Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime.

Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.

This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system [IVRS]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.

Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.

The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.

Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.