A Study To Evaluate The Effects Of Celecoxib (Celebrex®)... | NCT00807846

A Study To Evaluate The Effects Of Celecoxib (Celebrex®)... | NCT00807846 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Celecoxib	Experimental		Drug: Celecoxib
Naproxen	Experimental		Drug: Naproxen

Name	Type	Description	Arm Group Labels	Other Names
Celecoxib	Drug	Celecoxib 50 mg or 100 mg PO BID for 6 weeks	Celecoxib

Outcomes Module

Measure	Description	Time Frame
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit	Value at 6 weeks minus value at baseline.	6 Weeks/Final Visit

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 2 in SBP.	Value at 2 weeks minus value at baseline.	2 weeks
Change From Baseline in SBP at Week 4.	Value at 4 weeks minus value at baseline.

Other Outcomes

Measure	Description	Time Frame
Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit	Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.	6 weeks/Final Visit

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Catalina Pointe Clinical Research, Inc.		Tucson	Arizona	85704	United States
Arkansas Children's Hospital

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	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
FG001	Naproxen

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0005 subjects FG0010 subjects
Lack of Efficacy		FG0002 subjects FG0010 subjects
Protocol Violation		FG0002 subjects FG0011 subjects
Withdrawal by Subject		FG0002 subjects FG0011 subjects
Other		FG0001 subjects FG0012 subjects

Arm/Group Information

ID	Title	Description
BG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
BG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
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, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
	OG0000.366± 0.70 OG001-0.734± 0.70

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	The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.	ANCOVA		0.274		Mean Difference (Final Values)	1.100			2-Sided	90	-0.56	2.76					Superiority or Other (legacy)

Secondary

Change From Baseline to Week 2 in SBP.

Value at 2 weeks minus value at baseline.

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Posted

Least Squares Mean

Standard Error

mmHg

2 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants	OG000

Secondary

Change From Baseline in SBP at Week 4.

Value at 4 weeks minus value at baseline.

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Posted

Least Squares Mean

Standard Error

mmHg

4 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.

Value at 2 weeks minus value at baseline.

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Posted

Least Squares Mean

Standard Error

mmHg

2 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants	OG000

Secondary

Change From Baseline in DBP at Week 4.

Value at 4 weeks minus value at baseline.

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Posted

Least Squares Mean

Standard Error

mmHg

4 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants	OG000

Secondary

Change From Baseline in DBP at Week 6/Final Visit

Value at 6 weeks/Final Visit minus value at baseline.

Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.

For early terminations the LOCF was used to impute missing data.

Posted

Least Squares Mean

Standard Error

mmHg

6 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.

The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.

Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.

Posted

Least Squares Mean

Standard Error

mm (millimeter)

6 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants

Secondary

Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.

The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.

Posted

Number

Participants

Week 6/Final Visit

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units	Counts
Participants

Secondary

Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.

Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.

MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.

Posted

Least Squares Mean

Standard Error

6 weeks

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Units

Secondary

Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.

Posted

Number

Participants

Week 6/Final Visit

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Other Pre-specified

Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit

Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.

Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.

Posted

Mean

Standard Deviation

mmHg

6 weeks/Final Visit

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Other Pre-specified

Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit

Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.

Posted

Mean

Standard Deviation

bpm (beats per minute)

6 weeks/Final Visit

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Other Pre-specified

Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)

A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).

Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).

Posted

Mean

Standard Deviation

mmHg

6 weeks/Final Visit

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Other Pre-specified

Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)

A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).

Posted

Mean

Standard Deviation

bpm

6 weeks/Final Visit

ID	Title	Description
OG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
OG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Celecoxib	Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit			0	100	10	100
EG001	Naproxen	Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit			1	98	18	98

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hand fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Non-systematic Assessment		EG0000 affected100 at risk EG0011 affected98 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 15.1	Non-systematic Assessment	EG0004 affected100 at risk EG0019 affected98 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Non-systematic Assessment	EG0001 affected100 at risk EG0015 affected98 at risk
Headache	Nervous system disorders	MedDRA 15.1	Non-systematic Assessment	EG0007 affected100 at risk EG0014 affected98 at risk

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds

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	For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.	ANCOVA		0.148		Mean Difference (Final Values)	1.088			2-Sided	95	-0.39	2.57					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	For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.	ANCOVA		0.027		Mean Difference (Final Values)	1.837			2-Sided	95	0.21	3.46					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	For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.	ANCOVA		0.106		Mean Difference (Final Values)	-1.207			2-Sided	95	-2.67	0.26					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	For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.	ANCOVA		0.776		Mean Difference (Final Values)	-0.220			2-Sided	95	-1.30	1.74					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	For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.	ANCOVA		0.815		Mean Difference (Final Values)	-0.179			2-Sided	95	-1.69	1.33					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	Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.	ANCOVA		0.303		Mean Difference (Final Values)	3.033			2-Sided	95	-2.76	8.82					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	The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.	Chi-squared		0.392		Mean Difference (Final Values)	-0.061			2-Sided	95	-0.202	0.079			Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.		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	Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.	ANCOVA		0.897		Mean Difference (Final Values)	-0.402			2-Sided	95	-6.50	5.69					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	The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.	Chi-squared		0.200		Mean Difference (Final Values)	-0.102			2-Sided	95	-0.257	0.053			Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.		Superiority or Other (legacy)