An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.

Olfactory Changes as Measured by the Smell Identification Test (SIT)

The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.

Time frame: Screening, weeks 12, 24, 36, 48 and 51

Change From Baseline (Screening) in Nasal Mucosa.

Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."

Time frame: Screening, Weeks 12, 24, 36, 48 and 51

Change in Taste as Measured by a Taste Change Questionnaire

Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10).

Time frame: Weeks 12, 24