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The central randomisation schedule was generated by the sponsor using a validated computerised system (RandAll).
Patients were randomised using a registration and medication ordering system (RAMOS; GlaxoSmithKline, Brentford, UK), an automated, interactive telephone-based system, following the generation of a central randomisation schedule generated by the sponsor using a validated computerised system (RandAll; GlaxoSmithKline, Brentford, UK).
Patients were assigned to study treatment following a telephone call to the Registration and Medication Ordering System (RAMOS [GlaxoSmithKline, UK]) and randomised in accordance with a central randomisation schedule generated by the sponsor using a validated computerised system (RandAll [GlaxoSmithKline, UK]).
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Plasma samples were analysed using a validated analytical method.
Toxicokinetics were determined using a validated dual-analyte bioanalytical method.
Resource use was measured using a validated questionnaire.
Airway wall dimensions were calculated using a validated method.
Abdominal pain scores were recorded using a validated questionnaire.
Digoxin was analyzed by PPD using a validated radioimmunoassay procedure.
The drug concentrations were measured using a validated HPLC assay.
WML were segmented using a validated semi-automated method [ 24].
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