2.7.6. In-clinic testing and observations.
APS, ADVERSE EVENTS, BLOOD, CVD, PRESSURE AREA, COLLAGEN VASCULAR DISEASE, CHRONIC ENDOMETRITIS, ANTIPHOSPHOLIPID ANTIBODY SYNDROME
Vital signs, such as body temperature, heart rate, and blood pressure are checked during registration, drug administration, and at study drug discontinuation.Histological examination of the endometrium (5–7 days after ovulation) is performed during the screening period to confirm that the participants do not have chronic endometritis. The histological diagnostic criterion for chronic endometritis is defined as the presence of five or more CD138-positive plasma cells in 10 visual fields in the endometrial stroma.The laboratory tests used in this study are listed in Table Blood levels of tacrolimus are measured during registration, drug administration, and study drug discontinuation.Information on adverse events occurring during the drug administration and observation period is collected. Details of adverse events are noted separately.Laboratory test items.β2GP1 = β2-glycoprotein-1, Ab = antibody, Act = activity, Ag = antigen, APS = antiphospholipid antibody syndrome, CL = cardiolipin, CVD = collagen vascular disease, PE = phosphatidylethanolamine, PS/PT = phosphatidylserine/prothrombin.