data-ga-label="Ewa Janczewska">Ewa Janczewska</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Basic Medical Sciences, Faculty of Health Sciences in Bytom, Medical University of Silesia, Katowice, Poland." href="#short-view-affiliation-26" ref="linksrc=author_aff">
26
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="ID Clinic, Myslowice, Poland." href="#short-view-affiliation-27" ref="linksrc=author_aff">
27
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Leggett+BA&amp;cauthor_id=37386786"
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data-ga-label="Barbara A Leggett">Barbara A Leggett</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="School of Medicine, University of Queensland, Herston, Queensland, Australia." href="#short-view-affiliation-28" ref="linksrc=author_aff">
28
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Nevens+F&amp;cauthor_id=37386786"
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data-ga-label="Frederik Nevens">Frederik Nevens</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="University Hospitals KU Leuven, Belgium." href="#short-view-affiliation-29" ref="linksrc=author_aff">
29
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Center of European Reference Network (ERN) RARE-LIVER, Leuven, Belgium." href="#short-view-affiliation-30" ref="linksrc=author_aff">
30
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Vargas+V&amp;cauthor_id=37386786"
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data-ga-label="Victor Vargas">Victor Vargas</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Liver Unit, Hospital Universitari Vall d&#x27;Hebron, Universitat Autònoma de Barcelona, Bellaterra, Spain." href="#short-view-affiliation-31" ref="linksrc=author_aff">
31
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain." href="#short-view-affiliation-32" ref="linksrc=author_aff">
32
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Zuckerman+E&amp;cauthor_id=37386786"
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data-ga-label="Eli Zuckerman">Eli Zuckerman</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Liver Unit, Carmel Medical Center, Technion, Faculty of Medicine, Israeli Association for the Study of the Liver, Haifa, Israel." href="#short-view-affiliation-33" ref="linksrc=author_aff">
33
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Corpechot+C&amp;cauthor_id=37386786"
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data-ga-label="Christophe Corpechot">Christophe Corpechot</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department (MIVB-H), Filière Maladies Rares: Maladies Rares du Foie de l&#x27;Adulte et de l&#x27;Enfant (FILFOIE), European Reference Network (ERN) RARE-LIVER, Inserm, Centre de Recherche Saint-Antoine (CRSA), Assistance Publique-Hopitaux of Paris (AP-HP), Saint-Antoine Hospital, Sorbonne Universités, Paris, France." href="#short-view-affiliation-34" ref="linksrc=author_aff">
34
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Fassio+E&amp;cauthor_id=37386786"
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data-ga-label="Eduardo Fassio">Eduardo Fassio</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="DIM Clínica Privada, Ramos Mejía, Buenos Aires province, Argentina." href="#short-view-affiliation-35" ref="linksrc=author_aff">
35
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Hinrichsen+H&amp;cauthor_id=37386786"
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data-ga-label="Holger Hinrichsen">Holger Hinrichsen</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Gastroenterology-Hepatology Center Kiel, Kiel, Germany." href="#short-view-affiliation-36" ref="linksrc=author_aff">
36
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Invernizzi+P&amp;cauthor_id=37386786"
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data-ga-label="Pietro Invernizzi">Pietro Invernizzi</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medicine and Surgery, Center for Autoimmune Liver Diseases, University of Milano-Bicocca, Monza, Italy." href="#short-view-affiliation-37" ref="linksrc=author_aff">
37
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Division of Gastroenterology, Fondazione IRCCS San Gerardo dei Tintori &amp; European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Monza, Italy." href="#short-view-affiliation-38" ref="linksrc=author_aff">
38
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Trivedi+PJ&amp;cauthor_id=37386786"
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data-ga-label="Palak J Trivedi">Palak J Trivedi</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Centre for Liver and Gastroenterology Research, University of Birmingham, UK." href="#short-view-affiliation-39" ref="linksrc=author_aff">
39
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Liver Unit, University Hospitals Birmingham Queen Elizabeth, Birmingham, UK." href="#short-view-affiliation-40" ref="linksrc=author_aff">
40
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Institute of Immunology and Immunotherapy, University of Birmingham, UK." href="#short-view-affiliation-41" ref="linksrc=author_aff">
41
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Institute of Applied Health Research, University of Birmingham, UK." href="#short-view-affiliation-42" ref="linksrc=author_aff">
42
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Forman+L&amp;cauthor_id=37386786"
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data-ga-label="Lisa Forman">Lisa Forman</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="University of Colorado, Aurora, Colorado, USA." href="#short-view-affiliation-43" ref="linksrc=author_aff">
43
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Jones+DEJ&amp;cauthor_id=37386786"
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data-ga-label="David E J Jones">David E J Jones</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Institute of Cellular Medicine and National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK." href="#short-view-affiliation-44" ref="linksrc=author_aff">
44
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Ryder+SD&amp;cauthor_id=37386786"
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data-ga-label="Stephen D Ryder">Stephen D Ryder</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at Nottingham University Hospitals National Health Service (NHS) Trust and the University of Nottingham, Queens Medical Centre, Nottingham, UK." href="#short-view-affiliation-45" ref="linksrc=author_aff">
45
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Swain+MG&amp;cauthor_id=37386786"
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data-ga-label="Mark G Swain">Mark G Swain</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Department of Medicine, University of Calgary, Calgary, Alberta, Canada." href="#short-view-affiliation-46" ref="linksrc=author_aff">
46
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Steinberg+A&amp;cauthor_id=37386786"
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data-ga-label="Alexandra Steinberg">Alexandra Steinberg</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#short-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Boudes+PF&amp;cauthor_id=37386786"
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data-ga-action="author_link"
data-ga-label="Pol F Boudes">Pol F Boudes</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#short-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Choi+YJ&amp;cauthor_id=37386786"
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data-ga-label="Yun-Jung Choi">Yun-Jung Choi</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#short-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=McWherter+CA&amp;cauthor_id=37386786"
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data-ga-label="Charles A McWherter">Charles A McWherter</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="CymaBay Therapeutics, Newark, California, USA." href="#short-view-affiliation-47" ref="linksrc=author_aff">
47
</a></sup><span class="semicolon">;&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=ENHANCE+Study+Group%2A%5BCorporate+Author%5D"
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data-ga-label="ENHANCE Study Group*">ENHANCE Study Group*</a></span>
</div>
</div>
<div class="collaborations">
<h3 class="title">
Collaborators
</h3>
<ul class="group-list">
<li>
<strong class="title">ENHANCE Study Group*</strong>:
<div class="authors-list">
<span class="authors-list-item "><a class="full-name"
href="/?term=Adrover+R"
ref="linksrc=author_name_link"
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data-ga-action="author_link"
data-ga-label="Raul Adrover">Raul Adrover</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Agrawal+S"
ref="linksrc=author_name_link"
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data-ga-action="author_link"
data-ga-label="Saurabh Agrawal">Saurabh Agrawal</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Aigner+E"
ref="linksrc=author_name_link"
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data-ga-action="author_link"
data-ga-label="Elmar Aigner">Elmar Aigner</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Martinez+AA"
ref="linksrc=author_name_link"
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data-ga-label="Agustin A Martinez">Agustin A Martinez</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Jose Luis Calleja Panero">Jose Luis Calleja Panero</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Sven Francque">Sven Francque</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Francisco Alejandro Fuster Saldias">Francisco Alejandro Fuster Saldias</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Richard Gilroy">Richard Gilroy</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Goel+A"
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data-ga-label="Aparna Goel">Aparna Goel</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Tobias Goeser">Tobias Goeser</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Susan Greenbloom">Susan Greenbloom</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Waldemar Halota">Waldemar Halota</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Stephen A Harrison">Stephen A Harrison</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Marek Hartleb">Marek Hartleb</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Heo+J"
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data-ga-label="Jeong Heo">Jeong Heo</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Hofer+H"
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data-ga-label="Harald Hofer">Harald Hofer</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Jonathan C Huang">Jonathan C Huang</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Jason L Huffman">Jason L Huffman</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Hunyady+B"
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data-ga-label="Steven Johnson">Steven Johnson</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Kallis+Y"
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data-ga-label="Yiannis Kallis">Yiannis Kallis</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Arun Khazanchi">Arun Khazanchi</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Kim+KA"
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data-ga-label="Kyung-Ah Kim">Kyung-Ah Kim</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Seung Up Kim">Seung Up Kim</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Yoon Jun Kim">Yoon Jun Kim</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Kohli+A"
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data-ga-label="Anita Kohli">Anita Kohli</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Kontorinis+N"
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data-ga-label="Nicholas Kontorinis">Nicholas Kontorinis</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Lake+JR"
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data-ga-label="John R Lake">John R Lake</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Lee+KS"
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data-ga-label="Kwan Sik Lee">Kwan Sik Lee</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Mach+T"
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data-ga-label="Tomasz Mach">Tomasz Mach</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Manch+R"
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data-ga-label="Richard Manch">Richard Manch</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Maor-Kendler+Y"
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data-ga-label="Yaakov Maor-Kendler">Yaakov Maor-Kendler</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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href="/?term=Minuk+G"
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data-ga-label="Gerald Minuk">Gerald Minuk</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Modi+AA"
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data-ga-label="Apurva A Modi">Apurva A Modi</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Martin W Moehlen">Martin W Moehlen</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Cristina M Rodríguez">Cristina M Rodríguez</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Rosa Maria Morillas Cunill">Rosa Maria Morillas Cunill</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Mouzas+I"
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data-ga-label="Ioannis Mouzas">Ioannis Mouzas</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Muir+A"
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data-ga-label="Andrew Muir">Andrew Muir</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Nagy+I"
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data-ga-label="István Nagy">István Nagy</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Ngu+JHJ"
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data-ga-label="Jing Hieng Jeffrey Ngu">Jing Hieng Jeffrey Ngu</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Odin+J"
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data-ga-label="Joseph Odin">Joseph Odin</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Ogurtsov+P"
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data-ga-label="Pavel Ogurtsov">Pavel Ogurtsov</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Pabjan+P"
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data-ga-label="Pawel Pabjan">Pawel Pabjan</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Pagadala+M"
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data-ga-label="Mangesh Pagadala">Mangesh Pagadala</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Papp+M"
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data-ga-label="Mária Papp">Mária Papp</a><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
href="/?term=Par%C3%A9s+A"
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href="/?term=Peskov+A"
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href="/?term=Post+A"
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href="/?term=Pound+DC"
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data-ga-label="Massimo Zuin">Massimo Zuin</a></span>
</div>
</li>
</ul>
</div>
<div class="affiliations">
<h3 class="title">
Affiliations
</h3>
<ul class="item-list">
<li data-affiliation-id="short-view-affiliation-1"
id="short-view-affiliation-1"
><sup class="key">1</sup> University Health Network and Division of Gastroenterology and Hepatology, Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada.</li>
<li data-affiliation-id="short-view-affiliation-2"
id="short-view-affiliation-2"
><sup class="key">2</sup> Liver Institute of Virginia, Bon Secours Mercy Health, Bon Secours Liver Institute of Richmond, Richmond, Virginia, USA.</li>
<li data-affiliation-id="short-view-affiliation-3"
id="short-view-affiliation-3"
><sup class="key">3</sup> Bon Secours Liver Institute of Hampton Roads, Newport News, Virginia, USA.</li>
<li data-affiliation-id="short-view-affiliation-4"
id="short-view-affiliation-4"
><sup class="key">4</sup> University Health Network and Department of Medicine, Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada.</li>
<li data-affiliation-id="short-view-affiliation-5"
id="short-view-affiliation-5"
><sup class="key">5</sup> Liver Institute Northwest, Seattle, Washington, USA.</li>
<li data-affiliation-id="short-view-affiliation-6"
id="short-view-affiliation-6"
><sup class="key">6</sup> Departments of Medicine and Surgery, Baylor College of Medicine, Houston, Texas, USA.</li>
<li data-affiliation-id="short-view-affiliation-7"
id="short-view-affiliation-7"
><sup class="key">7</sup> Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.</li>
<li data-affiliation-id="short-view-affiliation-8"
id="short-view-affiliation-8"
><sup class="key">8</sup> Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.</li>
<li data-affiliation-id="short-view-affiliation-9"
id="short-view-affiliation-9"
><sup class="key">9</sup> Center for Autoimmune Liver Diseases, Tel-Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.</li>
<li data-affiliation-id="short-view-affiliation-10"
id="short-view-affiliation-10"
><sup class="key">10</sup> Department of Medical and Surgical Sciences, Division of Internal Medicine, Maternal-Infantile and Adult, University of Modena and Reggio Emilia, Modena, Italy.</li>
<li data-affiliation-id="short-view-affiliation-11"
id="short-view-affiliation-11"
><sup class="key">11</sup> Postgraduate School of Allergy and Clinical Immunology, University of Modena and Reggio Emilia, Italy.</li>
<li data-affiliation-id="short-view-affiliation-12"
id="short-view-affiliation-12"
><sup class="key">12</sup> Division of Hepatology, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Michigan, USA.</li>
<li data-affiliation-id="short-view-affiliation-13"
id="short-view-affiliation-13"
><sup class="key">13</sup> Division of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, California, USA.</li>
<li data-affiliation-id="short-view-affiliation-14"
id="short-view-affiliation-14"
><sup class="key">14</sup> Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas, USA.</li>
<li data-affiliation-id="short-view-affiliation-15"
id="short-view-affiliation-15"
><sup class="key">15</sup> Department of Hepatology, Portsmouth Liver Centre, Portsmouth Hospitals National Health Service Trust, Queen Alexandra Hospital, Portsmouth, UK.</li>
<li data-affiliation-id="short-view-affiliation-16"
id="short-view-affiliation-16"
><sup class="key">16</sup> Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Massachusetts, USA.</li>
<li data-affiliation-id="short-view-affiliation-17"
id="short-view-affiliation-17"
><sup class="key">17</sup> Saint Petersburg State University, St. Petersburg, Russia.</li>
<li data-affiliation-id="short-view-affiliation-18"
id="short-view-affiliation-18"
><sup class="key">18</sup> City Hospital 31, St. Petersburg, Russia.</li>
<li data-affiliation-id="short-view-affiliation-19"
id="short-view-affiliation-19"
><sup class="key">19</sup> Metepec Edo Mex., Mexico.</li>
<li data-affiliation-id="short-view-affiliation-20"
id="short-view-affiliation-20"
><sup class="key">20</sup> King&#x27;s College Hospital National Health Service Foundation Trust, London, UK.</li>
<li data-affiliation-id="short-view-affiliation-21"
id="short-view-affiliation-21"
><sup class="key">21</sup> Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.</li>
<li data-affiliation-id="short-view-affiliation-22"
id="short-view-affiliation-22"
><sup class="key">22</sup> Center of Research and Gastroenterology, Mexico City, Mexico.</li>
<li data-affiliation-id="short-view-affiliation-23"
id="short-view-affiliation-23"
><sup class="key">23</sup> Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, Texas, USA.</li>
<li data-affiliation-id="short-view-affiliation-24"
id="short-view-affiliation-24"
><sup class="key">24</sup> Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece.</li>
<li data-affiliation-id="short-view-affiliation-25"
id="short-view-affiliation-25"
><sup class="key">25</sup> Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.</li>
<li data-affiliation-id="short-view-affiliation-26"
id="short-view-affiliation-26"
><sup class="key">26</sup> Department of Basic Medical Sciences, Faculty of Health Sciences in Bytom, Medical University of Silesia, Katowice, Poland.</li>
<li data-affiliation-id="short-view-affiliation-27"
id="short-view-affiliation-27"
><sup class="key">27</sup> ID Clinic, Myslowice, Poland.</li>
<li data-affiliation-id="short-view-affiliation-28"
id="short-view-affiliation-28"
><sup class="key">28</sup> School of Medicine, University of Queensland, Herston, Queensland, Australia.</li>
<li data-affiliation-id="short-view-affiliation-29"
id="short-view-affiliation-29"
><sup class="key">29</sup> University Hospitals KU Leuven, Belgium.</li>
<li data-affiliation-id="short-view-affiliation-30"
id="short-view-affiliation-30"
><sup class="key">30</sup> Center of European Reference Network (ERN) RARE-LIVER, Leuven, Belgium.</li>
<li data-affiliation-id="short-view-affiliation-31"
id="short-view-affiliation-31"
><sup class="key">31</sup> Liver Unit, Hospital Universitari Vall d&#x27;Hebron, Universitat Autònoma de Barcelona, Bellaterra, Spain.</li>
<li data-affiliation-id="short-view-affiliation-32"
id="short-view-affiliation-32"
><sup class="key">32</sup> Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain.</li>
<li data-affiliation-id="short-view-affiliation-33"
id="short-view-affiliation-33"
><sup class="key">33</sup> Liver Unit, Carmel Medical Center, Technion, Faculty of Medicine, Israeli Association for the Study of the Liver, Haifa, Israel.</li>
<li data-affiliation-id="short-view-affiliation-34"
id="short-view-affiliation-34"
><sup class="key">34</sup> Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department (MIVB-H), Filière Maladies Rares: Maladies Rares du Foie de l&#x27;Adulte et de l&#x27;Enfant (FILFOIE), European Reference Network (ERN) RARE-LIVER, Inserm, Centre de Recherche Saint-Antoine (CRSA), Assistance Publique-Hopitaux of Paris (AP-HP), Saint-Antoine Hospital, Sorbonne Universités, Paris, France.</li>
<li data-affiliation-id="short-view-affiliation-35"
id="short-view-affiliation-35"
><sup class="key">35</sup> DIM Clínica Privada, Ramos Mejía, Buenos Aires province, Argentina.</li>
<li data-affiliation-id="short-view-affiliation-36"
id="short-view-affiliation-36"
><sup class="key">36</sup> Gastroenterology-Hepatology Center Kiel, Kiel, Germany.</li>
<li data-affiliation-id="short-view-affiliation-37"
id="short-view-affiliation-37"
><sup class="key">37</sup> Department of Medicine and Surgery, Center for Autoimmune Liver Diseases, University of Milano-Bicocca, Monza, Italy.</li>
<li data-affiliation-id="short-view-affiliation-38"
id="short-view-affiliation-38"
><sup class="key">38</sup> Division of Gastroenterology, Fondazione IRCCS San Gerardo dei Tintori &amp; European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Monza, Italy.</li>
<li data-affiliation-id="short-view-affiliation-39"
id="short-view-affiliation-39"
><sup class="key">39</sup> National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Centre for Liver and Gastroenterology Research, University of Birmingham, UK.</li>
<li data-affiliation-id="short-view-affiliation-40"
id="short-view-affiliation-40"
><sup class="key">40</sup> Liver Unit, University Hospitals Birmingham Queen Elizabeth, Birmingham, UK.</li>
<li data-affiliation-id="short-view-affiliation-41"
id="short-view-affiliation-41"
><sup class="key">41</sup> Institute of Immunology and Immunotherapy, University of Birmingham, UK.</li>
<li data-affiliation-id="short-view-affiliation-42"
id="short-view-affiliation-42"
><sup class="key">42</sup> Institute of Applied Health Research, University of Birmingham, UK.</li>
<li data-affiliation-id="short-view-affiliation-43"
id="short-view-affiliation-43"
><sup class="key">43</sup> University of Colorado, Aurora, Colorado, USA.</li>
<li data-affiliation-id="short-view-affiliation-44"
id="short-view-affiliation-44"
><sup class="key">44</sup> Institute of Cellular Medicine and National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK.</li>
<li data-affiliation-id="short-view-affiliation-45"
id="short-view-affiliation-45"
><sup class="key">45</sup> National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at Nottingham University Hospitals National Health Service (NHS) Trust and the University of Nottingham, Queens Medical Centre, Nottingham, UK.</li>
<li data-affiliation-id="short-view-affiliation-46"
id="short-view-affiliation-46"
><sup class="key">46</sup> Department of Medicine, University of Calgary, Calgary, Alberta, Canada.</li>
<li data-affiliation-id="short-view-affiliation-47"
id="short-view-affiliation-47"
><sup class="key">47</sup> CymaBay Therapeutics, Newark, California, USA.</li>
</ul>
</div>
</div>
<ul class="identifiers" id="short-view-identifiers">
<li>
<span class="identifier pubmed">
<span class="id-label">
PMID:
</span>
<strong class="current-id" title="PubMed ID">37386786</strong>
</span>
</li>
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<span class="identifier pmc">
<span class="id-label">
PMCID:
</span>
<a class="id-link"
target="_blank"
rel="noopener"
ref="linksrc=article_id_link&amp;article_id=PMC10344437&amp;id_type=PMC"
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PMC10344437
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<li>
<span class="identifier doi">
<span class="id-label">
DOI:
</span>
<a class="id-link"
target="_blank"
rel="noopener"
ref="linksrc=article_id_link&amp;article_id=10.1097/HEP.0000000000000395&amp;id_type=DOI"
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10.1097/HEP.0000000000000395
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<div class="abstract" id="abstract">
<h2 class="title">
Abstract
</h2>
<div class="abstract-content selected"
id="eng-abstract">
<p>
<strong class="sub-title">
Background and aims:
</strong>
ENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-δ (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).
</p>
<p>
<strong class="sub-title">
Approach and results:
</strong>
Patients were randomized 1:1:1 to oral seladelpar 5 mg (n=89), 10 mg (n=89), placebo (n=87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) &lt; 1.67×upper limit of normal (ULN), ≥15% ALP decrease from baseline, and total bilirubin ≤ ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score ≥4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial. While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10 mg: 78.2%) versus placebo (12.5%) ( p &lt; 0.0001). ALP normalization occurred in 5.4% ( p =0.08) and 27.3% ( p &lt; 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: -3.14 ( p =0.02); placebo: -1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% ( p =0.0008); 10 mg: 16.7% ( p =0.03); placebo: 4%]. There were no serious treatment-related adverse events.
</p>
<p>
<strong class="sub-title">
Conclusions:
</strong>
Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.
</p>
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<p class="copyright" id="copyright">
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
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<div class="conflict-of-interest" id="conflict-of-interest">
<h2 class="title">
Conflict of interest statement
</h2>
<div class="statement">
<p xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:p1="http://pubmed.gov/pub-one">Gideon M. Hirschfield consults for and received payment/honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from GlaxoSmithKline, Intercept Pharma, and Ipsen. He consults for CymaBay Therapeutics, Escient, Gilead, Mirum, and Pliant. Mitchell L. Shiffman consults for, is on the speakers bureau for, and received grants from Intercept. He consults for and is on the speakers bureau for Intra-Sana. He is on the speakers bureau for and received grants from Cymbay. He received grants from Genfit, Hightide, and Mirum. Aliya Gulamhusein consults for and is on the speakers bureau for Intercept. She consults for CymaBay. Kris V. Kowdley consults for, is on the speakers bureau for and received grants from 89 Bio, Genfit, Gilead, Intercept, and CymbaBay. He consults for and received grants from Madrigal, Mirum, NGM, Pliant, and Zydus. He consults for and owns stock in Inipharm. He consults for Calliditas and Ipsen. He is on the speakers bureau for AbbVie. He received grants from GSK, Pfizer, Hanmi, HighTide, Viking, and Janssen. He receives royalties from UpToDate. He received payment for expert testimony from the Department of Justice. He participated in a data safety monitoring board or advisory board for CTI, Durect, and Labcorp. He received equipment, materials, drugs, medical writing, gifts, or other services from Sonic Insight. John M. Vierling advises and received grants from CymaBay, Intercept, Lilly, Novartis, and Sagiment. He advises Arena, Blade, Kezar, Labcorp, Fractyl, Ipsen, Moderna, and Taiwan J. He received grants from Genfit. He is a board member of and owns stock in Athenex. Cynthia Levy consults for, advises, and received grants from Cara Therapeutics, CymaBay Therapeutics, and GlaxoSmith Kline. She consults for and received grants from Calliditas, Escient, Genfit, Gilead, Intercept, Ipsen, Mirum, and Target RWE. She received grants from HighTide, Novartis, and Zydus. Andreas E. Kremer consults for, received payment/honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from, received grants from, and advises AbbVie, Bayer, CymaBay Therapeutics, Gilead, GlaxoSmithKline, Intercept Pharma, and MSD. He received payment/honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from and received grants from AOP Orphan, Bristol Myers Squibb, CMS, Dr. Falk, Eisai, Eli Lily, Janssen, Newbridge, Novartis, and Zambon. He consults for and advises Beiersdorf, Escient, FMC, Guidepoint, Medscape, Mirum, Myr, Roche, and Viofor. Ehud Zigmond advises, received lecture fees from, and received grants from Neopharm LTD. Stuart C. Gordon consults for and received grants from CymaBay, Gilead, and GSK. He received grants from AbbVie, DURECT, Genfit, Hightide, Intercept Pharma, Merck, Mirum, Pliant, and Viking. Christopher L. Bowlus consults for and received grants from CymaBay Therapeutics, Eli Lilly, and GlaxoSmithKline. He consults for BiomX, Mirum, Shire, and Trevi Therapeutics. He received grants from Arena Pharmaceuticals, Bristol Myers Squibb, Calliditas Therapeutics, Chemomab, COUR Pharmaceuticals, Genfit, Gilead, GlaxoSmithKline, Hanmi, Intercept, Novartis, NovoNordisk, Pliant, Takeda, and TARGET. Eric J. Lawitz consults for, is on the speakers bureau for, and received grants from Intercept. He consults for and received grants from Akero, Boheringer Ingelheim, BMS, Novo Nordisk, Metacrine, Sagimet, and Terns. He is on the speakers bureau for and received grants from AbbVie and Gilead. He received grants from 89Bio Inc., Allergan, Alnylam Pharmaceuticals Inc., Amgen, Ascelia Pharma, Assemblybio, AstraZeneca, Axcella Health, Biocryst Pharmaceuticals, Bird Rock Bio Inc., Conatus Pharmaceuticals, CymaBay Therapeutics, CytoDyn, DSM, Durect Corporation, Eli Lilly, Enanta Pharmaceuticals, Enyo Pharma, Exalenz Bioscience, Galectin Therapeutics, Galmed Pharmaceuticals, Genentech, Genfit, GlaxoSmithKline, Hanmi Pharmaceuticals, HighTide Biopharma, Inventiva, Janssen Pharmaceuticals, Laboratory for Advanced Medicine, Loxo Oncology, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals Inc., Northsea Therapeutics, Novartis, Pfizer, Poxel Co., Roche, Synlogic Therapeutics, Viking Therapeutics, and Zydus Pharmaceuticals. Richard J. Aspinall consults for and is on the speakers bureau for Norgine UK. He is on the speakers bureau for Intercept UK. He owns stock in CymaBay. Daniel S. Pratt consults for Mediar Therapeutics. Karina Raikhelson received payment/honoraria for lectures presentations, speakers bureaus, manuscript writing, or educational events from Abbott Laboratories GmbH, Alfasigma Rus, Binnopharm Group, Dr. Falk Pharma GmbH, JSC Nizhfarm, and JSC Pharmstandard. She received payment/honoraria for lectures presentations, speakers bureaus, manuscript writing, or educational events and was expert witness for STPF “Polisan.” She received grants from CymaBay and Novartis. Michael A. Heneghan consulting for Ipsen, Eledon, and Moderna He recieved payment/honoraria for lectures, presentations, speakers bureau, manuscript writing, or educational events from Falk, Advanz Pharma, and Intercept Pharma. He receives royalties from UpToDate. Sook-Hyang Jeong received grants from Bristol Myers Squibb, CymaBay Therapeutics, Galmed, Gilead, Hoffmann-La Roche Ltd, Intercept, and MSD. Alma L. Ladrón de Guevara received grants from AstraZeneca, Cymabay, Lilly, Madrigal, Akero, Galectin, MSD and Novo Nordisk, and Viking. Marlyn J. Mayo consults for and received grants from CymaBay Therapeutics, GlaxoSmithKline, and Mallinckrodt. She received grants from Genfit, Intercept, Mirum, and TARGET. She consults for Ipsen. She is on the speakers bureau for Intra-Sana. George N. Dalekos advises, is on the speakers bureau for, and serves as principal investigator for Genkeyotex, Pfizer, and Sobi. He advises and is on the speakers bureau for Ipsen and Sanofi. He is a principal investigator for Amyndas Pharmaceuticals, CymBay Therapeutics, Intercept, Novo Nordisk, Regulus Therapeutics, and Tiziana Life Sciences. Joost P.H. Drenth consults for Camurus. He received grants from AbbVie and Gilead. He is on a data safety monitoring board or advisory board for COIN B Study. Ewa Janczewska advises and received grants from Novo Nordisk and Cellaion. She is on the speakers bureau for and received grants from Abbvie. She is on the speakers bureau for Roche. She received grants from Axella, Exelixis, CymaBay, Calliditas, BMS, GSK, Janssen-Cilag, Dr. Falk, Inventiva, and MSD. Barbara A. Leggett received grants from CymaBay Therapeutics. Frederik Nevens consults for and received grants from Gilead. He consults for Abbvie, W.L. Gore, Cook Medical, TwinPharma, Intercept, Genkyotex, Camurus, Chemomab Therapeutics, Agomab Therapeutics, Novartis Pharma, Mayoly Spindler, Calliditas Therapeutics, Norgine, Takeda, and Dynacure. He received grants from Promethera Therapeutics and Ipsen. Victor Vargas consults for Genfit. He is on the speakers bureau for Intercept. He is on the data safety monitoring board or advisory board for Promethera Biosciences/Cellaion. He received grants from Advanz Pharma. Christophe Corpechot consults for and received grants from Intercept and CymaBay. He consults for Genkyotex/Calliditas. He received grants from Arrow Génériques, Biotest, and Gilead. Eduardo L. Fassio received grants from Gador. Eli Zuckerman consults and is a speaker for AbbVie, Gilead, GlaxoSmithKline, Janssen, Merck, Neopharm, NovoNordisk, and Roche. He is also a speaker for Bristol Meyers Squibb and Novartis. Holger Hinrichsen consults for and received payment/honoraria for lectures, presentations, and speakers bureaus from AbbVie, Gilead, and Intercept Pharma. He received payment/honoraria for lectures, presentations, and speakers bureaus Norgine. Pietro Invernizzi advises, is on the speakers bureau for, and received grants from Intercept. He advises Calliditas and Zydus. He received grants from Abbvie. Palak J. Trivedi consults for and advises CymaBay. David E.J. Jones consults for, is on the speakers bureau for, and received funding from Intercept. He consults for CymaBay Therapeutics, Kowa, and Umecrine. He is on the speakers bureau for Falk, GlaxoSmithKline, and Ipsen. Mark G. Swain consults for, is on the speakers bureau for, and received grants from Gilead. He consults for and received grants from Pfizer and Novartis. He consults for Ipsen. He is on the speakers bureau for Abbott. He received grants from AbbVie, Ancella, AstraZeneca, Bristol Myers Squibb, Calliditas Therapeutics, Celgene, CymaBay Therapeutics, Galectin, Genfit, GlaxoSmithKline, Intercept, and Novo Nordisk. Alexandra Steinberg owns stock, has intellectual property rights in and was employed by CymaBay Therapeutics when the work was conducted, and is employed by Carmot Therapeutics. Pol F. Boudes was employed by CymaBay Therapeutics when the work was conducted and declares a seladelpar method of use patent for PBC. He is currently employed by Galectin Therapeutics. Yun-Jung Choi is employed by CymaBay Therapeutics. Charles A. McWherter owns stock and intellectual property rights in and is employed by CymaBay. He declares a seladelpar method of use patent for PBC and for cholestatic pruritus. The remaining authors have no conflicts to report.</p>
</div>
</div>
<div class="figures" id="figures">
<h2 class="title">
Figures
</h2>
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<p> Graphical abstract </p>
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Graphical abstract
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data-image-width="500"
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data-image-alt="FIGURE 1"
data-pmc-id="PMC10344437"
data-figure-id="F1">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-1"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b15/10344437/e31499a2ad7e/hep-78-397-g002.gif"
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<p> FIGURE 1 </p>
</strong>
<div class="figure-caption-contents"><p> Patient flowchart. Screen failures (a… </p></div>
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<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIGURE 1 </p>
</strong>
<div class="figure-caption-contents"><p> Patient flowchart. Screen failures (a patient may be counted in &gt;1 reason for… </p></div>
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<figcaption id="figure-caption-1" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIGURE 1
</strong>
<div class="figure-caption-contents">Patient flowchart. Screen failures (a patient may be counted in >1 reason for failure): alkaline phosphatase < 1.67× upper limit of normal (ULN) n=149, estimated glomerular filtration rate <60 mL/min/1.73 m<sup>2</sup> n=27, alanine aminotransferase &gt;3×ULN n=11, total bilirubin &gt; 2.0×ULN n=11, aspartate aminotransferase &gt;3×ULN n=10, did not meet primary biliary cholangitis (PBC) diagnosis criteria n=8, not on a stable and recommended dose of ursodeoxycholic acid (UDCA) for past 12 months OR intolerant to UDCA (last dose &gt;3 months before screening) n=7, creatine kinase &gt;1.0×ULN n=6, platelet count &lt;100×10<sup>3</sup>/µL n=6, had advanced PBC per Rotterdam criteria n=4, international normalized ratio &gt;1.0×ULN n=4, presence of clinically significant hepatic decompensation n=4, presence of chronic liver disease n=4, presence of any other condition that would compromise patient safety/clinical trial quality n=4, did not provide written informed consent n=4, evidence of drug abuse n=3, use of fibrates within 30 days before screening n=2, use of simvastatin within 7 days before screening n=2. Abbreviations: AE, adverse event; mITT, modified intent-to-treat; N, number of patients assigned to the treatment group; n, number of patients in the category.</div>
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<strong class="figure-label">
<p> FIGURE 2 </p>
</strong>
<div class="figure-caption-contents"><p> Proportion of patients who achieved… </p></div>
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<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIGURE 2 </p>
</strong>
<div class="figure-caption-contents"><p> Proportion of patients who achieved the composite biochemical end point at month 3.… </p></div>
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<figcaption id="figure-caption-2" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIGURE 2
</strong>
<div class="figure-caption-contents">Proportion of patients who achieved the composite biochemical end point at month 3. Composite end point was defined as alkaline phosphatase (ALP) serum levels < 1.67× upper limit of normal (ULN), 15% decrease in ALP serum levels, and total bilirubin serum levels ULN. <i>p</i>-values are based on the Cochran-Mantel-Haenszel test adjusted for both randomization stratification variables. Patients who discontinued treatment before month 3 due to reasons other than study termination and who did not have evaluable data at month 3 were considered nonresponders.</div>
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<p> FIGURE 3 </p>
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<div class="figure-caption-contents"><p> Proportion of patients who achieved… </p></div>
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<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIGURE 3 </p>
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<div class="figure-caption-contents"><p> Proportion of patients who achieved alkaline phosphatase (ALP) normalization at month 3 ALP… </p></div>
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FIGURE 3
</strong>
<div class="figure-caption-contents">Proportion of patients who achieved alkaline phosphatase (ALP) normalization at month 3 ALP normalization. ALP normalization was defined as serum levels ≤1.0×upper limit of normal. <i>p</i>-values are based on the Cochran-Mantel-Haenszel test adjusted for both randomization stratification variables. Patients who discontinued treatment before month 3 due to reasons other than study termination and who did not have evaluable data at month 3 were considered nonresponders.</div>
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<p> FIGURE 4 </p>
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<div class="figure-caption-contents"><p> Absolute LS mean (SE) change… </p></div>
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<p> FIGURE 4 </p>
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<div class="figure-caption-contents"><p> Absolute LS mean (SE) change from baseline in pruritus numerical rating scale (NRS)… </p></div>
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FIGURE 4
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<div class="figure-caption-contents">Absolute LS mean (SE) change from baseline in pruritus numerical rating scale (NRS) at month 3 (A) and proportion of patients who achieved point reductions from baseline in pruritus NRS at month 3 (B). For (A) and (B), populations included only patients with pruritus NRS ≥4 at baseline. For (A), change from baseline was estimated by an analysis of covariance model with treatment group and randomization alkaline phosphatase stratification as factors and baseline pruritus score as a covariate. For (B), patients who discontinued treatment before month 3 due to reasons other than study termination and who did not have evaluable data at month 3 were considered nonresponders. <i>p</i>-values are per Cochran-Mantel-Haenszel test adjusted for both randomization stratification variables. Abbreviations: LS, least squares; N, number of patients in the treatment group; n, number of patients in the category.</div>
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<p> FIGURE 5 </p>
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<div class="figure-caption-contents"><p> LS mean relative (percent) change… </p></div>
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<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIGURE 5 </p>
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<div class="figure-caption-contents"><p> LS mean relative (percent) change from baseline and mean absolute values for ALP… </p></div>
</div>
<figcaption id="figure-caption-5" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
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FIGURE 5
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<div class="figure-caption-contents">LS mean relative (percent) change from baseline and mean absolute values for ALP (A and B) and ALT (C and D) through month 6. *<i>p</i> &lt; 0.0001 versus placebo, †<i>p</i> ≤ 0.002 versus seladelpar 5-mg group. Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; LS, least squares; ULN, upper limit of normal.</div>
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<div id="mesh-terms" class="mesh-terms keywords-section">
<h2 class="title">
MeSH terms
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<div id="substances" class="substances keywords-section">
<h2 class="title">
Substances
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