Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Inclusion Criteria:

- Has completed double-blind treatment in either of the lead-in efficacy trials, 000079
or 000080.

- The patient reports having understood and has signed the Informed Consent Form (ICF)
and is willing to comply with all trial visits and assessments.

- The patient agrees to refrain from making any new, major life-style changes that may
affect Chronic Idiopathic Constipation (CIC) symptoms (i.e., starting a new diet,
changing an exercise plan) from the time of signing the ICF through to the last trial
visit.

Exclusion Criteria:

- The patient has been withdrawn/discontinued from the 000079 or 000080 trials.

- The patient is not willing to abide by the restrictions for intake of prohibited
medication.

- Women of childbearing potential (defined, for the purpose of this trial, as all
females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who
have a positive urine pregnancy test at Visit 1, together with agreement to use one
of the following methods of birth control from the day of signing the ICF until 30
days after the final dose of trial drug are excluded:

1. Transdermal patch

2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive)

3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm
plus spermicide, etc.)

4. Maintenance of a monogamous relationship with a male who has been surgically
sterilised by vasectomy

5. Sexual abstinence

- The patients is considered by the Investigator to be unsuitable to participate in the
trial for any other reason.