Koesnoe, Sukamto
Medise, Bernie Endyarni
Rengganis, Iris
Hadinegoro, Sri Rezeki
Puspita, Mita
Sari, Rini Mulia
Yang, Jae Seung
Sahastrabuddhe, Sushant
Soedjatmiko,
Gunardi, Hartono
Sekartini, Rini
Wirahmadi, Angga
Kekalih, Aria
Mukhi, Sreshta
Satari, Hindra Irawan
Bachtiar, Novilia Sjafri
Funding for this research was provided by:
PT Biofarma
Article History
Received: 7 August 2023
Accepted: 6 November 2023
First Online: 1 February 2024
Declarations
:
: Trial registration was approved by ClinicalTrials.gov. Clinical trial registration number: NCT03460405. Registered on 09/03/2018. URL: ExternalRef removed. We also received approval from the Ethics Committee of Universitas Indonesia with reference number 0276/UN2.F1/ETIK/2018 and Indonesian Trial registry with registry number INA-35ST1PS.Based on regulations by the Declaration of Helsinki, subjects were given detailed information regarding the trial and were made to sign an informed consent form prior to recruitment. For subjects 12–18 years, written consent was obtained from parents/legal guardians and the subjects themselves filled assent forms. For subjects above 18 years, the subjects themselves signed the informed consent form.
: All authors have given their consent for publication of this article.
: The authors declare no competing interests.