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Article History

Received: 13 July 2022

Accepted: 9 August 2022

First Online: 24 August 2022

Declarations

:

: This study protocol was approved by the following ethical approval bodies: Solutions IRB, Yarnell, Arizona, US (March 2020, Reference: #20200310); London School of Hygiene and Tropical Medicine, Research Ethics Committee, London, UK (July 2020, Reference: 18059); Ministry of Health and Human Services, Kahda District Mogadishu, Somalia (March 2020, Reference: MOH&HS/DGO/0429/03/202); Universite Des Sciences, Des Techniques Et Des Technologies De Bamako, Bamako, Mali (Oct 2020, Reference: 2020/202/CE/FMOS/FAPH); and Ministry of Health, Juba, South Sudan. (June 2020, Reference: MOH/ERB 6/2020).The study is conducted in accordance with ICH-GCP E6 guidelines. On the day of enrollment, participants are informed about the duration and requirements of participation in the study along with the potential harms and benefits of participation through an interactive oral presentation as well as through written consent forms. Caregivers are repeatedly told that participation is voluntary, and they can stop study participation at any time without consequences for the care they might receive. Only participants who express continued interest in the study after being fully informed are enrolled. As study participants are under 16 years old, consent forms are signed and dated by the responsible caregiver for the participating child. In the case of illiterate participants, a participant draws a cross in replacement of a signature. If study participants withdraw from the study after enrollment, any data already collected and analyzed will be used, unless the participant requests otherwise; however, no further analysis will be done, nor samples kept. All electronic data will be stored on a study-specific password-protected encrypted server and located within a protected network to enable safe access. All patient files and data collection forms will be maintained securely in a locked file throughout the study to ensure participant confidentiality.

: Not applicable.

: The authors declare they have no competing interests.