Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.

The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).

Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.

The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).

The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.

The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).

The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.

The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).