Randomisation, enrolment and intervention
albendazole-based
Eligible patients were randomized by an independent investigator to the inactive control group (CONTROL), or one of the following three albendazole-based fixed sequential treatment regimens: ALB, ALB-ALB, or ALB-IVM. Computer generated block randomization was used to generate the allocation list with a block size of 7 and an allocation ratio of 1:2:2:2. Once seven participants were judged eligible, the randomization procedure was initiated. Based on a sequential list of eligible patients, individuals dropping out before the end of the treatment period were replaced in the same treatment group with the next eligible participant. Participants in the control group (CONTROL) received symptomatic treatment with the antihistaminic drug loratadine 10 mg (Loratol Tabs. 10mg, Dafra Pharma GmbH) oral once daily, intake under supervision, for seven days. All participants enrolled in one of the three intervention groups received twice daily oral therapy with 400mg albendazole (Albendazole Tabs. 400mg, Medopharm, India) after food intake for 21 days. Supervision of drug intake was daily during the first week of treatment. For the remaining treatment duration directly observed treatment was done every second day and tablets for the unsupervised drug intakes were provided each time only for the following day. At each time point information on compliance and safety was provided. Participants randomized to the ALB-ALB group received an additional 14-day treatment course of twice daily 400 mg albendazole with the same supervision of drug intake as mentioned above. Participants allocated to the ALB-IVM group received supervised treatment with a single dose of 150 μg/kg ivermectin (Stromectol 3mg, MSD) on day 23. Ivermectin was administered only after assurance that 