Blinding and Randomization
Randomization of participants was carried out using a computer generated
scheme (Almac, Craigvon, UK) independent of the study site and
procedures. Blinded study medication was supplied to the pharmacy where
it was dispensed; un-blinding was by way of un-blinding scratch cards.
Matched placebos for both Lesogaberan and Baclofen were manufactured and
thus each study treatment consisted of 2 capsules Lesogaberan
120mg/matched Lesogaberan placebo plus Baclofen 40mg/matched Baclofen
placebo. Each subject received (in a random, double-blinded fashion) (i)
Lesogaberan plus Baclofen Placebo, (ii) Lesogaberan Placebo plus
Baclofen and (ii) Lesogaberan Placebo plus Baclofen Placebo.