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A randomisation list was generated using random permuted blocks through a computer algorithm and a pseudorandom number generator.

The list indicated, for each bottle number, the drug assigned to the corresponding study medication bottle. The patient was assigned a screening number at visit one (screening) and, if eligible for participation, was then assigned a randomisation number at visit two (baseline).

The investigator was provided a sealed copy of the randomisation codes and was instructed to break the treatment code only in the event of an emergency. Active treatment and corresponding placebo tablets were identical in packaging and appearance.

During the DB phase, the primary efficacy variables were responses to questions “When you attempted sexual intercourse, how often were you able to penetrate your partner?” (Q3) and “When you attempted sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner?” (Q4) of the 15 item International Index of Erectile Function (IIEF).

The IIEF is a validated questionnaire that has been used for the clinical assessment of ED. 18 Each question of the IIEF is scored on a categorical scale of 1 (“almost never/never”) to 5 (“almost always/always”), with a score of 0 indicating “did not attempt sexual intercourse”. Secondary efficacy variables were responses to three global efficacy questions (GEQs): GEQ1: “Compared to having no treatment at all for your erection generic viagra soft tabs online problem, has the medication you have been taking over the past 4 weeks improved your erections?” and GEQ2: “If yes, has the improvement in your erections allowed you to engage in satisfactory sexual activity?”.

GEQ3 asked: “When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual activity?”. Additional secondary efficacy measures were analyses of IIEF domains, for example, orgasmic function (Q9: “When you had sexual stimulation or intercourse, how often did you ejaculate?” and Q10: “When you had sexual stimulation or intercourse, how often did you have the feeling of orgasm?”) and sexual desire (Q11: “Over the past 4 weeks, how often have you felt sexual desire?” and Q12: “Over the past 4 weeks, how would you rate your level of sexual desire?”).

The DB end point efficacy assessment served as baseline for the OLE phase.

At the final OLE visit, a limited assessment of efficacy was made based on responses to the three GEQs.

The Life Satisfaction Checklist is an eight item general QoL questionnaire, with questions on the patient’s satisfaction with life as a whole, sexual life, partnership relation, family life, social contacts, and leisure, vocational, and financial situations.

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These were: “Were you frustrated about your erection problems?”, “Did you feel weighed down by your erection problems?”, “Were you discouraged by your erection problems?”, “Did you feel despair over your erection problems?”, and “Were your erection problems a worry in your life?”. Responses to each question of the Life Satisfaction Checklist and the Erection Distress Scale were scored from 1 (none of the time) to 6 (all of the time).

Calculations were performed to determine the sample size needed to detect a statistical difference in the mean end point response for sildenafil (combined 25, 50, and 100 mg dose wholesale viagra pills groups) versus placebo. Based upon a difference of 1.33 in mean scores and assuming a common standard deviation for sildenafil and placebo of 2.0, a sample size of 50 patients per treatment arm was sufficient to super active viagra 150 mg achieve a power of 90% to detect the specified difference between the two treatment groups using an approximation (two sided, ? = 0.05) to the test comparing two means for normally distributed responses. Assuming an overall drop out rate of 25%, a 1:1 randomisation ratio of sildenafil to placebo, sufficient power to be able to conduct the primary analysis of efficacy, analysis of covariance, including terms for treatment group, centre, baseline value super active viagra 150 mg for efficacy variables, and other covariates as required, 250 patients, 125 in each arm, were to be randomised to study drug; in total, 218 patients were randomised. Intent-to-treat analyses were performed on all efficacy and QoL variables, and included all patients with at least one assessment after randomisation who had taken at least one dose of study drug. To be eligible for inclusion in safety analyses, patients must have taken at least one dose of study drug. Statistical analysis of responses to IIEF Q3 and Q4 and GEQ3 was performed for each question using analysis of covariance. Statistical analysis of responses to GEQ1 and GEQ2 (yes/no) was performed for each question using a logistic regression model. The mean frequency of responses to each question of the Life Satisfaction Checklist and to the five questions of the Erection Distress Scale for each treatment was calculated and expressed as the least squares mean±standard error (SE). Each question was fitted with an analysis of covariance model, which included terms for treatment group, centre, patient age, baseline score, ED duration, baseline ED severity, and smoking status. All statistical tests were two sided and performed at the 5% significance level. A total of 217 men (mean age: 46 years; mean duration of ED: 5.7 years; mean duration of MS: 10.4 years) from 20 sites in the United States and Europe received treatment with sildenafil (n = 104) or placebo (n = 113) for 12 weeks.

The patients in the two treatment groups had similar demographic characteristics with respect to age, duration of ED, duration of MS, and EDSS score (table 1), but men in the placebo group reported more frequent use of antihypertensive agents and less use of corticosteroids compared with the treatment group. At the end of the 12 week period, almost two thirds of men (64%) receiving sildenafil were taking the 100 mg dose, compared with 32% on the 50 mg dose, and 4% on the 25 mg dose.