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The informed consent was formulated according to the guidelines of the Medical Ethics Committee and contained, among others, specific information on the content of both treatment arms and the random allocation.
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Know why this theory was formulated.
Based on recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, regulations regarding informed consent for research have been formulated for children between age 7 and 18 years.
Samples from biobanks may be analyzed years later to tackle research objectives that were specified and communicated to participants at the time of recruitment or that may be formulated after consent was obtained.
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