Outcome measurements
TG, Diteba
ADVERSE EVENTS, SECONDARY
The primary outcome measures were the intergroup comparisons of the ERC phospholipid fatty acid (PLFA) profiles at week 16 and the serum PLFA profiles at week 4. The secondary outcome measures were the comparisons of the ERC PLFA profiles at weeks 12 and 24, and blood lipids (i.e. TG, total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], and high-density lipoprotein cholesterol [HDL-C]) at week 24. Safety parameters, including vital signs, blood chemistry (Chem 20), biometrics and adverse events (AE), were also assessed at each visit. Intensity of AE was graded on a 3-point scale (mild, moderate, severe) and reported in detail in the study records. The Medical Dictionary for Regulatory Activities (MedDRA version 19.1) terminology was used to classify all AE with respect to System Organ Class and preferred term.Serum samples and ERC samples were analyzed for PLFA profiles by GC-FID (Gas Chromatography-Flame Ionization Detector) using in-house developed and validated methods (Diteba Laboratories, Inc., Mississauga, Ontario, Canada). Venous blood samples were collected in serum separator tubes (SST) and EDTA (K2) tubes. Samples were processed according to standard clinical procedures for these collection tubes, and serum was collected from the SST tubes. ERC were collected from the EDTA tubes as a red cell pack after removal of the plasma and white blood cells. Samples were stored at -80°C prior to analysis. At time of analysis, frozen samples were thawed in an ice water bath. Serum samples were extracted with chloroform/methanol 2:1. Prior to injection, PLs were separated with a Hybrid SPE-PL cartridge (MilliporeSigma, St. Louis, MO). ERC samples were processed with BCl