Of the 166 PWID confirmed HCV antibody negative and eligible for enrolment, 156 (94%) completed baseline procedures.
One-year follow-up measurements will be collected for most of the baseline procedures, with the exception of the lumbar puncture, the PET imaging, and apolipoprotein E genotyping.
After 4 months, baseline procedures were repeated.
Among those invited to participate, 75% (132/177) of subjects completed all baseline procedures and were enrolled.
Study participants provided signed informed consent before baseline procedures were performed.
Baseline procedures and administration of the first cycle of pemetrexed occur at the hospital (the investigative site).
The women without previous GDM will only participate in the study for the baseline OGTT and IIGI experimental days and their related baseline procedures.
No differences in cure rates were observed between treatment groups in either those who did or did not require baseline procedures (data not shown).
Other baseline procedures included taking medical histories (emphasizing respiratory symptoms and medications), pulmonary function testing (PFT) (spirometry on children 6 12 years of age and peak flow on all children), and blood collection (16 mL) by venipuncture.
Subjects were admitted to the clinical facility (BMS Clinical Research Center, Hamilton, New Jersey, USA) 2 days (day −2) prior to study drug administration for baseline procedures and remained in the facility until discharge (day 5).
