A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) (PRESENCE)

• ClinicalTrials.gov Identifier: NCT03305809
• Recruitment Status: Completed
• First Posted: October 10, 2017
• Results First Posted: July 23, 2021
• Last Update Posted: July 23, 2021
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Lewy Body Dementia
• Interventions: Drug: LY3154207; Drug: Placebo
• Enrollment: 344

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	10 Milligram (mg) LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description	Participants received placebo administered orally once a day (QD).	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Period Title: Overall Study
Started	86	86	85	87
Received at Least One Dose of Study Drug	86	86	85	87
Completed	79	78	66	60
Not Completed	7	8	19	27
Reason Not Completed
Adverse Event	2	2	6	6
Death	0	0	1	1
Lost to Follow-up	1	2	0	0
Sponsor Decision	1	0	1	8
Physician Decision	0	0	2	4
Progressive Disease	0	0	1	0
Protocol Violation	1	0	2	3
Withdrawal due to Assessment Committee Decision	0	0	0	2
Withdrawal by Subject	2	4	5	2
Withdrawal due to Caregiver Circumstances	0	0	1	1

Baseline Characteristics

Arm/Group Title		Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207	Total
Arm/Group Description		Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.	Total of all reporting groups
Overall Number of Baseline Participants		86	86	85	87	344
Baseline Analysis Population Description		All randomized participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	86 participants	86 participants	85 participants	87 participants	344 participants
		73.00 (7.02)	72.50 (6.70)	71.90 (7.35)	73.00 (5.21)	72.60 (6.60)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	86 participants	86 participants	85 participants	87 participants	344 participants
	Female	16	13	15	15	59
	Male	70	73	70	72	285
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	86 participants	86 participants	85 participants	87 participants	344 participants
	Hispanic or Latino	8	5	9	11	33
	Not Hispanic or Latino	77	81	76	75	309
	Unknown or Not Reported	1	0	0	1	2
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	86 participants	86 participants	85 participants	87 participants	344 participants
	American Indian or Alaska Native	1	1	0	0	2
	Asian	2	1	1	0	4
	Native Hawaiian or Other Pacific Islander	0	0	0	0	0
	Black or African American	4	3	2	2	11
	White	79	81	81	85	326
	More than one race	0	0	1	0	1
	Unknown or Not Reported	0	0	0	0	0
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	86 participants	86 participants	85 participants	87 participants	344 participants
Canada		3	2	3	2	10
Puerto Rico		5	2	4	4	15
United States		78	82	78	81	319

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
Description	The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug, who had the baseline efficacy assessment and had at least 1 postdose efficacy assessment.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	69	74	65	54
Least Squares Mean (95% Confidence Interval); Unit of Measure: Units on a scale
	1.04; (-0.339 to 2.373)	0.15; (-1.206 to 1.496)	0.96; (-0.448 to 2.362)	0.26; (-1.310 to 1.801)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.89
	Confidence Interval	(2-Sided) 95%; -2.776 to 0.969
	Estimation Comments	Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -1.996 to 1.879
	Estimation Comments	Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.78
	Confidence Interval	(2-Sided) 95%; -2.873 to 1.277
	Estimation Comments	Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.

2. Secondary Outcome

Title	Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
Description	The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse. Least squares (LS) means were calculated using mixed model repeated measures adjusting for treatment + visit + treatment*visit + age*acheifl + age + concomitant use of acetylcholinesterase inhibitor (AChEI).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline CGIC data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	73	77	69	55
Least Squares Mean (Standard Error); Unit of Measure: Score on a scale
	4.0 (0.13)	3.8 (0.12)	3.3 (0.13)	3.1 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.273
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.54 to 0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -1.02 to -0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -1.29 to -0.53
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
Description	The PoA is a composite score derived from the CDR-CCB that measures the intensity of concentration (ability to focus attention): the faster the responses, the more processes are being brought to bear upon the task. Power of attention is calculated from the sum of three cognitive function speed tests: simple reaction time, choice reaction time and the speed of detections in digit vigilance task. Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment Values are calculated by a computer and higher scores mean better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline CDR-CCB PoA data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	69	73	65	54
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	64.14 (48.681)	-6.57 (48.396)	-42.88 (49.804)	-59.58 (54.379)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.303
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-70.71
	Confidence Interval	(2-Sided) 95%; -205.53 to 64.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 68.495
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.125
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-107.02
	Confidence Interval	(2-Sided) 95%; -244.09 to 30.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 69.647
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.091
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-123.72
	Confidence Interval	(2-Sided) 95%; -267.18 to 19.74
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 72.892
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Description	The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline ADAS-Cog13 data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	68	73	67	54
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	-0.71 (0.707)	-1.11 (0.691)	-1.42 (0.720)	-1.59 (0.799)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.686
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -2.34 to 1.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.985
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.485
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -2.70 to 1.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.011
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.406
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.89
	Confidence Interval	(2-Sided) 95%; -2.98 to 1.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.064
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Screening in the Montreal Cognitive Assessment (MoCA) Score
Description	The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale. The MoCA is divided into 7 subscores (maximum possible subscore): visuospatial/executive (5 points), naming (3 points), memory (5 points for delayed recall), attention (6 points), language (3 points), abstraction (2 points) and orientation to time and place (6 points). A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Time Frame	Screening (Baseline), Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline MoCA data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	71	76	68	55
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	0.90 (0.432)	1.34 (0.423)	1.12 (0.448)	1.84 (0.496)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.464
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; -0.74 to 1.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.603
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.720
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -1.00 to 1.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.623
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.149
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; -0.34 to 2.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.655
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores
Description	The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD),as well as other related dementing disorders.It assesses 12 behavioral disturbances,namely delusions,hallucinations,depression/dysphoria,anxiety,agitation/aggression,elation/euphoria,disinhibition,irritability/lability,apathy, aberrant motor activity, night-time behavior disturbances,and appetite/eating abnormalities.The frequency scored from 0 (never) to 4 (very frequently).The Severity scored from 0 (none) to 3 (marked).The domain score is obtained by multiplying frequency and severity scores.The total NPI score is sum total of all of individual domain scores (0-144).Higher score indiciates more abnormal behaviors.LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline NPI score data.

Arm/Group Title		Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:		Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed		73	77	66	55
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Total Score	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		-1.62 (0.868)	-2.24 (0.852)	-3.32 (0.920)	-2.37 (1.005)
Delusions	Number Analyzed	73 participants	77 participants	66 participants	54 participants
		0.13 (0.124)	-0.04 (0.121)	-0.25 (0.130)	0.02 (0.144)
Hallucinations	Number Analyzed	73 participants	77 participants	66 participants	55 participants
		-0.09 (0.131)	-0.11 (0.128)	-0.44 (0.137)	-0.38 (0.151)
Agitation/Aggression	Number Analyzed	71 participants	77 participants	66 participants	55 participants
		0.04 (0.130)	-0.06 (0.126)	-0.02 (0.135)	-0.20 (0.148)
Depression/Dysphoria	Number Analyzed	73 participants	77 participants	66 participants	55 participants
		-0.22 (0.155)	-0.16 (0.151)	-0.33 (0.164)	-0.35 (0.179)
Anxiety	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		-0.15 (0.141)	-0.15 (0.138)	0.07 (0.149)	-0.22 (0.163)
Elation/Euphoria	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		0.14 (0.069)	0.03 (0.068)	0.00 (0.074)	0.06 (0.080)
Apathy/Indifference	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		-0.36 (0.191)	-0.81 (0.186)	-0.68 (0.202)	-0.55 (0.220)
Disinhibition	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		-0.13 (0.082)	-0.11 (0.080)	0.21 (0.087)	-0.09 (0.095)
Irritability/Lability	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		-0.19 (0.130)	-0.43 (0.127)	-0.25 (0.137)	0.02 (0.150)
Aberrant Motor Behavior	Number Analyzed	73 participants	77 participants	65 participants	55 participants
		-0.13 (0.106)	0.03 (0.103)	-0.23 (0.112)	-0.09 (0.122)
Sleep/Nighttime Behavior Disorders	Number Analyzed	73 participants	77 participants	66 participants	55 participants
		-0.19 (0.287)	0.00 (0.278)	-0.58 (0.302)	-0.30 (0.329)
Appetite/Eating Disorders	Number Analyzed	73 participants	77 participants	66 participants	55 participants
		-0.37 (0.270)	-0.47 (0.263)	-0.80 (0.284)	-0.27 (0.311)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Total Score
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.607
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -3.01 to 1.76
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.213
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Total Score
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.180
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.70
	Confidence Interval	(2-Sided) 95%; -4.19 to 0.79
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.265
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Total Score
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.572
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -3.36 to 1.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.325
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Delusions
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.320
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.173
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Delusions
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.037
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95%; -0.73 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.180
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Delusions
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.558
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.49 to 0.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.190
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Hallucinations
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.924
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.38 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.182
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Hallucinations
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.061
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.189
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Hallucinations
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.148
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.199
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Agitation/Aggression
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.552
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.46 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.180
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Agitation/Aggression
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.735
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.43 to 0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.188
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Agitation/Aggression
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.224
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -0.63 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.197
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Depression/Dysphoria
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.783
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.37 to 0.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.216
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Depression/Dysphoria
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.640
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.55 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.226
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Depression/Dysphoria
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.592
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.59 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.236
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Anxiety
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.993
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -0.39 to 0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.197
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Anxiety
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.290
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -0.19 to 0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.205
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Anxiety
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.722
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.50 to 0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.215
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Elation/Euphoria
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.246
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.30 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.097
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Elation/Euphoria
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.175
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.34 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.101
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Elation/Euphoria
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.482
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.28 to 0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.106
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Apathy/Indifference
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.091
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.97 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.266
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Apathy/Indifference
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.248
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.87 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.278
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Apathy/Indifference
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.516
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.76 to 0.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.290
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Disinhibition
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.875
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.21 to 0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.114
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Disinhibition
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.119
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Disinhibition
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.761
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.21 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.125
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Irritability/Lability
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.183
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -0.60 to 0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.181
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Irritability/Lability
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.765
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.43 to 0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.189
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Irritability/Lability
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.279
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.61
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.198
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Aberrant Motor Behavior
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.252
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95%; -0.12 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.147
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Aberrant Motor Behavior
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.526
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.40 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.154
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Aberrant Motor Behavior
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.800
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.28 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.161
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sleep/Nighttime Behavior Disorders
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.623
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; -0.59 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.400
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sleep/Nighttime Behavior Disorders
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.354
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -1.21 to 0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.418
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sleep/Nighttime Behavior Disorders
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.809
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.97 to 0.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.437
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Appetite/Eating Disorders
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.790
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.84 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.376
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Appetite/Eating Disorders
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.280
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -1.20 to 0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.392
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Appetite/Eating Disorders
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.797
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.92
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.412
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in the Epworth Sleepiness Scale (ESS) Score
Description	The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline ESS data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	73	77	67	55
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	-0.33 (0.437)	-1.04 (0.426)	-1.21 (0.452)	-1.92 (0.500)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.247
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.91 to 0.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.610
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.164
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95%; -2.12 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.631
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.017
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.59
	Confidence Interval	(2-Sided) 95%; -2.90 to -0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.663
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)
Description	Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for MDS-UPDRS MDS-UPDRS Part I (non-motor experiences of daily living) and Part II (motor experiences of daily living) scores, total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + levodopa equivalency dose (LED).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline MDS-UPDRS data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	56	70	61	50
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	-0.18 (2.112)	-6.58 (1.941)	-7.56 (2.084)	-10.77 (2.287)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.026
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.41
	Confidence Interval	(2-Sided) 95%; -12.04 to -0.77
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.860
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.014
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.39
	Confidence Interval	(2-Sided) 95%; -13.24 to -1.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.969
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.60
	Confidence Interval	(2-Sided) 95%; -16.72 to -4.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.104
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score
Description	The PDAQ-15 is a 15-item measure of instrumental activities of daily living (IADL) that are impacted by cognitive impairment in participants with parkinson's disease dementia (PDD). The PDAQ-15 is derived from the original 50-item scale, which has demonstrated test-retest reliability, construct validity, sensitivity, and specificity to Parkinson's disease (PD) cognitive impairment and the questionnaire is completed by the caregiver. The score range is 0 to 60, with higher scores indicating better function. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline PDAQ-15 data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	73	77	67	55
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	-0.32 (0.976)	0.23 (0.961)	2.09 (1.018)	1.24 (1.128)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.683
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; -2.13 to 3.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.362
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.089
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.41
	Confidence Interval	(2-Sided) 95%; -0.37 to 5.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.413
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.294
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; -1.37 to 4.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.489
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score
Description	The DKEFS verbal fluency category switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. Scales scores vary from 0 min to N/A max (no concrete maximum). Higher score = higher ability in language processing. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline D-KEFS data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	71	76	66	53
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	-0.19 (0.280)	0.44 (0.271)	0.88 (0.292)	0.30 (0.325)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.105
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; -0.13 to 1.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.389
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.27 to 1.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.406
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.253
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.35 to 1.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.428
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12
Description	Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for Part II total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + LED dose.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline MDS-UPDRS data.

Arm/Group Title		Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:		Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed		75	77	69	54
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Motor Experiences of Daily Living	Number Analyzed	73 participants	77 participants	69 participants	53 participants
		0.28 (0.656)	-1.45 (0.649)	-2.08 (0.700)	-3.22 (0.779)
Motor Exam	Number Analyzed	57 participants	71 participants	61 participants	52 participants
		-0.12 (1.343)	-3.39 (1.240)	-3.40 (1.331)	-4.35 (1.434)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Motor Experiences of Daily Living
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.061
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.74
	Confidence Interval	(2-Sided) 95%; -3.56 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.923
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Motor Experiences of Daily Living
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.014
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.37
	Confidence Interval	(2-Sided) 95%; -4.26 to -0.47
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.960
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Motor Experiences of Daily Living
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.50
	Confidence Interval	(2-Sided) 95%; -5.50 to -1.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.013
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Motor Exam
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.074
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.27
	Confidence Interval	(2-Sided) 95%; -6.86 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.822
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Motor Exam
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.085
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.27
	Confidence Interval	(2-Sided) 95%; -7.00 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.891
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Motor Exam
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.032
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.23
	Confidence Interval	(2-Sided) 95%; -8.09 to -0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.959
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3
Description	Number of participants who met the potentially clinically significant vital signs criteria at 3 consecutive time points at visit 3 were reported. In the event of an unacceptable rate of participants meeting day 1 stopping rules at other doses, adjustments to doses may be made for subsequently randomized participants at the discretion of the internal assessment committee (IAC).
Time Frame	Visit 3 (Day 1 stopping rules)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	86	86	65	87
Measure Type: Count of Participants; Unit of Measure: Participants
	0	0	1	1

13. Secondary Outcome

Title	Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose
Description	Systolic and diastolic blood pressure obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame	Baseline, 8 Hours Post Dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	81	82	79	85
Least Squares Mean (Standard Error); Unit of Measure: millimeter of mercury (mmHg)
Sitting Systolic Blood Pressure	9.8 (1.90)	10.1 (1.89)	10.4 (1.92)	19.2 (1.87)
Sitting Diastolic Blood Pressure	4.6 (0.99)	4.9 (0.98)	5.5 (1.00)	8.1 (0.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.898
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -4.92 to 5.61
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.821
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -4.71 to 5.94
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.4
	Confidence Interval	(2-Sided) 95%; 4.11 to 14.61
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.805
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -2.40 to 3.08
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.513
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -1.85 to 3.69
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 0.83 to 6.28
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Change From Baseline in Pulse Rate to 8 Hours Post Dose
Description	Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame	Baseline, 8 Hours Post Dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	81	82	79	85
Least Squares Mean (Standard Error); Unit of Measure: beats/min
	-2.2 (0.94)	0.2 (0.95)	1.3 (0.95)	6.4 (0.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.065
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; -0.16 to 5.08
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 0.93 to 6.21
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	8.7
	Confidence Interval	(2-Sided) 95%; 6.06 to 11.27
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Change From Baseline In-clinic BP to Week 12
Description	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	74	77	65	56
Least Squares Mean (Standard Error); Unit of Measure: millimeters of mercury (mmHg)
Sitting Systolic Blood Pressure	-1.2 (1.22)	0.5 (1.19)	0.1 (1.29)	3.0 (1.38)
Sitting Diastolic Blood Pressure	-0.9 (0.71)	-1.0 (0.70)	-0.2 (0.75)	0.3 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.339
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -1.72 to 4.99
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.486
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -2.26 to 4.73
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.024
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95%; 0.56 to 7.81
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.935
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -2.04 to 1.88
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.505
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -1.34 to 2.72
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.266
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; -0.91 to 3.30
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Change From Baseline in Pulse Rate to Week 12
Description	Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	74	77	65	56
Least Squares Mean (Standard Error); Unit of Measure: beats/min
	-0.2 (0.67)	0.3 (0.66)	1.5 (0.71)	2.6 (0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.550
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -1.28 to 2.41
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.069
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -0.14 to 3.68
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; 0.89 to 4.83
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12
Description	Systolic and diastolic blood pressure obtained from ABPM was evaluated. Participants followed a standardized measurement protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	48	51	41	41
Least Squares Mean (Standard Error); Unit of Measure: mmHg
Sitting Systolic Blood Pressure	-1.1 (2.52)	-8.2 (2.40)	2.0 (2.58)	-2.2 (2.62)
Sitting Diastolic Blood Pressure	1.5 (1.50)	-2.8 (1.45)	1.0 (1.55)	-0.8 (1.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.045
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -13.92 to -0.15
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.390
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; -4.05 to 10.32
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sitting Systolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.768
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -8.32 to 6.16
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.041
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.3
	Confidence Interval	(2-Sided) 95%; -8.48 to -0.17
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.802
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -4.81 to 3.72
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Sitting Diastolic Blood Pressure
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.284
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -6.67 to 1.97
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Change in HBPM for Pulse Rate From Baseline to Week 12
Description	Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to week 12 and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	48	51	41	41
Least Squares Mean (Standard Error); Unit of Measure: beats/min
	1.4 (1.52)	1.4 (1.47)	0.7 (1.59)	0.8 (1.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.996
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -4.17 to 4.19
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.767
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -4.99 to 3.69
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.791
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -4.96 to 3.79
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit
Description	The Penn PWC-20 is a 20-item checklist originally developed to assess the severity of withdrawal symptoms in anxiolytic medication discontinuation. To determine a change in the Intensity of Discontinuation symptoms, the PWC-20 administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3. 0. Not present; Mild; Moderate; Severe Total scores range from 0 to 60 with higher scores indicating more severe symptoms.Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Time Frame	Week 12, Follow-up (2 Weeks after Week 12)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline PWC-20 data.

Arm/Group Title	Placebo	10 mg LY3154207	30 mg LY3154207	75 mg LY3154207
Arm/Group Description:	Participants received placebo administered orally QD.	Participants received 10 mg LY3154207 administered orally QD.	Participants received 30 mg LY3154207 administered orally QD.	Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed	35	33	32	24
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 12	-1.51 (0.670)	-0.53 (0.690)	-0.47 (0.701)	0.05 (0.811)
Follow-up	-1.27 (0.844)	0.12 (0.877)	0.13 (0.904)	3.32 (1.040)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 10 mg LY3154207
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.312
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; -0.93 to 2.88
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 30 mg LY3154207
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.289
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; -0.89 to 2.95
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 75 mg LY3154207
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.141
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; -0.53 to 3.65
	Estimation Comments	[Not Specified]