Safety assessment
toxicity
ADVERSE REACTIONS
Participants were interviewed regarding side effects and adverse reactions during the follow-up visits. SAE forms were part of the patient diary, which were explained and reinforced at every follow up visit and on telephone calls once a week. The supplement and diet diary were checked at each follow-up to ensure completion and uniformity. To evaluate liver and kidney function and ensure safety for individuals in the treatment group, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and blood urea nitrogen to serum creatinine ratio (SC) levels were measured at the start of the study, 28 days, and 84 days. As the follow-up duration was limited to 84 days, SC ratios were used to quantifiably assess short-term renal toxicity for statistical analysis. Participants were routinely reminded to maintain the supplementation regimen and to update the supplement and diet diary regularly.