It was stated that the choice of measures of efficacy and safety is determined by the nature of the study and the hypothesis being tested. With regard to growth, the CoN suggested that growth measures be recorded in all nutrition trials involving infants and children, as safety if not as outcome measures. Examples of factors that may affect growth or body composition were summarized. These included birth weight for gestation (g and SD score for gender and gestation), gender of the infant, parental heights and weights, maternal smoking, and maternal alcohol, drug or substance abuse.
It was stated that the choice of measures of efficacy and safety is determined by the nature of the study and the hypothesis being tested. With regard to growth, the CoN suggested that growth measures be recorded in all nutrition trials involving infants and children, as safety if not as outcome measures. Examples of factors that may affect growth or body composition were summarized. These included birth weight for gestation (g and SD score for gender and gestation), gender of the infant, parental heights and weights, maternal smoking, and maternal alcohol, drug or substance abuse.
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