Funding for this research was provided by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (184452)
Danone, Nutricia Metabolics (000)
Bangerter Rhyner Foundation (000)
von Tobel Foundation (000)
Clinical Trial Unit, University of Bern (000)
Text and Data Mining valid from 2020-02-13
Received: 17 May 2019
Accepted: 20 December 2019
First Online: 13 February 2020
Ethics approval and consent to participate
: The research project has been approved by the ethics committee of the canton of Bern, Switzerland (KEK BE 2018–01609). Important study protocol modifications will be reported to the relevant parties. In addition, the research project is registered at in online platforms (ExternalRef removed and kofam.ch).After being verified as eligible for the study, the participants will receive adequate verbal information about the study. They will be given enough time to consider their participation, and the informed consent form will be sent to them. Written informed consent will be obtained of all participants by the study physician (R.T.) or the study coordinators (R.M., S.A.). Participants can withdraw from participating at any time without giving a reason. If participants discontinue, their data will still be analyzed. Individual medical information obtained as a result of this study is considered confidential, and disclosure to third parties is prohibited. Participants’ confidentiality will be further ensured by utilizing subject identification code numbers (both on paper and electronically) to correspond to treatment data in the computer files. The key (i.e., a list in which an alphanumeric code is linked to individual participants’ names) will be kept separately from the study data in a secured (locked) document. Access to documents, datasets, statistical codes, etc. during and after the study will only be granted to the PI and his designees (e.g., co-authors of the study protocol). The results of the present study will be submitted for publication in peer-reviewed journals and will be presented at national and international scientific meetings to healthcare professionals and/or the public. Authorship eligibility will be determined according to the Vancouver Convention established by the International Committee of Medical Journal Editors (ICMJE).
: Not applicable.
: The authors declare that they have no competing interests.