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Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.

Identifieur interne : 000070 ( PubMed/Corpus ); précédent : 000069; suivant : 000071

Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.

Auteurs : Pedro Cahn ; Richard Kaplan ; Paul E. Sax ; Kathleen Squires ; Jean-Michel Molina ; Anchalee Avihingsanon ; Winai Ratanasuwan ; Evelyn Rojas ; Mohammed Rassool ; Mark Bloch ; Linos Vandekerckhove ; Peter Ruane ; Yazdan Yazdanpanah ; Christine Katlama ; Xia Xu ; Anthony Rodgers ; Lilly East ; Larissa Wenning ; Sandy Rawlins ; Brenda Homony ; Peter Sklar ; Bach-Yen Nguyen ; Randi Leavitt ; Hedy Teppler

Source :

RBID : pubmed:28918877

Abstract

Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation.

DOI: 10.1016/S2352-3018(17)30128-5
PubMed: 28918877

Links to Exploration step

pubmed:28918877

Le document en format XML

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<name sortKey="Cahn, Pedro" sort="Cahn, Pedro" uniqKey="Cahn P" first="Pedro" last="Cahn">Pedro Cahn</name>
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<name sortKey="Kaplan, Richard" sort="Kaplan, Richard" uniqKey="Kaplan R" first="Richard" last="Kaplan">Richard Kaplan</name>
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<name sortKey="Sax, Paul E" sort="Sax, Paul E" uniqKey="Sax P" first="Paul E" last="Sax">Paul E. Sax</name>
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<nlm:affiliation>Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.</nlm:affiliation>
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<name sortKey="Squires, Kathleen" sort="Squires, Kathleen" uniqKey="Squires K" first="Kathleen" last="Squires">Kathleen Squires</name>
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<name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name>
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<nlm:affiliation>Department of Infectious Diseases, Saint-Louis Hospital, APHP, University of Paris, Paris, France.</nlm:affiliation>
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<name sortKey="Yazdanpanah, Yazdan" sort="Yazdanpanah, Yazdan" uniqKey="Yazdanpanah Y" first="Yazdan" last="Yazdanpanah">Yazdan Yazdanpanah</name>
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<name sortKey="Katlama, Christine" sort="Katlama, Christine" uniqKey="Katlama C" first="Christine" last="Katlama">Christine Katlama</name>
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<nlm:affiliation>Hôpital Pitié-Salpêtrière Pavillon Laveran, Paris, France.</nlm:affiliation>
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<name sortKey="Xu, Xia" sort="Xu, Xia" uniqKey="Xu X" first="Xia" last="Xu">Xia Xu</name>
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<name sortKey="Wenning, Larissa" sort="Wenning, Larissa" uniqKey="Wenning L" first="Larissa" last="Wenning">Larissa Wenning</name>
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<name sortKey="Rawlins, Sandy" sort="Rawlins, Sandy" uniqKey="Rawlins S" first="Sandy" last="Rawlins">Sandy Rawlins</name>
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<name sortKey="Homony, Brenda" sort="Homony, Brenda" uniqKey="Homony B" first="Brenda" last="Homony">Brenda Homony</name>
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<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
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<name sortKey="Sklar, Peter" sort="Sklar, Peter" uniqKey="Sklar P" first="Peter" last="Sklar">Peter Sklar</name>
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<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Nguyen, Bach Yen" sort="Nguyen, Bach Yen" uniqKey="Nguyen B" first="Bach-Yen" last="Nguyen">Bach-Yen Nguyen</name>
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<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Leavitt, Randi" sort="Leavitt, Randi" uniqKey="Leavitt R" first="Randi" last="Leavitt">Randi Leavitt</name>
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<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
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<name sortKey="Teppler, Hedy" sort="Teppler, Hedy" uniqKey="Teppler H" first="Hedy" last="Teppler">Hedy Teppler</name>
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<title xml:lang="en">Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.</title>
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<name sortKey="Cahn, Pedro" sort="Cahn, Pedro" uniqKey="Cahn P" first="Pedro" last="Cahn">Pedro Cahn</name>
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<nlm:affiliation>Fundación Huesped, Buenos Aires, Argentina.</nlm:affiliation>
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<name sortKey="Kaplan, Richard" sort="Kaplan, Richard" uniqKey="Kaplan R" first="Richard" last="Kaplan">Richard Kaplan</name>
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<nlm:affiliation>Desmond Tutu HIV Foundation, Cape Town, South Africa.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Sax, Paul E" sort="Sax, Paul E" uniqKey="Sax P" first="Paul E" last="Sax">Paul E. Sax</name>
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<nlm:affiliation>Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Squires, Kathleen" sort="Squires, Kathleen" uniqKey="Squires K" first="Kathleen" last="Squires">Kathleen Squires</name>
<affiliation>
<nlm:affiliation>Thomas Jefferson University, Philadelphia, PA, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name>
<affiliation>
<nlm:affiliation>Department of Infectious Diseases, Saint-Louis Hospital, APHP, University of Paris, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Avihingsanon, Anchalee" sort="Avihingsanon, Anchalee" uniqKey="Avihingsanon A" first="Anchalee" last="Avihingsanon">Anchalee Avihingsanon</name>
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<nlm:affiliation>HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Ratanasuwan, Winai" sort="Ratanasuwan, Winai" uniqKey="Ratanasuwan W" first="Winai" last="Ratanasuwan">Winai Ratanasuwan</name>
<affiliation>
<nlm:affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Rojas, Evelyn" sort="Rojas, Evelyn" uniqKey="Rojas E" first="Evelyn" last="Rojas">Evelyn Rojas</name>
<affiliation>
<nlm:affiliation>Cericap Multiclinicas, Edifico Galerías, Guatemala City, Guatemala.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Rassool, Mohammed" sort="Rassool, Mohammed" uniqKey="Rassool M" first="Mohammed" last="Rassool">Mohammed Rassool</name>
<affiliation>
<nlm:affiliation>University of Witwatersrand, Helen Joseph Hospital, Johannesburg, South Africa.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Bloch, Mark" sort="Bloch, Mark" uniqKey="Bloch M" first="Mark" last="Bloch">Mark Bloch</name>
<affiliation>
<nlm:affiliation>Holdsworth House Medical Practice, Sydney NSW, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Vandekerckhove, Linos" sort="Vandekerckhove, Linos" uniqKey="Vandekerckhove L" first="Linos" last="Vandekerckhove">Linos Vandekerckhove</name>
<affiliation>
<nlm:affiliation>Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Ruane, Peter" sort="Ruane, Peter" uniqKey="Ruane P" first="Peter" last="Ruane">Peter Ruane</name>
<affiliation>
<nlm:affiliation>Ruane Medical & Liver Health Institute, Los Angeles, CA, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Yazdanpanah, Yazdan" sort="Yazdanpanah, Yazdan" uniqKey="Yazdanpanah Y" first="Yazdan" last="Yazdanpanah">Yazdan Yazdanpanah</name>
<affiliation>
<nlm:affiliation>Hôpital Bichat-Claude Bernard, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Katlama, Christine" sort="Katlama, Christine" uniqKey="Katlama C" first="Christine" last="Katlama">Christine Katlama</name>
<affiliation>
<nlm:affiliation>Hôpital Pitié-Salpêtrière Pavillon Laveran, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Xu, Xia" sort="Xu, Xia" uniqKey="Xu X" first="Xia" last="Xu">Xia Xu</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Rodgers, Anthony" sort="Rodgers, Anthony" uniqKey="Rodgers A" first="Anthony" last="Rodgers">Anthony Rodgers</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="East, Lilly" sort="East, Lilly" uniqKey="East L" first="Lilly" last="East">Lilly East</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Wenning, Larissa" sort="Wenning, Larissa" uniqKey="Wenning L" first="Larissa" last="Wenning">Larissa Wenning</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Rawlins, Sandy" sort="Rawlins, Sandy" uniqKey="Rawlins S" first="Sandy" last="Rawlins">Sandy Rawlins</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Homony, Brenda" sort="Homony, Brenda" uniqKey="Homony B" first="Brenda" last="Homony">Brenda Homony</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Sklar, Peter" sort="Sklar, Peter" uniqKey="Sklar P" first="Peter" last="Sklar">Peter Sklar</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Nguyen, Bach Yen" sort="Nguyen, Bach Yen" uniqKey="Nguyen B" first="Bach-Yen" last="Nguyen">Bach-Yen Nguyen</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Leavitt, Randi" sort="Leavitt, Randi" uniqKey="Leavitt R" first="Randi" last="Leavitt">Randi Leavitt</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Teppler, Hedy" sort="Teppler, Hedy" uniqKey="Teppler H" first="Hedy" last="Teppler">Hedy Teppler</name>
<affiliation>
<nlm:affiliation>Merck & Co, Inc, Kenilworth, NJ, USA. Electronic address: hedy_teppler@merck.com.</nlm:affiliation>
</affiliation>
</author>
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<series>
<title level="j">The lancet. HIV</title>
<idno type="eISSN">2352-3018</idno>
<imprint>
<date when="2017" type="published">2017</date>
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<div type="abstract" xml:lang="en">Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation.</div>
</front>
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<DateCreated>
<Year>2017</Year>
<Month>09</Month>
<Day>18</Day>
</DateCreated>
<DateRevised>
<Year>2017</Year>
<Month>11</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">2352-3018</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>4</Volume>
<Issue>11</Issue>
<PubDate>
<Year>2017</Year>
<Month>Nov</Month>
</PubDate>
</JournalIssue>
<Title>The lancet. HIV</Title>
<ISOAbbreviation>Lancet HIV</ISOAbbreviation>
</Journal>
<ArticleTitle>Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial.</ArticleTitle>
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</Pagination>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/S2352-3018(17)30128-5</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Once daily regimens are preferred for HIV-1 treatment, to facilitate adherence and improve quality of life. We compared a new once daily formulation of raltegravir to the currently marketed twice daily formulation.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In this randomised, double-blind, parallel-group, phase 3, non-inferiority study, we enrolled participants aged 18 years or older with HIV-1 RNA of 1000 or more copies per mL and no previous antiretroviral treatment at 139 sites worldwide. We randomly assigned participants (2:1) via an interactive voice and web response system to raltegravir 1200 mg (two 600 mg tablets) orally once daily or raltegravir 400 mg (one tablet) orally twice daily, each with tenofovir disoproxil fumarate and emtricitabine orally once daily, for up to 96 weeks. A computer-generated allocation schedule stratified randomisation by screening HIV-1 RNA value and co-infection with hepatitis B or C. Participants, sponsor personnel, investigators, and study site personnel involved in the treatment or evaluation of the participants were unaware of the treatment group assignments. The primary endpoint was the proportion of participants with HIV-1 RNA less than 40 copies per mL at week 48 assessed with the US Food and Drug Administration Snapshot algorithm. Non-inferiority was concluded if the lower bound of the two-sided 95% CI was greater than -10%. We assessed efficacy and safety in all participants who received one dose or more of study treatment. This study is registered with ClinicalTrials.gov, number NCT02131233.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between May 26, 2014, and Dec 5, 2014, 802 participants were enrolled and randomly assigned, 533 to once daily treatment and 269 to twice daily; 797 received study therapy, 531 once daily and 266 twice daily. At week 48, 472 (89%) of 531 once daily recipients and 235 (88%) of 266 twice daily recipients achieved HIV-1 RNA less than 40 copies per mL (treatment difference 0·5%, 95% CI -4·2 to 5·2). Drug-related adverse events occurred in 130 (24%) of 531 participants in the once daily group (one of which was serious; none led to treatment discontinuation) and 68 (26%) of 266 participants in the twice daily group (two of which were serious; two led to treatment discontinuation). The most common drug-related adverse events were nausea (39 [7%] vs 18 [7%]), headache (16 [3%] vs 12 [5%]), and dizziness (12 [2%] vs eight [3%]). No treatment-related deaths were reported.</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">A once daily raltegravir 1200 mg regimen was non-inferior compared with raltegravir 400 mg twice daily for initial treatment of HIV-1 infection. These results support the use of raltegravir 1200 mg once daily for first-line therapy.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Merck & Co, Inc.</AbstractText>
<CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
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<Author ValidYN="Y">
<LastName>Cahn</LastName>
<ForeName>Pedro</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Fundación Huesped, Buenos Aires, Argentina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kaplan</LastName>
<ForeName>Richard</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Desmond Tutu HIV Foundation, Cape Town, South Africa.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sax</LastName>
<ForeName>Paul E</ForeName>
<Initials>PE</Initials>
<AffiliationInfo>
<Affiliation>Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Squires</LastName>
<ForeName>Kathleen</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Thomas Jefferson University, Philadelphia, PA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Molina</LastName>
<ForeName>Jean-Michel</ForeName>
<Initials>JM</Initials>
<AffiliationInfo>
<Affiliation>Department of Infectious Diseases, Saint-Louis Hospital, APHP, University of Paris, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Avihingsanon</LastName>
<ForeName>Anchalee</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ratanasuwan</LastName>
<ForeName>Winai</ForeName>
<Initials>W</Initials>
<AffiliationInfo>
<Affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rojas</LastName>
<ForeName>Evelyn</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>Cericap Multiclinicas, Edifico Galerías, Guatemala City, Guatemala.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rassool</LastName>
<ForeName>Mohammed</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>University of Witwatersrand, Helen Joseph Hospital, Johannesburg, South Africa.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bloch</LastName>
<ForeName>Mark</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Holdsworth House Medical Practice, Sydney NSW, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Vandekerckhove</LastName>
<ForeName>Linos</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ruane</LastName>
<ForeName>Peter</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
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