A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. Time to recurrence of rCDI was to be assessed using Kaplan-Meier estimation.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. Severe CDI was defined as CDI with white blood cell count >15,000 cells/milliliter and/or serum creatinine ≥1.5 milligram/deciliter.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence.

Participants underwent watchful waiting. No treatment was administered.

Total of all reporting groups

Due to the small sample size, data was not reported for participant confidentiality reasons.

Due to the small sample size, data was not reported for participant confidentiality reasons.

Due to the small sample size, data was not reported for participant confidentiality reasons.

Participants underwent watchful waiting. No treatment was administered.

A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

All randomized participants who received at least 1 dose of REC-3964 intervention or who were followed-up on in the Observation arm.

A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An Investigator who was qualified in medicine determined relationship to the study drug for each AE (unrelated or related). The Investigator decided whether, in his or her medical judgment, if there was a reasonable biological possibility that the event may have been caused by the study drug.

All randomized participants who received at least 1 dose of REC-3964 intervention or who were followed-up on in the Observation arm.

A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A Serious TEAE was defined as results in death, immediately life-threatening, requires in-participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity in conducting activities of daily living for at least 28 days, results in a congenital abnormality or birth defect, or an important medical event that may jeopardize the participant or may require medical intervention.

All randomized participants who received at least 1 dose of REC-3964 intervention or who were followed-up on in the Observation arm.

A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

All randomized participants who received at least 1 dose of REC-3964 intervention or who were followed-up on in the Observation arm.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence.

The rate of rCDI was defined as the proportion of participants who had the Clostridioides difficile recurrence among randomized participants.

Data for this outcome measure was not summarized since there was only 1 participant in each treatment arm.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. Time to recurrence of rCDI was to be assessed using Kaplan-Meier estimation.

Data for this outcome measure could not be estimated since no recurrence events occurred during this study.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence. Severe CDI was defined as CDI with white blood cell count >15,000 cells/milliliter and/or serum creatinine ≥1.5 milligram/deciliter.

Data for this outcome measure was not assessed since no recurrence events occurred.

Recurrent CDI was defined as a new episode of CDI associated with a new positive Clostridioides difficile stool toxin within 8 weeks of the cessation of initial curative treatment. The number of unformed [types 5-7 on the Bristol stool scale] bowel movements per day were recorded by the participant in the stool diary in order to identify a new episode of diarrhea. All new episodes of diarrhea were tested for toxigenic Clostridioides difficile to confirm CDI recurrence.

Data for this outcome measure was not assessed since no recurrence events occurred.

Data for this outcome measure was not summarized since there was only 1 participant in each treatment arm.

Data for this outcome measure was not summarized since there was only 1 participant in each treatment arm.

Data for this outcome measure was not summarized since there was only 1 participant in each treatment arm.

Participants received REC-3964 given at a dose of 500 mg q12h.

Participants underwent watchful waiting. No treatment was administered.