- A score above 10 in either the Anxiety or Depression portions of the Hospital Anxiety and Depression Scale (HADS) at Visit 13/20. Subjects whose HADS score at Visit 13/20 exceeds 10 in either the Anxiety or Depression portions of the HADS will be allowed in the study only after they are examined and it is determined that the symptoms of anxiety and/or depression are not of a severity that is incompatible with further treatment with velneperit. Permission must also be obtained from the Sponsor or Sponsor's designated medical representative for subjects with scores above 10 on these HADS subscores