Table 2.

Inclusion criteria

● Healthy male or female volunteers ≥35 to ≤70 years of age.

● Able to understand study procedures and provide signed informed consent, and authorizes release of relevant health information to study investigator.

● Willing to maintain current background dietary and physical activity pattern throughout study period.

● Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.

● Knee joint:

○ No knee joint discomfort at rest.

○ Experience knee joint discomfort with activity or exercise within the last 2 weeks of at least 30 mm out of 100 mm on VAS rating for “knee discomfort with activity or exercise at any time over the last 2 weeks”.

○ Must achieve a rating of at least 30 mm on a 100 mm VAS at any point throughout the standardized lower extremity exercise performance screening test (Screening test = 3 sets of 10–12 repetitions on seated knee extension machine +3-min walk test at maximal walking velocity).

● Females:

● Non-pregnant, non-lactating females who agree to use effective contraceptive methods throughout the course of the study.

● Females of childbearing potential must agree to use one of the following acceptable birth control methods:

○ Surgically sterile (hysterectomy or bilateral oophorectomy);

○ Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)

○ Intrauterine device (IUD) in place for at least 3 months

○ Abstinence (not having sexual intercourse)

○ Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion