Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.

Change = Endpoint - Baseline.

p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.

Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.

p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.

Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.

p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.

Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.

p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.

p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.

Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)

Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.

p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.