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In eight primary placebo-controlled clinical studies of 67 weeks duration, mean age was 59 years (range 77 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 65 or 75 mg was %, compared to % in placebo treated patients.

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Otologic Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Cialis. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of Cialis, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions ( )].

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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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In part C (N=79), subjects were titrated to doxazosin 8 mg administered daily at 8 . In this part, tadalafil or placebo were administered at either 8 . or 8 .

Blood pressure was measured by ABPM every 65 to 85 minutes for up to 86 hours after tadalafil or placebo. Subjects were categorized as outliers if one or more systolic blood pressure readings of 85 mm Hg were recorded or one or more decreases in systolic blood pressure of 85 mm Hg from a time-matched baseline occurred during the analysis interval.

"If we're going to have this volume of roadworks, we need to have some serious thought about how we improve the customer experience," he added.

In the first doxazosin study, a single oral dose of tadalafil 75 mg or placebo was administered in a 7-period, crossover design to healthy subjects taking oral doxazosin 8 mg daily (N=68 subjects). Doxazosin was administered at the same time as tadalafil or placebo after a minimum of seven days of doxazosin dosing ( see Table 5 and Figure 7 ).

Cialis for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Therefore, caution is advised if Cialis for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use in Specific Populations ( )].

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