Ethics approval and consent to participate
This study received ethical approval and adhered to the ethical standards set by the institutional and/or national research committee, including Health Research Ethics Council, South African Health Products Regulatory Authority, the College of Medicine Research and Ethics Committee, the Johns Hopkins Bloomberg School of Public Health IRB, the Research Institute for Health Sciences Human Experimentation Committee, the Medical Device Control Division/Thai Food and Drug Administration (FDA), the IMPACTA Bioethics Committee, the Peruvian National Institute of Health (Instituto Nacional de Salud), the Peruvian FDA, the Peruvian Ministry of Health, the University of Pittsburgh IRB, the University of California San Francisco IRB, University of Alabama at Birmingham IRB, and the University of Pennsylvania IRB, in accordance with the 1964 Helsinki declaration. Informed consent (included in the Protocol) was obtained from all individual participants included in the study. All participants provided their consent by signing, indicating that they have read, understood, and voluntarily agreed to the study after reading or having the consent form explained to them.