Pascale, Juan Miguel
Franco, Danilo
Devadiga, Raghavendra
DeAntonio, Rodrigo
Dominguez-Salazar, Elidia Lourdes
dos Santos, Gael
Juliao, Patricia http://orcid.org/0000-0001-6241-483X
Funding for this research was provided by:
GlaxoSmithKline
Article History
Received: 29 March 2021
Accepted: 7 July 2021
First Online: 23 August 2021
Acknowledgements
:
: GlaxoSmithKline Biologicals SA funded this study (205049) and covered all costs associated with the development and publication of this manuscript including the journal’s rapid service fee.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
: Juan Miguel Pascale, Danilo Franco, Raghavendra Devadiga, Rodrigo DeAntonio, Elidia Lourdes Dominguez-Salazar, Gael dos Santos and Patricia Juliao participated to the concept, design, analysis, draft and review of this manuscript.
: The authors would like to thank Business & Decision Life Sciences platform for editorial assistance and manuscript coordination, on behalf of GSK. Pierre-Paul Prévot coordinated manuscript development and editorial support. Marie Cloes provided medical writing support.
: Raghavendra Devadiga, Elidia Lourdes Dominguez-Salazar, Gael dos Santos and Patricia Juliao are employed by the GSK group of companies. Gael dos Santos, Elidia Lourdes Dominguez-Salazar and Patricia Juliao hold shares in the GSK group of companies. Rodrigo DeAntonio was an employee of the GSK group at the time of this study. Juan Miguel Pascale and Danilo Franco declare no financial relationships and activities, and all authors declare no non-financial relationships and activities.
: The study was performed in accordance with the Declaration of Helsinki, the principles of Good Clinical Practice, and all applicable regulatory requirements, including Good Epidemiological Practice. The study protocol, any subsequent amendments, and other information that required preapproval were reviewed and approved by the Independent Ethics Committee of the ICGES. The ICGES database was fully coded and data were anonymised prior to data processing and analysis so that no third party could link data to an identifiable individual. Therefore, no patient consent was needed.
: The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
: Some of the study results included in this manuscript were presented at the 18<sup>th</sup> International Congress on Infectious Diseases, March 1–4, 2018, Buenos Aires, Argentina.