Text and Data Mining valid from 2018-09-10
Received: 26 March 2018
Accepted: 29 August 2018
First Online: 10 September 2018
Ethics approval and consent to participate
: This study protocol was reviewed and approved by the Ethics Committee FMUI Indonesia (No. 852/UN2.F1/ETIK/2017 and Amendment No. 1088/UN2.F1/ETIK/X/2017) and the BUHREC Australia (No. 16151 and Amendment No. 16208). We 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). We will also seek clinical study permits from the Training and Research division at each participating hospital.We will provide the patient information sheet, including the whole study process and procedures and potential risks from the study, and obtain consent from the parent(s) or legal guardian of patients, before conducting the recruitment and randomisation process. However, for children aged 12 years, they have also to provide their consent to participate in the study (Additional file InternalRef removed. Case report forms—Pilot OPAL Study: CRF01. Information sheet and consent form). The person who delivers the consent also will provide their signatures on the consent form, stating that they have provided information and opportunity for potential participants to understand and raise relevant questions to the study. We will ensure that the consent process is free of coercion. As the participation into the study is voluntary, we will emphasise 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.
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