
Safety

ADVERSE EVENTS, ADVERSE EVENT, EVENTS, DISEASES
The research staff asked participants over telephone whether they had experienced any adverse events, once every 2 weeks. This study defined adverse events as undesired/unintended signs, symptoms, or diseases that occurred during the intervention without clear causality. Adverse events were also objectively evaluated using follow‐up hematological and biochemical tests: white and red blood cell count and aspartate transaminase, alanine transaminase, γ‐glutamyl transpeptidase, platelets, blood urea nitrogen and creatinine levels. These events were assessed as newly identified abnormal values (out of reference range) at week 12. A study physician determined the seriousness of adverse events and their potential association with the intervention.