Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Health Status (WOMAC questionnaire 0-Best health status, 96-worst health status). Measuring Time: At baseline, at the end of the 6, 12, 18 and 24 weeks.
Key secondary outcomes:
Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: At baseline, at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks.
Stiffness (WOMAC questionnaire. Value between 0 and 8 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks.
Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks.
Pain (Visual Analogue Scale. Value between 0-no pain-100 points-Worst pain bearable). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks.
Segurity and tolerability:
Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks.
Biochemistry tests (laboratory values). Measuring time: At baseline, at the end of the 12 and 24 weeks.
Adverse Events (description (AE name), intensity (mild, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of the 6, 12, 18 and 24 weeks.