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Standardization Phase: 3 Days Following baseline assessment, a subject will enter the 3 consecutive day standardization phase that requires the subject to commence recording his or her daily pain intensity rating, and to commence standardization and recording of usage of pain and insomnia medication(s), as needed, to his or her 30-day prior use pain and insomnia medication(s), as determined during study qualification evaluation. The subject will record the following in the Subject Daily Diary, as indicated below.
Following completion of the 3-day standardization phase, the subject will fax his or her completed daily subject diary 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:
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 pain ratings recorded on the 0-10 Numeric Pain Intensity Scale during the standardization phase will serve as the subject‟s baseline pain intensity rating. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
