Pussig, Bram http://orcid.org/0000-0003-1332-1017
Pas, Lodewijk
Li, Ann
Vermandere, Mieke
Aertgeerts, Bert
Matheï, Catharina
Funding for this research was provided by:
AB Inbev Foundation
Article History
Received: 2 October 2020
Accepted: 4 June 2021
First Online: 1 July 2021
Declarations
:
: This study will be conducted in accordance with the principles outlined in the Declaration of Helsinki (seventh revision). Written ethical approval was obtained by the Ethics Committee for Research of UZ/KU Leuven (reference number s63342 and G-2020-2177-R2(MAR)). Any substantial protocol amendments will be submitted to the ethics committee. The trial is registered on ExternalRef removed under the identifier NCT04398576. The list with study sites and all materials can be obtained via the corresponding author.The researchers will present an informed consent form (Additional file InternalRef removed) to all participants, which states that they authorize to send clinical audit data and inquiry data to a double secured server at the Academic Centre for General Practice. This consent form states that the obtained data will be used for scientific publication and that any reference to the participants will be anonymised. Participants who disagree with the terms described in the informed consent form, will not be included in the study.
: All authors provided consent to publish this protocol manuscript of the PINO-project.
: The authors declare that they have no competing interests.