clinicaltrials.gov/ct2/show/NCT00580619 http://clinicaltrials.gov/ct2/show/NCT00580619 NCT00580619 http://clinicaltrials.gov/ct2/show/NCT00580619 http://clinicaltrials.gov/ct2/show/NCT00580619 clinicaltrials.gov/ct2/show/NCT00580619