anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CID 118984462
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.

Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.

Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Type 1 diabetes
HbA1c (glycosylated haemoglobin) below or equal to 8.5%
Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
BMI (body mass index) below 35 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months
Intervention: Ergocalciferol
Trial phase: Not Applicable
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 50,000 units of ergocalciferol once a week for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male and nonpregnant females greater than 18 years of age
≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
Serum 25-hydroxyvitamin D < 20 ng/ml

Exclusion Criteria:

confinement to a nursing facility, institution or home
GFR < 60 ml/min (by MDRD equation)
presence of liver disease
hypercalcemia
NYHA class III or IV heart failure
cardiogenic shock at time of presentation
current planned or emergent CABG
prior gastric or small bowel surgery
pancreatitis
malabsorption
inflammatory bowel disease
autoimmune disease
active malignancy
current use of > 800 IU/day of vitamin D
Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Intervention: Chlordiazepoxide
Trial phase: Phase 4
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: 25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c
Eligibility criteria:
Inclusion Criteria:

Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

Benzodiazepine dependent
Intervention: Bupropion Hydrochloride
Trial phase: Phase 4
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1166
Group description: This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
Eligibility criteria:
Inclusion Criteria:

Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Intervention: alpha-Linolenic acid
Trial phase: Phase 2
SMILES: CC/C=C\C/C=C\C/C=C\CCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Patients receive aminolevulinic acid PO 2-4 hours before surgery.

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery
Eligibility criteria:
Inclusion Criteria:

Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent GBM or suspected GBM (in patient with pathologically diagnosed prior World Health Organization [WHO] grade II or III tumor) in a patient undergoing a clinically-indicated surgery.
Age >= 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Life expectancy is not a consideration for protocol entry
Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine within normal institutional limits; OR
Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Prior therapy is not an exclusion criterion
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to aminolevulinic acid (ALA)
Current treatment with hypericin (or an extract) or other photosensitizing agents
Personal or immediate family (parents, siblings, children) history of porphyrias
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ALA
Intervention: Lurasidone
Trial phase: Phase 3
ATC code: N05AE05
SMILES: [H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 377
Group description: Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily
Eligibility criteria:
Inclusion Criteria:

Subject has agreed to participate by providing written informed consent.
Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).
Intervention: Betrixaban
Trial phase: Phase 3
ATC code: B01AF04
SMILES: COc1ccc(NC(=O)c2ccc(C(=N)N(C)C)cc2)c(C(=O)Nc2ccc(Cl)cn2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3716
Group description: Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Eligibility criteria:
Inclusion Criteria:

men and non-pregnant, non-breastfeeding women
anticipated to be severely immobilized for at least 24 hours after randomization

hospitalized with one of the following

congestive heart failure
acute respiratory failure,
acute infection without septic shock,
acute rheumatic disorders
acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

a condition requiring prolonged anticoagulation or anti-platelets
active bleeding or at high risk of bleeding
contraindication to anticoagulant therapy
general conditions in which subjects are not suitable to participate in the study
Intervention: Fingolimod Hydrochloride
Trial phase: Phase 4
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6998
Group description: Fingolimod 0.5 mg by mouth once daily for 7 days.
Eligibility criteria:
Key Inclusion Criteria:

Subjects with relapsing remitting MS.
Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

- or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key Exclusion Criteria:

immunocompromised patients
active infections
pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
presence of malignancy (other than localized basal cell carcinoma of the skin).
Intervention: Fluorescein
Trial phase: Phase 2 | Phase 3
ATC code: S01JA01 | S01JA51
SMILES: O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Without LSC, standard cytarabine consolidation

Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years
Able to give informed consent
New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
Pregnancy: Women of childbearing potential who are β- HCG+
Intervention: Fluorescein
Trial phase: Phase 2 | Phase 3
ATC code: S01JA01 | S01JA51
SMILES: O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: LSC present, randomized to cytarabine consolidation

Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years
Able to give informed consent
New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
Pregnancy: Women of childbearing potential who are β- HCG+
Intervention: Glycocholic acid
Trial phase: Phase 3
SMILES: [H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])C[C@H](O)[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)NCC(=O)[O-])[C@]1([H])[C@H](O)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 15 mg/kg bw/day
Eligibility criteria:
Inclusion Criteria:

Confirmation of a diagnosis of an inborn error of bile acid synthesis/conjugation based upon urine analysis by FAB-MS.
Any age
Participant must be willing and able to comply with study assessments and procedures.
The participant and/or parent/legal guardian must have signed the written informed consent document prior to study start.

Exclusion Criteria

1. No confirmed diagnosis of inborn error of bile acid synthesis/conjugation based upon urine analysis by FAB-MS.
Intervention: PEXIGANAN
Trial phase: Phase 3
SMILES: CC[C@H](C)[C@H](NC(=O)CN)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(N)=O)[C@@H](C)CC)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Topical pexiganan cream 0.8%: 14 days of treatment
Eligibility criteria:
Inclusion Criteria:

Diabetes mellitus.
Male or female at least 18 years old.
Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
Subject is to be treated on an outpatient basis.
Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
Localized mild infection of the ulcer.
The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

IDSA-defined moderate infection.
IDSA-defined severe infection.
Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
> 1 infected foot ulcer.
Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
Subject has received a systemic antibiotic within 48 hours prior to Screening.
Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
Bone or joint involvement is suspected based on clinical examination or plain X-ray.
Clinically significant peripheral arterial disease requiring vascular intervention.
Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.
Intervention: Memantine Hydrochloride
Trial phase: Phase 2
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 747
Group description: To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.

Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
Eligibility criteria:
Inclusion Criteria:

Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior
Intervention: IVERMECTIN
Trial phase: Phase 4
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose
Eligibility criteria:
INCLUSION CRITERIA (SCREENING):

A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply:

male or non-pregnant and not breastfeeding female subjects,
age 20-60 years (per participant self-report)
resident of Akonolinga
Loa microfilaremia from 20 to 5000 mf/mL from the prior screening in the village or did not participate in the prior screening
consent to a blood draw to screen for infection with Loa loa
must be willing to have blood samples stored

EXCLUSION CRITERIA (SCREENING):

A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply:

Known to be pregnant (by history) or breastfeeding
Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant
History of hypersensitivity reaction to DEC or IVM

INCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will be eligible for participation in the interventional portion of the study only if all of the following additional inclusion criteria apply:

Loa loa microfilaremia between 20 and 2,000 mf/mL blood drawn between 11:30 am and 2:30 pm measured within 30 days prior to the baseline visit
The subject agrees to storage of samples for study

EXCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment:

Pregnancy (by serum or urine beta-HCG) or breastfeeding
Chronic kidney or liver disease
Hgb < 10 gm/dL
Filarial infection other than Loa loa or M. perstans (O. volvulus, or W. bancrofti)
Use of DEC or IVM within the past 6 months
Use of immunosuppressive therapies, including steroids, within the past month
Any condition that in the investigator s opinion places the subject at undue risk by participating in the study

EXCLUSION OF CHILDREN AND PREGNANT WOMEN:

Pregnant women and children (the age of consent in Cameroon is 20 years of age) will be excluded from this study since it involves administration of medications contraindicated in pregnancy and more than minimal risk with no prospect of direct benefit, respectively.
Intervention: PEXIGANAN
Trial phase: Phase 3
SMILES: CC[C@H](C)[C@H](NC(=O)CN)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(N)=O)[C@@H](C)CC)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment
Eligibility criteria:
Inclusion Criteria:

Diabetes mellitus.
Male or female at least 18 years old.
Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
Subject is to be treated on an outpatient basis.
Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
Localized mild infection of the ulcer.
The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
IDSA-defined severe infection, including systemic toxicity or metabolic instability.
Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
> 1 infected foot ulcer.
Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
Subject has received a systemic antibiotic within 48 hours prior to Screening.
Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
Bone or joint involvement is suspected based on clinical examination or plain X-ray.
Clinically significant peripheral arterial disease requiring vascular intervention.
Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.