Table 1:

Criteria for inclusion of pregnant women from the code of regulations 45 CFR 46, Protection of Human Subjects

Previous Supportive Studies	Preclinical studies, including pregnant animals, and clinical studies, including non-pregnant women, have been conducted and provide data for assessing potential risk to pregnant women and fetuses
Risk	The risk to the fetus is not greater than minimal, and the purpose of the research is the development of important biochemical knowledge, which cannot be obtained by any other means