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.

Time frame: 4 weeks

Population: Full Analysis Set (FAS) All subjects in the randomized set with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment. Subjects were analyzed according to the treatment assigned. Missing data for the primary endpoint were imputed using a multiple imputation approach assuming that the missingness mechanism can be retrieved from observed data. The imputation model included the treatment group and the longitudinal sequence of HAM-A Total Score.

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)

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: End of Study (12 weeks)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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

Time frame: 4 weeks

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned. Missing data was not imputed for analysis of non-key secondary efficacy endpoints or safety endpoints. No adjustment for multiplicity was performed for testing the non-key secondary and exploratory endpoints.

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

Time frame: 8 weeks

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned. Missing data was not imputed for analysis of non-key secondary efficacy endpoints or safety endpoints. No adjustment for multiplicity was performed for testing the non-key secondary and exploratory endpoints.

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)

Time frame: 12 weeks

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned. Missing data was not imputed for analysis of non-key secondary efficacy endpoints or safety endpoints. No adjustment for multiplicity was performed for testing the non-key secondary and exploratory endpoints.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: End of study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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).

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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).

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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).

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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).

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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).

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: 8 weeks

Population: Full Analysis Set (FAS) All subjects in the randomized set with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment. Subjects were analyzed according to the treatment assigned. Missing data for key secondary endpoint were imputed using a multiple imputation approach assuming that the missingness mechanism can be retrieved from observed data. The imputation model included the treatment group and the longitudinal sequence of HAM-A Total Score.

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.

Time frame: End of Study (12 weeks)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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).

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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)

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: End of Study (Week 12)

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 1

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 12

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 2

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 4

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.

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.

Time frame: Week 8

Population: All randomized subjects with a valid Baseline HAM-A assessment and at least one valid post-baseline HAM-A assessment were included in the FAS. Subjects were analyzed according to the treatment assigned.