Discuss how the results might have been affected if the

• Discuss how the results might have been affected if the comparison group was: (1) no milk instead of non-fortified milk; (2) milk fortified with other nutrients besides those being investigated in the study. • Do you see any ethical issues in this study in terms of equipoise? • Discuss the meaning of informed consent in vulnerable or underage populations. Can truly informed consent ever be obtained in these populations? How would you as a study investigator make sure that patients enrolled in the study were fully informed? What elements should go into an informed consent in this type of study?

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