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Study eligibility was confirmed at the randomisation visit, at which subjects were randomised to receive CAT-354 or placebo in addition to their usual medication (ICS and SABA).
The subjects were randomised using a computer-generated sequence; the person responsible for the randomisation and the people making the study measurements were blinded.
Subjects were randomised to the intervention group or the control group using a web based randomisation service provided by the Clinical Trials Support Unit, University of Nottingham.
After neuroophtalmologic examination, eligible subjects were randomised into two groups.
Interventions: Subjects were randomised to one of three groups: traditionally prepared homeopathic A. nitricum 12X, radionically-prepared A. nitricum 12X, or placebo.
A total of 405 subjects were randomised to a treatment at one of three specialist outpatient drug treatment centres in Adelaide and Sydney, Australia.
After the saline inhalation the subjects were randomised to treatment with Salmeterol 50 μg twice daily and placebo in a double-blind double-dummy crossover design.
After inclusion, the subjects were randomised to one of the four conditions: behaviour-oriented physiotherapy (PT), cognitive behavioural therapy (CBT), behavioural medicine rehabilitation consisting of PT+CBT (BM) and a 'treatment-as-usual' control group (CG).
All subjects were randomised to receive either RTS,S/AS01E (GlaxoSmithKline [GSK] Biologicals, Belgium) or a rabies vaccine.
Subjects were randomised to either SHC or ESDS.
77 subjects were randomised with 71 completing the study.
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