Serveur d'exploration COVID et hydrochloroquine

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Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial.

Identifieur interne : 001128 ( Main/Curation ); précédent : 001127; suivant : 001129

Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial.

Auteurs : Oriol Mitjà [Espagne, Papouasie-Nouvelle-Guinée] ; Marc Corbacho-Monné [Espagne] ; Maria Ubals [Espagne] ; Cristian Tebe [Espagne] ; Judith Pe Afiel [Espagne] ; Aurelio Tobias [Espagne] ; Ester Ballana [Espagne] ; Andrea Alemany [Espagne] ; Núria Riera-Martí [Espagne] ; Carla A. Pérez [Espagne] ; Clara Su Er [Espagne] ; Pep Laporte [Espagne] ; Pol Admella [Espagne] ; Jordi Mitjà [Espagne] ; Mireia Clua [Espagne] ; Laia Bertran [Espagne] ; Maria Sarquella [Espagne] ; Sergi Gavilán [Espagne] ; Jordi Ara [Espagne] ; Josep M. Argimon [Espagne] ; Jordi Casabona [Espagne] ; Gabriel Cuatrecasas [Espagne] ; Paz Ca Adas [Espagne] ; Aleix Elizalde-Torrent [Espagne] ; Robert Fabregat [Espagne] ; Magí Farré [Espagne] ; Anna Forcada [Espagne] ; Gemma Flores-Mateo [Espagne] ; Esteve Muntada [Espagne] ; Núria Nadal [Espagne] ; Silvia Narejos [Espagne] ; Aroa N. Gil-Ortega [Espagne] ; Nuria Prat [Espagne] ; Jordi Puig [Espagne] ; Carles Qui Ones [Espagne] ; Juliana Reyes-Ure A [Espagne] ; Ferran Ramírez-Viaplana [Espagne] ; Lidia Ruiz [Espagne] ; Eva Riveira-Mu Oz [Espagne] ; Alba Sierra [Espagne] ; César Velasco [Espagne] ; Rosa Maria Vivanco-Hidalgo [Espagne] ; Alexis Sentís [Espagne] ; Camila G-Beiras [Espagne] ; Bonaventura Clotet [Espagne] ; Martí Vall-Mayans [Espagne]

Source :

RBID : pubmed:32674126

Abstract

BACKGROUND

No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be more efficacious than no-treatment for outpatients with mild Covid-19.

METHODS

We conducted a multicenter, open label, randomized controlled trial in Catalonia (Spain) between March 17, and May 26, 2020. Eligible Covid-19 cases were non-hospitalized adult patients with recently confirmed SARS-CoV-2 infection and less than five days of symptoms. Patients were assigned to receive HCQ (800 mg on day 1, followed by 400 mg once daily for 6 days) or no antiviral treatment (not-placebo controlled). Study outcomes were the reduction of viral RNA load in nasopharyngeal swabs up to 7 days after treatment start, patient disease progression using the WHO scale up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.

RESULTS

A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD 12.6), mean viral load at baseline was 7.90 (SD 1.82) Log10 copies/mL, and median time from symptom onset to randomization was 3 days. No significant differences were found in the mean reduction of viral load at day 3 (-1.41 vs. -1.41 Log10 copies/mL in the control and intervention arm, respectively; difference 0.01 [95% CI -0.28;0.29]) or at day 7 (-3.37 vs. -3.44; d -0.07 [-0.44;0.29]). This treatment regimen did not reduce risk of hospitalization (7.1%, control vs. 5.9%, intervention; RR 0.75 [0.32;1.77]) nor shortened the time to complete resolution of symptoms (12 days, control vs. 10 days, intervention; p = 0.38). No relevant treatment-related AEs were reported.

CONCLUSIONS

In patients with mild Covid-19, no benefit was observed with HCQ beyond the usual care.


DOI: 10.1093/cid/ciaa1009
PubMed: 32674126
PubMed Central: PMC7454406

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Le document en format XML

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<name sortKey="Qui Ones, Carles" sort="Qui Ones, Carles" uniqKey="Qui Ones C" first="Carles" last="Qui Ones">Carles Qui Ones</name>
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<name sortKey="Reyes Ure A, Juliana" sort="Reyes Ure A, Juliana" uniqKey="Reyes Ure A J" first="Juliana" last="Reyes-Ure A">Juliana Reyes-Ure A</name>
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<name sortKey="Ruiz, Lidia" sort="Ruiz, Lidia" uniqKey="Ruiz L" first="Lidia" last="Ruiz">Lidia Ruiz</name>
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<title xml:lang="en">Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial.</title>
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<name sortKey="Mitja, Oriol" sort="Mitja, Oriol" uniqKey="Mitja O" first="Oriol" last="Mitjà">Oriol Mitjà</name>
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<wicri:regionArea>Hospital Universitari Germans Trias i Pujol, Badalona</wicri:regionArea>
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<nlm:affiliation>IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.</nlm:affiliation>
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<nlm:affiliation>Gerència territorial de Catalunya Central, Institut Català de la Salut, St Fruitós del Bages, Spain.</nlm:affiliation>
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<nlm:affiliation>Gerència territorial de Barcelona, Institut Català de la Salut, Barcelona, Spain.</nlm:affiliation>
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<name sortKey="Prat, Nuria" sort="Prat, Nuria" uniqKey="Prat N" first="Nuria" last="Prat">Nuria Prat</name>
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<name sortKey="Qui Ones, Carles" sort="Qui Ones, Carles" uniqKey="Qui Ones C" first="Carles" last="Qui Ones">Carles Qui Ones</name>
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<name sortKey="Reyes Ure A, Juliana" sort="Reyes Ure A, Juliana" uniqKey="Reyes Ure A J" first="Juliana" last="Reyes-Ure A">Juliana Reyes-Ure A</name>
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<nlm:affiliation>Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:affiliation>Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid</wicri:regionArea>
</affiliation>
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<author>
<name sortKey="Ramirez Viaplana, Ferran" sort="Ramirez Viaplana, Ferran" uniqKey="Ramirez Viaplana F" first="Ferran" last="Ramírez-Viaplana">Ferran Ramírez-Viaplana</name>
<affiliation wicri:level="1">
<nlm:affiliation>Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fight AIDS and Infectious Diseases Foundation, Badalona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ruiz, Lidia" sort="Ruiz, Lidia" uniqKey="Ruiz L" first="Lidia" last="Ruiz">Lidia Ruiz</name>
<affiliation wicri:level="1">
<nlm:affiliation>IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Riveira Mu Oz, Eva" sort="Riveira Mu Oz, Eva" uniqKey="Riveira Mu Oz E" first="Eva" last="Riveira-Mu Oz">Eva Riveira-Mu Oz</name>
<affiliation wicri:level="1">
<nlm:affiliation>IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Sierra, Alba" sort="Sierra, Alba" uniqKey="Sierra A" first="Alba" last="Sierra">Alba Sierra</name>
<affiliation wicri:level="1">
<nlm:affiliation>Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fight AIDS and Infectious Diseases Foundation, Badalona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Velasco, Cesar" sort="Velasco, Cesar" uniqKey="Velasco C" first="César" last="Velasco">César Velasco</name>
<affiliation wicri:level="1">
<nlm:affiliation>Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Vivanco Hidalgo, Rosa Maria" sort="Vivanco Hidalgo, Rosa Maria" uniqKey="Vivanco Hidalgo R" first="Rosa Maria" last="Vivanco-Hidalgo">Rosa Maria Vivanco-Hidalgo</name>
<affiliation wicri:level="1">
<nlm:affiliation>Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Sentis, Alexis" sort="Sentis, Alexis" uniqKey="Sentis A" first="Alexis" last="Sentís">Alexis Sentís</name>
<affiliation wicri:level="1">
<nlm:affiliation>Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="G Beiras, Camila" sort="G Beiras, Camila" uniqKey="G Beiras C" first="Camila" last="G-Beiras">Camila G-Beiras</name>
<affiliation wicri:level="1">
<nlm:affiliation>Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fight AIDS and Infectious Diseases Foundation, Badalona</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Clotet, Bonaventura" sort="Clotet, Bonaventura" uniqKey="Clotet B" first="Bonaventura" last="Clotet">Bonaventura Clotet</name>
<affiliation wicri:level="1">
<nlm:affiliation>Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fight AIDS and Infectious Diseases Foundation, Badalona</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:affiliation>Hospital Universitari Germans Trias i Pujol, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitari Germans Trias i Pujol, Badalona</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:affiliation>Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC), Vic, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC), Vic</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Vall Mayans, Marti" sort="Vall Mayans, Marti" uniqKey="Vall Mayans M" first="Martí" last="Vall-Mayans">Martí Vall-Mayans</name>
<affiliation wicri:level="1">
<nlm:affiliation>Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fight AIDS and Infectious Diseases Foundation, Badalona</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:affiliation>Hospital Universitari Germans Trias i Pujol, Badalona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitari Germans Trias i Pujol, Badalona</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title>
<idno type="eISSN">1537-6591</idno>
<imprint>
<date when="2020" type="published">2020</date>
</imprint>
</series>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be more efficacious than no-treatment for outpatients with mild Covid-19.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>We conducted a multicenter, open label, randomized controlled trial in Catalonia (Spain) between March 17, and May 26, 2020. Eligible Covid-19 cases were non-hospitalized adult patients with recently confirmed SARS-CoV-2 infection and less than five days of symptoms. Patients were assigned to receive HCQ (800 mg on day 1, followed by 400 mg once daily for 6 days) or no antiviral treatment (not-placebo controlled). Study outcomes were the reduction of viral RNA load in nasopharyngeal swabs up to 7 days after treatment start, patient disease progression using the WHO scale up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD 12.6), mean viral load at baseline was 7.90 (SD 1.82) Log10 copies/mL, and median time from symptom onset to randomization was 3 days. No significant differences were found in the mean reduction of viral load at day 3 (-1.41 vs. -1.41 Log10 copies/mL in the control and intervention arm, respectively; difference 0.01 [95% CI -0.28;0.29]) or at day 7 (-3.37 vs. -3.44; d -0.07 [-0.44;0.29]). This treatment regimen did not reduce risk of hospitalization (7.1%, control vs. 5.9%, intervention; RR 0.75 [0.32;1.77]) nor shortened the time to complete resolution of symptoms (12 days, control vs. 10 days, intervention; p = 0.38). No relevant treatment-related AEs were reported.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>In patients with mild Covid-19, no benefit was observed with HCQ beyond the usual care.</p>
</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="Publisher" Owner="NLM">
<PMID Version="1">32674126</PMID>
<DateRevised>
<Year>2020</Year>
<Month>09</Month>
<Day>01</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1537-6591</ISSN>
<JournalIssue CitedMedium="Internet">
<PubDate>
<Year>2020</Year>
<Month>Jul</Month>
<Day>16</Day>
</PubDate>
</JournalIssue>
<Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title>
<ISOAbbreviation>Clin Infect Dis</ISOAbbreviation>
</Journal>
<ArticleTitle>Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">ciaa1009</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/ciaa1009</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">No therapeutics have yet been proven effective for the treatment of mild-illness caused by SARS-CoV-2. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be more efficacious than no-treatment for outpatients with mild Covid-19.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">We conducted a multicenter, open label, randomized controlled trial in Catalonia (Spain) between March 17, and May 26, 2020. Eligible Covid-19 cases were non-hospitalized adult patients with recently confirmed SARS-CoV-2 infection and less than five days of symptoms. Patients were assigned to receive HCQ (800 mg on day 1, followed by 400 mg once daily for 6 days) or no antiviral treatment (not-placebo controlled). Study outcomes were the reduction of viral RNA load in nasopharyngeal swabs up to 7 days after treatment start, patient disease progression using the WHO scale up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD 12.6), mean viral load at baseline was 7.90 (SD 1.82) Log10 copies/mL, and median time from symptom onset to randomization was 3 days. No significant differences were found in the mean reduction of viral load at day 3 (-1.41 vs. -1.41 Log10 copies/mL in the control and intervention arm, respectively; difference 0.01 [95% CI -0.28;0.29]) or at day 7 (-3.37 vs. -3.44; d -0.07 [-0.44;0.29]). This treatment regimen did not reduce risk of hospitalization (7.1%, control vs. 5.9%, intervention; RR 0.75 [0.32;1.77]) nor shortened the time to complete resolution of symptoms (12 days, control vs. 10 days, intervention; p = 0.38). No relevant treatment-related AEs were reported.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In patients with mild Covid-19, no benefit was observed with HCQ beyond the usual care.</AbstractText>
<CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.</CopyrightInformation>
</Abstract>
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<LastName>Mitjà</LastName>
<ForeName>Oriol</ForeName>
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<Affiliation>Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Hospital Universitari Germans Trias i Pujol, Badalona, Spain.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Lihir Medical Centre - InternationalSOS, Lihir Island, Papua New Guinea.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Corbacho-Monné</LastName>
<ForeName>Marc</ForeName>
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</AffiliationInfo>
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<LastName>Tebe</LastName>
<ForeName>Cristian</ForeName>
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<Affiliation>Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain.</Affiliation>
</AffiliationInfo>
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<LastName>Peñafiel</LastName>
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</AffiliationInfo>
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<ForeName>Aurelio</ForeName>
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</AffiliationInfo>
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<ForeName>Ester</ForeName>
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</AffiliationInfo>
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<LastName>Laporte</LastName>
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</AffiliationInfo>
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</AffiliationInfo>
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<LastName>Clua</LastName>
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<LastName>Bertran</LastName>
<ForeName>Laia</ForeName>
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<LastName>Argimon</LastName>
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</AffiliationInfo>
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</AffiliationInfo>
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</AffiliationInfo>
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<LastName>Cuatrecasas</LastName>
<ForeName>Gabriel</ForeName>
<Initials>G</Initials>
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<Affiliation>Equip d'atenció primària de Sarria, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
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<LastName>Cañadas</LastName>
<ForeName>Paz</ForeName>
<Initials>P</Initials>
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<Affiliation>SYNLAB, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
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<LastName>Elizalde-Torrent</LastName>
<ForeName>Aleix</ForeName>
<Initials>A</Initials>
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</AffiliationInfo>
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<ForeName>Robert</ForeName>
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</AffiliationInfo>
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<ForeName>Anna</ForeName>
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<ForeName>Gemma</ForeName>
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</AffiliationInfo>
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<ForeName>Esteve</ForeName>
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</AffiliationInfo>
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<ForeName>Silvia</ForeName>
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</AffiliationInfo>
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<LastName>Gil-Ortega</LastName>
<ForeName>Aroa N</ForeName>
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</AffiliationInfo>
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<LastName>Prat</LastName>
<ForeName>Nuria</ForeName>
<Initials>N</Initials>
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</AffiliationInfo>
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<LastName>Puig</LastName>
<ForeName>Jordi</ForeName>
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</AffiliationInfo>
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<LastName>Quiñones</LastName>
<ForeName>Carles</ForeName>
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</AffiliationInfo>
</Author>
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<LastName>Reyes-Ureña</LastName>
<ForeName>Juliana</ForeName>
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</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.</Affiliation>
</AffiliationInfo>
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<LastName>Ramírez-Viaplana</LastName>
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</AffiliationInfo>
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</AffiliationInfo>
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<LastName>Riveira-Muñoz</LastName>
<ForeName>Eva</ForeName>
<Initials>E</Initials>
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</AffiliationInfo>
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<LastName>Sierra</LastName>
<ForeName>Alba</ForeName>
<Initials>A</Initials>
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</AffiliationInfo>
</Author>
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