A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.

Intent-to-treat population with evaluable SBM data during the given month

A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)

Intent-to-treat population with evaluable BM data during the given month

A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).

A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.

Intent-to-treat

Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.

Intent-to-treat with evaluable data at the given time point

Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.

Intent-to-treat with evaluable data at the given time point

Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

The highest score is 4, but the best score is 0.

Intent-to-treat with evaluable scores at the given time point

Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

The highest score is 4, but the best score is 0.

Intent-to-treat with evaluable data at the given time point

Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

The highest score is 4, but the best score is 0.

Intent-to-treat with evaluable data at the given time point

Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.

The highest score is 7, but the best score is 1.

Intent-to-treat with evaluable data at the given time point

Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.

The highest and best score is 4.

Intent-to-treat with evaluable data at the given time point

Participants rate each SBM as complete if their bowels feel completely empty after the SBM

Intent-to-treat with evaluable data at the time point

Participants rate each BM as complete if their bowels feel completely empty after the BM

Intent-to-treat with evaluable data at the time point