Ethics approval and consent to participate
The study was approved by the Bioethics Review Committee of Jujuy’s Ministry of Health and the CEMIC’s Institutional Review Boards, Harvard T.H Chan School of Public Health and Rutgers University, and the Deakin University Human Research Ethics Committee. All participant women signed an informed consent and all methods were carried out in accordance with the Declaration of Helsinki. The trial has been registered in ClinicalTrials.gov (NCT03478397, Registered on 20 March 2018). Data collection was carried out using specific instruments and data storage was done with appropriate security, privacy and automatic backup system. All data was treated as confidential and kept for as long as required by The Argentinean Personal Data Protection Law No. 25,326. Each participating subject was assigned a unique study identification number with a defined format. All the participant’s forms and electronic records will be identified with this unique number. Access to the database will be restricted to the principal investigator of the study and the authorized working group.