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Working with Medidata Solutions , Janssen Pharmaceutica ( a division of Johnson & Johnson ) took a step forward , going paperless in two separate clinical trials at 230 sites . " Generally recognized as safe and effective " means there exists substantial evidence by means of at least two well-controlled clinical studies that the new or novel procedure will have the effect that is represented and the procedure does not pose a significant risk to the physical or emotional health of the patient and has a low reported incidence of adverse reactions or significant side effects . Researchers in two large clinical trials found that women with HER-2-neu breast cancer who used this combination of chemotherapy and targeted therapy significantly decreased their risk of breast cancer recurrence when compared with women who underwent chemotherapy alone . This research has been targeted towards two specific clinical scenarios . Subsequently the benefits of walnuts were reported and two new clinical trials are now investigating the nutritional effects of almonds and pecans .