Trial monitoring
Database collection within and between Experimental and Control intervention group will be monitored and the trial responsible will be alerted if any deviation occurs. Any modifications to the protocol which may impact on the conduct of the study, including changes of study objectives, study design, participant population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment will be agreed upon by the principal investigator and approved by the Ethics Committee prior to implementation and notified to the National Ministry of Health (sponsor).