Beeres, Dorien Tecla
Pulkki-Brännström, Anni-Maria
Nilsson, Maria
Galanti, Maria Rosaria
Funding for this research was provided by:
Folkhälsomyndigheten (01346-2017 2.3.2)
Karolinska Institute
Article History
Accepted: 4 October 2023
First Online: 25 October 2023
Declarations
:
: The study was approved by the Regional Ethics Review Board, Umeå (registration nr. 2017/255–31). Prior to inclusion, all individuals and caregivers of the adolescents were required to give explicit informed consent to data collection, analysis, and reporting of the results. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The trial has been registered at Current Controlled Trials ISRCTN52858080, on January 4, 2019, i.e., after the enrollment of the first participant but prior to completed baseline assessment. The study protocol including the pre-registered research questions and planned data analysis has been published elsewhere (Galanti et al., CitationRef removed). Anonymized data from the TOPAS study can be accessed via the last author, Maria Rosaria Galanti, upon reasonable request and in line with the data share policy as described in the study protocol. The data share policy includes a formal written agreement with the requesting investigators and agencies to commit themselves to the same confidentiality levels as the leader institution.
: The authors declare no competing interests.