STANDARDIZATION PHASE: 3 DAYS

Following baseline assessment, a subject will enter the 3 consecutive day standardization phase that requires the subject to commence standardization and recording of usage of pain relief medication(s), as needed, to his or her 30-day prior use pain medication(s), as determined during study qualification evaluation.

Also during the 3-day standardization phase, the subject will commence recording the following:

(i) Daily Hip Pain Rating: The subject will record his or her current degree of pain rating on the 0-100 VAS upon waking each morning, prior to taking his or her first dose of permissible pain medication for the day, for the study hip (The study hip is the hip side that is to be evaluated in this study). The subject may take a dose of his or her permissible pain medication immediately following recording of this morning pain rating, as needed.

(ii) Rescue Pain Medication Use: The subject will record each time that he or she takes a dose of the study permissible rescue pain medication.

(iii) Body Pain Diary: The subject will complete the Body Pain Diary at two times on each of the 3 standardization phase days:

• upon waking in the morning, prior to taking his or her first dose of permissible pain medication for the day.
  
• prior to retiring to bed for the evening, such that it has been at least 4 hours since the subject took his or her last dose of permissible rescue pain medication. The subject may take a dose of his or her permissible pain medication immediately following completion of the evening Body Pain Diary entries, as needed.

(iv) Concomitant Medication and Therapy Use: The subject will record each use of concomitant medications and therapies.

Following completion of the 3-day standardization phase, the subject will bring, mail or fax his or her completed materials to the testing site for evaluation by the sub-PI. Based on this evaluation, subject continued study participation is determined according to the following criteria:

(i) The subject‘s 3-recording average of degree of study hip pain ratings on the VAS for the standardization phase is at least 40.

(ii) The subject did not take a pain medication dose prior to recording each of the 3 morning standardization phase degree of hip pain ratings.

(iii) The subject has refrained from consuming any non-approved medication indicated for the relief of pain during the 3-day standardization phase.

If any of the above conditions are not satisfied, the subject will be disqualified from further participation in the study at this point.

The average of the subject‘s 3 daily degree of study hip pain ratings recorded on the 0-100 VAS Scale during the standardization phase will serve as the subject‘s baseline study hip pain intensity rating.

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