Safety and Maintenance of Effect of Ziprasidone Plus a Mo... | NCT00280566

Safety and Maintenance of Effect of Ziprasidone Plus a Mo... | NCT00280566 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ziprasidone	Experimental	Active treatment, double-blind, randomized arm	Drug: Ziprasidone Oral Capsule
Placebo	Placebo Comparator	Placebo treatment, double-blind, randomized arm	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Intervention for a Mood Episode During Double Blind Period	Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.	Period 2: 24 weeks or time of early termination

Secondary Outcomes

Measure	Description	Time Frame
Time to Discontinuation for Any Reason During Double Blind Period 2	Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.	Period 2: 24 weeks or time of early termination
Modified Time to Intervention for a Mood Episode (TIME)

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35226	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20122373	Derived	Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Period 1 Open Label Ziprasidone	40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
FG001	Ziprasidone

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Lack of Efficacy		FG00031 subjects FG0010 subjects FG0020 subjects
Laboratory Abnormality		FG0003 subjects FG0010 subjects FG0020 subjects
Adverse Event		FG000148 subjects FG0010 subjects FG0020 subjects
Lost to Follow-up		FG00035 subjects FG0010 subjects FG0020 subjects
Withdrawal by Subject		FG00076 subjects FG0010 subjects FG0020 subjects
Miscellaneous		FG00050 subjects FG0010 subjects FG0020 subjects

Period 2 Double Blind

Type	Comment	Milestone Data
STARTED		FG0000 subjects1 subject in Period 1 did not want to be randomized into Period 2 FG001127 subjects FG002111 subjects
COMPLETED		FG0000 subjects FG00184 subjects FG00254 subjects
NOT COMPLETED		FG0000 subjects FG00143 subjects FG00257 subjects

Type	Comment	Reasons
Lack of Efficacy		FG0000 subjects FG0019 subjects FG00222 subjects
Laboratory Abnormality		FG000

Arm/Group Information

ID	Title	Description
BG000	Ziprasidone	Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
BG001	Placebo	Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00039.6± 12.3 BG00138.0± 11.6 BG00238.4± 11.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00051 BG00158 BG002

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

Time to Intervention for a Mood Episode During Double Blind Period

Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.

Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.

Posted

Mean

Standard Error

Days

Period 2: 24 weeks or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000127 OG001111

Title

Denominators

Categories

Title	Measurements
	OG000172.159± 5.646(7 to 201) OG001143.133± 7.532

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	Equality of Survival Curves across the treatment groups.	Log Rank	alpha = 0.05 level of significance	0.0104														Superiority or Other (legacy)

Secondary

Time to Discontinuation for Any Reason During Double Blind Period 2

Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.

Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively.

Posted

Mean

Standard Error

days

Period 2: 24 weeks or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Secondary

Modified Time to Intervention for a Mood Episode (TIME)

Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.

Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode

Posted

Mean

Standard Error

Days

Period 2: Week 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants

Secondary

Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period

Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.

Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 1 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts

Secondary

Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.

intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 1 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Secondary

Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period

Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.

Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 1 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.

Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 1 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)

intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 4 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).

intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 4 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period

Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).

intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.

Posted

Mean

Standard Deviation

scores on scale

Period 2: Weeks 4 - 24 or time of early termination

ID	Title	Description
OG000	Ziprasidone	Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
OG001	Placebo	Randomized to Double Blind Therapy with Placebo plus mood stabilizer

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)
EG000	Period 1 Open Label Ziprasidone	40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.	15	362
EG001	Ziprasidone	Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.	3	22
EG002	Placebo	Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2	2	24

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Influenza	Infections and infestations	MedDRA v 11.0	Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Arrhythmia	Cardiac disorders		Systematic Assessment	EG0000 affected584 at risk EG0011 affected127 at risk EG0020 affected112 at risk
Dystonia	Nervous system disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Affect lability	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Anxiety	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Bipolar I disorder	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Bipolar disorder	Psychiatric disorders		Systematic Assessment	EG0002 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Depression	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Depression suicidal	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Mania	Psychiatric disorders		Systematic Assessment	EG0002 affected584 at risk EG0010 affected127 at risk EG0022 affected112 at risk
Psychiatric decompensation	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Psychotic disorder	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Suicidal ideation	Psychiatric disorders		Systematic Assessment	EG0002 affected584 at risk EG0012 affected127 at risk EG0020 affected112 at risk
Suicide attempt	Psychiatric disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Thrombophlebitis	Vascular disorders		Systematic Assessment	EG0001 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA v 11.0	Systematic Assessment	EG00042 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Fatigue	General disorders	MedDRA v11.0	Systematic Assessment	EG00044 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Upper respiratory tract infection	Infections and infestations		Systematic Assessment	EG0000 affected584 at risk EG0015 affected127 at risk EG0026 affected112 at risk
Akathisia	Nervous system disorders		Systematic Assessment	EG00047 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG00049 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Headache	Nervous system disorders		Systematic Assessment	EG00032 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Sedation	Nervous system disorders		Systematic Assessment	EG000134 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Somnolence	Nervous system disorders		Systematic Assessment	EG00099 affected584 at risk EG0010 affected127 at risk EG0020 affected112 at risk
Tremor	Nervous system disorders		Systematic Assessment	EG00073 affected584 at risk EG0018 affected127 at risk EG0024 affected112 at risk
Insomnia	Psychiatric disorders		Systematic Assessment	EG00059 affected584 at risk EG0017 affected127 at risk EG00212 affected112 at risk
Mania	Psychiatric disorders		Systematic Assessment	EG0000 affected584 at risk EG0013 affected127 at risk EG0026 affected112 at risk

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	alpha = 0.05 level of significance	Log Rank	No adjustment made for multiple comparisons	0.0047														Superiority or Other (legacy)

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	alpha = 0.05 level of significance	Log Rank		0.0205	No adjustment made for multiple comparisons													Superiority or Other (legacy)

Title

Denominators

Categories

Week 1 (n=121, 106)

Title	Measurements
	OG000-0.2± 3.0 OG0010.8± 5.1

Week 2 (n=116, 95)

Title	Measurements
	OG000-0.4± 4.2 OG001-0.1± 4.7

Week 4 (n=117,95)

Title	Measurements
	OG000-0.6± 3.7 OG0010.2± 5.4

Week 8 (n=107, 79)

Title	Measurements
	OG000-0.3± 5.7 OG0010.8± 5.4

Week 12 (n=98, 70)

Title	Measurements
	OG000-1.0± 4.3 OG0011.2± 8.2

Week 16 (n=94,65)

Title	Measurements
	OG000-1.4± 4.3 OG0011.2± 6.3

Week 20 (n=84, 58)

Title	Measurements
	OG000-1.1± 6.5 OG0010.2± 5.1

Week 24 (n=85,53)

Title	Measurements
	OG000-1.1± 5.5 OG0010.3± 4.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1247	Mean Difference (Final Values)	-0.85	Standard Error of the Mean	0.55	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance	0.7515	Mean Difference (Final Values)	-0.20	Standard Error of the Mean	0.62	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance	0.3074	Mean Difference (Final Values)	-0.63	Standard Error of the Mean	0.62	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0758	Mean Difference (Final Values)	-1.25	Standard Error of the Mean	0.71	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0162	Mean Difference (Final Values)	-1.98	Standard Error of the Mean	0.82	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance	0.0003	Mean Difference (Final Values)	-3.01	Standard Error of the Mean	0.83	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0242	Mean Difference (Final Values)	-2.21	Standard Error of the Mean	0.98	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0161	Mean Difference (Final Values)	-1.71	Standard Error of the Mean	0.71	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

Title

Denominators

Categories

Week 1 (n=122, 106)

Title	Measurements
	OG0000.1± 0.7 OG0010.3± 1.0

Week 2 (n=117, 95)

Title	Measurements
	OG0000.2± 0.9 OG0010.2± 1.0

Week 4 (n=117, 95)

Title	Measurements
	OG000-0.0± 0.7 OG0010.1± 0.9

Week 8 (n=107, 79)

Title	Measurements
	OG000-0.0± 0.8 OG001-0.1± 0.8

Week 12 (n=98, 70)

Title	Measurements
	OG000-0.1± 0.9 OG0010.0± 1.1

Week 16 (n=94, 65)

Title	Measurements
	OG000-0.1± 0.9 OG0010.0± 1.1

Week 20 (n=83, 58)

Title	Measurements
	OG000-0.1± 0.9 OG001-0.2± 1.0

Week 24 (n=85, 53)

Title	Measurements
	OG000-0.2± 1.0 OG001-0.2± 1.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0088	Mean Difference (Final Values)	-0.24	Standard Error of the Mean	0.09	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.3677	Mean Difference (Final Values)	-0.11	Standard Error of the Mean	0.13	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0734	Mean Difference (Final Values)	-0.18	Standard Error of the Mean	0.10	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.9166	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.11	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.2791	Mean Difference (Final Values)	-0.14	Standard Error of the Mean	0.13	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1460	Mean Difference (Final Values)	-0.23	Standard Error of the Mean	0.16	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.7301	Mean Difference (Final Values)	-0.05	Standard Error of the Mean	0.15	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.8162	Mean Difference (Final Values)	-0.03	Standard Error of the Mean	0.14	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

Title

Denominators

Categories

Week 1 (n=122, 106)

Title	Measurements
	OG0002.3± 1.2 OG0012.8± 1.6

Week 2 (n=117, 95)

Title	Measurements
	OG0002.4± 1.4 OG0012.6± 1.6

Week 4 (n=117, 95

Title	Measurements
	OG0002.3± 1.2 OG0012.5± 1.5

Week 8 (n=107, 79)

Title	Measurements
	OG0002.3± 1.4 OG0012.2± 1.2

Week 12 (n=98, 70)

Title	Measurements
	OG0002.2± 1.3 OG0012.2± 1.4

Week 16 (n=94, 65)

Title	Measurements
	OG0002.3± 1.4 OG0012.5± 1.5

Week 20 (n=83, 58)

Title	Measurements
	OG0002.1± 1.4 OG0012.1± 1.4

Week 24 (n=85, 53)

Title	Measurements
	OG0002.2± 1.3 OG0012.2± 1.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0013	Mean Difference (Final Values)	-0.48	Standard Error of the Mean	0.15	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1167	Mean Difference (Final Values)	-0.27	Standard Error of the Mean	0.17	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0188	Mean Difference (Final Values)	-0.40	Standard Error of the Mean	0.17	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.3413	Mean Difference (Final Values)	-0.15	Standard Error of the Mean	0.16	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.2760	Mean Difference (Final Values)	-0.18	Standard Error of the Mean	0.16	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0085	Mean Difference (Final Values)	-0.51	Standard Error of the Mean	0.19	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1317	Mean Difference (Final Values)	-0.27	Standard Error of the Mean	0.18	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1666	Mean Difference (Final Values)	-0.25	Standard Error of the Mean	0.18	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

Title

Denominators

Categories

Week 1 (n=121, 106)

Title	Measurements
	OG000-0.2± 4.9 OG0012.7± 7.3

Week 2 (n=117, 95)

Title	Measurements
	OG0001.1± 7.4 OG0012.7± 7.1

Week 4 (n=117, 95)

Title	Measurements
	OG000-0.3± 5.3 OG0011.6± 6.0

Week 8 (n=107, 79)

Title	Measurements
	OG0000.4± 5.9 OG0010.4± 5.3

Week 12 (n=98, 70)

Title	Measurements
	OG0001.1± 5.9 OG0010.6± 5.4

Week 16 (n=94,65)

Title	Measurements
	OG0001.2± 6.3 OG0010.4± 3.9

Week 20 (n=84, 58)

Title	Measurements
	OG0000.5± 5.6 OG001-0.2± 4.9

Week 24 (n=85, 53)

Title	Measurements
	OG0000.4± 6.4 OG0011.0± 6.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0023	Mean Difference (Final Values)	-2.29	Standard Error of the Mean	0.75	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1412	Mean Difference (Final Values)	-1.34	Standard Error of the Mean	0.91	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0861	Mean Difference (Final Values)	-1.49	Standard Error of the Mean	0.87	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.5992	Mean Difference (Final Values)	-0.43	Standard Error of the Mean	0.82	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.5873	Mean Difference (Final Values)	0.41	Standard Error of the Mean	0.76	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.2116	Mean Difference (Final Values)	0.97	Standard Error of the Mean	0.78	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1847	Mean Difference (Final Values)	0.90	Standard Error of the Mean	0.68	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.9972	Mean Difference (Final Values)	-0.00	Standard Error of the Mean	0.82	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

Title

Denominators

Categories

Week 4 (n=123, 98)

Title	Measurements
	OG0000.4± 8.7 OG0011.5± 6.9

Week 8 (n=107, 79)

Title	Measurements
	OG000-0.1± 8.3 OG001-0.8± 6.0

Week 12 (n=98, 70)

Title	Measurements
	OG000-0.1± 6.5 OG0010.3± 9.4

Week 16 (n=94, 65)

Title	Measurements
	OG000-0.0± 7.1 OG0010.7± 8.7

Week 20 (n=84, 58)

Title	Measurements
	OG000-0.2± 7.4 OG001-1.0± 6.1

Week 24 (n=85, 53)

Title	Measurements
	OG000-0.6± 8.0 OG001-0.9± 7.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.5954	Mean Difference (Final Values)	-0.49	Standard Error of the Mean	0.93	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.3414	Mean Difference (Final Values)	0.89	Standard Error of the Mean	0.93	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.9745	Mean Difference (Final Values)	0.04	Standard Error of the Mean	1.23	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.5627	Mean Difference (Final Values)	-0.85	Standard Error of the Mean	1.47	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.7410	Mean Difference (Final Values)	0.36	Standard Error of the Mean	1.10	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.9632	Mean Difference (Final Values)	-0.04	Standard Error of the Mean	0.88	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

Title

Denominators

Categories

Week 4 (n=123, 98)

Title	Measurements
	OG0000.0± 1.6 OG0010.1± 1.4

Week 8 (n=107, 79)

Title	Measurements
	OG000-0.2± 2.0 OG001-0.2± 1.9

Week 12 (n=98, 70)

Title	Measurements
	OG000-0.3± 1.7 OG0010.3± 3.3

Week 16 (n=94, 65)

Title	Measurements
	OG000-0.4± 1.8 OG0010.0± 2.1

Week 20 (n=84, 58)

Title	Measurements
	OG000-0.2± 2.2 OG001-0.1± 2.1

Week 24 (n=85, 53)

Title	Measurements
	OG000-0.2± 2.2 OG001-0.1± 2.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.9538	Mean Difference (Final Values)	0.01	Standard Error of the Mean	0.22	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.8541	Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.25	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1084	Mean Difference (Final Values)	-0.52	Standard Error of the Mean	0.32	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0380	Mean Difference (Final Values)	-0.56	Standard Error of the Mean	0.27	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.2649	Mean Difference (Final Values)	-0.39	Standard Error of the Mean	0.35	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.2394	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.27	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

Title

Denominators

Categories

Week 4 (n=123, 98)

Title	Measurements
	OG0000.2± 3.1 OG0010.4± 2.2

Week 8 (n=107, 79)

Title	Measurements
	OG0000.2± 3.2 OG001-0.1± 1.8

Week 12 (n=98, 70)

Title	Measurements
	OG0000.1± 2.5 OG0010.1± 2.1

Week 16 (n=94, 65)

Title	Measurements
	OG0000.3± 3.1 OG0010.4± 2.6

Week 20 (n=84, 58)

Title	Measurements
	OG000-0.0± 2.3 OG001-0.4± 1.8

Week 24 (n=85, 53)

Title	Measurements
	OG000-0.1± 2.6 OG001-0.1± 2.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Estimate Comment	Non-Inferiority Type
OG000 OG001	Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.8117	Mean Difference (Final Values)	0.07	Standard Error of the Mean	0.29	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.0443	Mean Difference (Final Values)	0.51	Standard Error of the Mean	0.26	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.3039	Mean Difference (Final Values)	0.29	Standard Error of the Mean	0.28	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.9953	Mean Difference (Final Values)	0.00	Standard Deviation	0.46	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.1653	Mean Difference (Final Values)	0.44	Standard Error of the Mean	0.32	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)
OG000 OG001	Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.	MMRM ANCOVA	MMRM ANCOVA = mixed effects repeated measures analysis of covariance.	0.5771	Mean Difference (Final Values)	0.18	Standard Error of the Mean	0.32	Mean Difference (Final Values) = Least Squares Mean	Superiority or Other (legacy)

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders