Ogal, Mercedes
Johnston, Sebastian L.
Klein, Peter
Schoop, Roland http://orcid.org/0000-0002-0473-7697
Funding for this research was provided by:
A.Vogel AG, Switzerland
Article History
Received: 12 November 2020
Accepted: 12 March 2021
First Online: 8 April 2021
Declarations
:
: This study was approved by local and lead ethic committees (EKNZ, Switzerland, 17th October 2016) of the respective districts as well as by the national authority (Swissmedic) and strictly followed the regulations from ICH-GCP and the declaration of Helsinki (version 21st October 2013). Parents and/or children have given their informed consent prior to any trial-related intervention.
: Participants have given their consent that data from this study can be published in an anonymized form.
: MO and PK declare no conflict of interest. SLJ is a consultant to A. Vogel AG, Switzerland. Data evaluation was carried out by an independent provider of data management and statistical services (d.s.h. GmbH, Germany). RS is an employee at A. Vogel AG, Switzerland, who was however not involved in data collection or analysis.