At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.

The full analysis population (FAP) (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.

The FAP (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

A subject's response to treatment was defined as the percentage reduction from the baseline "average pain over the last 24 hours" score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having > 0 % reduction; non-responders were defined as having ≤ 0% reduction.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).

The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).

The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 ("worst imaginable health state") to 100 ("best imaginable health state").

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding "very much improved" and "much improved" was summarized by treatment group.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.

The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.

Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.

The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.

Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.

The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.