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Subjects who were taking antibiotics within two weeks before the screening visit or throughout the study were excluded, as were those on concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study.
Eligible patients had detectable HCV RNA in the serum (>12 IU/ml), elevated serum alanine aminotransferase (ALAT) levels, a liver biopsy taken within 2 years before the screening visit showing chronic hepatitis and compensated liver disease.
Epileptic seizure 6 months before the screening visit.
Patients using prohibited medications underwent up to 6 weeks' washout before the screening visit.
Patients had used inhaled corticosteroids (ICSs) daily for ≥ 30 days before the screening visit and were on stable ICS doses for ≥ 2 weeks before screening.
The use of non-pharmacological therapy (e.g. bed alarms) for nocturnal enuresis during the 60 days before the screening visit was not permitted for study participants.
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The owners answered multi-dimensional questionnaires about their dogs at seven different times: Six weeks before the first screening visit (W−8 = 8 weeks before baseline), during the screening visit (W−2 ), at the baseline visit (W0), at home once a month between visits (W4, W8, and W12) and at the end of trial-visit (W16).
All participants provided informed consent, and minor children confirmed assent according to local guidelines before participation in the screening visit.
There was a washout period before screening and, following the screening visit, there was a 2-week run-in period prior to randomization to ensure clinical stability.
†Evaluated in the screening visit (before and after salbutamol inhalation).
PROs were measured at the screening visit before randomization, throughout the treatment period, and at the end of treatment or patient withdrawal from the study.
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