At each study visit, the subjects were assessed for general health (e.g., presence of ailments or illnesses, and any concurrent use of food supplements or medications). Each adverse event was recorded for the duration, severity, action taken, and date and time of resolution at each study visit, and their relatedness to the test article was assessed by the investigator. A complete physical examination was performed at the screening visit, and at visits 4, 6, 8, and 10. Anthropometric assessments such as height and weight measurements, and body mass index (BMI) calculation were performed at each visit. Blood and urine samples were collected from the children at the screening visit and at the end
of the study. Blood samples were collected from 331 of the children at the screening visit, and from 195 children at the end of study.
A subset of these samples was analyzed for standard hematological
and clinical chemistry parameters by M/s Piramal Diagnostics
using an automated analyzer (Randox Imola), in accordance with
Standard Operating Procedures.
At each study visit, the subjects were assessed for general health (e.g., presence of ailments or illnesses, and any concurrent use of food supplements or medications). Each adverse event was recorded for the duration, severity, action taken, and date and time of resolution at each study visit, and their relatedness to the test article was assessed by the investigator. A complete physical examination was performed at the screening visit, and at visits 4, 6, 8, and 10. Anthropometric assessments such as height and weight measurements, and body mass index (BMI) calculation were performed at each visit. Blood and urine samples were collected from the children at the screening visit and at the end
of the study. Blood samples were collected from 331 of the children at the screening visit, and from 195 children at the end of study.
A subset of these samples was analyzed for standard hematological
and clinical chemistry parameters by M/s Piramal Diagnostics
using an automated analyzer (Randox Imola), in accordance with
Standard Operating Procedures.
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