Created at Source Raw Value Validated value
July 16, 2021, 2 p.m. oms

1. Participation on a voluntary basis (signing of the Informed Consent by parents or legal guardians with legal and mental capacity to represent the minor, as well as the signing of the Informed Consent for participants over 12 years of age).2. Female or male sex and ages between 3 and 18 years at the time of inclusion.3. Apparently healthy child or adolescent, based on medical history, physical examination, and evaluation by the investigating pediatrician.4. Nutritional assessment: Weight / height between 10 and 90 percentile for children between 3 and 9 years old.Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years.According to the cut-off points for the Cuban pediatric population.5. Laboratory tests within or outside the reference range, but not clinically significant (Phase I only).

1. Participation on a voluntary basis (signing of the Informed Consent by parents or legal guardians with legal and mental capacity to represent the minor, as well as the signing of the Informed Consent for participants over 12 years of age).2. Female or male sex and ages between 3 and 18 years at the time of inclusion.3. Apparently healthy child or adolescent, based on medical history, physical examination, and evaluation by the investigating pediatrician.4. Nutritional assessment: Weight / height between 10 and 90 percentile for children between 3 and 9 years old.Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years.According to the cut-off points for the Cuban pediatric population.5. Laboratory tests within or outside the reference range, but not clinically significant (Phase I only).