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.