Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., <3 unformed bowel movements [UBM] [Bristol Stool Scale score of 5, 6, or 7] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day 12 visit.

ITT: All randomized participants

Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., <3 unformed bowel movements [UBM] [Bristol Stool Scale score of 5, 6, or 7] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day12 visit.

mITT: Participants in the ITT population who have Cdiff isolated in culture and who are Cdiff toxin positive from a screening or Day 1 fecal sample

Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., <3 unformed bowel movements [UBM] [Bristol Stool Scale score of 5, 6, or 7] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day12 visit.

PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations

Total relief of symptoms at TOC/Day 12 is defined as resolution (< 3 per day) of unformed bowel movements, an investigator's assessment of clinical cure, and the resolution of signs or symptoms of CDI recorded at baseline. Numbers reported below indicate participants from each cohort that had total relief of symptoms at TOC/Day 12 and those that did not.

mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample

Total relief of symptoms at TOC/Day 12 is defined as resolution (< 3 per day) of unformed bowel movements, an investigator's assessment of clinical cure, and the resolution of signs or symptoms of CDI recorded at baseline. Numbers reported below indicate participants from each cohort that had total relief of symptoms at TOC/Day 12 and those that did not.

PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations

The time to resolution of diarrhea is defined as the time elapsed from the first dose of study treatment to the last unformed bowel movement before 2 consecutive days of < 3 unformed bowel movements (Bristol Stool Scale score of 5, 6, or 7) per day through TOC/Day 12. Values reported below are median days to resolution for each cohort.

mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample

The time to resolution of diarrhea is defined as the time elapsed from the first dose of study treatment to the last unformed bowel movement before 2 consecutive days of < 3 unformed bowel movements (Bristol Stool Scale score of 5, 6, or 7) per day through TOC/Day 12. Values reported below are median days to resolution for each cohort.

PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations

Rate of early recurrence of C. difficile infection (CDI) is defined as a new episode of diarrhea (≥ 3 unformed bowel movements [Bristol Stool Scale score of 5, 6, or 7] in a 24-hour period) with a positive toxin result and requires retreatment for CDI before Day 40. The table below shows the number of participants per cohort that experienced a recurrence before Day 40 and those that did not. Only participants that were clinical cures at TOC/Day 12 were included in the analysis.

mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample

Rate of early recurrence of C. difficile infection (CDI) is defined as a new episode of diarrhea (≥ 3 unformed bowel movements [Bristol Stool Scale score of 5, 6, or 7] in a 24-hour period) with a positive toxin result and requires retreatment for CDI before Day 40. The table below shows the number of participants per cohort that experienced a recurrence before Day 40 and those that did not. Only participants that were clinical cures at TOC/Day 12 were included in the analysis.

ME: Participants in the PP and Micro-ITT populations

Rate of late recurrence of CDI is defined as a new episode of diarrhea (≥ 3 unformed bowel movements [Bristol Stool Scale score of 5, 6, or 7] in a 24-hour period), with a positive toxin result and requires retreatment of CDI between Day 40 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between Day 40 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12. Participants that were indeterminate at TOC/Day 12 or recurrent prior to Day 40 were excluded.

mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample

Rate of late recurrence of CDI is defined as a new episode of diarrhea (≥ 3 unformed bowel movements [Bristol Stool Scale score of 5, 6, or 7] in a 24-hour period), with a positive toxin result and requires retreatment of CDI between Day 40 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between Day 40 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12. Participants that were indeterminate at TOC/Day 12 or recurrent prior to Day 40 were excluded.

ME: Participants in the PP and Micro-ITT populations

Rate of recurrence of CDI is defined as a new episode of diarrhea (≥3 unformed bowel movements [Bristol Stool Scale score of 5, 6, or 7] in a 24-hour period) with a positive toxin result and requires retreatment for CDI at any point between TOC/Day 12 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12.

Micro-ITT: All participants in the ITT population who have C. difficile isolated in culture and who are C. difficile toxin positive at the central laboratory from a screening or Day 1 fecal sample

Rate of recurrence of CDI is defined as a new episode of diarrhea (≥3 unformed bowel movements [Bristol Stool Scale score of 5, 6, or 7] in a 24-hour period) with a positive toxin result and requires retreatment for CDI at any point between TOC/Day 12 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12.

ME: Participants in the PP and Micro-ITT populations.

Global cure is defined as a clinical cure at TOC/Day 12 without recurrence through Day 40. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 40 and those that did not.

mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample

Global cure is defined as a clinical cure at TOC/Day 12 without recurrence through Day 40. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 40 and those that did not.

PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations