18 Years and up
Accepting Healthy Volunteers?
1. Subject voluntarily gives informed consent to participate in the study.
2. The subject participated in study RIN-PH-201, remained on study drug, was compliant
with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that
the study was discontinued by the sponsor.
3. Females of reproductive potential must be non-pregnant (as confirmed by a urine
pregnancy test at Baseline) and non-lactating, and will:
- Either abstain from intercourse (when it is in line with their preferred and
usual lifestyle), or
- Use two medically acceptable, highly-effective forms of contraception for the
duration of study, and at least 30 days after discontinuing study drug.
4. Males must use a condom for the duration of treatment and for at least 48 hours after
discontinuing study drug.
1. The subject is pregnant or lactating.
2. The subject was prematurely discontinued from study RIN-PH-201.
3. The subject developed a concurrent illness or condition during the conduct of
RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to
overall health if they enrolled in this study.