Zaccaria, Edoardo
Klaassen, Tim
Alleleyn, Annick M. E.
Boekhorst, Jos
Smokvina, Tamara
Kleerebezem, Michiel
Troost, Freddy J.
Funding for this research was provided by:
Danone Research (INSIDE:PLF-8712-GD, INSIDE:PLF-8712-GD, INSIDE:PLF-8712-GD, INSIDE:PLF-8712-GD, INSIDE:PLF-8712-GD)
Article History
Received: 25 February 2022
Accepted: 6 February 2023
First Online: 7 March 2023
Declarations
:
: This study was approved by the Medical Ethics Committee of Maastricht University (MU), Maastricht, the Netherlands, and performed in full accordance with the Declaration of Helsinki (latest amendment by the World Medic Association in Fortaleza, Brazil, in 2013) and Dutch Regulations on Medical Research involving Human Subjects (WMO, 1998), as well as with the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP) guidelines. The study was performed at MU from October 27th, 2016 (screening visit, first subject) until October 27th, 2017 (last visit last subject). This study was registered in the US National Library of Medicine (ExternalRef removed, ID NCT NCT02920294). All subjects gave written informed consent before screening.
: Not applicable.
: This author discloses the following: T. Smokvina is an employee of Danone Research. The remaining authors declare that they have no competing interests.