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We, Kewpie Corporation, have developed an innovative hyaluronic acid specially designed for knee osteoarthritis, Hyabest®(J). For this product, we obtained 8-week clinical data based on WOMAC randomized double-blind placebo-controlled clinical trial.
Attached herewith, please find out related exhibits.
We did one survey in Japan based on JKOM (Japanese Knee Osteoarthritis Measurement Japanse equivalent of WOMAC), and came by satisfactory result as attached (see Exhibit 1). However, the survey was done for the Japanese, and was not double-blind placebo-controlled, therefore we later did another one in USA ,more authentic worldly known one, WOMAC.
2. General observation
As has been stipulated in the report, Hyabest®(J), both in case of 200mg/day dosage and 100mg/day dosage, proved to contribute to significant improvement in all scores of WOMAC (see Exhibit 2).
It is the fact, however, that result of placebo was also good especially during 1st half (0-4 weeks). For this, please refer to N Engl J Med 354:8, 795-794, 2006, in which you may notice how placebo tends to produce good result.
Furthermore, we did an exploratory analysis for the subgroup (moderate-to-severe conditioned subjects) (see Exhibit 3), from which you may understand how our Hyabest®(J) ,both 200mg and 100mg were effective for the group of people.