Created at Source Raw Value Validated value
Oct. 7, 2021, 9:30 a.m. oms

1. Subjects aged between 2 and 18 years. 2. Voluntariness expressed through informed consent to participate in the study: - Subjects aged 2-11 years: Informed consent of parents or legal guardians. - Subjects aged 12-18 years: Informed Consent of the parents or legal guardians and Informed Assent of the adolescent. 3. Weight-height nutritional assessment between the 10th and 90th percentile (for subjects between 2 and 9 years of age) or the BMI between the 10th and 90th percentile for subjects between 10 and 18 years of age), according to the cut-off points for the Cuban pediatric population. 4. General, regional and apparatus physical examination without alterations. 5. Laboratory results within or outside the range of reference values ??but not clinically significant (For the subjects to be included in phase I). 6. Women of childbearing potential use safe contraceptive methods during the study.

1. Subjects aged between 2 and 18 years. 2. Voluntariness expressed through informed consent to participate in the study: - Subjects aged 2-11 years: Informed consent of parents or legal guardians. - Subjects aged 12-18 years: Informed Consent of the parents or legal guardians and Informed Assent of the adolescent. 3. Weight-height nutritional assessment between the 10th and 90th percentile (for subjects between 2 and 9 years of age) or the BMI between the 10th and 90th percentile for subjects between 10 and 18 years of age), according to the cut-off points for the Cuban pediatric population. 4. General, regional and apparatus physical examination without alterations. 5. Laboratory results within or outside the range of reference values ??but not clinically significant (For the subjects to be included in phase I). 6. Women of childbearing potential use safe contraceptive methods during the study.