Trial Outcomes & Findings for Effects of Oral Sildenafil on Mortality in Adults With PAH (NCT NCT02060487)

NCT ID: NCT02060487

Last Updated: 2022-05-13

Results Overview

In this outcome measure number of deaths during the study were reported.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 385 participants
• Primary outcome timeframe: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
• Results posted on: 2022-05-13

Participant Flow

This was a randomized, double-blind, parallel-group, multinational and multicenter study to assess the effects of oral sildenafil on mortality in adult participants with pulmonary arterial hypertension (PAH). The study was conducted at 68 active sites in 23 countries.

Participant milestones

Measure	Sildenafil 5 mg Participants received a single tablet of sildenafil at a dose of 5 milligram (mg) along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally thrice daily (TID) until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Overall Study STARTED	129	128	128
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	129	128	128

Reasons for withdrawal

Measure	Sildenafil 5 mg Participants received a single tablet of sildenafil at a dose of 5 milligram (mg) along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally thrice daily (TID) until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Overall Study Other	1	2	1
Overall Study Lack of Efficacy	0	1	0
Overall Study Withdrawal by Subject	3	10	4
Overall Study Study Terminated By Sponsor	87	89	100
Overall Study Randomized in error	1	0	0
Overall Study Protocol Violation	0	1	1
Overall Study Lost to Follow-up	3	0	2
Overall Study Death	34	25	19
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Effects of Oral Sildenafil on Mortality in Adults With PAH

Baseline characteristics by cohort

Measure	Sildenafil 5 mg n=129 Participants Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=128 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=128 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Total n=385 Participants Total of all reporting groups
Age, Continuous	51.4 Years STANDARD_DEVIATION 15.02 • n=5 Participants	51.2 Years STANDARD_DEVIATION 15.81 • n=7 Participants	52.1 Years STANDARD_DEVIATION 14.72 • n=5 Participants	51.6 Years STANDARD_DEVIATION 15.16 • n=4 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	102 Participants n=7 Participants	98 Participants n=5 Participants	297 Participants n=4 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	26 Participants n=7 Participants	30 Participants n=5 Participants	88 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=5 Participants	124 Participants n=7 Participants	125 Participants n=5 Participants	373 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	113 Participants n=7 Participants	108 Participants n=5 Participants	325 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)

Population: The intent-to-treat population (ITT) included all randomized participants treated with study treatment.

In this outcome measure number of deaths during the study were reported.

Outcome measures

Measure	Sildenafil 5 mg n=129 Participants Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=128 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=128 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Overall Survival	34 Participants	25 Participants	19 Participants

SECONDARY outcome

Timeframe: Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)

Population: ITT population included all randomized participants treated with study treatment.

Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure [RHF], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.

Outcome measures

Measure	Sildenafil 5 mg n=129 Participants Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=128 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=128 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Number of Participants With Clinical Worsening Events	52 Participants	36 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population included all randomized participants treated with study treatment. Here, "overall number of participants analyzed" signifies number of participants who were evaluable for this outcome measure.

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.

Outcome measures

Measure	Sildenafil 5 mg n=113 Participants Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=118 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=116 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6	12.2 Meters Interval -0.67 to 25.16	27.3 Meters Interval 14.52 to 39.99	31.2 Meters Interval 18.68 to 43.66

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population included all randomized participants treated with study treatment. Here, "overall number of participants analyzed" signifies number of participants who were evaluable for this outcome measure.

6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.

Outcome measures

Measure	Sildenafil 5 mg n=88 Participants Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=89 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=89 Participants Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12	14.3 Meters Interval -0.58 to 29.27	35.7 Meters Interval 20.91 to 50.48	34.8 Meters Interval 20.21 to 49.43

Adverse Events

Sildenafil 5 mg

Serious events: 66 serious events

Other events: 108 other events

Deaths: 34 deaths

Sildenafil 20 mg

Serious events: 49 serious events

Other events: 107 other events

Deaths: 25 deaths

Sildenafil 80 mg

Serious events: 51 serious events

Other events: 111 other events

Deaths: 19 deaths

Serious adverse events

Measure	Sildenafil 5 mg n=129 participants at risk Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=128 participants at risk Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=128 participants at risk Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Blood and lymphatic system disorders Anaemia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Acute coronary syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Atrial flutter	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Bradyarrhythmia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac arrest	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac failure	7.0% 9/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac failure acute	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac failure congestive	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiogenic shock	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Coronary artery disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Left ventricular failure	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Myocardial ischaemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Pericardial effusion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Right ventricular failure	8.5% 11/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Supraventricular extrasystoles	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Dyspepsia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastritis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Inguinal hernia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Pancreatitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Umbilical hernia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Chest pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Condition aggravated	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Death	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Disease progression	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Exercise tolerance decreased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders General physical health deterioration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Multiple organ dysfunction syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Oedema	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Peripheral swelling	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Sudden cardiac death	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Sudden death	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Vascular stent stenosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cholecystitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cholecystitis acute	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatic failure	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Portal vein thrombosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Drug hypersensitivity	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Appendicitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Bronchitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Cellulitis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Cystitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Dengue fever	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Diarrhoea infectious	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Encephalitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Endocarditis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Erysipelas	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Escherichia urinary tract infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gangrene	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastroenteritis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastroenteritis viral	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastrointestinal infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations H1N1 influenza	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Infectious pleural effusion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Influenza	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Klebsiella bacteraemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Leptospirosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Lower respiratory tract infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Lung abscess	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Osteomyelitis chronic	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Parainfluenzae virus infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pharyngitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pneumonia	5.4% 7/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pneumonia influenzal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Postoperative wound infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Respiratory tract infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Sepsis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Septic shock	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Sinusitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Staphylococcal infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Streptococcal bacteraemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Upper respiratory tract infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Viral infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Haemodynamic test	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Haemoglobin decreased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Weight decreased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Cachexia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Fluid overload	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypovolaemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Connective tissue disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Oligoarthritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic malignant fibrous histiocytoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Ataxia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Dizziness	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Guillain-Barre syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Migraine	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Presyncope	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Sciatica	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Syncope	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Product Issues Device dislocation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Delusion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Acute kidney injury	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Renal failure	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	13.2% 17/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Systemic sclerosis pulmonary	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord dysfunction	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Vasculitic rash	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Drug therapy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Hospitalisation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Lung transplant	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Aortic stenosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Hypertension	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Peripheral arterial occlusive disease	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Shock	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Varicose ulceration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.

Other adverse events

Measure	Sildenafil 5 mg n=129 participants at risk Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 20 mg n=128 participants at risk Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	Sildenafil 80 mg n=128 participants at risk Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
Investigations Blood iron decreased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood potassium abnormal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood pressure decreased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood pressure diastolic decreased	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood pressure increased	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood pressure measurement	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood urea increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood uric acid increased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Body temperature increased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Breath sounds abnormal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Colonoscopy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Endoscopy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Fibrin D dimer increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Haemodynamic test	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Heart rate	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Anaemia	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	8.6% 11/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Bicytopenia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Cytopenia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Hypothrombinaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Increased tendency to bruise	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Heart rate decreased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Macrocytosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Polycythaemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Angina pectoris	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Arrhythmia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Atrial fibrillation	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Atrial flutter	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Atrial thrombosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Atrioventricular block first degree	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Bradycardia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac failure	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac failure acute	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac failure congestive	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Cardiac ventricular thrombosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Coronary artery stenosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Extrasystoles	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Palpitations	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Right ventricular dysfunction	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Right ventricular failure	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Supraventricular extrasystoles	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Tachycardia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Tricuspid valve incompetence	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Ventricular extrasystoles	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Cardiac disorders Ventricular tachycardia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Congenital, familial and genetic disorders Atrial septal defect	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Congenital, familial and genetic disorders Thyroid malformation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Cerumen impaction	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Ear congestion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Ear pain	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Hypoacusis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Mixed deafness	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Tinnitus	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Ear and labyrinth disorders Vertigo	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Cushing's syndrome	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Hypothyroidism	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Primary hypothyroidism	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Endocrine disorders Thyroid mass	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Asthenopia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Astigmatism	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Blepharitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Cataract	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Chalazion	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Chromatopsia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Conjunctival haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Cornea verticillata	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Corneal oedema	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Corneal opacity	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Dacryostenosis acquired	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Dark circles under eyes	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Diplopia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Dry eye	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Dyschromatopsia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye inflammation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye irritation	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye pruritus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Eye swelling	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Foreign body sensation in eyes	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Glaucoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Hypermetropia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Keratitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Lacrimation increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Macular degeneration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Maculopathy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Ocular hyperaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Periorbital pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Periorbital swelling	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Photophobia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Photopsia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Pterygium	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Retinal vascular disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Swelling of eyelid	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Vision blurred	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Visual impairment	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Visual snow syndrome	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Eye disorders Xerophthalmia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Abdominal discomfort	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Abdominal distension	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Abdominal pain	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Abdominal pain upper	4.7% 6/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	5.5% 7/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	8.6% 11/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Abdominal symptom	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Angular cheilitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Ascites	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Chronic gastritis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Colitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Constipation	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Dental necrosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Diarrhoea	10.1% 13/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	13.3% 17/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	15.6% 20/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Diverticulum intestinal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Duodenal bulb deformity	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Duodenal ulcer	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Duodenal vascular ectasia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Duodenogastric reflux	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Dyspepsia	4.7% 6/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Enteritis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Enterocolitis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Epigastric discomfort	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Eructation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Faeces discoloured	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Flatulence	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Food poisoning	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Frequent bowel movements	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastric disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastric polyps	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastritis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastritis erosive	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gingival bleeding	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Gingival pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Hiatus hernia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Intestinal polyp	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Irritable bowel syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Large intestine polyp	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Nausea	12.4% 16/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	9.4% 12/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Oesophageal disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Peptic ulcer	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Rectal haemorrhage	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Tongue erythema	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Tongue ulceration	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Toothache	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Umbilical hernia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Varices oesophageal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Gastrointestinal disorders Vomiting	5.4% 7/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	5.5% 7/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Asthenia	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	5.5% 7/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Catheter site erythema	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Chest discomfort	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Chest pain	5.4% 7/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	11.7% 15/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.2% 13/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Chills	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Crying	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Cyst	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Disease progression	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Face oedema	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Facial pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Fatigue	8.5% 11/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.0% 9/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Feeling cold	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Feeling hot	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Gait disturbance	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders General physical health deterioration	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Generalised oedema	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Ill-defined disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Inflammation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Influenza like illness	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Infusion site pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Injection site hypersensitivity	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Malaise	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Mucosal dryness	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Oedema	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Oedema peripheral	10.9% 14/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	13.3% 17/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Pain	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Peripheral swelling	5.4% 7/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Pyrexia	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.0% 9/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.0% 9/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Swelling	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Swelling face	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Ulcer	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Vessel puncture site bruise	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
General disorders Vessel puncture site haematoma	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Biliary dilatation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cardiac cirrhosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cholecystitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cholecystocholangitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Cholelithiasis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Congestive hepatopathy	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatic cirrhosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatomegaly	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hepatosplenomegaly	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Liver disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Hepatobiliary disorders Ocular icterus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Allergy to arthropod bite	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Drug hypersensitivity	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Food allergy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Hypersensitivity	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Multiple allergies	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Seasonal allergy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Immune system disorders Secondary immunodeficiency	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Abdominal abscess	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Acute sinusitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Bacterial disease carrier	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Bacterial infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Bacterial rhinitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Bronchitis	8.5% 11/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	8.6% 11/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Bronchitis viral	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations COVID-19	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Cellulitis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Chronic sinusitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Chronic tonsillitis 0 0	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Conjunctivitis	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Cystitis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Device related infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Device related sepsis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Diverticulitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Ear infection	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Enteritis infectious	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Erysipelas	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Eye infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastric infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastroenteritis	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastrointestinal candidiasis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastrointestinal infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gastrointestinal viral infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Genital infection female	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Gingivitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Groin abscess	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Helicobacter gastritis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Helicobacter infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Hepatitis B	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Herpes simplex	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Herpes virus infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Herpes zoster	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Hordeolum	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Incision site abscess	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Influenza	4.7% 6/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	8.6% 11/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Joint abscess	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Laryngitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Localised infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Lower respiratory tract infection	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Nasopharyngitis	14.7% 19/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	12.5% 16/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	14.8% 19/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Oesophageal candidiasis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Onychomycosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Oral candidiasis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Oral fungal infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Oral herpes	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Otitis media	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Otitis media chronic	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Paronychia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Periodontitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pharyngitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pharyngitis bacterial	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pneumonia	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pulpitis dental	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Pyelonephritis chronic	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Respiratory tract infection	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Respiratory tract infection viral	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Rhinitis	3.9% 5/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Salpingo-oophoritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Sinusitis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Skin infection	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tinea pedis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tongue fungal infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tonsillitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tonsillitis bacterial	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tooth abscess	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tracheitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Tracheobronchitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Upper respiratory tract infection	12.4% 16/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	6.2% 8/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.2% 13/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Urinary tract infection	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Vaginal infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Varicella	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Viral infection	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Viral rhinitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Viral upper respiratory tract infection	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Heart rate increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Back injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Burn oral cavity	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Chest injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Contusion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Exposure via breast milk	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Fall	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Ligament sprain	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Limb injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Muscle injury	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Muscle strain	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Oral contusion	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Procedural pain	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Road traffic accident	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Scar	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Skin abrasion	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Skin laceration	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Soft tissue injury	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Tooth fracture	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Alanine aminotransferase increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood albumin abnormal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood alkaline phosphatase increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood bilirubin increased	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood cholesterol increased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood creatinine increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Blood glucose decreased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Heart sounds abnormal	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Liver function test abnormal	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Oxygen saturation decreased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Platelet count decreased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Protein total abnormal	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations SARS-CoV-2 test positive	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Staphylococcus test positive	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Transaminases increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Troponin increased	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Ultrasound scan	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Venous pressure jugular increased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Vitamin D decreased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Walking distance test abnormal	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Weight decreased	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations Weight increased	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Investigations White blood cell count increased	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Cachexia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Calcium deficiency	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Decreased appetite	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Fluid overload	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Fluid retention	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Glucose tolerance impaired	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Gout	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hyperkalaemia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hyperuricaemia	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypokalaemia	7.8% 10/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Insulin resistance	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Mineral metabolism disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Obesity	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Steroid diabetes	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	10.9% 14/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.2% 13/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	11.7% 15/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Arthritis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Back pain	12.4% 16/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.9% 14/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Limb mass	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Muscle contracture	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	7.8% 10/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	9.4% 12/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteochondrosis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	4.7% 6/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.9% 14/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Pain in jaw	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Sclerodactylia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Scleroderma	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Spinal disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Systemic scleroderma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Musculoskeletal and connective tissue disorders Undifferentiated connective tissue disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage IV	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Ageusia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Amnesia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Anosmia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Aphasia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Balance disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Burning sensation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Carpal tunnel syndrome	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Cerebral atrophy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Cervical radiculopathy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Cognitive disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Diabetic neuropathy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Dizziness	9.3% 12/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	11.7% 15/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	14.1% 18/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Dizziness exertional	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Encephalopathy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Epilepsy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Head discomfort	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Headache	20.2% 26/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	35.2% 45/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	25.8% 33/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Hypoaesthesia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Hypotonia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Intercostal neuralgia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Lethargy	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Loss of consciousness	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Migraine	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Neuralgia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Neuritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Paraesthesia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Postictal paralysis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Presyncope	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Radiculopathy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Sciatica	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Sensory loss	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Sinus headache	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Somnolence	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Syncope	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Tension headache	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Tremor	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Trigeminal neuralgia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Trigeminal neuritis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Nervous system disorders Vascular encephalopathy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Product Issues Device breakage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Product Issues Device fastener issue	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Anxiety	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Apathy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Confusional state	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Depressed mood	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Depression	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Emotional disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Initial insomnia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Insomnia	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Mental disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Mood altered	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Mood swings	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Nervousness	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Psychiatric disorders Sleep disorder	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Acute kidney injury	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Azotaemia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Dysuria	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Haematuria	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Proteinuria	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Renal cyst	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Renal failure	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Renal impairment	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Renal and urinary disorders Urinary retention	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Amenorrhoea	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Breast cyst	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Breast inflammation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Breast mass	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Endometriosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Menorrhagia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Priapism	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Uterine polyp	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Cough	10.9% 14/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	8.6% 11/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	9.4% 12/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.3% 12/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	12.5% 16/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	8.6% 11/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Emphysema	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.5% 11/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.2% 13/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	10.2% 13/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 8/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Prolonged expiration	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	7.8% 10/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	5.5% 7/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary vascular disorder	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Sinonasal obstruction	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Vasomotor rhinitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Chronic spontaneous urticaria	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Erythema	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Pruritus	3.1% 4/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Rash	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Rash erythematous	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Rash macular	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin disorder	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Skin ulcer	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Skin and subcutaneous tissue disorders Yellow skin	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Cancer surgery	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Cardiac ablation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Cataract operation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Dental operation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Haematoma evacuation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Myomectomy	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Tooth extraction	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Tooth repair	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Surgical and medical procedures Vascular operation	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Aortic stenosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Cyanosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Flushing	4.7% 6/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.1% 4/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Haematoma	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Haemorrhage	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Hot flush	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	2.3% 3/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	1.6% 2/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Hyperaemia	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Hypertension	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	3.9% 5/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Hypertensive crisis	2.3% 3/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Hypotension	7.0% 9/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	4.7% 6/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	5.5% 7/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Jugular vein thrombosis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Labile blood pressure	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Lymphoedema	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Neovascularisation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Pelvic venous thrombosis	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Peripheral venous disease	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Phlebitis	1.6% 2/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Raynaud's phenomenon	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Thrombophlebitis	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Varicose vein	0.78% 1/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.
Vascular disorders Vasodilatation	0.00% 0/129 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.00% 0/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.	0.78% 1/128 • Baseline up to 28 days after last dose of study treatment (up to a maximum duration of 2108 days for sildenafil 5 mg; up to a maximum duration of 2012 days for sildenafil 20 mg; up to a maximum duration of 2101 days for sildenafil 80 mg) An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all randomized participants treated with study treatment.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER