A Study in Schizophrenic Patients

• Sponsor: Denovo Biopharma LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01125358
• Collaborator: (none)
• Enrollment: 82
• Locations: 22
• Arms: 4
• Duration (Months): 28.1
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: LY2140023; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10 milligrams (mg) LY2140023	Drug: LY2140023; Administered orally, twice daily for up to 7 weeks of treatment
Experimental: 80 mg LY2140023	Drug: LY2140023; Administered orally, twice daily for up to 7 weeks of treatment
Experimental: 160 mg LY2140023	Drug: LY2140023; Administered orally, twice daily for up to 7 weeks of treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered orally, twice daily for up to 7 weeks of treatment

Outcome Measures

Primary Outcome Measures

1. Clinical Utility Index (CUI) [Baseline through Week 6]

   CUI measures the efficacy (response), tolerability (time on treatment) and safety [incidence of adverse events (AEs)] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.

Secondary Outcome Measures

1. Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale [Baseline, Week 6]

   The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.

2. Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [Baseline, Week 6]

   The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.

3. Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16) [Baseline, Week 6]

   The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.

4. The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS) [Baseline up to Week 6]

   Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.)

5. Percentage of Participants Who Discontinued (Rate of Discontinuation) [Baseline through Week 6]

   Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID)

• Non pregnant female participants who agree to use acceptable birth control

• At entry to the study must be considered moderately ill in the opinion of the investigator

• 1 year history of Schizophrenia prior to entering the study

• At study entry participants with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study based on the investigator's clinical judgment. Participants who have never taken antipsychotic treatment may enter the study even without a history of hospitalization

• At study entry participants with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Participants who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years

• At study entry participants must have experienced an exacerbation of illness within the 4 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in participants who are presently hospitalized, the participants must not have been hospitalized longer than 60 days at entry of the study

Exclusion Criteria:

• Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1

• Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity

• Have any known history of receiving treatment with clozapine at any dose, as determined at baseline

• Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study

• Participants who are currently suicidal

• Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study

• Participants with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, untreated thyroid condition or other serious or unstable illnesses

• Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years

• Participants are excluded if their biological father, mother, brother, sister, or child has a history of idiopathic epilepsy

• Within 1 year of study enrollment, participants have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive

• Participants are excluded if they have a lifetime history of any of the following:

• head trauma, stroke, or central nervous system (CNS) infection with persistent neurological deficit (focal or diffuse);

• brain surgery;

• an electroencephalogram with paroxysmal (epileptiform) activity, or

• brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome

• Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study

• Leukopenia

• Medical history of Human Immunodeficiency Virus positive (HIV+) status

• Higher than normal blood prolactin levels

• Certain electrocardiogram results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aichi		Japan	470-1168
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kanagawa		Japan	216-0003
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kumamoto		Japan	861-0002
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kyoto		Japan	625-8502
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagano		Japan	384-8540
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagasaki		Japan	856-0847
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nara		Japan	634-8522
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Osaka		Japan	569-1041
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saga		Japan	842-0192
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo		Japan	114-0024
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Toyama		Japan	939-8073
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Yamaguchi		Japan	759-6321
13	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Goyang-Si		Korea, Republic of	410-719
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Incheon		Korea, Republic of	400-711
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Naju		Korea, Republic of	520-833
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seoul		Korea, Republic of	150-713
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Suwon-City		Korea, Republic of	442-723
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Yongin		Korea, Republic of	446-769
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Changhua		Taiwan	50550
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hsinchu		Taiwan	802
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taipei		Taiwan	110
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taipei		Taiwan	114

Sponsors and Collaborators

• Denovo Biopharma LLC

Investigators

• Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4459 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Denovo Biopharma LLC
• ClinicalTrials.gov Identifier: NCT01125358
• Other Study ID Numbers: 13560; H8Y-JE-HBDC
• First Posted: May 18, 2010
• Last Update Posted: Sep 14, 2021
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Schizophrenia

Study Results

Participant Flow

Pre-assignment Detail	This study consisted of a 1-week placebo lead-in period and a 6-week randomized, double-blind treatment period. Placebo responder is defined as ≥25% improvement in Positive and Negative Syndrome Scale (PANSS) Total Score from the start of placebo lead-in period to the end of placebo lead-in period.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.
Period Title: Overall Study
STARTED	21	21	20	20
Received at Least 1 Dose of Study Drug	21	21	20	20
Placebo Responder	1	0	0	0
COMPLETED	9	17	11	12
NOT COMPLETED	12	4	9	8

Baseline Characteristics

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo	Total
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.	Total of all reporting groups
Overall Participants	21	21	20	20	82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.99 (10.98)	42.03 (10.41)	43.16 (10.33)	38.34 (9.91)	41.14 (10.38)
Sex: Female, Male (Count of Participants)
Female	11 52.4%	10 47.6%	9 45%	10 50%	40 48.8%
Male	10 47.6%	11 52.4%	11 55%	10 50%	42 51.2%
Race/Ethnicity, Customized (participants) [Number]
Asian	21 100%	21 100%	20 100%	20 100%	82 100%
Region of Enrollment (participants) [Number]
Taiwan	1 4.8%	2 9.5%	1 5%	1 5%	5 6.1%
Japan	18 85.7%	16 76.2%	17 85%	17 85%	68 82.9%
Korea, Republic of	2 9.5%	3 14.3%	2 10%	2 10%	9 11%

Outcome Measures

1. Primary Outcome

Title	Clinical Utility Index (CUI)
Description	CUI measures the efficacy (response), tolerability (time on treatment) and safety [incidence of adverse events (AEs)] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.
Time Frame	Baseline through Week 6

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug and had CUI Total Score measurement at Week 6.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.
Measure Participants	21	21	20
Least Squares Mean (Standard Error) [units on a scale]	8.30 (0.54)	10.32 (0.52)	9.27 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, 80 mg LY2140023
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-2.02
	Confidence Interval	(2-Sided) 90%; -3.37 to 0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, 160 mg LY2140023
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-1.05
	Confidence Interval	(2-Sided) 90%; -2.42 to 0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
Description	The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline PANSS measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.
Measure Participants	19	21	20	20
PANSS Total Score	-0.49	-2.56	1.40	9.35
PANSS Positive Subscore (n=19, 21, 20, 20)	0.33	-2.30	-0.05	1.93
PANSS Negative Subscore	0.23	-0.22	0.33	2.70
PANSS General Psychopathology Subscore	-0.88	-0.31	1.18	4.79

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.222
	Comments	P-value is for PANSS Total Score.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-9.84
	Confidence Interval	(2-Sided) 95%; -25.80 to 6.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.96
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.105
	Comments	P-value is for PANSS Total Score.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-11.91
	Confidence Interval	(2-Sided) 95%; -26.42 to 2.60
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.308
	Comments	P-value is for PANSS Total Score.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-7.96
	Confidence Interval	(2-Sided) 95%; -23.46 to 7.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.73
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.441
	Comments	P-value is for PANSS Positive Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-1.60
	Confidence Interval	(2-Sided) 95%; -5.74 to 2.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.06
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments	P-value is for PANSS Positive Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-4.22
	Confidence Interval	() 95%; -8.01 to -0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.88
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.323
	Comments	P-value is for PANSS Positive Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-1.98
	Confidence Interval	(2-Sided) 95%; -5.96 to 2.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.98
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.285
	Comments	P-value is for PANSS Negative Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-2.46
	Confidence Interval	(2-Sided) 95%; -7.05 to 2.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.28
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.166
	Comments	P-value is for PANSS Negative Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-2.92
	Confidence Interval	(2-Sided) 95%; -7.10 to 1.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.07
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.286
	Comments	P-value is for PANSS Negative Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-2.37
	Confidence Interval	(2-Sided) 95%; -6.79 to 2.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.20
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.177
	Comments	P-value is for PANSS General Psychopathology Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-5.67
	Confidence Interval	(2-Sided) 95%; -13.96 to 2.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.14
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.178
	Comments	P-value is for PANSS General Psychopathology Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-5.10
	Confidence Interval	(2-Sided) 95%; -12.60 to 2.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.74
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.377
	Comments	P-value is for PANSS General Psychopathology Subscore.
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-3.61
	Confidence Interval	(2-Sided) 95%; -11.72 to 4.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.05
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
Description	The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline CGI-S measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.
Measure Participants	19	21	20	20
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.62	-0.49	0.14	-0.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.077
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; -0.10 to 1.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.48
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.592
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -1.12 to 0.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.44
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.395
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; -0.53 to 1.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.46
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)
Description	The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline NSA-16 Total Score measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.
Measure Participants	13	17	14	13
Least Squares Mean (95% Confidence Interval) [units on a scale]	3.42	-0.40	-6.31	-1.22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.306
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	4.64
	Confidence Interval	(2-Sided) 95%; -4.37 to 13.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.49
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.849
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; -7.74 to 9.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.26
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.259
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	LS Mean Differences
	Estimated Value	-5.09
	Confidence Interval	() 95%; -14.05 to 3.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.46
	Estimation Comments

5. Secondary Outcome

Title	The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description	Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.)
Time Frame	Baseline up to Week 6

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline C-SSRS measurements.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.
Measure Participants	20	21	20	20
Treatment-Emergent Suicidal Ideation	1 4.8%	1 4.8%	2 10%	1 5%
Treatment-Emergent Suicidal Behavior	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Percentage of Participants Who Discontinued (Rate of Discontinuation)
Description	Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100.
Time Frame	Baseline through Week 6

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	10 mg LY2140023	80 mg LY2140023	160 mg LY2140023	Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.	40 mg of LY2140023 orally, twice daily for 6 weeks.	80 mg of LY2140023 orally, twice daily for 6 weeks.	Placebo orally, twice daily for 6 weeks.
Measure Participants	21	21	20	20
Number [percentage of participants]	57.1 271.9%	19.0 90.5%	45.0 225%	40.0 200%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.354
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	80 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.181
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	160 mg LY2140023, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	10 mg LY2140023		80 mg LY2140023		160 mg LY2140023		Placebo
Arm/Group Description	5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.		40 mg of LY2140023 orally, twice daily for 6 weeks.		80 mg of LY2140023 orally, twice daily for 6 weeks.		Placebo orally, twice daily for 6 weeks.
All Cause Mortality
	10 mg LY2140023		80 mg LY2140023		160 mg LY2140023		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	10 mg LY2140023		80 mg LY2140023		160 mg LY2140023		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)		2/21 (9.5%)		0/20 (0%)		2/20 (10%)
Nervous system disorders
Psychomotor hyperactivity	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Psychiatric disorders
Schizophrenia	0/21 (0%)	0	2/21 (9.5%)	2	0/20 (0%)	0	2/20 (10%)	2
Other (Not Including Serious) Adverse Events
	10 mg LY2140023		80 mg LY2140023		160 mg LY2140023		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/21 (61.9%)		13/21 (61.9%)		12/20 (60%)		9/20 (45%)
Eye disorders
Visual impairment	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/20 (5%)	1
Cheilitis	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	1/20 (5%)	1
Constipation	1/21 (4.8%)	2	1/21 (4.8%)	1	0/20 (0%)	0	1/20 (5%)	1
Dry mouth	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Nausea	2/21 (9.5%)	2	3/21 (14.3%)	3	2/20 (10%)	3	1/20 (5%)	1
Oral disorder	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Retching	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Stomatitis	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Vomiting	1/21 (4.8%)	1	4/21 (19%)	4	1/20 (5%)	1	2/20 (10%)	2
General disorders
Malaise	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/20 (5%)	1
Infections and infestations
Nasopharyngitis	1/21 (4.8%)	1	0/21 (0%)	0	3/20 (15%)	3	1/20 (5%)	1
Oral herpes	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Tinea pedis	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Injury, poisoning and procedural complications
Accidental overdose	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	1/20 (5%)	1
Contusion	1/21 (4.8%)	1	1/21 (4.8%)	2	0/20 (0%)	0	0/20 (0%)	0
Excoriation	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Joint injury	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Laceration	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Upper limb fracture	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Investigations
Alanine aminotransferase increased	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Aspartate aminotransferase increased	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Blood bilirubin increased	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Blood bilirubin unconjugated increased	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/20 (5%)	1
Blood glucose increased	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Blood prolactin increased	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Blood uric acid increased	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/20 (5%)	1
Neutrophil count decreased	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Weight decreased	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	0/21 (0%)	0	2/21 (9.5%)	2	1/20 (5%)	2	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Musculoskeletal stiffness	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Myalgia	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Nervous system disorders
Dizziness	1/21 (4.8%)	1	1/21 (4.8%)	1	1/20 (5%)	1	0/20 (0%)	0
Headache	3/21 (14.3%)	3	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Somnolence	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Tremor	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Psychiatric disorders
Affect lability	1/21 (4.8%)	2	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Affective disorder	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Agitation	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Anxiety	1/21 (4.8%)	1	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Delusion	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Depression	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Hallucination	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Restlessness	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Schizophrenia	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/10 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Upper respiratory tract inflammation	0/21 (0%)	0	1/21 (4.8%)	1	1/20 (5%)	1	0/20 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Blister	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Dermatitis	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/20 (0%)	0
Hair colour changes	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Pruritus	0/21 (0%)	0	1/21 (4.8%)	1	2/20 (10%)	2	0/20 (0%)	0
Rash	0/21 (0%)	0	1/21 (4.8%)	1	1/20 (5%)	1	0/20 (0%)	0
Vascular disorders
Hot flush	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Hypertension	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.