A Study to Evaluate Efficacy and Safety of SAGE-547 in Pa... | NCT02942004

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.	Drug: Placebo
SAGE-547 60 μg/kg/h	Experimental	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).	Drug: SAGE-547 60 μg/kg/h
SAGE-547 90 μg/kg/h	Experimental	Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).	Drug: SAGE-547 90 μg/kg/h

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.	Placebo

Measure	Description	Time Frame
Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score	The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.	Baseline, Hour 60

Measure	Description	Time Frame
Change From Baseline in HAM-D Total Score at Day 30	The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Name	Affiliation	Role
Helen Colquhoun, MD	Sage Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sage Investigational Site		Chandler	Arizona	85226	United States
Sage Investigational Site

PubMed Identifier	Type	Citation	Retractions
33181049	Derived	Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.
30177236	Derived

Label	URL
Related Info	View source

ID	Title	Description
FG000	Placebo	Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.
FG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 16, 2017	Apr 11, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score

The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Hour 60

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
OG002	SAGE-547 90 μg/kg/h	Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).

Units	Counts
Participants	OG00043 OG00137 OG00239

Title

Denominators

Categories

Title	Measurements
	OG000-14.04± 1.148 OG001-19.54± 1.231 OG002-17.72± 1.193

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM		0.0013		Least Square (LS) Mean Difference	-5.50	Standard Error of the Mean	1.664	2-Sided	95	-8.80	-2.20					Superiority

Secondary

Change From Baseline in HAM-D Total Score at Day 30

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Change From Baseline in HAM-D Total Score

All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Percentage of Participants With HAM-D Response

The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Posted

Number

percentage of participants

Hour 60, Days 7 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Percentage of Participants With HAM-D Remission

The HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Posted

Number

percentage of participants

Hour 60, Days 7 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Change From Baseline in HAM-D Bech 6 Subscale

The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Hour 60, Days 7 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
OG002

Secondary

Change From Baseline in HAM-D Individual Item Scores

The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 72 and Days 7, 14, 21 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Hour 60, Days 7 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response

The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved).

Posted

Number

percentage of participants

Hour 60, Days 7 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score

The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Hour 60, Days 7, 14, 21 and 30

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).

Secondary

Percentage of Participants With Treatment-Emergent Adverse Events

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent AE (TEAE) is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.

The Safety Set included all randomized participants who started the study drug infusion.

Posted

Number

percentage of participants

Up to approximately 37 days.

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
OG002	SAGE-547 90 μg/kg/h

Secondary

Time to Change in Antidepressant Medication

The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.

Posted

Median

Full Range

days

Up to approximately 37 days.

ID	Title	Description
OG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
OG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
OG002	SAGE-547 90 μg/kg/h	Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9681	LS mean difference	-0.01	Standard Error of the Mean	0.191	2-Sided	95	-0.39	0.37	Superiority
OG000 OG002	Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6337	LS mean difference	0.09	Standard Error of the Mean	0.185	2-Sided	95	-0.28	0.46	Superiority
OG000 OG001	Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4690	LS mean difference	-0.17	Standard Error of the Mean	0.238	2-Sided	95	-0.64	0.30	Superiority
OG000 OG002	Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9905	LS mean difference	0.00	Standard Error of the Mean	0.232	2-Sided	95	-0.46	0.46	Superiority
OG000 OG001	Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3984	LS mean difference	-0.20	Standard Error of the Mean	0.240	2-Sided	95	-0.68	0.27	Superiority
OG000 OG002	Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7042	LS mean difference	0.09	Standard Error of the Mean	0.234	2-Sided	95	-0.37	0.55	Superiority
OG000 OG001	Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4941	LS mean difference	-0.17	Standard Error of the Mean	0.247	2-Sided	95	-0.66	0.32	Superiority
OG000 OG002	Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4572	LS mean difference	0.18	Standard Error of the Mean	0.240	2-Sided	95	-0.30	0.65	Superiority
OG000 OG001	Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9866	LS mean difference	0.00	Standard Error of the Mean	0.236	2-Sided	95	-0.47	0.46	Superiority
OG000 OG002	Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7490	LS mean difference	-0.07	Standard Error of the Mean	0.229	2-Sided	95	-0.53	0.38	Superiority
OG000 OG001	Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0235	LS mean difference	-0.57	Standard Error of the Mean	0.247	2-Sided	95	-1.06	-0.08	Superiority
OG000 OG002	Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9286	LS mean difference	-0.02	Standard Error of the Mean	0.239	2-Sided	95	-0.50	0.45	Superiority
OG000 OG001	Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0544	LS mean difference	-0.49	Standard Error of the Mean	0.251	2-Sided	95	-0.99	0.01	Superiority
OG000 OG002	Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2903	LS mean difference	-0.26	Standard Error of the Mean	0.244	2-Sided	95	-0.74	0.22	Superiority
OG000 OG001	Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0044	LS mean difference	-0.71	Standard Error of the Mean	0.244	2-Sided	95	-1.19	-0.23	Superiority
OG000 OG002	Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1339	LS mean difference	-0.36	Standard Error of the Mean	0.238	2-Sided	95	-0.83	0.11	Superiority
OG000 OG001	Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0149	LS mean difference	-0.58	Standard Error of the Mean	0.234	2-Sided	95	-1.04	-0.11	Superiority
OG000 OG002	Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3213	LS mean difference	-0.23	Standard Error of the Mean	0.228	2-Sided	95	-0.68	0.22	Superiority
OG000 OG001	Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0703	LS mean difference	-0.45	Standard Error of the Mean	0.246	2-Sided	95	-0.94	0.04	Superiority
OG000 OG002	Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8152	LS mean difference	-0.06	Standard Error of the Mean	0.240	2-Sided	95	-0.53	0.42	Superiority
OG000 OG001	Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0805	LS mean difference	-0.53	Standard Error of the Mean	0.301	2-Sided	95	-1.13	0.07	Superiority
OG000 OG002	Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6964	LS mean difference	-0.11	Standard Error of the Mean	0.291	2-Sided	95	-0.69	0.46	Superiority
OG000 OG001	Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2998	LS mean difference	-0.32	Standard Error of the Mean	0.304	2-Sided	95	-0.92	0.29	Superiority
OG000 OG002	Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3448	LS mean difference	-0.28	Standard Error of the Mean	0.291	2-Sided	95	-0.85	0.30	Superiority
OG000 OG001	Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0089	LS mean difference	-0.66	Standard Error of the Mean	0.248	2-Sided	95	-1.15	-0.17	Superiority
OG000 OG002	Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0772	LS mean difference	-0.44	Standard Error of the Mean	0.244	2-Sided	95	-0.92	0.05	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6809	LS mean difference	-0.08	Standard Error of the Mean	0.191	2-Sided	95	-0.46	0.30	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7297	LS mean difference	0.06	Standard Error of the Mean	0.185	2-Sided	95	-0.30	0.43	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0626	LS mean difference	-0.43	Standard Error of the Mean	0.226	2-Sided	95	-0.87	0.02	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5196	LS mean difference	-0.14	Standard Error of the Mean	0.220	2-Sided	95	-0.58	0.29	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0772	LS mean difference	-0.42	Standard Error of the Mean	0.234	2-Sided	95	-0.88	0.05	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6610	LS mean difference	-0.10	Standard Error of the Mean	0.228	2-Sided	95	-0.55	0.35	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4007	LS mean difference	-0.20	Standard Error of the Mean	0.239	2-Sided	95	-0.67	0.27	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2292	LS mean difference	0.28	Standard Error of the Mean	0.232	2-Sided	95	-0.18	0.74	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0540	LS mean difference	-0.45	Standard Error of the Mean	0.234	2-Sided	95	-0.92	0.01	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9590	LS mean difference	0.01	Standard Error of the Mean	0.227	2-Sided	95	-0.44	0.46	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1048	LS mean difference	-0.36	Standard Error of the Mean	0.218	2-Sided	95	-0.79	0.08	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8979	LS mean difference	-0.03	Standard Error of the Mean	0.210	2-Sided	95	-0.44	0.39	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0819	LS mean difference	-0.38	Standard Error of the Mean	0.219	2-Sided	95	-0.82	0.05	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1099	LS mean difference	-0.34	Standard Error of the Mean	0.213	2-Sided	95	-0.77	0.08	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0373	LS mean difference	-0.45	Standard Error of the Mean	0.215	2-Sided	95	-0.88	-0.03	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0577	LS mean difference	-0.40	Standard Error of the Mean	0.209	2-Sided	95	-0.81	0.01	Superiority
OG000 OG001	Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2023	LS mean difference	-0.27	Standard Error of the Mean	0.210	2-Sided	95	-0.69	0.15	Superiority
OG000 OG002	Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4444	LS mean difference	-0.16	Standard Error of the Mean	0.204	2-Sided	95	-0.56	0.25	Superiority
OG000 OG001	Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3645	LS mean difference	-0.20	Standard Error of the Mean	0.220	2-Sided	95	-0.64	0.24	Superiority
OG000 OG002	Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4035	LS mean difference	-0.18	Standard Error of the Mean	0.214	2-Sided	95	-0.60	0.24	Superiority
OG000 OG001	Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4877	LS mean difference	-0.16	Standard Error of the Mean	0.232	2-Sided	95	-0.62	0.30	Superiority
OG000 OG002	Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3134	LS mean difference	-0.23	Standard Error of the Mean	0.226	2-Sided	95	-0.68	0.22	Superiority
OG000 OG001	Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0922	LS mean difference	-0.41	Standard Error of the Mean	0.240	2-Sided	95	-0.89	0.07	Superiority
OG000 OG002	Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0761	LS mean difference	-0.41	Standard Error of the Mean	0.230	2-Sided	95	-0.87	0.04	Superiority
OG000 OG001	Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3275	LS mean difference	-0.21	Standard Error of the Mean	0.217	2-Sided	95	-0.64	0.22	Superiority
OG000 OG002	Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3041	LS mean difference	-0.22	Standard Error of the Mean	0.213	2-Sided	95	-0.64	0.20	Superiority
OG000 OG001	Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0450	LS mean difference	-0.30	Standard Error of the Mean	0.146	2-Sided	95	-0.59	-0.01	Superiority
OG000 OG002	Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5351	LS mean difference	0.09	Standard Error of the Mean	0.143	2-Sided	95	-0.19	0.37	Superiority
OG000 OG001	Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0525	LS men difference	-0.28	Standard Error of the Mean	0.142	2-Sided	95	-0.56	0.00	Superiority
OG000 OG002	Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7932	LS mean difference	0.04	Standard Error of the Mean	0.139	2-Sided	95	-0.24	0.31	Superiority
OG000 OG001	Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1300	LS mean difference	-0.20	Standard Error of the Mean	0.128	2-Sided	95	-0.45	0.06	Superiority
OG000 OG002	Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1631	LS mean difference	0.17	Standard Error of the Mean	0.125	2-Sided	95	-0.07	0.42	Superiority
OG000 OG001	Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8215	LS mean difference	0.03	Standard Error of the Mean	0.129	2-Sided	95	-0.23	0.29	Superiority
OG000 OG002	Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0380	LS mean difference	0.26	Standard Error of the Mean	0.126	2-Sided	95	0.01	0.51	Superiority
OG000 OG001	Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5070	LS mean difference	-0.08	Standard Error of the Mean	0.124	2-Sided	95	-0.33	0.16	Superiority
OG000 OG002	Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1094	LS mean difference	0.19	Standard Error of the Mean	0.120	2-Sided	95	-0.04	0.43	Superiority
OG000 OG001	Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3112	LS mean difference	-0.10	Standard Error of the Mean	0.099	2-Sided	95	-0.30	0.10	Superiority
OG000 OG002	Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1345	LS mean difference	0.14	Standard Error of the Mean	0.096	2-Sided	95	-0.05	0.33	Superiority
OG000 OG001	Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5148	LS mean difference	-0.06	Standard Error of the Mean	0.091	2-Sided	95	-0.24	0.12	Superiority
OG000 OG002	Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3863	LS mean difference	-0.08	Standard Error of the Mean	0.088	2-Sided	95	-0.25	0.10	Superiority
OG000 OG001	Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0209	LS mean difference	-0.22	Standard Error of the Mean	0.094	2-Sided	95	-0.41	-0.03	Superiority
OG000 OG002	Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0616	LS men difference	-0.17	Standard Error of the Mean	0.092	2-Sided	95	-0.35	0.01	Superiority
OG000 OG001	Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1860	LS mean difference	-0.13	Standard Error of the Mean	0.099	2-Sided	95	-0.33	0.06	Superiority
OG000 OG002	Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7730	LS mean difference	-0.03	Standard Error of the Mean	0.095	2-Sided	95	-0.22	0.16	Superiority
OG000 OG001	Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1593	LS mean difference	-0.18	Standard Error of the Mean	0.129	2-Sided	95	-0.44	0.07	Superiority
OG000 OG002	Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6371	LS mean difference	-0.06	Standard Error of the Mean	0.126	2-Sided	95	-0.31	0.19	Superiority
OG000 OG001	Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5655	LS mean difference	-0.07	Standard Error of the Mean	0.124	2-Sided	95	-0.32	0.18	Superiority
OG000 OG002	Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3326	LS mean difference	0.12	Standard Error of the Mean	0.121	2-Sided	95	-0.12	0.36	Superiority
OG000 OG001	Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3577	LS mean difference	-0.19	Standard Error of the Mean	0.201	2-Sided	95	-0.59	0.22	Superiority
OG000 OG002	Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1646	LS mean difference	-0.27	Standard Error of the Mean	0.192	2-Sided	95	-0.66	0.11	Superiority
OG000 OG001	Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0545	LS mean difference	-0.23	Standard Error of the Mean	0.118	2-Sided	95	-0.46	0.00	Superiority
OG000 OG002	Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2903	LS mean difference	-0.12	Standard Error of the Mean	0.115	2-Sided	95	-0.35	0.11	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0395	LS mean difference	0.23	Standard Error of the Mean	0.112	2-Sided	95	0.01	0.45	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4690	LS mean difference	0.08	Standard Error of the Mean	0.108	2-Sided	95	-0.14	0.29	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6066	LS difference	0.07	Standard Error of the Mean	0.139	2-Sided	95	-0.20	0.35	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9737	LS mean difference	0.00	Standard Error of the Mean	0.136	2-Sided	95	-0.26	0.27	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4030	LS mean difference	0.12	Standard Error of the Mean	0.148	2-Sided	95	-0.17	0.42	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6357	LS mean difference	-0.07	Standard Error of the Mean	0.145	2-Sided	95	-0.36	0.22	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8605	LS mean difference	-0.02	Standard Error of the Mean	0.134	2-Sided	95	-0.29	0.24	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7534	LS mean difference	-0.04	Standard Error of the Mean	0.130	2-Sided	95	-0.30	0.22	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0021	LS mean difference	-0.63	Standard Error of the Mean	0.201	2-Sided	95	-1.03	-0.23	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0394	LS mean difference	-0.41	Standard Error of the Mean	0.196	2-Sided	95	-0.80	-0.02	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	Wilcoxon (Mann-Whitney)	0.0039	LS mean difference	-0.61	Standard Error of the Mean	0.208	2-Sided	95	-1.03	-0.20	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1591	LS mean difference	-0.29	Standard Error of the Mean	0.202	2-Sided	95	-0.69	0.11	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1402	LS mean difference	-0.31	Standard Error of the Mean	0.210	2-Sided	95	-0.73	0.10	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0143	LS mean difference	-0.51	Standard Error of the Mean	0.205	2-Sided	95	-0.91	-0.10	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2293	LS mean difference	-0.25	Standard Error of the Mean	0.204	2-Sided	95	-0.65	0.16	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0884	LS mean difference	-0.34	Standard Error of the Mean	0.200	2-Sided	95	-0.74	0.05	Superiority
OG000 OG001	Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0622	LS mean difference	-0.39	Standard Error of the Mean	0.207	2-Sided	95	-0.80	0.02	Superiority
OG000 OG002	Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0955	LS mean difference	-0.34	Standard Error of the Mean	0.202	2-Sided	95	-0.74	0.06	Superiority
OG000 OG001	Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0173	LS mean difference	-0.51	Standard Error of the Mean	0.210	2-Sided	95	-0.92	-0.09	Superiority
OG000 OG002	Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1687	LS mean difference	-0.29	Standard Error of the Mean	0.206	2-Sided	95	-0.69	0.12	Superiority
OG000 OG001	Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	Wilcoxon (Mann-Whitney)	0.3861	LS mean difference	-0.22	Standard Error of the Mean	0.258	2-Sided	95	-0.74	0.29	Superiority
OG000 OG002	Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7060	LS mean difference	-0.09	Standard Error of the Mean	0.249	2-Sided	95	-0.59	0.40	Superiority
OG000 OG001	Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0112	LS mean difference	-0.59	Standard Error of the Mean	0.230	2-Sided	95	-1.05	-0.14	Superiority
OG000 OG002	Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0570	LS mean difference	-0.42	Standard Error of the Mean	0.219	2-Sided	95	-0.86	0.01	Superiority
OG000 OG001	Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0018	LS mean difference	-0.67	Standard Error of the Mean	0.208	2-Sided	95	-1.08	-0.26	Superiority
OG000 OG002	Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0443	LS mean difference	-0.42	Standard Error of the Mean	0.205	2-Sided	95	-0.83	-0.01	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1197	LS mean difference	0.16	Standard Error of the Mean	0.104	2-Sided	95	-0.04	0.37	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7171	LS mean difference	-0.04	Standard Error of the Mean	0.101	2-Sided	95	-0.24	0.16	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7151	LS mean difference	-0.05	Standard Error of the Mean	0.138	2-Sided	95	-0.32	0.22	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5210	LS mean difference	-0.09	Standard Error of the Mean	0.134	2-Sided	95	-0.35	0.18	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7332	LS mean difference	0.05	Standard Error of the Mean	0.142	2-Sided	95	-0.23	0.33	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4163	LS mean difference	-0.11	Standard Error of the Mean	0.139	2-Sided	95	-0.39	0.16	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8625	LS mean difference	-0.02	Standard Error of the Mean	0.132	2-Sided	95	-0.28	0.24	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6196	LS mean difference	-0.06	Standard Error of the Mean	0.128	2-Sided	95	-0.32	0.19	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0373	LS mean difference	-0.41	Standard Error of the Mean	0.197	2-Sided	95	-0.80	-0.02	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0644	LS mean difference	-0.36	Standard Error of the Mean	0.191	2-Sided	95	-0.74	0.02	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1347	LS mean difference	-0.29	Standard Error of the Mean	0.191	2-Sided	95	-0.66	0.09	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1269	LS mean difference	-0.28	Standard Error of the Mean	0.185	2-Sided	95	-0.65	0.08	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1650	LS mean difference	-0.27	Standard Error of the Mean	0.192	2-Sided	95	-0.65	0.11	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1291	LS mean difference	-0.29	Standard Error of the Mean	0.188	2-Sided	95	-0.66	0.08	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0402	LS mean difference	-0.39	Standard Error of the Mean	0.189	2-Sided	95	-0.77	-0.02	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0342	LS mean difference	-0.40	Standard Error of the Mean	0.185	2-Sided	95	-0.76	-0.03	Superiority
OG000 OG001	Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1269	LS mean difference	-0.30	Standard Error of the Mean	0.193	2-Sided	95	-0.68	0.09	Superiority
OG000 OG002	Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3945	LS mean difference	-0.16	Standard Error of the Mean	0.188	2-Sided	95	-0.53	0.21	Superiority
OG000 OG001	Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5828	LS mean difference	-0.10	Standard Error of the Mean	0.185	2-Sided	95	-0.47	0.26	Superiority
OG000 OG002	Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6625	LS mean difference	0.08	Standard Error of the Mean	0.182	2-Sided	95	-0.28	0.44	Superiority
OG000 OG001	Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0041	LS mean difference	-0.64	Standard Error of the Mean	0.216	2-Sided	95	-1.07	-0.21	Superiority
OG000 OG002	Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2222	LS mean difference	-0.26	Standard Error of the Mean	0.210	2-Sided	95	-0.67	0.16	Superiority
OG000 OG001	Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0245	LS mean difference	-0.50	Standard Error of the Mean	0.218	2-Sided	95	-0.93	-0.07	Superiority
OG000 OG002	Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5119	LS mean difference	-0.14	Standard Error of the Mean	0.209	2-Sided	95	-0.55	0.28	Superiority
OG000 OG001	Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0299	LS mean difference	-0.43	Standard Error of the Mean	0.197	2-Sided	95	-0.82	-0.04	Superiority
OG000 OG002	Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2824	LS mean difference	-0.21	Standard Error of the Mean	0.195	2-Sided	95	-0.60	0.18	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1768	LS mean difference	0.18	Standard Error of the Mean	0.129	2-Sided	95	-0.08	0.43	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6498	LS mean difference	-0.06	Standard Error of the Mean	0.126	2-Sided	95	-0.31	0.19	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7689	LS mean difference	0.04	Standard Error of the Mean	0.150	2-Sided	95	-0.25	0.34	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2236	LS mean difference	-0.18	Standard Error of the Mean	0.146	2-Sided	95	-0.47	0.11	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6952	LS mean difference	-0.06	Standard Error of the Mean	0.148	2-Sided	95	-0.35	0.23	Superiority
OG000	Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1184	LS mean difference	-0.23	Standard Error of the Mean	0.144	2-Sided	95	-0.51	0.06	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3031	LS mean difference	0.15	Standard Error of the Mean	0.149	2-Sided	95	-0.14	0.45	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3091	LS mean difference	-0.15	Standard Error of the Mean	0.145	2-Sided	95	-0.44	0.14	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1525	LS mean difference	-0.26	Standard Error of the Mean	0.179	2-Sided	95	-0.61	0.10	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1214	LS mean difference	-0.27	Standard Error of the Mean	0.174	2-Sided	95	-0.62	0.07	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3811	LS mean difference	-0.16	Standard Error of the Mean	0.187	2-Sided	95	-0.53	0.21	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3851	LS mean difference	-0.16	Standard Error of the Mean	0.180	2-Sided	95	-0.51	0.20	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1373	LS mean difference	-0.27	Standard Error of the Mean	0.182	2-Sided	95	-0.63	0.09	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1360	LS mean difference	-0.27	Standard Error of the Mean	0.177	2-Sided	95	-0.62	0.09	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1264	LS mean difference	-0.27	Standard Error of the Mean	0.176	2-Sided	95	-0.62	0.08	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0567	LS mean difference	-0.33	Standard Error of the Mean	0.172	2-Sided	95	-0.67	0.01	Superiority
OG000 OG001	Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7447	LS mean difference	-0.06	Standard Error of the Mean	0.176	2-Sided	95	-0.41	0.29	Superiority
OG000 OG002	Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7727	LS mean difference	-0.05	Standard Error of the Mean	0.172	2-Sided	95	-0.39	0.29	Superiority
OG000 OG001	Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6590	LS mean difference	0.08	Standard Error of the Mean	0.183	2-Sided	95	-0.28	0.44	Superiority
OG000 OG002	Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3951	LS mean difference	-0.15	Standard Error of the Mean	0.180	2-Sided	95	-0.51	0.20	Superiority
OG000 OG001	Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4576	LS mean difference	-0.17	Standard Error of the Mean	0.230	2-Sided	95	-0.63	0.28	Superiority
OG000 OG002	Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7609	LS mean difference	-0.07	Standard Error of the Mean	0.223	2-Sided	95	-0.51	0.37	Superiority
OG000 OG001	Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6220	LS mean difference	-0.12	Standard Error of the Mean	0.234	2-Sided	95	-0.58	0.35	Superiority
OG000 OG002	Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9081	LS mean difference	0.03	Standard Error of the Mean	0.225	2-Sided	95	-0.42	0.47	Superiority
OG000 OG001	Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1668	LS mean difference	-0.27	Standard Error of the Mean	0.191	2-Sided	95	-0.65	0.11	Superiority
OG000 OG002	Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0935	LS mean difference	-0.32	Standard Error of the Mean	0.189	2-Sided	95	-0.69	0.05	Superiority
OG000 OG001	Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4038	LS mean difference	-0.13	Standard Error of the Mean	0.150	2-Sided	95	-0.42	0.17	Superiority
OG000 OG002	Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7559	LS mean difference	0.05	Standard Error of the Mean	0.145	2-Sided	95	-0.24	0.33	Superiority
OG000 OG001	Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2006	LS mean difference	-0.23	Standard Error of the Mean	0.181	2-Sided	95	-0.59	0.13	Superiority
OG000 OG002	Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6334	LS mean difference	0.08	Standard Error of the Mean	0.175	2-Sided	95	-0.26	0.43	Superiority
OG000 OG001	Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5431	LS mean difference	-0.14	Standard Error of the Mean	0.230	2-Sided	95	-0.60	0.32	Superiority
OG000 OG002	Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5278	LS mean difference	0.14	Standard Error of the Mean	0.225	2-Sided	95	-0.30	0.59	Superiority
OG000 OG001	Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4312	LS mean difference	-0.18	Standard Error of the Mean	0.232	2-Sided	95	-0.64	0.28	Superiority
OG000 OG002	Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3947	LS mean difference	0.19	Standard Error of the Mean	0.225	2-Sided	95	-0.25	0.64	Superiority
OG000 OG001	Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6081	LS mean difference	-0.13	Standard Error of the Mean	0.244	2-Sided	95	-0.61	0.36	Superiority
OG000 OG002	Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8949	LS mean difference	0.03	Standard Error of the Mean	0.238	2-Sided	95	-0.44	0.50	Superiority
OG000 OG001	Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1120	LS mean difference	-0.38	Standard Error of the Mean	0.236	2-Sided	95	-0.84	0.09	Superiority
OG000 OG002	Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1842	LS mean difference	0.30	Standard Error of the Mean	0.228	2-Sided	95	-0.15	0.76	Superiority
OG000 OG001	Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2646	LS mean difference	-0.29	Standard Error of the Mean	0.260	2-Sided	95	-0.81	0.22	Superiority
OG000 OG002	Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8101	LS mean difference	-0.06	Standard Error of the Mean	0.253	2-Sided	95	-0.56	0.44	Superiority
OG000 OG001	Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0215	LS mean difference	-0.58	Standard Error of the Mean	0.248	2-Sided	95	-1.07	-0.09	Superiority
OG000 OG002	Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3226	LS mean difference	-0.24	Standard Error of the Mean	0.242	2-Sided	95	-0.72	0.24	Superiority
OG000 OG001	Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0339	LS mean difference	-0.51	Standard Error of the Mean	0.238	2-Sided	95	-0.98	-0.04	Superiority
OG000 OG002	Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9824	LS mean difference	0.01	Standard Error of the Mean	0.232	2-Sided	95	-0.46	0.47	Superiority
OG000 OG001	Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0950	LS mean difference	-0.43	Standard Error of the Mean	0.254	2-Sided	95	-0.93	0.08	Superiority
OG000 OG002	Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4865	LS mean difference	-0.17	Standard Error of the Mean	0.249	2-Sided	95	-0.67	0.32	Superiority
OG000 OG001	Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9861	LS mean difference	0.01	Standard Error of the Mean	0.292	2-Sided	95	-0.57	0.58	Superiority
OG000 OG002	Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9266	LS mean difference	-0.03	Standard Error of the Mean	0.283	2-Sided	95	-0.59	0.54	Superiority
OG000 OG001	Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0360	LS mean difference	-0.61	Standard Error of the Mean	0.285	2-Sided	95	-1.17	-0.04	Superiority
OG000 OG002	Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0583	LS mean difference	-0.52	Standard Error of the Mean	0.273	2-Sided	95	-1.06	0.02	Superiority
OG000 OG001	Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0404	LS mean difference	-0.53	Standard Error of the Mean	0.254	2-Sided	95	-1.03	-0.02	Superiority
OG000 OG002	Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1352	LS mean difference	-0.37	Standard Error of the Mean	0.249	2-Sided	95	-0.87	0.12	Superiority
OG000 OG001	Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0056	LS mean difference	0.34	Standard Error of the Mean	0.121	2-Sided	95	0.10	0.58	Superiority
OG000 OG002	Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1537	LS mean difference	0.17	Standard Error of the Mean	0.118	2-Sided	95	-0.06	0.40	Superiority
OG000 OG001	Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0142	LS mean difference	0.32	Standard Error of the Mean	0.129	2-Sided	95	0.07	0.58	Superiority
OG000 OG002	Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0159	LS mean difference	0.31	Standard Error of the Mean	0.126	2-Sided	95	0.06	0.56	Superiority
OG000 OG001	Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2255	LS mean difference	0.16	Standard Error of the Mean	0.132	2-Sided	95	-0.10	0.42	Superiority
OG000 OG002	Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1069	LS mean difference	0.21	Standard Error of the Mean	0.129	2-Sided	95	-0.05	0.46	Superiority
OG000 OG001	Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4932	LS mean difference	0.10	Standard Error of the Mean	0.144	2-Sided	95	-0.19	0.39	Superiority
OG000 OG002	Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2634	LS mean difference	0.16	Standard Error of the Mean	0.140	2-Sided	95	-0.12	0.43	Superiority
OG000 OG001	Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9284	LS mean difference	0.01	Standard Error of the Mean	0.133	2-Sided	95	-0.25	0.28	Superiority
OG000 OG002	Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9459	LS mean difference	0.01	Standard Error of the Mean	0.129	2-Sided	95	-0.25	0.26	Superiority
OG000 OG001	Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2908	LS mean difference	-0.16	Standard Error of the Mean	0.151	2-Sided	95	-0.46	0.14	Superiority
OG000 OG002	Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6834	LS mean difference	0.06	Standard Error of the Mean	0.146	2-Sided	95	-0.23	0.35	Superiority
OG000 OG001	Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3579	LS mean difference	-0.13	Standard Error of the Mean	0.142	2-Sided	95	-0.41	0.15	Superiority
OG000 OG002	Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8270	LS mean difference	-0.03	Standard Error of the Mean	0.138	2-Sided	95	-0.30	0.24	Superiority
OG000 OG001	Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5292	LS mean difference	-0.08	Standard Error of the Mean	0.130	2-Sided	95	-0.34	0.18	Superiority
OG000 OG002	Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8790	LS mean difference	0.02	Standard Error of the Mean	0.127	2-Sided	95	-0.23	0.27	Superiority
OG000 OG001	Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1347	LS mean difference	-0.20	Standard Error of the Mean	0.133	2-Sided	95	-0.46	0.06	Superiority
OG000 OG002	Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2874	LS mean difference	-0.14	Standard Error of the Mean	0.129	2-Sided	95	-0.40	0.12	Superiority
OG000 OG001	Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0086	LS mean difference	-0.35	Standard Error of the Mean	0.132	2-Sided	95	-0.61	-0.09	Superiority
OG000 OG002	Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7864	LS mean difference	-0.03	Standard Error of the Mean	0.129	2-Sided	95	-0.29	0.22	Superiority
OG000 OG001	Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4383	LS mean difference	-0.13	Standard Error of the Mean	0.172	2-Sided	95	-0.48	0.21	Superiority
OG000 OG002	Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8767	LS mean difference	-0.03	Standard Error of the Mean	0.167	2-Sided	95	-0.36	0.31	Superiority
OG000 OG001	Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0341	LS mean difference	-0.33	Standard Error of the Mean	0.153	2-Sided	95	-0.63	-0.03	Superiority
OG000 OG002	Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5629	LS mean difference	-0.09	Standard Error of the Mean	0.147	2-Sided	95	-0.38	0.21	Superiority
OG000 OG001	Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0016	LS mean difference	-0.42	Standard Error of the Mean	0.129	2-Sided	95	-0.67	-0.16	Superiority
OG000 OG002	Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0495	LS mean difference	-0.25	Standard Error of the Mean	0.126	2-Sided	95	-0.50	0.00	Superiority
OG000 OG001	Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7177	LS mean difference	-0.06	Standard Error of the Mean	0.155	2-Sided	95	-0.36	0.25	Superiority
OG000 OG002	Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9401	LS mean difference	0.01	Standard Error of the Mean	0.151	2-Sided	95	-0.29	0.31	Superiority
OG000 OG001	Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3201	LS mean difference	-0.15	Standard Error of the Mean	0.147	2-Sided	95	-0.44	0.15	Superiority
OG000 OG002	Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8286	LS mean difference	0.03	Standard Error of the Mean	0.144	2-Sided	95	-0.25	0.32	Superiority
OG000 OG001	Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3022	LS mean difference	-0.17	Standard Error of the Mean	0.162	2-Sided	95	-0.49	0.15	Superiority
OG000 OG002	Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8022	LS mean difference	-0.04	Standard Error of the Mean	0.158	2-Sided	95	-0.35	0.27	Superiority
OG000 OG001	Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5665	LS mean difference	-0.10	Standard Error of the Mean	0.165	2-Sided	95	-0.42	0.23	Superiority
OG000 OG002	Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8170	LS mean difference	-0.04	Standard Error of the Mean	0.161	2-Sided	95	-0.36	0.28	Superiority
OG000 OG001	Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0404	LS mean difference	-0.32	Standard Error of the Mean	0.155	2-Sided	95	-0.63	-0.01	Superiority
OG000 OG002	Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3128	LS mean difference	-0.15	Standard Error of the Mean	0.151	2-Sided	95	-0.45	0.15	Superiority
OG000 OG001	Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2400	LS mean difference	-0.19	Standard Error of the Mean	0.162	2-Sided	95	-0.51	0.13	Superiority
OG000 OG002	Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4840	LS mean difference	-0.11	Standard Error of the Mean	0.157	2-Sided	95	-0.42	0.20	Superiority
OG000 OG001	Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7768	LS mean difference	-0.04	Standard Error of the Mean	0.141	2-Sided	95	-0.32	0.24	Superiority
OG000 OG002	Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7713	LS mean difference	-0.04	Standard Error of the Mean	0.137	2-Sided	95	-0.31	0.23	Superiority
OG000 OG001	Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0716	LS mean difference	-0.28	Standard Error of the Mean	0.151	2-Sided	95	-0.58	0.02	Superiority
OG000 OG002	Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4317	LS mean difference	-0.12	Standard Error of the Mean	0.148	2-Sided	95	-0.41	0.18	Superiority
OG000 OG001	Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2115	LS mean difference	-0.20	Standard Error of the Mean	0.162	2-Sided	95	-0.52	0.12	Superiority
OG000 OG002	Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2818	LS mean difference	-0.17	Standard Error of the Mean	0.158	2-Sided	95	-0.48	0.14	Superiority
OG000 OG001	Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2018	LS mean difference	-0.18	Standard Error of the Mean	0.140	2-Sided	95	-0.46	0.10	Superiority
OG000 OG002	Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6554	LS mean difference	-0.06	Standard Error of the Mean	0.137	2-Sided	95	-0.33	0.21	Superiority
OG000 OG001	Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4754	LS mean difference	0.12	Standard Error of the Mean	0.168	2-Sided	95	-0.21	0.46	Superiority
OG000 OG002	Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7776	LS mean difference	0.05	Standard Error of the Mean	0.163	2-Sided	95	-0.28	0.37	Superiority
OG000 OG001	Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7172	LS mean difference	-0.08	Standard Error of the Mean	0.213	2-Sided	95	-0.50	0.35	Superiority
OG000 OG002	Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4791	LS mean difference	-0.14	Standard Error of the Mean	0.203	2-Sided	95	-0.55	0.26	Superiority
OG000 OG001	Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3562	LS mean difference	-0.15	Standard Error of the Mean	0.164	2-Sided	95	-0.48	0.17	Superiority
OG000 OG002	Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8859	LS mean difference	0.02	Standard Error of the Mean	0.162	2-Sided	95	-0.30	0.34	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5888	LS mean difference	-0.10	Standard Error of the Mean	0.192	2-Sided	95	-0.49	0.28	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3992	LS mean difference	-0.16	Standard Error of the Mean	0.187	2-Sided	95	-0.53	0.21	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1212	LS mean difference	-0.35	Standard Error of the Mean	0.227	2-Sided	95	-0.80	0.10	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3185	LS mean difference	-0.22	Standard Error of the Mean	0.221	2-Sided	95	-0.66	0.22	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4809	LS mean difference	-0.16	Standard Error of the Mean	0.231	2-Sided	95	-0.62	0.29	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8953	LS mean difference	0.03	Standard Error of the Mean	0.225	2-Sided	95	-0.42	0.48	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5616	LS mean difference	-0.13	Standard Error of the Mean	0.223	2-Sided	95	-0.57	0.31	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8571	LS mean difference	0.04	Standard Error of the Mean	0.216	2-Sided	95	-0.39	0.47	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0037	LS mean difference	-0.63	Standard Error of the Mean	0.213	2-Sided	95	-1.05	-0.21	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0386	LS mean difference	-0.43	Standard Error of the Mean	0.206	2-Sided	95	-0.84	-0.02	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0044	LS mean difference	-0.63	Standard Error of the Mean	0.216	2-Sided	95	-1.05	-0.20	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8308	LS mean difference	-0.04	Standard Error of the Mean	0.208	2-Sided	95	-0.46	0.37	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0388	LS mean difference	-0.45	Standard Error of the Mean	0.215	2-Sided	95	-0.87	-0.02	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1622	LS mean difference	-0.29	Standard Error of the Mean	0.209	2-Sided	95	-0.71	0.12	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0179	LS mean difference	-0.49	Standard Error of the Mean	0.204	2-Sided	95	-0.89	-0.09	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4283	LS mean difference	-0.16	Standard Error of the Mean	0.198	2-Sided	95	-0.55	0.24	Superiority
OG000 OG001	Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1899	LS mean difference	-0.29	Standard Error of the Mean	0.219	2-Sided	95	-0.72	0.15	Superiority
OG000 OG002	Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8022	LS mean difference	-0.05	Standard Error of the Mean	0.213	2-Sided	95	-0.48	0.37	Superiority
OG000 OG001	Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3780	LS mean difference	-0.19	Standard Error of the Mean	0.215	2-Sided	95	-0.62	0.24	Superiority
OG000 OG002	Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8110	LS mean difference	-0.05	Standard Error of the Mean	0.210	2-Sided	95	-0.47	0.36	Superiority
OG000 OG001	Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8908	LS mean difference	-0.04	Standard Error of the Mean	0.272	2-Sided	95	-0.58	0.50	Superiority
OG000 OG002	Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3596	LS mean difference	0.24	Standard Error of the Mean	0.263	2-Sided	95	-0.28	0.76	Superiority
OG000 OG001	Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7617	LS mean difference	-0.09	Standard Error of the Mean	0.293	2-Sided	95	-0.67	0.49	Superiority
OG000 OG002	Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5498	LS mean difference	-0.17	Standard Error of the Mean	0.281	2-Sided	95	-0.73	0.39	Superiority
OG000 OG001	Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2066	LS mean difference	-0.30	Standard Error of the Mean	0.235	2-Sided	95	-0.76	0.17	Superiority
OG000 OG002	Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2321	LS mean difference	-0.28	Standard Error of the Mean	0.230	2-Sided	95	-0.73	0.18	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5582	LS mean difference	-0.11	Standard Error of the Mean	0.191	2-Sided	95	-0.49	0.27	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2945	LS mean difference	-0.20	Standard Error of the Mean	0.186	2-Sided	95	-0.56	0.17	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2684	LS mean difference	-0.23	Standard Error of the Mean	0.208	2-Sided	95	-0.64	0.18	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9396	LS mean difference	-0.02	Standard Error of the Mean	0.202	2-Sided	95	-0.42	0.39	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0283	LS mean difference	-0.43	Standard Error of the Mean	0.195	2-Sided	95	-0.82	-0.05	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1794	LS mean difference	-0.26	Standard Error of the Mean	0.189	2-Sided	95	-0.63	0.12	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1091	LS mean difference	-0.30	Standard Error of the Mean	0.188	2-Sided	95	-0.68	0.07	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7921	LS mean difference	-0.05	Standard Error of the Mean	0.182	2-Sided	95	-0.41	0.31	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0055	LS mean difference	-0.47	Standard Error of the Mean	0.166	2-Sided	95	-0.80	-0.14	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0300	LS mean difference	-0.35	Standard Error of the Mean	0.161	2-Sided	95	-0.67	-0.03	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0118	LS mean difference	-0.47	Standard Error of the Mean	0.185	2-Sided	95	-0.84	-0.11	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2266	LS mean difference	-0.22	Standard Error of the Mean	0.178	2-Sided	95	-0.57	0.14	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0025	LS mean difference	-0.56	Standard Error of the Mean	0.181	2-Sided	95	-0.92	-0.20	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0555	LS mean difference	-0.34	Standard Error of the Mean	0.176	2-Sided	95	-0.69	0.01	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0013	LS mean difference	-0.58	Standard Error of the Mean	0.176	2-Sided	95	-0.93	-0.23	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0775	LS mean difference	-0.31	Standard Error of the Mean	0.171	2-Sided	95	-0.64	0.03	Superiority
OG000 OG001	Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0006	LS mean difference	-0.67	Standard Error of the Mean	0.190	2-Sided	95	-1.05	-0.30	Superiority
OG000 OG002	Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0415	LS mean difference	-0.38	Standard Error of the Mean	0.185	2-Sided	95	-0.75	-0.01	Superiority
OG000 OG001	Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0581	LS mean difference	-0.37	Standard Error of the Mean	0.193	2-Sided	95	-0.75	0.01	Superiority
OG000 OG002	Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6826	LS mean difference	-0.08	Standard Error of the Mean	0.188	2-Sided	95	-0.45	0.30	Superiority
OG000 OG001	Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0912	LS mean difference	-0.38	Standard Error of the Mean	0.226	2-Sided	95	-0.83	0.06	Superiority
OG000 OG002	Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3988	LS mean difference	-0.19	Standard Error of the Mean	0.218	2-Sided	95	-0.62	0.25	Superiority
OG000 OG001	Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0504	LS mean difference	-0.46	Standard Error of the Mean	0.231	2-Sided	95	-0.91	0.00	Superiority
OG000 OG002	Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6019	LS mean difference	-0.12	Standard Error of the Mean	0.220	2-Sided	95	-0.55	0.32	Superiority
OG000 OG001	Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0070	LS mean difference	-0.61	Standard Error of the Mean	0.222	2-Sided	95	-1.05	-0.17	Superiority
OG000 OG002	Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3785	LS mean difference	-0.19	Standard Error of the Mean	0.218	2-Sided	95	-0.62	0.24	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9609	LS mean difference	-0.01	Standard Error of the Mean	0.159	2-Sided	95	-0.32	0.31	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9183	LS mean difference	-0.02	Standard Error of the Mean	0.154	2-Sided	95	-0.32	0.29	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0710	LS mean difference	-0.27	Standard Error of the Mean	0.149	2-Sided	95	-0.57	0.02	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2607	LS mean difference	-0.16	Standard Error of the Mean	0.143	2-Sided	95	-0.45	0.12	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2466	LS mean difference	-0.18	Standard Error of the Mean	0.158	2-Sided	95	-0.50	0.13	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3461	LS mean difference	-0.14	Standard Error of the Mean	0.153	2-Sided	95	-0.45	0.16	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0919	LS mean difference	-0.28	Standard Error of the Mean	0.162	2-Sided	95	-0.60	0.05	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7554	LS mean difference	-0.05	Standard Error of the Mean	0.157	2-Sided	95	-0.36	0.26	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0150	LS mean difference	-0.41	Standard Error of the Mean	0.166	2-Sided	95	-0.74	-0.08	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0482	LS mean difference	-0.32	Standard Error of the Mean	0.160	2-Sided	95	-0.64	0.00	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0003	LS mean difference	-0.61	Standard Error of the Mean	0.163	2-Sided	95	-0.93	-0.28	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1182	LS mean difference	-0.25	Standard Error of the Mean	0.156	2-Sided	95	-0.56	0.06	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0008	LS mean difference	-0.55	Standard Error of the Mean	0.159	2-Sided	95	-0.87	-0.24	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1379	LS mean difference	-0.23	Standard Error of the Mean	0.154	2-Sided	95	-0.54	0.08	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0040	LS mean difference	-0.43	Standard Error of the Mean	0.145	2-Sided	95	-0.71	-0.14	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3100	LS mean difference	-0.14	Standard Error of the Mean	0.140	2-Sided	95	-0.42	0.14	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0003	LS mean difference	-0.56	Standard Error of the Mean	0.148	2-Sided	95	-0.85	-0.26	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0223	LS mean difference	-0.33	Standard Error of the Mean	0.143	2-Sided	95	-0.61	-0.05	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0276	LS mean difference	-0.37	Standard Error of the Mean	0.166	2-Sided	95	-0.70	-0.04	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8516	LS mean difference	-0.03	Standard Error of the Mean	0.161	2-Sided	95	-0.35	0.29	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1669	LS mean difference	-0.26	Standard Error of the Mean	0.186	2-Sided	95	-0.63	0.11	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4935	LS mean difference	-0.12	Standard Error of the Mean	0.180	2-Sided	95	-0.48	0.23	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0202	LS mean difference	-0.47	Standard Error of the Mean	0.197	2-Sided	95	-0.86	-0.07	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2683	LS mean difference	-0.21	Standard Error of the Mean	0.188	2-Sided	95	-0.58	0.16	Superiority
OG000 OG001	Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0531	LS mean difference	-0.32	Standard Error of the Mean	0.165	2-Sided	95	-0.65	0.00	Superiority
OG000 OG002	Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5609	LS mean difference	-0.09	Standard Error of the Mean	0.160	2-Sided	95	-0.41	0.22	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6779	LS mean difference	-0.05	Standard Error of the Mean	0.123	2-Sided	95	-0.30	0.19	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4559	LS mean difference	0.09	Standard Error of the Mean	0.119	2-Sided	95	-0.15	0.32	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2254	LS mean difference	-0.16	Standard Error of the Mean	0.133	2-Sided	95	-0.43	0.10	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6437	LS mean difference	-0.06	Standard Error of the Mean	0.129	2-Sided	95	-0.32	0.20	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6678	LS mean difference	-0.06	Standard Error of the Mean	0.133	2-Sided	95	-0.32	0.21	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9321	LS mean difference	-0.01	Standard Error of the Mean	0.129	2-Sided	95	-0.27	0.24	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9778	LS mean difference	0.00	Standard Error of the Mean	0.157	2-Sided	95	-0.31	0.32	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9307	LS mean difference	0.01	Standard Error of the Mean	0.152	2-Sided	95	-0.29	0.31	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6791	LS mean difference	-0.07	Standard Error of the Mean	0.172	2-Sided	95	-0.41	0.27	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7769	LS mean difference	0.05	Standard Error of the Mean	0.167	2-Sided	95	-0.28	0.38	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7206	LS mean difference	-0.06	Standard Error of the Mean	0.163	2-Sided	95	-0.38	0.26	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3549	LS mean difference	-0.15	Standard Error of the Mean	0.156	2-Sided	95	-0.45	0.16	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0231	LS mean difference	-0.38	Standard Error of the Mean	0.164	2-Sided	95	-0.70	-0.05	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1450	LS mean difference	-0.23	Standard Error of the Mean	0.159	2-Sided	95	-0.55	0.08	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0855	LS mean difference	-0.28	Standard Error of the Mean	0.162	2-Sided	95	-0.60	0.04	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3068	LS mean difference	-0.16	Standard Error of the Mean	0.157	2-Sided	95	-0.47	0.15	Superiority
OG000 OG001	Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0069	LS mean difference	-0.45	Standard Error of the Mean	0.164	2-Sided	95	-0.77	-0.13	Superiority
OG000 OG002	Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2174	LS mean difference	-0.20	Standard Error of the Mean	0.159	2-Sided	95	-0.51	0.12	Superiority
OG000 OG001	Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1020	LS mean difference	-0.29	Standard Error of the Mean	0.174	2-Sided	95	-0.63	0.06	Superiority
OG000 OG002	Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9587	LS mean difference	0.01	Standard Error of the Mean	0.170	2-Sided	95	-0.33	0.35	Superiority
OG000 OG001	Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1690	LS mean difference	-0.28	Standard Error of the Mean	0.203	2-Sided	95	-0.69	0.12	Superiority
OG000 OG002	Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7919	LS mean difference	0.05	Standard Error of the Mean	0.197	2-Sided	95	-0.34	0.44	Superiority
OG000 OG001	Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0192	LS mean difference	-0.49	Standard Error of the Mean	0.205	2-Sided	95	-0.89	-0.08	Superiority
OG000 OG002	Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3887	LS mean difference	-0.17	Standard Error of the Mean	0.196	2-Sided	95	-0.56	0.22	Superiority
OG000 OG001	Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0719	LS mean difference	-0.34	Standard Error of the Mean	0.189	2-Sided	95	-0.72	0.03	Superiority
OG000 OG002	Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1195	LS mean difference	-0.29	Standard Error of the Mean	0.185	2-Sided	95	-0.66	0.08	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9552	LS mean difference	0.00	Standard Error of the Mean	0.079	2-Sided	95	-0.16	0.15	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0384	LS mean difference	-0.16	Standard Error of the Mean	0.076	2-Sided	95	-0.31	-0.01	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2582	LS mean difference	-0.11	Standard Error of the Mean	0.097	2-Sided	95	-0.30	0.08	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1511	LS mean difference	-0.14	Standard Error of the Mean	0.094	2-Sided	95	-0.32	0.05	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4631	LS mean difference	-0.09	Standard Error of the Mean	0.126	2-Sided	95	-0.34	0.16	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4628	LS mean difference	-0.09	Standard Error of the Mean	0.123	2-Sided	95	-0.33	0.15	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9005	LS mean difference	-0.01	Standard Error of the Mean	0.110	2-Sided	95	-0.23	0.20	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1121	LS mean difference	-0.17	Standard Error of the Mean	0.107	2-Sided	95	-0.38	0.04	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4167	LS mean difference	-0.12	Standard Error of the Mean	0.145	2-Sided	95	-0.40	0.17	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4071	LS mean difference	-0.12	Standard Error of the Mean	0.141	2-Sided	95	-0.40	0.16	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1278	LS mean difference	-0.23	Standard Error of the Mean	0.150	2-Sided	95	-0.53	0.07	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0573	LS mean difference	-0.28	Standard Error of the Mean	0.145	2-Sided	95	-0.57	0.01	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4842	LS mean difference	-0.11	Standard Error of the Mean	0.156	2-Sided	95	-0.42	0.20	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0692	LS mean difference	-0.28	Standard Error of the Mean	0.152	2-Sided	95	-0.58	0.02	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4028	LS mean difference	-0.13	Standard Error of the Mean	0.157	2-Sided	95	-0.44	0.18	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0354	LS mean difference	-0.33	Standard Error of the Mean	0.154	2-Sided	95	-0.63	-0.02	Superiority
OG000 OG001	Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1228	LS mean difference	-0.24	Standard Error of the Mean	0.156	2-Sided	95	-0.55	0.07	Superiority
OG000 OG002	Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0099	LS mean difference	-0.40	Standard Error of the Mean	0.152	2-Sided	95	-0.70	-0.10	Superiority
OG000 OG001	Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2174	LS mean difference	-0.20	Standard Error of the Mean	0.164	2-Sided	95	-0.53	0.12	Superiority
OG000 OG002	Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0820	LS mean difference	-0.28	Standard Error of the Mean	0.161	2-Sided	95	-0.60	0.04	Superiority
OG000 OG001	Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2642	LS mean difference	-0.22	Standard Error of the Mean	0.194	2-Sided	95	-0.60	0.17	Superiority
OG000 OG002	Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0718	LS mean difference	-0.34	Standard Error of the Mean	0.189	2-Sided	95	-0.72	0.03	Superiority
OG000 OG001	Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3055	LS mean difference	-0.22	Standard Error of the Mean	0.212	2-Sided	95	-0.64	0.20	Superiority
OG000 OG002	Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3533	LS mean difference	-0.19	Standard Error of the Mean	0.202	2-Sided	95	-0.59	0.21	Superiority
OG000 OG001	Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4514	LS mean difference	-0.15	Standard Error of the Mean	0.193	2-Sided	95	-0.53	0.24	Superiority
OG000 OG002	Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4907	LS mean difference	-0.13	Standard Error of the Mean	0.191	2-Sided	95	-0.51	0.25	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6949	LS mean difference	-0.06	Standard Error of the Mean	0.151	2-Sided	95	-0.36	0.24	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4670	LS mean difference	-0.11	Standard Error of the Mean	0.147	2-Sided	95	-0.40	0.18	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6556	LS mean difference	-0.07	Standard Error of the Mean	0.160	2-Sided	95	-0.39	0.25	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9272	LS mean difference	-0.01	Standard Error of the Mean	0.156	2-Sided	95	-0.32	0.29	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1395	LS mean difference	-0.24	Standard Error of the Mean	0.164	2-Sided	95	-0.57	0.08	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2601	LS mean difference	-0.18	Standard Error of the Mean	0.159	2-Sided	95	-0.50	0.14	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5626	LS mean difference	-0.09	Standard Error of the Mean	0.158	2-Sided	95	-0.40	0.22	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4622	LS mean difference	-0.11	Standard Error of the Mean	0.153	2-Sided	95	-0.42	0.19	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2858	LS mean difference	-0.16	Standard Error of the Mean	0.151	2-Sided	95	-0.46	0.14	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5369	LS mean difference	-0.09	Standard Error of the Mean	0.146	2-Sided	95	-0.38	0.20	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1510	LS mean difference	-0.22	Standard Error of the Mean	0.150	2-Sided	95	-0.52	0.08	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5107	LS mean difference	-0.10	Standard Error of the Mean	0.146	2-Sided	95	-0.38	0.19	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3301	LS mean difference	-0.15	Standard Error of the Mean	0.151	2-Sided	95	-0.45	0.15	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5139	LS mean difference	-0.10	Standard Error of the Mean	0.147	2-Sided	95	-0.39	0.19	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4073	LS mean difference	-0.12	Standard Error of the Mean	0.144	2-Sided	95	-0.40	0.17	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4649	LS mean difference	-0.10	Standard Error of the Mean	0.140	2-Sided	95	-0.38	0.17	Superiority
OG000 OG001	Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6926	LS mean difference	-0.06	Standard Error of the Mean	0.141	2-Sided	95	-0.34	0.22	Superiority
OG000 OG002	Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7260	LS mean difference	0.05	Standard Error of the Mean	0.137	2-Sided	95	-0.22	0.32	Superiority
OG000 OG001	Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1486	LS mean difference	-0.20	Standard Error of the Mean	0.136	2-Sided	95	-0.47	0.07	Superiority
OG000 OG002	Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4800	LS mean difference	-0.09	Standard Error of the Mean	0.133	2-Sided	95	-0.36	0.17	Superiority
OG000 OG001	Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7792	LS mean difference	-0.05	Standard Error of the Mean	0.177	2-Sided	95	-0.40	0.30	Superiority
OG000 OG002	Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8644	LS mean difference	0.03	Standard Error of the Mean	0.171	2-Sided	95	-0.31	0.37	Superiority
OG000 OG001	Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7994	LS mean difference	0.04	Standard Error of the Mean	0.158	2-Sided	95	-0.27	0.35	Superiority
OG000 OG002	Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0811	LS mean difference	0.27	Standard Error of the Mean	0.152	2-Sided	95	-0.03	0.57	Superiority
OG000 OG001	Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6978	LS mean difference	-0.06	Standard Error of the Mean	0.144	2-Sided	95	-0.34	0.23	Superiority
OG000 OG002	Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9749	LS mean difference	0.00	Standard Error of the Mean	0.141	2-Sided	95	-0.28	0.28	Superiority
OG000 OG001	Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3158	LS mean difference	0.08	Standard Error of the Mean	0.081	2-Sided	95	-0.08	0.24	Superiority
OG000 OG002	Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1901	LS mean difference	0.10	Standard Error of the Mean	0.079	2-Sided	95	-0.05	0.26	Superiority
OG000 OG001	Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7229	LS mean difference	0.03	Standard Error of the Mean	0.073	2-Sided	95	-0.12	0.17	Superiority
OG000 OG002	Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2715	LS mean difference	0.08	Standard Error of the Mean	0.071	2-Sided	95	-0.06	0.22	Superiority
OG000 OG001	Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5421	LS mean difference	0.05	Standard Error of the Mean	0.086	2-Sided	95	-0.12	0.22	Superiority
OG000 OG002	Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7215	LS mean difference	0.03	Standard Error of the Mean	0.083	2-Sided	95	-0.14	0.19	Superiority
OG000 OG001	Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2246	LS mean difference	0.12	Standard Error of the Mean	0.098	2-Sided	95	-0.07	0.31	Superiority
OG000 OG002	Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9671	LS mean difference	0.00	Standard Error of the Mean	0.096	2-Sided	95	-0.19	0.19	Superiority
OG000 OG001	Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6527	LS mean difference	-0.05	Standard Error of the Mean	0.121	2-Sided	95	-0.29	0.19	Superiority
OG000 OG002	Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1647	LS mean difference	-0.17	Standard Error of the Mean	0.118	2-Sided	95	-0.40	0.07	Superiority
OG000 OG001	Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7093	LS mean difference	0.04	Standard Error of the Mean	0.110	2-Sided	95	-0.18	0.26	Superiority
OG000 OG002	Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6333	LS mean difference	-0.05	Standard Error of the Mean	0.107	2-Sided	95	-0.26	0.16	Superiority
OG000 OG001	Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5238	LS mean difference	-0.08	Standard Error of the Mean	0.120	2-Sided	95	-0.31	0.16	Superiority
OG000 OG002	Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0782	LS mean difference	-0.21	Standard Error of the Mean	0.117	2-Sided	95	-0.44	0.02	Superiority
OG000 OG001	Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2346	LS mean difference	-0.16	Standard Error of the Mean	0.138	2-Sided	95	-0.44	0.11	Superiority
OG000 OG002	Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0631	LS mean difference	-0.25	Standard Error of the Mean	0.134	2-Sided	95	-0.52	0.01	Superiority
OG000 OG001	Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6274	LS mean difference	-0.06	Standard Error of the Mean	0.131	2-Sided	95	-0.32	0.20	Superiority
OG000 OG002	Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3589	LS mean difference	-0.12	Standard Error of the Mean	0.128	2-Sided	95	-0.37	0.14	Superiority
OG000 OG001	Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7604	LS mean difference	-0.06	Standard Error of the Mean	0.187	2-Sided	95	-0.43	0.31	Superiority
OG000 OG002	Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1106	LS mean difference	-0.30	Standard Error of the Mean	0.185	2-Sided	95	-0.66	0.07	Superiority
OG000 OG001	Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9776	LS mean difference	0.01	Standard Error of the Mean	0.222	2-Sided	95	-0.43	0.45	Superiority
OG000 OG002	Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3239	LS mean difference	-0.21	Standard Error of the Mean	0.217	2-Sided	95	-0.65	0.22	Superiority
OG000 OG001	Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6736	LS mean difference	-0.10	Standard Error of the Mean	0.238	2-Sided	95	-0.57	0.37	Superiority
OG000 OG002	Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6136	LS mean difference	-0.12	Standard Error of the Mean	0.231	2-Sided	95	-0.58	0.34	Superiority
OG000 OG001	Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1141	LS mean difference	-0.31	Standard Error of the Mean	0.195	2-Sided	95	-0.70	0.08	Superiority
OG000 OG002	Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2185	LS mean difference	-0.24	Standard Error of the Mean	0.194	2-Sided	95	-0.62	0.14	Superiority
OG000 OG001	Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6191	LS mean difference	0.03	Standard Error of the Mean	0.054	2-Sided	95	-0.08	0.13	Superiority
OG000 OG002	Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6169	LS mean difference	0.03	Standard Error of the Mean	0.053	2-Sided	95	-0.08	0.13	Superiority
OG000 OG001	Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9911	LS mean difference	0.00	Standard Error of the Mean	0.054	2-Sided	95	-0.11	0.11	Superiority
OG000 OG002	Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3360	LS mean difference	0.05	Standard Error of the Mean	0.053	2-Sided	95	-0.05	0.15	Superiority
OG000 OG001	Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9638	LS mean difference	0.00	Standard Error of the Mean	0.054	2-Sided	95	-0.11	0.10	Superiority
OG000 OG002	Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1610	LS mean difference	0.07	Standard Error of the Mean	0.053	2-Sided	95	-0.03	0.18	Superiority
OG000 OG001	Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5763	LS mean difference	-0.03	Standard Error of the Mean	0.054	2-Sided	95	-0.14	0.08	Superiority
OG000 OG002	Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.0599	LS mean difference	0.10	Standard Error of the Mean	0.053	2-Sided	95	0.00	0.20	Superiority
OG000 OG001	Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3916	LS mean difference	-0.05	Standard Error of the Mean	0.054	2-Sided	95	-0.15	0.06	Superiority
OG000 OG002	Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9602	LS mean difference	0.00	Standard Error of the Mean	0.053	2-Sided	95	-0.10	0.11	Superiority
OG000 OG001	Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9676	LS mean difference	0.00	Standard Error of the Mean	0.055	2-Sided	95	-0.11	0.11	Superiority
OG000 OG002	Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6397	LS mean difference	0.02	Standard Error of the Mean	0.053	2-Sided	95	-0.08	0.13	Superiority
OG000 OG001	Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3400	LS mean difference	0.05	Standard Error of the Mean	0.054	2-Sided	95	-0.05	0.16	Superiority
OG000 OG002	Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3472	LS mean difference	0.05	Standard Error of the Mean	0.053	2-Sided	95	-0.05	0.15	Superiority
OG000 OG001	Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9160	LS mean difference	-0.01	Standard Error of the Mean	0.054	2-Sided	95	-0.11	0.10	Superiority
OG000 OG002	Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.5948	LS mean difference	-0.03	Standard Error of the Mean	0.053	2-Sided	95	-0.13	0.08	Superiority
OG000 OG001	Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3755	LS mean difference	0.05	Standard Error of the Mean	0.054	2-Sided	95	-0.06	0.16	Superiority
OG000 OG002	Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9752	LS mean difference	0.00	Standard Error of the Mean	0.053	2-Sided	95	-0.11	0.10	Superiority
OG000 OG001	Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.9188	LS mean difference	-0.01	Standard Error of the Mean	0.054	2-Sided	95	-0.11	0.10	Superiority
OG000 OG002	Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.6379	LS mean difference	0.02	Standard Error of the Mean	0.053	2-Sided	95	-0.08	0.13	Superiority
OG000 OG001	Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.4967	LS mean difference	-0.04	Standard Error of the Mean	0.061	2-Sided	95	-0.16	0.08	Superiority
OG000 OG002	Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.3492	LS mean difference	-0.06	Standard Error of the Mean	0.059	2-Sided	95	-0.17	0.06	Superiority
OG000 OG001	Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.7136	LS mean difference	0.02	Standard Error of the Mean	0.062	2-Sided	95	-0.10	0.14	Superiority
OG000 OG002	Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.8163	LS mean difference	0.01	Standard Error of the Mean	0.059	2-Sided	95	-0.10	0.13	Superiority
OG000 OG001	Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.2825	LS mean difference	-0.06	Standard Error of the Mean	0.055	2-Sided	95	-0.17	0.05	Superiority
OG000 OG002	Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.	MMRM	0.1603	LS mean difference	-0.08	Standard Error of the Mean	0.054	2-Sided	95	-0.18	0.03	Superiority

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Intentional overdose	Injury, poisoning and procedural complications	MedDRA v19.1	Systematic Assessment		EG0000 affected43 at risk EG0011 affected38 at risk EG0020 affected41 at risk
Suicidal ideation	Psychiatric disorders	MedDRA v19.1	Systematic Assessment		EG0000 affected43 at risk EG0011 affected38 at risk EG0020 affected41 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dry mouth	Gastrointestinal disorders	MedDRA v19.1	Systematic Assessment	EG0000 affected43 at risk EG0014 affected38 at risk EG0020 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA v19.1	Systematic Assessment	EG0003 affected43 at risk EG0011 affected38 at risk EG0020 affected41 at risk
Infusion site pain	General disorders	MedDRA v19.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected38 at risk EG0024 affected41 at risk
Dizziness	Nervous system disorders	MedDRA v19.1	Systematic Assessment	EG0001 affected43 at risk EG0016 affected38 at risk EG0026 affected41 at risk
Headache	Nervous system disorders	MedDRA v19.1	Systematic Assessment	EG0007 affected43 at risk EG0017 affected38 at risk EG0026 affected41 at risk
Loss of consciousness	Nervous system disorders	MedDRA v19.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected38 at risk EG0021 affected41 at risk
Somnolence	Nervous system disorders	MedDRA v19.1	Systematic Assessment	EG0003 affected43 at risk EG0017 affected38 at risk EG0022 affected41 at risk
Flushing	Vascular disorders	MedDRA v19.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected38 at risk EG0020 affected41 at risk

ID	Term
D011644	Puerperal Disorders
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
BG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
BG002	SAGE-547 90 μg/kg/h	Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.	43	0	43	9	43
EG001	SAGE-547 60 μg/kg/h	Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).	38	1	38	17	38
EG002	SAGE-547 90 μg/kg/h	Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).	41	0	41	13	41