Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Patients receiving parenteral hydration within 24 hours after the first dose of study medication.

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale ("BSS"), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.

Patients were required to stay in the ED for at least 2 hours (first 172 patients) and subsequently, when post-treatment ECGs were introduced, for 4 hours. Since not all patients had prolonged ED stays, a difference in time until patients were clinically eligible for discharge may have been masked.

Time from first dose of study medication to resumption of normal activities (work/school/household).

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.

The number of treated patients requiring hospitalization was low in this study (14 patients). In the RHB-102 group, 11 patients (5.7%) were hospitalized, including one who returned to the ED for gastrointestinal symptoms 2 days after initial treatment. In the placebo treatment group, 3 patients (2.3%) were hospitalized.

Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge

Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.

Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose

The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of study medication if they vomited within 15 minutes of receiving the first dose, & did not have a primary diagnosis upon discharge from ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.

Examination of treatment success rates by age (<18 and ≥18 years).

The Per Protocol (PP) Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.

Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)

The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. The primary efficacy analysis was conducted using the ITT Population.

Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)

The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving the first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.