If the investigators are only interested in the effects of the intervention on subjects at increased risk [ 1] or if the study is designed to be a preliminary investigation in preparation for a definitive study in the general population, we think this restriction is reasonable.
Well-known menstrual risk factors for breast cancer, such as early age at menarche, late age at menopause, or hormone replacement therapy use, did not show definitive associations in the current study population.
As such, the findings will be a useful basis for further definitive studies in other populations.
Definitive studies in select populations (ie, ApoE e4 non-carriers with low dietary intake of saturated fat and n-6 fatty acids) may assist in the development of rationally-guided, individualized therapies for the subset of AD subjects that may benefit from omega-3 PUFA administration.
Finally, it is difficult to draw definitive conclusions about safety from this fairly limited study population.
We recommend aggressive nutritional supplementation for the study population, while efforts at early definitive corrective interventions including surgery should be intensified.
However, the small sample of our study population does not allow to draw definitive conclusions, hence the study will be further continued to extend sample size.
