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Study overview and ethical considerations

FL Françoise Lazarini
SL Sarah Levivien
YM Yoann Madec
FT Fabien Taieb
EM Estelle Mottez
TB Tan-Phuc Buivan
AM Audrey Maudoux
SW Sylvette Wiener-Vacher
JN Jérôme Nevoux
TA Thierry Van Den Abbeele
PG Pierre Gressens
PL Pierre-Marie Lledo
NT Natacha Teissier
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The main objective of this study was to investigate the association between hearing loss and olfactory performance in children with a congenital CMV infection followed in Robert Debré (Paris) and Bicêtre (Le Kremlin- Bicêtre) hospitals, in France. This prospective study is a nontrial, nondrug study, qualified as exploratory, multicenter, in a paediatric population (ClinicalTrials.gov number, NCT02782988). It received ethical approval (No. 3372) from Comité de Protection des Personnes (CPP IDF-3). Children were included in the study after explanation of the study and obtaining of written informed consent from both parents.

Copyright and License information: The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature ©2022
This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

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