Looijesteijn, Ellen
Brouwer, Rutger W. W.
Schoemaker, Ruud J. W.
Ulfman, Laurien H.
Ham, Stephanie L.
Jeurink, Prescilla
Karaglani, Eva
van IJcken, Wilfred F. J.
Manios, Yannis
Article History
Received: 20 January 2022
Accepted: 22 July 2022
First Online: 29 August 2022
Declarations
:
: The study was performed in accordance with the current version of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The trial was conducted in agreement with the International Conference on Harmonisation (ICH) guidelines on Good Clinical Practise (GCP). All participating parents (both mothers and fathers) provided written informed consent for the participation of their infants in the study prior to being screened. The parental information letter detailed the procedures of the study (aim, methodology, measurements, etc.) and the paediatricians explained them to parents who expressed interest in the study. The parents were then given sufficient time (± one week) to consider the information before signing and dating the informed consent form, indicating that they fully understood the information, and willingly volunteered to participate in the study. The participating parents were given a copy of the informed consent form for their information. The original copy of the informed consent was kept in a confidential file in the Principal Investigator’s central records.
: Not applicable.
: EL, RS, LU are, and PJ was, employed by FrieslandCampina. The other authors report no conflicts of interest. SLH is an employee at Metabolon, Inc. and, as such, has affiliations with or financial involvement with Metabolon, Inc.