Proportion of patients with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension.

The mannitol dose to be used in phase III was singled out on an algorithm that calculated a total score for each dose starting from the scores assigned to the three main criteria through a ranking system and proportionally to the importance given to each main criterion: A - rate of adequate bowel cleansing (most important - primary endpoint), B - rate of patients in safe conditions and C - clinical judgement score (least important - partially based on subjective assessments).

Percentages were computed on patients belonging to the PP population.

Proportion of patients with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension.

Percentages were computed on patients belonging to the PP Population.

The percentage of patients with appendiceal orifice visible to the endoscopist. Evaluation will be performed during conduction of colonoscopy run on visit 4. Timing for treatment administration was described in the protocol and change among arms.

Percentages were computed on patients belonging to the PP population.

Proportion of patient that completely taken assigned mannitol dose.

Percentages were computed on patients belonging to the PP population. Overall Number of Participants Analyzed referred to patient that completely taken assigned mannitol dose.

Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy).

Percentages were computed on patients belonging to the PP population.

Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies.

Percentages were computed on patients belonging to the PP population.

Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good).

Percentages were computed on patients belonging to the PP population.

descriptive statistics (mean) of peak plasma concentration (Cmax) as pharmacokinetic parameter.

Percentages were computed on patients belonging to the PK population.

Descriptive statistics (Median) of time to maximum concentration (tmax) as pharmacokinetic parameter.

Percentages were computed on patients belonging to the PK population.

Descriptive statistics (Mean) of area under the curve from t0 to the last blood sampling time point (AUC 0-t8), as pharmacokinetic parameter.

Percentages were computed on patients belonging to the PK population.

Descriptive statistics (Mean) of elimination half life (t1/2), as pharmacokinetic parameter.

Percentages were computed on patients belonging to the PK population.

The percentage of patients with at least one lesion detected.

Percentages were computed on patients belonging to the Full Analysis Set.

Ottawa scale is used to measure the quality of the preparation in three different parts of the colon before washing and insufflation. descriptive statistics (Mean) of the total score (from 0 excellent to 14 inadequate).

Percentages were computed on patients belonging to the Full Analysis Set.

The percentage of patients with appendiceal orifice visible to the endoscopist.

Percentages were computed on patients belonging to the Full Analysis Set.

The BOCLIR is a questionnaire filled in by patients to measure the acceptability and tolerability of bowel cleansers consisting of three unidimensional scales (satisfaction, symptoms and activity limitations) with good psychometric and scaling properties. Item responses are summed to provide a score for each scale and a total score. The satisfaction scale contains eight items and the score ranges from 0 (highly satisfied) to 32 (highly dissatisfied). The symptoms scale includes 14 items and the score ranges from 0 (no symptoms) to 42 (severe symptoms).

The activity limitations scale is made up of 12 items and the score ranges from 0 (no effect on activities) to 36 (activities greatly affected). The total score is the sum of the three scales and ranges from 0 to 110. Patients who report a worse experience in terms of the three factors score higher on the BOCLIR scale.

Percentages were computed on patients belonging to Italian centers in the Safety set.

Proportion of patients that completely taken, partially taken or not taken assigned mannitol dose

Percentages were computed on patients belonging to the Safety set who have been administered questionnaire on adherence and acceptability.

Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy).

Percentages were computed on patients belonging to the Safety set.

Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies.

Percentages were computed on patients belonging to the Safety set who have been administered questionnaire on adherence and ac ceptability.

Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good).

Percentages were computed on patients belonging to the Safety set.

Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentrations of gases (H2>4% and CH4 >5%)

Percentages were computed on patients belonging to the PP population evaluable for potentially dangerous levels of H2 and CH4

Incidence of adverse events occuring starting from enrollment

Percentages were computed on patients belonging to the Safety set.

Proportion of patients with change from baseline considered clinically significant by the Investigator of haematological and chemical parameters (CBC, creatinine, BUN, eGFR, ALT, AST, glucose, electrolytes) 4 hours and 8 hours after completion of study drug self-administration.

Percentages were computed on patients belonging to the Safety set.

Proportion of patients with change of vital signs during colonoscopy considered clinically significant by the Investigator (heart rate and pulse oximetry).

Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentration of gases (H2>4% and CH4 >5%)

Percentages were computed on patients belonging to the safety set evaluable for potentially dangerous levels of H2 and CH4. Some patients were excluded from the analysis because their gas concentrations were measured through a device with malfunction issues

Incidence of adverse events occuring starting from enrollment

Percentages were computed on patients belonging to the Safety set.

Proportion of patients with change from baseline considered clinically significant by the Investigator of haematological and chemical parameters (CBC, creatinine, BUN, eGFR, ALT, AST, glucose, electrolytes) 4 hours and 8 hours after completion of study drug self-administration.

Percentages were computed on patients belonging to the Safety set.

Proportion of patients with change of vital signs from baseline considered clinically significant by the Investigator (heart rate, systolic and diastolic blood pressure), as well as clinically significant change during colonoscopy of pulse oximetry, systolic and diastolic blood pressure and heart rate.

Percentages were computed on patients belonging to the Safety set.