The study was conducted strictly in accordance with the guidelines for the protection of human subjects of research. Study protocol and informed consent forms were approved by the School of Public Health of Tulane University, the Committee of Ethics of Investigation Protocols of Buenos Aires Hospital Italiano (Argentina); the Ethics Committee of the School of Medicine of Universidad de La Frontera (Chile), and the School of Medicine of Universidad de la República (Uruguay).

All participants were required to sign an informed consent form, which was delivered to them during screening visits. Said informed consent forms clearly stated study objectives, characteristics, and inclusion criteria, as well as potential benefits and risks for participants. To protect personally identifiable information, each participant received an individual identifying code (ID).