If the clinical trial is not of a drug or device subject to FDA regulation, and, thus, not an applicable clinical trial, at the time of the initiation of the trial, then the statement is not required.
Risks of Bioidentical Hormones. The jury's out on whether bio-identical hormones are safer. In 2002, a large federally funded study by the Women's Health Initiative revealed an increased risk of heart disease, breast cancer and stroke in women using synthetic prescription hormone replacement therapy.
1 If the mother herself is a fraternal twin. the chances of having twins increases about four-fold.  The rate for identical. or monozygotic. multiples is random and universal; it's the same in all populations regardless of race. heredity or other factors. and it has remained constant over time.