Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Conditions:	Generalized Anxiety Disorder Panic Disorder
Interventions:	Drug: Niravam Drug: SSRI/SNRI

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants Flow shows 418 subjects that have been enrolled and randomized. The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Baseline Characteristics are only available for the Intent-to-treat population (subjects who received one dose of SSRI/SNRI and/or Niravam and have an assessment beyond the Baseline assessment)

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
STARTED	137	138	72	71
COMPLETED	92	92	55	49
NOT COMPLETED	45	46	17	22
Lack of Efficacy	2	6	1	2
Adverse Event	7	2	1	1
Lost to Follow-up	18	21	6	8
Withdrawal by Subject	6	10	3	9
Protocol Violation	5	3	4	2
unspecified	7	4	2	0

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone	Total
Number of Participants [units: participants]	125	120	67	62	374
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	120	119	66	61	366
>=65 years	5	1	1	1	8
Age [units: years] Mean ± Standard Deviation	40.1 ± 12.24	38.1 ± 12.55	40.1 ± 12.64	43.6 ± 12.20	40 ± 12
Gender [units: participants]
Female	102	93	50	42	287
Male	23	27	17	20	87
Region of Enrollment [units: participants]
United States	125	120	67	62	374

Measure Type	Primary
Measure Title	Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Time Frame	10 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	125	120	67	62
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) [units: cumulative percent of responders]
Week 1	1.60	0.83	1.49	1.61
Week 2	3.20	21.73	32.93	27.52
Week 3	45.83	39.43	51.22	48.89
Week 4	59.22	52.40	57.32	62.14
Week 5	69.68	65.99	66.47	65.92
Week 6	71.57	69.79	69.66	71.94
Week 7	74.59	74.11	74.66	73.94
Week 8	76.62	76.27	76.47	73.94
Weeks 9 to 10	83.30	82.20	83.82	76.11

Statistical Analysis 1 for Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Generalized Wilcoxon
P Value ^[3]	0.1143

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Generalized Wilcoxon
P Value ^[3]	0.4544

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Primary
Measure Title	Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Time Frame	10 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per Protocol Population (subjects of ITT population who have no major protocol violations)

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	104	106	53	49
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) [units: cumulative percent of responders]
Week 1	1.92	0.94	1.89	2.04
Week 2	35.58	24.53	33.96	30.78
Week 3	51.23	41.54	52.83	53.16
Week 4	63.18	54.19	58.49	67.21
Week 5	75.45	67.59	67.92	71.89
Week 6	77.59	71.94	71.70	79.56
Week 7	79.83	75.77	77.70	79.56
Week 8	80.95	78.32	79.93	79.56
Week 9 to 10	86.60	84.82	86.62	82.48

Statistical Analysis 1 for Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Generalized Wilcoxon Test
P Value ^[3]	0.044

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Generalized Wilcoxon Test
P Value ^[3]	0.6587

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 1 Week
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with values at baseline and time point are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	112	109	63	57
Change From Baseline in the Total HAM-A Score After 1 Week [units: Units on a scale] Mean ± Standard Deviation	-9.3 ± 11.50	-5.8 ± 9.04	-7.8 ± 7.43	-4.6 ± 8.33

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 1 Week

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0173

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 1 Week

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0516

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 2 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 2 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	108	103	61	53
Change From Baseline in the Total HAM-A Score After 2 Weeks [units: Units on a scale] Mean ± Standard Deviation	-11.6 ± 10.98	-8.2 ± 9.37	-10.0 ± 8.75	-6.1 ± 9.06

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0361

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0366

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 3 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	101	92	58	52
Change From Baseline in the Total HAM-A Score After 3 Weeks [units: Units on a scale] Mean ± Standard Deviation	-14.3 ± 11.81	-12.9 ± 11.03	-10.9 ± 9.70	-9.5 ± 9.49

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 3 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.7390

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 3 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.6735

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 4 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 4 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	97	90	54	48
Change From Baseline in the Total HAM-A Score After 4 Weeks [units: Units on a scale] Mean ± Standard Deviation	-15.2 ± 11.66	-13.7 ± 10.58	-12.9 ± 9.47	-8.3 ± 8.35

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 4 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.4261

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 4 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0231

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 5 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 5 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	89	81	51	48
Change From Baseline in the Total HAM-A Score After 5 Weeks [units: Units on a scale] Mean ± Standard Deviation	-16.7 ± 11.81	-14.4 ± 11.69	-13.3 ± 8.41	-10.3 ± 10.99

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 5 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1820

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 5 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.2187

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 6 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	87	81	47	47
Change From Baseline in the Total HAM-A Score After 6 Weeks [units: Units on a scale] Mean ± Standard Deviation	-17.7 ± 11.94	-15.1 ± 11.59	-13.4 ± 8.00	-11.0 ± 10.44

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 6 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1456

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 6 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3618

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 7 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 7 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	83	82	53	49
Change From Baseline in the Total HAM-A Score After 7 Weeks [units: Units on a scale] Mean ± Standard Deviation	-17.7 ± 12.75	-15.6 ± 11.78	-13.3 ± 8.85	-11.3 ± 11.32

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 7 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3535

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 7 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.5660

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score After 8 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time Frame	Baseline and 8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	84	84	53	47
Change From Baseline in the Total HAM-A Score After 8 Weeks [units: Units on a scale] Mean ± Standard Deviation	-18.5 ± 13.38	-16.6 ± 10.72	-13.9 ± 8.71	-12.3 ± 9.49

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score After 8 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3414

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score After 8 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.7344

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.
Time Frame	Baseline and at endpoint during the 8 week treatment period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, Last Observation Carried Forward imputation was applied

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	117	117	64	59
Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period [units: Units on a scale] Mean ± Standard Deviation	-17.3 ± 13.03	-14.3 ± 11.32	-13.6 ± 8.85	-11.5 ± 10.44

Statistical Analysis 1 for Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1197

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Statistical Analysis 2 for Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.4416

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	112	109	63	57
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week [units: participants]
Response	39	24	22	16
No Response	73	85	41	41

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.0350

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.4205

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	2 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	108	103	61	53
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks [units: participants]
Response	48	38	30	23
No Response	60	65	31	30

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.2645

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.5369

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	101	92	58	52
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks [units: participants]
Response	56	51	33	31
No Response	45	41	25	21

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.9988

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.7729

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	4 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	97	90	54	48
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks [units: participants]
Response	58	56	37	25
No Response	39	34	17	23

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.7338

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.0897

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	5 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	89	81	51	48
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks [units: participants]
Response	59	51	33	30
Non Response	30	30	18	18

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.6501

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.8196

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	87	81	47	47
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks [units: participants]
Response	63	56	31	32
No Response	24	25	16	15

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.6404

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.8263

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	7 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	83	82	53	49
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks [units: participants]
Response	60	57	37	34
No Response	23	25	16	15

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.6946

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.9629

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time Frame	8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with a non-missing value at timepoint are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	84	84	53	47
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks [units: participants]
Response	61	62	38	35
No Response	23	22	15	12

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.8617

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.7555

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.
Time Frame	at endpoint during the 8 week treatment period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, Last Observation Carried Forward imputation was applied

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	117	117	64	59
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period [units: participants]
Response	78	74	44	40
No Response	39	43	20	19

Statistical Analysis 1 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.5836

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	Chi-squared
P Value ^[3]	0.9096

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis refers to test of differences in response rates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
Measure Description	The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Time Frame	Baseline and 2 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with non-missing values were included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	119	107	66	57
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks [units: Participants]
Very much improved	6	1	4	2
much improved	38	23	25	10
minimally improved	53	35	27	20
No change	17	40	9	18
Minimally worse	4	7	1	6
Much worse	1	1	0	1
Very much worse	0	0	0	0

Statistical Analysis 1 for Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0002

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0006

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Measure Description	The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Time Frame	Baseline and 4 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	107	99	60	46
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks [units: participants]
Very much improved	18	5	12	1
Much improved	40	40	26	18
Minimally improved	35	23	13	17
No change	7	19	7	9
Minimally worse	6	9	1	1
Much worse	1	2	0	0
Very much worse	0	1	1	0

Statistical Analysis 1 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0255

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0065

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Measure Description	The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Time Frame	Baseline and 8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	93	96	57	51
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks [units: participants]
Very much improved	28	27	14	12
Much improved	44	27	25	22
Minimally improved	16	19	11	13
No change	3	19	5	4
Minimally worse	2	1	1	0
Much worse	0	2	1	0
Very much worse	0	1	0	0

Statistical Analysis 1 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0370

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.9569

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Measure Description	The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.
Time Frame	Baseline and at endpoint during the 8 week treatment period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	122	113	66	59
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period [units: participants]
Very much improved	31	27	14	12
Much improved	47	31	29	23
Minimally improved	30	24	12	16
No change	7	25	8	5
Minimally worse	6	2	2	2
Much worse	1	3	1	1
Very much worse	0	1	0	0

Statistical Analysis 1 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0978

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.7096

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only patients with non-missing values are included in the analysis

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	109	102	61	53
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week [units: participants]
Very much better	7	0	3	0
Much better	24	5	10	7
A little better	35	40	27	9
Unchanged	39	46	20	31
A little worse	2	6	1	3
Much worse	1	5	0	2
Very much worse	1	0	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0003

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.
Time Frame	2 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	110	104	62	54
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks [units: participants]
Very much better	10	2	5	4
Much better	30	16	21	7
A little better	34	38	21	20
Unchanged	29	37	13	17
A little worse	3	3	0	3
Much worse	4	5	1	2
Very much worse	0	3	1	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0025

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0101

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	107	95	61	53
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks [units: participants]
Very much better	22	7	10	2
Much better	23	21	21	14
A little better	33	28	16	22
Unchanged	24	31	12	13
A little worse	2	3	1	0
Much worse	1	5	1	1
Very much worse	2	0	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0095

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0390

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	4 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	102	93	57	49
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks [units: participants]
Very much better	18	13	13	6
Much better	38	24	19	14
A little better	26	20	16	18
Unchanged	14	28	5	8
A little worse	2	4	2	1
Much worse	2	3	2	1
Very much worse	2	1	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0160

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.1024

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	5 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	94	84	54	49
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks [units: participants]
Very much better	21	10	13	5
Much better	32	27	19	20
A little better	16	19	18	10
Unchanged	16	19	4	12
A little worse	3	2	0	1
Much worse	6	6	0	0
Very much worse	0	1	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0761

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0376

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	93	84	50	48
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks [units: participants]
Very much better	22	16	15	6
Much better	29	24	20	15
A little better	23	17	11	16
Unchanged	16	18	4	8
A little worse	2	2	0	2
Much worse	1	5	0	0
Very much worse	0	2	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.1196

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0029

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	7 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	88	84	56	50
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks [units: participants]
Very much better	23	21	12	8
Much better	28	24	23	23
A little better	17	17	11	7
Unchanged	15	18	8	9
A little worse	3	1	2	1
Much worse	2	1	0	1
Very much worse	0	2	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.6323

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.5533

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time Frame	8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, Last Observation Carried Forward imputation was applied

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	88	86	56	48
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks [units: participants]
Very much better	28	23	20	13
Much better	28	22	14	13
A little better	17	21	13	12
Unchanged	13	16	8	7
A little worse	2	0	1	1
Much worse	0	3	0	1
Very much worse	0	1	0	1

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.1705

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.3196

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Measure Description	The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.
Time Frame	at endpoint during the 8 week treatment period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, Last Observation Carried Forward imputation was applied

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	123	119	66	60
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period [units: participants]
Very much better	34	25	21	14
Much better	36	27	14	15
A little better	27	30	17	14
Unchanged	20	30	12	11
A little worse	3	0	1	1
Much worse	3	6	1	3
Very much worse	0	1	0	2

Statistical Analysis 1 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.0419

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	van Elteren test
P Value ^[3]	0.2541

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 1 Week
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	112	109	63	57
Change From Baseline in HAM-A-insomnia Subscore After 1 Week [units: Units on a scale] Mean ± Standard Deviation	-0.9 ± 1.42	-0.6 ± 1.43	-1.0 ± 1.40	-0.5 ± 1.40

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 1 Week

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0677

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 1 Week

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0273

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 2 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	108	103	61	53
Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.0 ± 1.49	-0.9 ± 1.40	-1.2 ± 1.50	-0.6 ± 1.50

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.5153

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0122

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	101	92	58	52
Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.2 ± 1.48	-1.1 ± 1.43	-1.4 ± 1.40	-1.2 ± 1.36

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.4648

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.5502

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 4 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	97	90	54	48
Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.3 ± 1.65	-1.4 ± 1.47	-1.6 ± 1.34	-1.1 ± 1.42

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.9093

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1354

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 5 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	89	81	51	48
Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.3 ± 1.56	-1.4 ± 1.52	-1.5 ± 1.36	-1.1 ± 1.22

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.7434

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1148

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	87	81	47	47
Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.4 ± 1.64	-1.5 ± 1.52	-1.6 ± 1.25	-1.1 ± 1.39

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.9346

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.2709

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 7 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	83	82	53	49
Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.5 ± 1.63	-1.4 ± 1.49	-1.6 ± 1.32	-1.2 ± 1.40

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3827

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.2513

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time Frame	Baseline and 8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	84	84	53	47
Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks [units: Units on a scale] Mean ± Standard Deviation	-1.6 ± 1.57	-1.6 ± 1.41	-1.6 ± 1.33	-1.3 ± 1.41

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3930

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.5461

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Time Frame	Baseline and at endpoint during the 8 week treatment period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, Last Observation Carried Forward imputation was applied

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	117	117	64	59
Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period [units: Units on a scale] Mean ± Standard Deviation	-1.6 ± 1.53	-1.4 ± 1.49	-1.5 ± 1.38	-1.3 ± 1.51

Statistical Analysis 1 for Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0722

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.4639

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	112	109	63	57
Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week [units: Units on a scale] Mean ± Standard Deviation	-4.9 ± 5.73	-2.9 ± 4.78	-4.5 ± 4.53	-3.3 ± 4.08

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0075

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1641

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 2 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	108	103	61	53
Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks [units: Units on a scale] Mean ± Standard Deviation	-6.0 ± 5.97	-4.5 ± 4.88	-5.8 ± 5.23	-4.1 ± 4.53

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0932

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0852

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	101	92	58	52
Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks [units: Units on a scale] Mean ± Standard Deviation	-7.3 ± 5.98	-6.8 ± 5.42	-6.4 ± 5.44	-6.1 ± 4.87

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.7896

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.9651

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 4 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	97	90	54	48
Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks [units: Units on a scale] Mean ± Standard Deviation	-7.7 ± 5.95	-7.4 ± 5.57	-7.8 ± 5.14	-5.9 ± 4.80

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.8280

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0936

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 5 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	89	81	51	48
Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks [units: Units on a scale] Mean ± Standard Deviation	-8.7 ± 5.84	-7.7 ± 5.99	-7.9 ± 5.08	-6.8 ± 5.76

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3539

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.4672

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	87	81	47	47
Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks [units: Units on a scale] Mean ± Standard Deviation	-9.4 ± 5.84	-8.3 ± 5.66	-8.7 ± 4.81	-7.2 ± 5.82

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.2550

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3125

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 7 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	83	82	53	49
Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks [units: Units on a scale] Mean ± Standard Deviation	-9.6 ± 6.27	-8.4 ± 5.75	-8.1 ± 5.16	-7.6 ± 6.19

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3174

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.9427

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time Frame	Baseline and 8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	84	84	53	47
Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks [units: Units on a scale] Mean ± Standard Deviation	-9.9 ± 6.63	-8.9 ± 5.13	-8.5 ± 4.91	-8.5 ± 5.51

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.3252

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.6090

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Time Frame	Baseline and at endpoint during the 8 week treatment period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, Last Observation Carried Forward imputation was applied

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	117	117	64	59
Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period [units: Units on a scale] Mean ± Standard Deviation	-9.1 ± 6.58	-7.6 ± 5.82	-7.9 ± 5.19	-7.9 ± 5.81

Statistical Analysis 1 for Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1247

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.8430

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-somatic Subscore After 1 Week
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time Frame	Baseline and 1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	112	109	63	57
Change From Baseline in HAM-A-somatic Subscore After 1 Week [units: Units on a scale] Mean ± Standard Deviation	-4.4 ± 6.95	-2.9 ± 5.80	-3.3 ± 4.46	-1.4 ± 5.43

Statistical Analysis 1 for Change From Baseline in HAM-A-somatic Subscore After 1 Week

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.1031

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-somatic Subscore After 1 Week

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0543

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-somatic Subscore After 2 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time Frame	Baseline and 2 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups

	Description
Panic: Niravam+SSRI/SNRI	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI Alone	Panic Disorder: Newly prescribed SSRI or SNRI alone
GAD : Niravam+SSRI/SNRI	Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
GAD: SSRI/SNRI Alone	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Measured Values

	Panic: Niravam+SSRI/SNRI	Panic: SSRI/SNRI Alone	GAD : Niravam+SSRI/SNRI	GAD: SSRI/SNRI Alone
Number of Participants Analyzed [units: participants]	108	103	61	53
Change From Baseline in HAM-A-somatic Subscore After 2 Weeks [units: Units on a scale] Mean ± Standard Deviation	-5.6 ± 6.31	-3.7 ± 6.18	-4.2 ± 5.52	-2.0 ± 6.05

Statistical Analysis 1 for Change From Baseline in HAM-A-somatic Subscore After 2 Weeks

Groups ^[1]	Panic: Niravam+SSRI/SNRI vs. Panic: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0508

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate

Statistical Analysis 2 for Change From Baseline in HAM-A-somatic Subscore After 2 Weeks

Groups ^[1]	GAD : Niravam+SSRI/SNRI vs. GAD: SSRI/SNRI Alone
Method ^[2]	ANCOVA
P Value ^[3]	0.0871

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate

Measure Type	Secondary
Measure Title	Change From Baseline in HAM-A-somatic Subscore After 3 Weeks
Measure Description	The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time Frame	Baseline and 3 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population, but only subjects with non-missing values have been included

Reporting Groups