Fat‐soluble vitamins and essential fatty acids
beta‐carotene
In the phase 3 trial, levels of fat‐soluble vitamins remained relatively stable through week 78 of phase 3 study. Mean vitamin E levels (which were supplemented with 400 IU vitamin E daily) decreased by −1.2 mg/dl from baseline to weeks 26 and 78, but values did not fall below the normal range (Table The fat‐soluble vitamins A, D and K, and beta‐carotene, which were not supplemented in the diet, were measured throughout the study. Mean levels of vitamins A, D and K, increased from baseline to weeks 28 and 78, while beta‐carotene decreased slightly or remained unchanged. Mean levels of essential fatty acids (supplemented in the diet according to the prescribing information) decreased over time compared to baseline in the phase 3 study. However, there were no shifts to below‐normal levels in the fatty acids linoleic acid, alpha‐linolenic acid, arachidonic acid, EPA and DHA during 78 weeks of treatment (Table 