2.2. Intervention and Study Procedures
pain
ADVERSE EVENTS
Participants were randomly assigned in equal proportion to one of the four study groups using a simple randomization procedure with the Epidat 4.1 software program. The study groups were as follows: (a) The tablets of the products under investigation were Participants visited the institute within ± 7 days of the baseline visit, in which the written informed consent was obtained, the inclusion criteria were checked, and randomization was performed. The study included a baseline visit (visit 1) and a visit after 60 days (visit 2, end of study). Participants also received a telephone call on day 30 to check adherence with the assigned product. Intensity of pain, QoL, functional mobility, muscle function, sleep quality, level of physical activity, and body composition were assessed at visits 1 and 2. A blood sample was drawn at visits 1 and 2 for routine safety testing. At visit 2, adverse events were recorded, and the study product was collected.