Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
Identifieur interne : 002465 ( Ncbi/Checkpoint ); précédent : 002464; suivant : 002466Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
Auteurs : Yaseen M. Arabi [Arabie saoudite] ; Ayed Y. Asiri [Arabie saoudite] ; Abdullah M. Assiri [Arabie saoudite] ; Hani A. Aziz Jokhdar [Arabie saoudite] ; Adel Alothman [Arabie saoudite] ; Hanan H. Balkhy [Arabie saoudite] ; Sameera Aljohani [Arabie saoudite] ; Shmeylan Al Harbi [Arabie saoudite] ; Suleiman Kojan [Arabie saoudite] ; Majed Al Jeraisy [Arabie saoudite] ; Ahmad M. Deeb [Arabie saoudite] ; Ziad A. Memish [Arabie saoudite] ; Sameeh Ghazal [Arabie saoudite] ; Sarah Al Faraj [Arabie saoudite] ; Fahad Al-Hameed [Arabie saoudite] ; Asim Alsaedi [Arabie saoudite] ; Yasser Mandourah [Arabie saoudite] ; Ghaleb A. Al Mekhlafi [Arabie saoudite] ; Nisreen Murad Sherbeeni [Arabie saoudite] ; Fatehi Elnour Elzein [Arabie saoudite] ; Abdullah Almotairi [Arabie saoudite] ; Ali Al Bshabshe [Arabie saoudite] ; Ayman Kharaba [Arabie saoudite] ; Jesna Jose [Arabie saoudite] ; Abdulrahman Al Harthy [Arabie saoudite] ; Mohammed Al Sulaiman [Arabie saoudite] ; Ahmed Mady [Arabie saoudite, Égypte] ; Robert A. Fowler [Canada] ; Frederick G. Hayden ; Abdulaziz Al-Dawood [Arabie saoudite] ; Mohamed Abdelzaher [Arabie saoudite, Égypte] ; Wail Bajhmom [Arabie saoudite] ; Mohamed A. Hussein [Arabie saoudite]Source :
- Trials [ 1745-6215 ] ; 2020.
Abstract
The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment.
ClinicalTrials.gov,
Url:
DOI: 10.1186/s13063-019-3846-x
PubMed: 31900204
PubMed Central: 6942374
Affiliations:
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<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah</wicri:regionArea>
<wicri:noRegion>Al-Madinah Al-Monawarah</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name>
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<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>Department Biostatistics and Bioinformatics,</institution>
<institution>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Harthy, Abdulrahman" sort="Al Harthy, Abdulrahman" uniqKey="Al Harthy A" first="Abdulrahman" last="Al Harthy">Abdulrahman Al Harthy</name>
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<institution-id institution-id-type="GRID">grid.415998.8</institution-id>
<institution>Intensive Care Unit,</institution>
<institution>King Saud Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Sulaiman, Mohammed" sort="Al Sulaiman, Mohammed" uniqKey="Al Sulaiman M" first="Mohammed" last="Al Sulaiman">Mohammed Al Sulaiman</name>
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<institution-id institution-id-type="GRID">grid.415998.8</institution-id>
<institution>Infectious Disease,</institution>
<institution>King Saud Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name>
<affiliation wicri:level="1"><nlm:aff id="Aff27"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0445 6726</institution-id>
<institution-id institution-id-type="GRID">grid.415998.8</institution-id>
<institution>Intensive Care Department,</institution>
<institution>King Saud Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff28"><institution-wrap><institution-id institution-id-type="GRID">grid.479691.4</institution-id>
<institution>Department of Anesthesiology and Intensive Care,</institution>
<institution>Tanta University Hospitals,</institution>
</institution-wrap>
Tanta, Egypt</nlm:aff>
<country xml:lang="fr">Égypte</country>
<wicri:regionArea>Tanta</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A." last="Fowler">Robert A. Fowler</name>
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<institution-id institution-id-type="GRID">grid.17063.33</institution-id>
<institution>Institute of Health Policy Management and Evaluation,</institution>
<institution>University of Toronto,</institution>
</institution-wrap>
Toronto, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Toronto</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff30"><institution-wrap><institution-id institution-id-type="GRID">grid.416745.5</institution-id>
<institution>Department of Critical Care Medicine and Department of Medicine,</institution>
<institution>Sunnybrook Hospital,</institution>
</institution-wrap>
Bayview Avenue, Room D478, Toronto, 2075 Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Bayview Avenue, Room D478, Toronto</wicri:regionArea>
<wicri:noRegion>Toronto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G." last="Hayden">Frederick G. Hayden</name>
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<institution-id institution-id-type="GRID">grid.27755.32</institution-id>
<institution>International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), Division of Infectious Diseases and International Health, Department of Medicine,</institution>
<institution>University of Virginia School of Medicine,</institution>
</institution-wrap>
Charlottesville, Virginia USA</nlm:aff>
<wicri:noCountry code="subfield">Virginia USA</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Intensive Care Department,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
ICU 1425, P.O. Box 22490, Riyadh, 11426 Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>ICU 1425, P.O. Box 22490, Riyadh</wicri:regionArea>
<wicri:noRegion>Riyadh</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name>
<affiliation wicri:level="1"><nlm:aff id="Aff32">Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah</wicri:regionArea>
<wicri:noRegion>Jeddah</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff33"><institution-wrap><institution-id institution-id-type="GRID">grid.476980.4</institution-id>
<institution>Critical Care Medicine Department,</institution>
<institution>Cairo University Hospital,</institution>
</institution-wrap>
Cairo, Egypt</nlm:aff>
<country xml:lang="fr">Égypte</country>
<wicri:regionArea>Cairo</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name>
<affiliation wicri:level="1"><nlm:aff id="Aff34"><institution-wrap><institution-id institution-id-type="GRID">grid.415696.9</institution-id>
<institution>Internal Medicine Department,</institution>
<institution>King Fahad General Hospital, Ministry of Health,</institution>
</institution-wrap>
Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Jeddah</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A." last="Hussein">Mohamed A. Hussein</name>
<affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff24"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>Department Biostatistics and Bioinformatics,</institution>
<institution>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial</title>
<author><name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M." last="Arabi">Yaseen M. Arabi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Intensive Care Department,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
ICU 1425, P.O. Box 22490, Riyadh, 11426 Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>ICU 1425, P.O. Box 22490, Riyadh</wicri:regionArea>
<wicri:noRegion>Riyadh</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Asiri, Ayed Y" sort="Asiri, Ayed Y" uniqKey="Asiri A" first="Ayed Y." last="Asiri">Ayed Y. Asiri</name>
<affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.440269.d</institution-id>
<institution>Prince Mohammed bin Abdulaziz Hospital,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Assiri, Abdullah M" sort="Assiri, Abdullah M" uniqKey="Assiri A" first="Abdullah M." last="Assiri">Abdullah M. Assiri</name>
<affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.415696.9</institution-id>
<institution>Infection Prevention and Control, Assistant Deputy Minister, Preventive Health,</institution>
<institution>Ministry of Health,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Aziz Jokhdar, Hani A" sort="Aziz Jokhdar, Hani A" uniqKey="Aziz Jokhdar H" first="Hani A." last="Aziz Jokhdar">Hani A. Aziz Jokhdar</name>
<affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="GRID">grid.415696.9</institution-id>
<institution>Deputy Minister for Public Health, Ministry of Health,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Department of Medicine,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Department of Infection Prevention and Control,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Department of Pathology and Laboratory Medicine,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Pharmaceutical Care Department,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Department of Medicine,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name>
<affiliation wicri:level="1"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Pharmaceutical Care Department,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M." last="Deeb">Ahmad M. Deeb</name>
<affiliation wicri:level="1"><nlm:aff id="Aff11"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Memish, Ziad A" sort="Memish, Ziad A" uniqKey="Memish Z" first="Ziad A." last="Memish">Ziad A. Memish</name>
<affiliation wicri:level="1"><nlm:aff id="Aff13"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1758 7207</institution-id>
<institution-id institution-id-type="GRID">grid.411335.1</institution-id>
<institution>Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine,</institution>
<institution>Alfaisal University,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation><nlm:aff id="Aff14"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0941 6502</institution-id>
<institution-id institution-id-type="GRID">grid.189967.8</institution-id>
<institution>Hubert Department of Global Health,</institution>
<institution>Rollins School of Public Health, Emory University,</institution>
</institution-wrap>
Atlanta, Georgia USA</nlm:aff>
<wicri:noCountry code="subfield">Georgia USA</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Ghazal, Sameeh" sort="Ghazal, Sameeh" uniqKey="Ghazal S" first="Sameeh" last="Ghazal">Sameeh Ghazal</name>
<affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.440269.d</institution-id>
<institution>Prince Mohammed bin Abdulaziz Hospital,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Faraj, Sarah" sort="Al Faraj, Sarah" uniqKey="Al Faraj S" first="Sarah" last="Al Faraj">Sarah Al Faraj</name>
<affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.440269.d</institution-id>
<institution>Prince Mohammed bin Abdulaziz Hospital,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name>
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<institution-id institution-id-type="GRID">grid.452607.2</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Jeddah</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff16">Intensive Care Department, Ministry of the National Guard - Health Affairs, Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Intensive Care Department, Ministry of the National Guard - Health Affairs, Jeddah</wicri:regionArea>
<wicri:noRegion>Jeddah</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff15"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id>
<institution-id institution-id-type="GRID">grid.452607.2</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Jeddah</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff17">Department of Infection Prevention and Control, Ministry of the National Guard - Health Affairs, Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Infection Prevention and Control, Ministry of the National Guard - Health Affairs, Jeddah</wicri:regionArea>
<wicri:noRegion>Jeddah</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name>
<affiliation wicri:level="1"><nlm:aff id="Aff18"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id>
<institution-id institution-id-type="GRID">grid.415989.8</institution-id>
<institution>Military Medical Services, Ministry of Defense,</institution>
<institution>Prince Sultan Military Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Mekhlafi, Ghaleb A" sort="Al Mekhlafi, Ghaleb A" uniqKey="Al Mekhlafi G" first="Ghaleb A." last="Al Mekhlafi">Ghaleb A. Al Mekhlafi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff19"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id>
<institution-id institution-id-type="GRID">grid.415989.8</institution-id>
<institution>Department of Intensive Care Services,</institution>
<institution>Prince Sultan Military Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name>
<affiliation wicri:level="1"><nlm:aff id="Aff20"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id>
<institution-id institution-id-type="GRID">grid.415989.8</institution-id>
<institution>Infectious Diseases Division,</institution>
<institution>Prince Sultan Military Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Elzein, Fatehi Elnour" sort="Elzein, Fatehi Elnour" uniqKey="Elzein F" first="Fatehi Elnour" last="Elzein">Fatehi Elnour Elzein</name>
<affiliation wicri:level="1"><nlm:aff id="Aff20"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id>
<institution-id institution-id-type="GRID">grid.415989.8</institution-id>
<institution>Infectious Diseases Division,</institution>
<institution>Prince Sultan Military Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff21"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0593 1832</institution-id>
<institution-id institution-id-type="GRID">grid.415277.2</institution-id>
<institution>Department of Critical Care Medicine,</institution>
<institution>King Fahad Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Bshabshe, Ali" sort="Al Bshabshe, Ali" uniqKey="Al Bshabshe A" first="Ali" last="Al Bshabshe">Ali Al Bshabshe</name>
<affiliation wicri:level="1"><nlm:aff id="Aff22">Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha</wicri:regionArea>
<wicri:noRegion>Abha</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name>
<affiliation wicri:level="1"><nlm:aff id="Aff23">Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah</wicri:regionArea>
<wicri:noRegion>Al-Madinah Al-Monawarah</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name>
<affiliation wicri:level="1"><nlm:aff id="Aff24"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>Department Biostatistics and Bioinformatics,</institution>
<institution>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Harthy, Abdulrahman" sort="Al Harthy, Abdulrahman" uniqKey="Al Harthy A" first="Abdulrahman" last="Al Harthy">Abdulrahman Al Harthy</name>
<affiliation wicri:level="1"><nlm:aff id="Aff25"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0445 6726</institution-id>
<institution-id institution-id-type="GRID">grid.415998.8</institution-id>
<institution>Intensive Care Unit,</institution>
<institution>King Saud Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Al Sulaiman, Mohammed" sort="Al Sulaiman, Mohammed" uniqKey="Al Sulaiman M" first="Mohammed" last="Al Sulaiman">Mohammed Al Sulaiman</name>
<affiliation wicri:level="1"><nlm:aff id="Aff26"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0445 6726</institution-id>
<institution-id institution-id-type="GRID">grid.415998.8</institution-id>
<institution>Infectious Disease,</institution>
<institution>King Saud Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name>
<affiliation wicri:level="1"><nlm:aff id="Aff27"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0445 6726</institution-id>
<institution-id institution-id-type="GRID">grid.415998.8</institution-id>
<institution>Intensive Care Department,</institution>
<institution>King Saud Medical City,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff28"><institution-wrap><institution-id institution-id-type="GRID">grid.479691.4</institution-id>
<institution>Department of Anesthesiology and Intensive Care,</institution>
<institution>Tanta University Hospitals,</institution>
</institution-wrap>
Tanta, Egypt</nlm:aff>
<country xml:lang="fr">Égypte</country>
<wicri:regionArea>Tanta</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A." last="Fowler">Robert A. Fowler</name>
<affiliation wicri:level="1"><nlm:aff id="Aff29"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2157 2938</institution-id>
<institution-id institution-id-type="GRID">grid.17063.33</institution-id>
<institution>Institute of Health Policy Management and Evaluation,</institution>
<institution>University of Toronto,</institution>
</institution-wrap>
Toronto, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Toronto</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff30"><institution-wrap><institution-id institution-id-type="GRID">grid.416745.5</institution-id>
<institution>Department of Critical Care Medicine and Department of Medicine,</institution>
<institution>Sunnybrook Hospital,</institution>
</institution-wrap>
Bayview Avenue, Room D478, Toronto, 2075 Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Bayview Avenue, Room D478, Toronto</wicri:regionArea>
<wicri:noRegion>Toronto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G." last="Hayden">Frederick G. Hayden</name>
<affiliation><nlm:aff id="Aff31"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9136 933X</institution-id>
<institution-id institution-id-type="GRID">grid.27755.32</institution-id>
<institution>International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), Division of Infectious Diseases and International Health, Department of Medicine,</institution>
<institution>University of Virginia School of Medicine,</institution>
</institution-wrap>
Charlottesville, Virginia USA</nlm:aff>
<wicri:noCountry code="subfield">Virginia USA</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Intensive Care Department,</institution>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
ICU 1425, P.O. Box 22490, Riyadh, 11426 Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>ICU 1425, P.O. Box 22490, Riyadh</wicri:regionArea>
<wicri:noRegion>Riyadh</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name>
<affiliation wicri:level="1"><nlm:aff id="Aff32">Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah</wicri:regionArea>
<wicri:noRegion>Jeddah</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff33"><institution-wrap><institution-id institution-id-type="GRID">grid.476980.4</institution-id>
<institution>Critical Care Medicine Department,</institution>
<institution>Cairo University Hospital,</institution>
</institution-wrap>
Cairo, Egypt</nlm:aff>
<country xml:lang="fr">Égypte</country>
<wicri:regionArea>Cairo</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name>
<affiliation wicri:level="1"><nlm:aff id="Aff34"><institution-wrap><institution-id institution-id-type="GRID">grid.415696.9</institution-id>
<institution>Internal Medicine Department,</institution>
<institution>King Fahad General Hospital, Ministry of Health,</institution>
</institution-wrap>
Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Jeddah</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A." last="Hussein">Mohamed A. Hussein</name>
<affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0607 2419</institution-id>
<institution-id institution-id-type="GRID">grid.416641.0</institution-id>
<institution>Ministry of the National Guard - Health Affairs,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff24"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0608 0662</institution-id>
<institution-id institution-id-type="GRID">grid.412149.b</institution-id>
<institution>Department Biostatistics and Bioinformatics,</institution>
<institution>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center,</institution>
</institution-wrap>
Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2020">2020</date>
</imprint>
</series>
</biblStruct>
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</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Abstract</title>
<p id="Par1">The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment.</p>
</sec>
<sec><title>Trial registration</title>
<p id="Par2">ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02845843">NCT02845843</ext-link>
. Registered on 27 July 2016.</p>
</sec>
</div>
</front>
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<biblStruct></biblStruct>
<biblStruct></biblStruct>
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<biblStruct><analytic><author><name sortKey="Gamble, C" uniqKey="Gamble C">C Gamble</name>
</author>
<author><name sortKey="Krishan, A" uniqKey="Krishan A">A Krishan</name>
</author>
<author><name sortKey="Stocken, D" uniqKey="Stocken D">D Stocken</name>
</author>
<author><name sortKey="Lewis, S" uniqKey="Lewis S">S Lewis</name>
</author>
<author><name sortKey="Juszczak, E" uniqKey="Juszczak E">E Juszczak</name>
</author>
<author><name sortKey="Dore, C" uniqKey="Dore C">C Dore</name>
</author>
<author><name sortKey="Williamson, Pr" uniqKey="Williamson P">PR Williamson</name>
</author>
<author><name sortKey="Altman, Dg" uniqKey="Altman D">DG Altman</name>
</author>
<author><name sortKey="Montgomery, A" uniqKey="Montgomery A">A Montgomery</name>
</author>
<author><name sortKey="Lim, P" uniqKey="Lim P">P Lim</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Srivastava, Dk" uniqKey="Srivastava D">DK Srivastava</name>
</author>
<author><name sortKey="Rai, Sn" uniqKey="Rai S">SN Rai</name>
</author>
<author><name sortKey="Pan, J" uniqKey="Pan J">J Pan</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Rubin, Db" uniqKey="Rubin D">DB Rubin</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Benjamini, Y" uniqKey="Benjamini Y">Y Benjamini</name>
</author>
<author><name sortKey="Hochberg, Y" uniqKey="Hochberg Y">Y Hochberg</name>
</author>
</analytic>
</biblStruct>
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</TEI>
<affiliations><list><country><li>Arabie saoudite</li>
<li>Canada</li>
<li>Égypte</li>
</country>
</list>
<tree><noCountry><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G." last="Hayden">Frederick G. Hayden</name>
</noCountry>
<country name="Arabie saoudite"><noRegion><name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M." last="Arabi">Yaseen M. Arabi</name>
</noRegion>
<name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name>
<name sortKey="Al Bshabshe, Ali" sort="Al Bshabshe, Ali" uniqKey="Al Bshabshe A" first="Ali" last="Al Bshabshe">Ali Al Bshabshe</name>
<name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name>
<name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name>
<name sortKey="Al Faraj, Sarah" sort="Al Faraj, Sarah" uniqKey="Al Faraj S" first="Sarah" last="Al Faraj">Sarah Al Faraj</name>
<name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name>
<name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name>
<name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name>
<name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name>
<name sortKey="Al Harthy, Abdulrahman" sort="Al Harthy, Abdulrahman" uniqKey="Al Harthy A" first="Abdulrahman" last="Al Harthy">Abdulrahman Al Harthy</name>
<name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name>
<name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name>
<name sortKey="Al Mekhlafi, Ghaleb A" sort="Al Mekhlafi, Ghaleb A" uniqKey="Al Mekhlafi G" first="Ghaleb A." last="Al Mekhlafi">Ghaleb A. Al Mekhlafi</name>
<name sortKey="Al Sulaiman, Mohammed" sort="Al Sulaiman, Mohammed" uniqKey="Al Sulaiman M" first="Mohammed" last="Al Sulaiman">Mohammed Al Sulaiman</name>
<name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name>
<name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name>
<name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name>
<name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name>
<name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name>
<name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name>
<name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name>
<name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M." last="Arabi">Yaseen M. Arabi</name>
<name sortKey="Asiri, Ayed Y" sort="Asiri, Ayed Y" uniqKey="Asiri A" first="Ayed Y." last="Asiri">Ayed Y. Asiri</name>
<name sortKey="Assiri, Abdullah M" sort="Assiri, Abdullah M" uniqKey="Assiri A" first="Abdullah M." last="Assiri">Abdullah M. Assiri</name>
<name sortKey="Aziz Jokhdar, Hani A" sort="Aziz Jokhdar, Hani A" uniqKey="Aziz Jokhdar H" first="Hani A." last="Aziz Jokhdar">Hani A. Aziz Jokhdar</name>
<name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name>
<name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name>
<name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name>
<name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M." last="Deeb">Ahmad M. Deeb</name>
<name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M." last="Deeb">Ahmad M. Deeb</name>
<name sortKey="Elzein, Fatehi Elnour" sort="Elzein, Fatehi Elnour" uniqKey="Elzein F" first="Fatehi Elnour" last="Elzein">Fatehi Elnour Elzein</name>
<name sortKey="Ghazal, Sameeh" sort="Ghazal, Sameeh" uniqKey="Ghazal S" first="Sameeh" last="Ghazal">Sameeh Ghazal</name>
<name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A." last="Hussein">Mohamed A. Hussein</name>
<name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A." last="Hussein">Mohamed A. Hussein</name>
<name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name>
<name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name>
<name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name>
<name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name>
<name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name>
<name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name>
<name sortKey="Memish, Ziad A" sort="Memish, Ziad A" uniqKey="Memish Z" first="Ziad A." last="Memish">Ziad A. Memish</name>
<name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name>
</country>
<country name="Égypte"><noRegion><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name>
</noRegion>
<name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name>
</country>
<country name="Canada"><noRegion><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A." last="Fowler">Robert A. Fowler</name>
</noRegion>
<name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A." last="Fowler">Robert A. Fowler</name>
</country>
</tree>
</affiliations>
</record>
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