Clinical and safety assessments
HEPATITIS B, BLOOD, ADVERSE EVENTS, ADVERSE EVENT
Participants underwent a physical examination with demographic data and medical history recorded at the baseline visit. Blood samples were taken for haematology (red blood cell count, haemoglobin, haematocrit, leukocyte count with differential and platelet count), biochemistry (bilirubin, transaminases alanine aminotransferase and aspartate aminotransferase, urea, creatinine and glucose) and viral serology (hepatitis B and C). A urine pregnancy test (SAS Ultimate hCG—SA Scientific Ltd.) for women under the age of 55 was performed to rule out pregnancy and counselling to avoid conception during the study period was provided. Assessments of treatment adherence, clinical status, adverse events, and concomitant medications were recorded at each visit during the treatment and follow-up period. In addition, participants were advised to contact the study health centre in case of occurrence of any adverse event. Follow-up visits were conducted by a trained nurse and a fieldworker. Any potential signs or symptoms recorded by them were discussed with the study doctor for further assessment or necessary action. Tolerability and safety assessments were performed until study completion at Day-168 including the recording of adverse events and clinical laboratory test results. A further urine pregnancy test was done for female participants <55 years of age at the end of the study follow-up period. All participants randomized in the control group were offered a 28 days albendazole treatment regimen at the end of 6 months follow up period.