Impact Of Viagra On Sexual Satisfaction Of Men With Mild... | NCT00301262

Name	Class
Pfizer	INDUSTRY

Name	Type	Description	Arm Group Labels	Other Names
Viagra (Sildenafil citrate)	Drug

Impact Of Viagra On Sexual Satisfaction Of Men With Mild... | NCT00301262 | Trialant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)	adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index	Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).	Week 8, Week 14
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Calgary	Alberta	T2L 1K8	Canada
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28892218	Derived	Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DB Viagra / OL Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

No data available

No data is available for this block.

More Info Module

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects
Lack of Efficacy		FG0000 subjects FG0011 subjects
Lost to Follow-up		FG0003 subjects FG0013 subjects
Withdrawal by Subject		FG0005 subjects FG0015 subjects
Other		FG0001 subjects FG0014 subjects

Open Label Phase (OL)

Type	Comment	Milestone Data
STARTED		FG00083 subjects FG00169 subjects
COMPLETED		FG00079 subjects FG00167 subjects
NOT COMPLETED		FG0004 subjects FG0012 subjects

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects
Lost to Follow-up		FG0001 subjects FG001

Arm/Group Information

ID	Title	Description
BG000	Start : DB Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
BG001	Start : DB Placebo	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

DB Viagra/OL Viagra=52.2+/-12.1(n=83) DB Placebo/OL Viagra=48.4+/-12.2(n=69)

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051.6± 12.5 BG00148.0± 11.9 BG00249.9± 12.3

Sex: Female, Male

DB Viagra/OL Viagra Male/Female=83/0 DB Placebo/OL Viagra Male/Female=69/0

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)

adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).

number of subjects in the Full Analysis Set (FAS) population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG00088 OG00173

Title

Denominators

Categories

Title	Measurements
	OG00080.27± 2.329 OG00162.15± 2.524

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.	ANCOVA		<0.0001	Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.	Mean Difference (Final Values)	18.13	Standard Error of the Mean	3.405		95	11.40	24.86			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.

Secondary

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index

Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score

adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Patient Reported Erectile Function Assessment (PREFA) Total Score

PREFA Total Score: 8 = worst, 32 = best.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra /OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function

adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function

adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire

adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction

adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction

adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

International Index of Erectile Function (IIEF) Domain Scores- Erectile Function

Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function

Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire

Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction

Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction

Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score

adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Erectile Distress Scale (EDS) Total Score

Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score

adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).

number of subjects in the FAS population with an observation

Posted

Least Squares Mean

Standard Error

scores on a scale

Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG000

Secondary

Quality of Erection Questionnaire (QEQ) Total Score

QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).

Full Analysis Set

Posted

Mean

Standard Deviation

scores on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)

GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.

number of subjects in the FAS population with an observation

Posted

Number

percentage of subjects

Week 8, Week 14

ID	Title	Description
OG000	Week 8 DB Viagra
OG001	Week 8 DB Placebo
OG002	Week 14 DB Viagra/OL Viagra
OG003	Week 14 DB Placebo/OL Viagra

Units	Counts
Participants

Secondary

Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)

GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.

number of subjects in the FAS population with an observation

Posted

Number

percentage of subjects

Week 8, Week 14

ID	Title	Description
OG000	Week 8 DB Viagra
OG001	Week 8 DB Placebo
OG002	Week 14 DB Viagra/OL Viagra
OG003	Week 14 DB Placebo/OL Viagra

Units	Counts
Participants

Secondary

Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)

GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.

number of subjects in the FAS population with an observation

Posted

Number

percentage of subjects

Week 8, Week 14

ID	Title	Description
OG000	Week 8 DB Viagra
OG001	Week 8 DB Placebo
OG002	Week 14 DB Viagra/OL Viagra
OG003	Week 14 DB Placebo/OL Viagra

Units	Counts
Participants

Secondary

Percentage of Occasions of Successful Intercourse (Event Log)

Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to Week 8

ID	Title	Description
OG000	DB Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
OG001	DB Placebo	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Units	Counts
Participants

Secondary

Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

Percentage of occasions

Baseline to Week 8

ID	Title	Description
OG000	DB Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
OG001	DB Placebo	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Units	Counts
Participants

Secondary

Percentage of Occasions of Successful Intercourse (Event Log)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Week 8 to Week 14

ID	Title	Description
OG000	DB Viagra / OL Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
OG001	DB Placebo/OL Viagra	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).

Secondary

Percentage of Occasions of Ejaculation and/or Orgasm Event Log

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Week 8 to Week 14

ID	Title	Description
OG000	DB Viagra / OL Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
OG001	DB Placebo/OL Viagra	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).

Secondary

Change From Baseline to Week 8 in Analog Scales- Firmness

mean change - scale of 0 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

baseline to Week 8

ID	Title	Description
OG000	DB Viagra
OG001	DB Placebo

Units	Counts
Participants	OG00089 OG001

Secondary

Change From Baseline to Week 8 in Analog Scales- Maintenance

mean change - scale of 0 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

baseline to Week 8

ID	Title	Description
OG000	DB Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
OG001	DB Placebo	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 8 in Analog Scales- Reliability

mean change - scale of 0 (worst) to 10 (best).

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

baseline to Week 8

ID	Title	Description
OG000	DB Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
OG001	DB Placebo	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 8 in Analog Scales- General Sexual Performance

mean change - scale of 0 (worst) to 10 (best)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

baseline to week 8

ID	Title	Description
OG000	DB Viagra	Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
OG001	DB Placebo	Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).

Units	Counts
Participants	OG000

Secondary

Analog Scales- Firmness

mean - scale of 0 (worst) to 10 (best)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Analog Scales- Maintenance

mean - scale of 0 (worst) to 10 (best)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Analog Scales- Reliability

mean - scale of 0 (worst) to 10 (best)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Analog Scales- General Sexual Performance

mean - scale of 0 (worst) to 10 (best)

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

units on a scale

Week 8, Week 14

ID	Title	Description
OG000	DB Viagra Week 8
OG001	DB Viagra/OL Viagra Week 14
OG002	DB Placebo Week 8
OG003	DB Placebo/OL Viagra Week 14

Units	Counts
Participants	OG000

Secondary

Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1

number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.

Posted

Number

subjects

Week 8 to Week 14

ID	Title	Description
OG000	DB Viagra / OL Viagra
OG001	DB Placebo/ OL Viagra

Units	Counts
Participants	OG000

Secondary

Shift in Responder Rate From Week 8 to Week 14 for GEQ2

number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.

Posted

Number

subjects

Week 8 to Week 14

ID	Title	Description
OG000	DB Viagra / OL Viagra
OG001	DB Placebo / OL Viagra

Units	Counts
Participants	OG000

Secondary

Shift in Responder Rate From Week 8 to Week 14 for GEQ3

GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.

number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.

Posted

Number

subjects

Week 8 to Week 14

ID	Title	Description
OG000	DB Viagra / OL Viagra
OG001	DB Placebo / OL Viagra

Units	Counts
Participants	OG000

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0

Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline to < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1

Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <= Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2

Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3

Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4

Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4

Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0

Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1

Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2

Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3

Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4

Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4

Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Secondary

Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections

Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

number of subjects in the FAS population with an observation

Posted

Mean

Standard Deviation

percentage of occasions

Baseline to <Week 8 and Week 8 to <=Week 14

ID	Title	Description
OG000	DB Viagra Baseline < Week 8
OG001	DB Placebo Baseline < Week 8
OG002	DB Viagra/OL Viagra Week 8 to <=Week 14
OG003	DB Placebo/OL Viagra Week 8 to <=Week 14

Units	Counts
Participants

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological
D052801	Male Urogenital Diseases
D020018	Sexual Dysfunctions, Psychological
D001523	Mental Disorders

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457	Sulfur Compounds
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0028		Mean Difference (Net)	5.09	Standard Deviation	14.761		95	1.800	8.370			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	26.02	Standard Deviation	22.294		95	20.580	31.455			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0080		Mean Difference (Final Values)	1.76	Standard Error of the Mean	0.656		95	0.47	3.06			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0051		Mean Difference (Net)	0.94	Standard Deviation	2.909		95	0.290	1.585			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	2.79	Standard Deviation	4.013		95	1.812	3.770			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0054		Mean Difference (Final Values)	2.61	Standard Error of the Mean	0.922		95	0.78	4.43			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.4232		Mean Difference (Final Values)	0.30	Standard Error of the Mean	0.368		95	-0.43	1.02			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0156		Mean Difference (Final Values)	0.68	Standard Error of the Mean	0.277		95	0.13	1.22			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0096		Mean Difference (Final Values)	1.20	Standard Error of the Mean	0.458		95	0.30	2.11			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0135		Mean Difference (Final Values)	0.90	Standard Error of the Mean	0.359		95	0.19	1.61			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0033		Mean Difference (Net)	1.49	Standard Deviation	4.392		95	0.0510	2.465			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	5.22	Standard Deviation	6.346		95	3.676	6.772			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.2581		Mean Difference (Net)	0.20	Standard Deviation	1.570		95	-0.149	0.549			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	1.39	Standard Deviation	2.582		95	0.758	2.018			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.2857		Mean Difference (Net)	0.18	Standard Deviation	1.456		95	-0.149	0.499			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		0.0005		Mean Difference (Net)	0.76	Standard Deviation	1.706		95	0.345	1.177			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0102		Mean Difference (Net)	0.75	Standard Deviation	2.548		95	0.183	1.317			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	2.28	Standard Deviation	2.979		95	1.557	3.010			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0016		Mean Difference (Net)	0.68	Standard Deviation	1.847		95	0.264	1.086			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	1.90	Standard Deviation	2.297		95	1.335	2.456			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0083		Mean Difference (Final Values)	2.78	Standard Error of the Mean	1.038		95	0.73	4.83			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.9146		Mean Difference (Net)	-0.06	Standard Deviation	5.193		95	-1.218	1.093			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	5.54	Standard Deviation	6.463		95	3.961	7.114			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0002		Mean Difference (Final Values)	18.42	Standard Error of the Mean	4.826		95	8.88	27.96			Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0064		Mean Difference (Net)	6.41	Standard Deviation	20.444		95	1.857	10.956			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	26.80	Standard Deviation	29.384	2-Sided	95	19.636	33.971			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.0001		Odds Ratio (OR)	6.491				95	3.042	13.851					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		<0.0001		Odds Ratio (OR)	4.915				95	2.396	10.080					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.0187		Odds Ratio (OR)	3.676				95	1.242	10.875					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		independent-samples t-test		0.0037		Mean Difference (Net)	13.90	Standard Error of the Mean	4.716		95	4.59	23.22			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		independent-samples t-test		0.0321		Mean Difference (Net)	9.72	Standard Error of the Mean	4.496		95	0.84	18.60			Mean Difference = Week 8 - Baseline		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		independent-samples t-test		0.0427		Mean Difference (Net)	-7.97	Standard Error of the Mean	3.901		95	-15.68	-0.27			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		independent-samples t-test		0.0533		Mean Difference (Net)	-7.60	Standard Error of the Mean	3.903		95	-15.32	0.11			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		2-sample independent t-test		0.0002		Mean Difference (Net)	1.1670	Standard Error of the Mean	0.3041		95	0.566	1.768			A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		2-sample independent t-test		0.0001		Mean Difference (Net)	1.4454	Standard Error of the Mean	0.3638		95	0.727	2.164			A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		2-sample independent t-test		0.0032		Mean Difference (Net)	1.1821	Standard Error of the Mean	0.3946		95	0.403	1.961			A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		2-sample independent t-test		0.0008		Mean Difference (Net)	1.2123	Standard Error of the Mean	0.3549		95	0.511	1.913			A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0195		Mean Difference (Net)	0.39	Standard Deviation	1.454		95	0.064	0.711			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	2.09	Standard Deviation	2.207		95	1.551	2.628			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0186		Mean Difference (Net)	0.40	Standard Deviation	1.489		95	0.069	0.731			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	2.67	Standard Deviation	2.573		95	2.044	3.299			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0033		Mean Difference (Net)	0.65	Standard Deviation	1.917		95	0.223	1.077			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	2.61	Standard Deviation	2.335		95	2.042	3.182			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		paired t-test		0.0143		Mean Difference (Net)	0.45	Standard Deviation	1.606		95	0.093	0.807			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)
OG002 OG003		paired t-test		<0.0001		Mean Difference (Net)	1.99	Standard Deviation	2.178		95	1.454	2.516			A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).		Superiority or Other (legacy)

Title

Denominators

Categories

Responder at Week 8 / Responder at Week 14

Title	Measurements
	OG00061 OG00127

Responder at Week 8 / Non-Responder at Week 14

Title	Measurements
	OG0003 OG0010

Non-Responder at Week 8 / Responder at Week 14

Title	Measurements
	OG00011 OG00136

Non-Responder at Week 8 / Non-Responder at Week 14

Title	Measurements
	OG0005 OG0014

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.	McNemar		0.0325							95							Superiority or Other (legacy)
OG001	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.	McNemar		<0.0001							95							Superiority or Other (legacy)

Title

Denominators

Categories

Responder at Week 8 / Responder at Week 14

Title	Measurements
	OG00060 OG00129

Responder at Week 8 / Non-Responder at Week 14

Title	Measurements
	OG0001 OG0010

Non-Responder at Week 8 / Responder at Week 14

Title	Measurements
	OG0008 OG00133

Non-Responder at Week 8 / Non-Responder at Week 14

Title	Measurements
	OG00010 OG0015

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.	McNemar		0.0196							95							Superiority or Other (legacy)
OG001	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.	McNemar		<0.0001							95							Superiority or Other (legacy)

Title

Denominators

Categories

Responder at Week 8 / Responder at Week 14

Title	Measurements
	OG00074 OG00154

Responder at Week 8 / Non-Responder at Week 14

Title	Measurements
	OG0000 OG0010

Non-Responder at Week 8 / Responder at Week 14

Title	Measurements
	OG0001 OG00110

Non-Responder at Week 8 / Non-Responder at Week 14

Title	Measurements
	OG0004 OG0011

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.	McNemar		0.3173							95							Superiority or Other (legacy)
OG001	Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.	McNemar		0.0016							95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.0624		Mean Difference (Net)	-5.55	Standard Error of the Mean	2.958		95	-11.39	0.29			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.4523		Mean Difference (Net)	1.38	Standard Error of the Mean	1.835		95	-2.24	5.01			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.2081		Mean Difference (Net)	-2.48	Standard Error of the Mean	1.962		95	-6.35	1.40			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.4131		Mean Difference (Net)	1.61	Standard Error of the Mean	1.958		95	-2.26	5.48			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.4069		Mean Difference (Net)	-1.77	Standard Error of the Mean	2.126		95	-5.97	2.43			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.1137		Mean Difference (Net)	2.37	Standard Error of the Mean	1.489		95	-0.57	5.31			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.0123		Mean Difference (Net)	-12.23	Standard Error of the Mean	4.829		95	-21.77	-2.70			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.8993		Mean Difference (Net)	-0.62	Standard Error of the Mean	4.883		95	-10.27	9.03			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		<0.0001		Mean Difference (Net)	22.03	Standard Error of the Mean	5.458		95	11.25	32.81			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.4165		Mean Difference (Net)	-4.74	Standard Error of the Mean	5.818		95	-16.24	6.76			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.0257		Mean Difference (Net)	9.80	Standard Error of the Mean	4.351		95	1.21	18.39			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.0971		Mean Difference (Net)	-5.36	Standard Error of the Mean	3.209		95	-11.70	0.98			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.0726		Mean Difference (Net)	-3.18	Standard Error of the Mean	1.754		95	-6.66	0.30			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.2581		Mean Difference (Net)	-2.04	Standard Error of the Mean	1.798		95	-5.61	1.52			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.8158		Mean Difference (Net)	-1.04	Standard Error of the Mean	4.450		95	-9.86	7.78			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.8464		Mean Difference (Net)	-0.33	Standard Error of the Mean	1.692		95	-3.68	3.02			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.9529		Mean Difference (Net)	-0.34	Standard Error of the Mean	5.789		95	-11.82	11.13			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.8899		Mean Difference (Net)	-0.69	Standard Error of the Mean	4.994		95	-10.59	9.20			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.2001		Mean Difference (Net)	-10.18	Standard Error of the Mean	7.897		95	-25.83	5.47			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.1527		Mean Difference (Net)	9.68	Standard Error of the Mean	6.724		95	-3.64	23.01			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.0606		Mean Difference (Net)	14.74	Standard Error of the Mean	7.774		95	-0.67	30.15			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.3678		Mean Difference (Net)	-6.62	Standard Error of the Mean	7.318		95	-21.12	7.88			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.5429		Mean Difference (Net)	4.56	Standard Error of the Mean	7.474		95	-10.25	19.37			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.5849		Mean Difference (Net)	3.07	Standard Error of the Mean	5.595		95	-8.02	14.15			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Independent-samples t-test		0.0002		Mean Difference (Net)	18.86	Standard Error of the Mean	4.952		95	9.08	28.64			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)
OG002 OG003		Independent-samples t-test		0.4290		Mean Difference (Net)	4.93	Standard Error of the Mean	6.212		95	-7.35	17.20			Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.		Superiority or Other (legacy)