A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 4. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.

To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 8. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.

To determine the change from Baseline of 4 doses of MM120 (25, 50, 100 or 200 μg free base equivalent) compared to Placebo as measured by the change in HAM-A Total Score from Baseline to Week 4 Hamilton Anxiety Rating Scale (HAM-A) consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness. Data shown are change in HAM-A Total Score from Baseline to Week 4

To determine the change from Baseline in HAM-A total scores of 4 doses of MM120 (25, 50, 100 or 200 μg free base equivalent) compared with placebo from Baseline to Week 8. Hamilton Anxiety Rating Scale (HAM-A) consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness. Data shown are change in HAM-A Total Score from Baseline to Week 8

To determine the change from Baseline in HAM-A total scores of 4 doses of MM120 (25, 50, 100 or 200 μg free base equivalent) compared with placebo from Baseline to End of Study (Week 12). Hamilton Anxiety Rating Scale (HAM-A) consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness. Data shown are change in HAM-A Total Score from Baseline to end of study (12 weeks)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in depressive symptoms as measured by the MADRS. The Montgomery-Åsberg Depression Rating Scale (MADRS) - used to assess depression severity and to detect changes due to treatment. Questionnaire included 10 clinician-completed items. Each of 10 questions scored with a range of 0-6 points. An item score of 0 indicated item not present or normal, while an item score of 6 indicated severe or continuous presence of the symptoms. The total possible score was 60, and higher scores represented a more severe condition. A decrease in score by ≥ 50% indicated a response to treatment, and an actual score of ≤ 10 indicated a remission of symptoms.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in depressive symptoms measured via the MADRS. The Montgomery-Åsberg Depression Rating Scale (MADRS) - used to assess depression severity and to detect changes due to treatment. Questionnaire included 10 clinician-completed items. Each of 10 questions scored with a range of 0-6 points. An item score of 0 indicated item not present or normal, while an item score of 6 indicated severe or continuous presence of the symptoms. The total possible score was 60, and higher scores represented a more severe condition. A decrease in score by ≥ 50% indicated a response to treatment, and an actual score of ≤ 10 indicated a remission of symptoms.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in depressive symptoms measured via the MADRS. The Montgomery-Åsberg Depression Rating Scale (MADRS) - used to assess depression severity and to detect changes due to treatment. Questionnaire included 10 clinician-completed items. Each of 10 questions scored with a range of 0-6 points. An item score of 0 indicated item not present or normal, while an item score of 6 indicated severe or continuous presence of the symptoms. The total possible score was 60, and higher scores represented a more severe condition. A decrease in score by ≥ 50% indicated a response to treatment, and an actual score of ≤ 10 indicated a remission of symptoms.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in depressive symptoms measured via the MADRS. The Montgomery-Åsberg Depression Rating Scale (MADRS) - used to assess depression severity and to detect changes due to treatment. Questionnaire included 10 clinician-completed items. Each of 10 questions scored with a range of 0-6 points. An item score of 0 indicated item not present or normal, while an item score of 6 indicated severe or continuous presence of the symptoms. The total possible score was 60, and higher scores represented a more severe condition. A decrease in score by ≥ 50% indicated a response to treatment, and an actual score of ≤ 10 indicated a remission of symptoms.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in depressive symptoms measured via the MADRS. The Montgomery-Åsberg Depression Rating Scale (MADRS) - used to assess depression severity and to detect changes due to treatment. Questionnaire included 10 clinician-completed items. Each of 10 questions scored with a range of 0-6 points. An item score of 0 indicated item not present or normal, while an item score of 6 indicated severe or continuous presence of the symptoms. The total possible score was 60, and higher scores represented a more severe condition. A decrease in score by ≥ 50% indicated a response to treatment, and an actual score of ≤ 10 indicated a remission of symptoms.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-S. The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-S. The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-S. The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-S. The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-S. The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-I. The Clinical Global Impression - Improvement (CGI-I) was used to measure the clinician's assessment of how much the subject's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-I. The Clinical Global Impression - Improvement (CGI-I) was used to measure the clinician's assessment of how much the subject's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-I. The Clinical Global Impression - Improvement (CGI-I) was used to measure the clinician's assessment of how much the subject's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-I. The Clinical Global Impression - Improvement (CGI-I) was used to measure the clinician's assessment of how much the subject's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. (minimum score 1, maximum score 7).

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the CGI-I. The Clinical Global Impression - Improvement (CGI-I) was used to measure the clinician's assessment of how much the subject's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. (minimum score 1, maximum score 7)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-S. The Patient Global Impression - Severity (PGI-S) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure disease severity (PGI-S). The PGI-S comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates more severe illness. (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-S. The Patient Global Impression - Severity (PGI-S) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure disease severity (PGI-S). The PGI-S comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates more severe illness. (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-S. The Patient Global Impression - Severity (PGI-S) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure disease severity (PGI-S). The PGI-S comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates more severe illness. (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-S. The Patient Global Impression - Severity (PGI-S) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure disease severity (PGI-S). The PGI-S comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates more severe illness. (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-S. The Patient Global Impression - Severity (PGI-S) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure disease severity (PGI-S). The PGI-S comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates more severe illness. (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in anxiety symptoms measured via the PGI-C. The Patient Global Impression - Change (PGI-C) is the patient-reported outcome counterpart to the CGI scale. The PGI is adapted to the patient population and can be used to measure changes in disease severity (PGI-C). The PGI-C comprises 1 subject-completed item with 5 possible ratings (1-5). A higher score indicates change for the worse (worsening symptoms). (minimum score 1, maximum score 5)

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in functional disability symptoms measured via the SDS. The Sheehan Disability Scale (SDS) is a composite of 3 self-rated items designed to measure the extent to which 3 major domains in the patient's life (work, social life/leisure activities and family life/home responsibilities) are functionally impaired by psychiatric or medical symptoms. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10).

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in functional disability symptoms measured via the SDS. The Sheehan Disability Scale (SDS) is a composite of 3 self-rated items designed to measure the extent to which 3 major domains in the patient's life (work, social life/leisure activities and family life/home responsibilities) are functionally impaired by psychiatric or medical symptoms. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10).

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in functional disability symptoms measured via the SDS. The Sheehan Disability Scale (SDS) is a composite of 3 self-rated items designed to measure the extent to which 3 major domains in the patient's life (work, social life/leisure activities and family life/home responsibilities) are functionally impaired by psychiatric or medical symptoms. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10).

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in functional disability symptoms measured via the SDS. The Sheehan Disability Scale (SDS) is a composite of 3 self-rated items designed to measure the extent to which 3 major domains in the patient's life (work, social life/leisure activities and family life/home responsibilities) are functionally impaired by psychiatric or medical symptoms. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10).

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in functional disability symptoms measured via the SDS. The Sheehan Disability Scale (SDS) is a composite of 3 self-rated items designed to measure the extent to which 3 major domains in the patient's life (work, social life/leisure activities and family life/home responsibilities) are functionally impaired by psychiatric or medical symptoms. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10).

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in quality of life. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) was used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The VAS for the subject's health status scored as ranging from 0 = worst health you can imagine, to 100 = best health you can imagine.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in quality of life. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) was used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The VAS for the subject's health status scored as ranging from 0 = worst health you can imagine, to 100 = best health you can imagine.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in quality of life. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) was used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The VAS for the subject's health status scored as ranging from 0 = worst health you can imagine, to 100 = best health you can imagine.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in quality of life. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) was used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The VAS for the subject's health status scored as ranging from 0 = worst health you can imagine, to 100 = best health you can imagine.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in quality of life. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) was used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The VAS for the subject's health status scored as ranging from 0 = worst health you can imagine, to 100 = best health you can imagine.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in sleep measured via the PSQI. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality and disturbances over the preceding month. The questionnaire had a Component Score for each of these with a range of 0-3 points: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbance, Use of sleeping medication, and Daytime dysfunction. The sum of the Component Scores = a Global Score. Global Score of 0 indicated no difficulty and a Global Score of 21 indicated severe difficulty in all areas.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in sleep measured via the PSQI. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality and disturbances over the preceding month. The questionnaire had a Component Score for each of these with a range of 0-3 points: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbance, Use of sleeping medication, and Daytime dysfunction. The sum of the Component Scores = a Global Score. Global Score of 0 indicated no difficulty and a Global Score of 21 indicated severe difficulty in all areas.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in subjects with anxiety symptoms, including improvements in sleep measured via the PSQI. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality and disturbances over the preceding month. The questionnaire had a Component Score for each of these with a range of 0-3 points: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbance, Use of sleeping medication, and Daytime dysfunction. The sum of the Component Scores = a Global Score. Global Score of 0 indicated no difficulty and a Global Score of 21 indicated severe difficulty in all areas.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in female subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in female subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in female subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in female subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in female subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in male subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in male subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in male subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in male subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

To determine whether MM120 (25, 50, 100, or 200 µg freebase-equivalent) improves functionality and quality of life measures in male subjects with anxiety symptoms, including improvements in sexual function measured via the ASEX. The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.

Number of Participants with sexual dysfunction n (%) vs. Number of Participants without sexual dysfunction n (%). The Arizona Sexual Experiences Questionnaire (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm over the past week. Possible total scores on the ASEX range of 5-30, with a higher score indicating more sexual dysfunction.