Casella, Caio Borba http://orcid.org/0000-0003-2048-5909
Zuccolo, Pedro Fonseca
Sugaya, Luisa
de Souza, Aline Santana
Otoch, Luara
Alarcão, Fernanda
Gurgel, Wagner
Fatori, Daniel
Polanczyk, Guilherme V.
Funding for this research was provided by:
Fundação de Amparo à Pesquisa do Estado de São Paulo (16/22455-9)
Article History
Received: 13 August 2022
Accepted: 11 October 2022
First Online: 22 October 2022
Declarations
:
: This study was approved by the Research Ethics Committee of the University of São Paulo School of Medicine Hospital das Clínicas (Reference no. 4,229,188). After this approval, we carried out a pilot trial. The result allowed us to identify the need for a few changes in the protocol. We increased the minimum age for participation (from 5 to 8 years), as the techniques proved to be less effective with younger children. In addition, we decided to include the EMA protocol. We submitted the changes to the Research Ethics Committee, which approved them (Reference no. 4,687,243). All participating children and adolescents will be required to provide informed assent and informed consent (from their guardians).
: Consent and assent forms are available from the corresponding author on request.
: GVP has served as a consultant/speaker to Abbott, Ache, Medice, Novo Nordisk and Takeda; he has received royalties from Editora Manole. The other authors declare that they have no competing interests.