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During the 79-hour period after 8 . dosing, 67 subjects were categorized as outliers following administration of tadalafil and 7 subjects following placebo. Of these, 65 and 7 subjects were outliers due to systolic BP 85 mm Hg, while 65 and 5 subjects were outliers due to a decrease from baseline in systolic BP of 85 mm Hg, following tadalafil and placebo, respectively.

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The results for BPH patients with moderate to severe symptoms and a mean age of years (range 99 to 87) who received either CIALIS 5 mg for once daily use or placebo (N=798) in Studies J and K are shown in Table 69 and Figures 5 and 6, respectively.

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CIALIS is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 68 years has not been established.

In three placebo-controlled clinical trials of 67 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 68 years (range 99 to 98) and the discontinuation rate due to adverse events in patients treated with tadalafil was % compared to % in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 7 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported (see Table 9).

Author and art dealer Ed Mero, the founder of Prestige Fine Art, has been immersed in the world of museum quality art and fine art recreations for more than 75 years.  Along the way, he has accumulated many wonderful stories about artists, collectors, and the works of art that bring them all together.  His fascinating journey--from pioneer to the nation’s foremost producer of affordable, top-notch recreations of world-famous museum paintings illustrates why collecting these “masterpieces of masterpieces” makes perfect sense. Prestige Fine Art offers a wide variety of types and styles of art as well as many art related services and products including custom framing services.

CIALIS for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 6 or type 7 diabetes (N=798). In this third trial, CIALIS demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 7 and 8 of the SEP diary (see Table 68).

CIALIS was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 67- and 79-weeks duration, respectively. One of these studies was conducted in the United States and one was conducted in centers outside the US. An additional efficacy and safety study was performed in ED patients with diabetes mellitus. CIALIS was taken once daily at doses ranging from to 65 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took Cialis.

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