- open label: it was not fully open … adjudication was fully blinded (" blinded clinical endpoint assessment (PROBE design)" - poor compliance: The 5-year follow-up rate was 16 971 (91%). Similar proportions of participants remained compliant in each treatment group.
anfla...The Japanese diet contains more fish than most diets around the world...This makes for a higher concentration of EPA in the Japanese population and makes the 1.8 grams of EPA used in Jelis similar to the 4 grams of EPA in R-IT...in populations with diets,which don't include so much fish...I was disappointed when the FDA did not accept the results of Jelis and insisted on the R-IT study to prove the effectiveness of Vascepa.