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Authors
Ranakusuma, Respati W. https://orcid.org/0000-0002-6678-7876
McCullough, Amanda R.
Safitri, Eka D.
Pitoyo, Yupitri
Widyaningsih, Widyaningsih
Del Mar, Christopher B.
Beller, Elaine M.
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Funding
Funding for this research was provided by:
National Health and Medical Research Council (1044904, 1044904)
the Advance Queensland (WAF-7026811-298)
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Article History
Received: 18 September 2019
Accepted: 19 August 2020
First Online: 29 August 2020
Ethics approval and consent to participate
: Our study protocol was reviewed and approved by the Ethics Committee Faculty of Medicine Universitas Indonesia (No. 852/UN2.F1/ETIK/2017 and Amendment No. 1088/UN2.F1/ETIK/X/2017) and the Bond University Human Research Ethics Committee (BUHREC) Australia (No. 16151 and Amendment No. 16208). We also received approval for conducting clinical research from the One Stop Integrated Service Agency Province of DKI Jakarta (No. 0204/AF.1/31/-1.862.9/2017) and the Training and Research divisions at each participating hospital. Prior to the recruitment and randomisation process, we provided the information sheet and obtained consent from the parent(s) or legal guardian of patients. Children aged 12 years had to provide their consent to participate in the study. The person who delivered the consent also provided their signatures on the consent form, stating that they had provided information and opportunity for potential participants to understand and raise relevant questions to the study. We ensured the consent process is free of coercion. As the study participation was voluntary, we emphasised their rights to withdraw from the study at any time without any consequences, particularly on the quality of their healthcare services.
: Not applicable.
: The authors declare that they have no competing interests.
