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Two deaths occurred during the double-blind period: a 29-year-old Caucasian woman randomized to placebo died of acute respiratory failure after being diagnosed with pneumonia; and a 27-year-old Caucasian man randomized to ESL 800 mg was found dead in bed with a bitten tongue (during the titration phase, while receiving 400 mg ESL).
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[24], [26] The independent variables of interest were: circumcision group (men randomized to receive circumcision versus those randomized to remain uncircumcised); time (indicator variables for 6 month and 12 month follow-up); and the interaction between circumcision group and time.
Moreover, many of the men randomized to the control group continued to have PSA tests irrespective of randomized assignment: 40% of men in the control group received a PSA test in the first year after randomization.
Although most studies found no association between alcohol intake and prostate cancer (PCa) risk, an analysis of the Prostate Cancer Prevention Trial found that high alcohol intake significantly increased PCa risk among men randomized to the 5α-reductase inhibitor (5-ARI) finasteride.
There were 84 men randomized to receive clodronate or placebo (McCloskey et al 1999).
Zoledronic acid-treated men had fewer morphological vertebral fractures at the end of the 2-year study, compared to the men randomized to placebo infusion.
The Japanese trial (24) included 458 IGT men randomized to receive either intensive lifestyle intervention (n = 102) or standard intervention (n = 356).
Patient reported urinary incontinence and erectile dysfunction, but not bowel dysfunction, were more common at two years in men randomized to surgery.
The first of these trials (MRC PR05), published in 2003, assessed 311 men randomized to clodronate 2,080 mg daily (as four 520 mg tablets) or matching placebo.
Another as yet unpublished trial of 168 men randomized to monthly oral ibandronate 150 mg or placebo has the primary outcome of change in lumbar spine BMD.
13 The study recruited 1,199 men, randomized to enzalutamide (160 mg/day by oral administration) or placebo in a 2 1 ratio, resulting in 800 men within the enzalutamide arm and 399 men within the placebo arm.
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