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Profile of Randomised Controlled Trial. 79 subjects were assessed for eligibility which resulted in 19 subjects in the placebo group and 17 subjects in the ALRV5XR (treatment) group completing the trial and were included in the safety analysis. Evaluable subjects for primary efficacy analysis at 24 weeks resulted in 11 from the placebo group and 11 from the ALRV5XR group.
