IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.