Kabatende, Joseph http://orcid.org/0000-0002-3718-3213
Barry, Abbie http://orcid.org/0000-0002-3859-3660
Mugisha, Michael
Ntirenganya, Lazare
Bergman, Ulf
Bienvenu, Emile http://orcid.org/0000-0002-1555-7376
Aklillu, Eleni http://orcid.org/0000-0002-9788-0790
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (CSA2016S-1618)
Styrelsen för Internationellt Utvecklingssamarbete (Co-funding CSA2016S-1618)
Karolinska Institute
Article History
Accepted: 6 June 2022
First Online: 11 July 2022
Declarations
:
: This study was conducted as part of the Pharmacovigilance Infrastructure and Postmarketing Surveillance System Capacity Building for Regional Medicine Regulatory Harmonization in East Africa (PROFORMA) project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) 2 program supported by the European Union (Grant number CSA2016S-1618) and the Swedish International Development Cooperation Agency (SIDA).
: Conceptualization: AB, JK, MM, LN, EB and EA. Data curation: JK, AB, MM, LN, and EA. Formal analysis: AB, JK, LN, and MM. Investigation: JK, AB, EB, MM, and EA. Methodology: AB, JK, EB, and EA. Supervision: EB, UB, and EA. Writing—original draft: JK and AB. Writing—review and editing: AB, JK, MM, LN, EB, UB, and EA. All authors read and approved the final version.
: Joseph Kabatende, Abbie Barry, Michael Mugisha, Lazare Ntirenganya, Ulf Bergman, Emile Bienvenu, and Eleni Aklillu declare no conflicts of interest.
: This study was approved by the Rwandan National Ethics Committee (Review Approval Notice No. 0064/RNEC/2019) and the National Health Research Committee of the Ministry of Health, Rwanda (NHRC/2018/PROT/042).
: Participant consent was documented on a written informed consent form, which was accompanied by written information for parents/guardians, and the informed consent forms were approved by the same Ethics Committees that approved this protocol.
: Not applicable.
: Data are available upon reasonable request owing to privacy and ethical restrictions from the authors.
: Not applicable.