Common use of Study Medications Clause in Contracts

Study Medications. All study medications are for investigational use only and are to be used only within the context of this study. The Sponsor will supply all study medications. BA058 80 µg, Placebo and teriparatide will be supplied by the Sponsor. Pen devices and needles for administration of study medications also will be supplied to the study sites. BA058 80 µg for Injection: Each multi-dose cartridge contains 2 mg/mL BA058 (free base) in 5 mg/mL tri-hydrate sodium acetate and 5 mg/mL of phenol (preservative) adjusted at pH 5.1 with acetic acid. BA058 80 µg is supplied as a liquid in a 1.5 mL Type 1 glass cartridge and is stored refrigerated at 5 ± 3ºC. The multi-dose cartridge is designed to deliver a dose of 80 µg of BA058 in 40 µL of fluid when inserted into the Pen Injector device. The pen is also capable of delivering a half dose of BA058, or 40 µg of BA058 in 20 µL of fluid, with appropriate manual adjustment. When in use, multi-dose cartridges of BA058 80 µg can be stored for up to 30 days at room temperature. When used with the supplied pen and needles, each cartridge may be used to deliver study medication at the required daily dose for 30 days. Patients will be provided with a sufficient number of cartridges to continue on treatment until the next scheduled return to the study site.