Table 2.
Overview of laboratory measures.
| Visit 1 |
Visit 2 |
Visit 3 |
* |
|
|---|---|---|---|---|
| Screening | 6 weeks of treatment | End of treatment | Early termination | |
| Week | 0 | 6 | 12 | - |
| Kidney function (eGFR, creatinine) | x | |||
| Liver enzymes and function (serum bilirubin, γ-GT, AF, ALAT, ASAT) | x | x** | x** | x** |
| Triglycerides, total cholesterol, HDL- and LDL-cholesterol | x | x** | x | x |
| CRP | x | x | x | |
| Hormonal biomarkers | x | x | x | |
| for men: prolactin, 17β-estradiol, free testosterone, SHBG | ||||
| for women: prolactin, FSH, β-HCG, 17β-estradiol | ||||
| β-HCG*** | x | x | x | x |
* performed if a patient prematurely discontinues the study. ** Performed when levels are above the upper limit of normal at baseline. ***Only for WOCBP. LHT, lithium heparin tube; SCT, sodium citrate tube; SST, serum separator tube; eGFR, estimated glomerular filtration rate; ASAT, aspartate aminotransferase; ALAT, alanine aminotransferase; γ-GT, gamma glutamyl transpeptidase; AF, alkaline phosphatase; HDL, high-density lipoprotein; LDL, low-density lipoprotein; CRP, C-reactive protein; APTT, activated partial thrombin time; FSH, follicle stimulating hormone; SHBG, sex hormone-binding globulin; β-HCG, beta-human chorionic gonadotropin