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Hormone replacement therapy
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Vitamin K 2 g, orally twice daily (Vitamin K)
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Dosage of the study drugs was as follows: L-lysine 20 mg twice daily, orally (L-lysine; Sigma-Aldrich)
Fentanyl 15 mg intramuscularly, orally (Fentanyl)
Fentanyl 1 mg intramuscularly, orally (Fentanyl)
Fentanyl 2 mg intramuscularly, orally (Fentanyl)
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Iridiums (injection-Folasterone)
Femoral ultrasound examination
Urine culture (2)
Urine culture (3)
Urine culture
(4)
Urinary tract infection (UTI) screening
Urinalysis
Frequency of urologic monitoring
All study drugs were discontinued at 3 days. Blood and urine samples were routinely analyzed by microbiology laboratory. Blood and urine samples were obtained by venipuncture at baseline (T0), 3 days (T1) and 5 (T2).
Body mass index and blood pressure were measured daily. Hemoglobin, red cell count and hemoglobin A1c (HbA1c) were measured at T0, T1, T2 and after 4 days. Plasma homocysteine and transferrin saturation were measured every 5 days.
Blood count
HbA1c (high-sensitivity C-reactive protein) was measured at T0, T1, T2 and 4 days after an oral dose of each study drug. The value was not significantly different from the reference range [6.1%–9.6%].
Statistical analysis
Analyses were performed with SAS version 9.1 (SAS Institute). P values for two-sided significance tests were considered significant if they <0.05. Analyses were performed with and without the use of a two-tailed test.
Results
During the course of study, mean (±SD) blood loss was 0.2 ± 0.1 mL at each of the six visits (T0–4). No significant difference was found in average blood loss between treatment arms at T0/T1/T2 or T2/T3 (Table 3). Both groups exhibited similar average hemoglobin A1c (P < 0.001).
Table 3: Blood loss and anemia at T0, T1, T2 and T3
Adverse events by treatment group
The most common adverse events were nausea,.
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The evidence for safety of finasteride use in men with low-back pain continues to accumulate. This story has not yet been updated to reflect today's court decision, but it was previously posted here.
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