anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 20 mL of 0.25% plain bupivacaine

Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
Eligibility criteria:
Inclusion Criteria:

Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed National Military Medical Center.
Patients must be able to read and understand written English or have an appropriate certified medical translator available.

Exclusion Criteria:

Known allergy to amide local anesthetics.
Unstable cardiac arrhythmia.
Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer).
Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable).
Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery.
Significant history of opioid or alcohol abuse or addiction (requiring treatment).
Concurrent pain management requiring the use of epidural anesthesia.
Intervention: Remibrutinib
Trial phase: Phase 2
SMILES: C=CC(=O)N(C)CCOc1c(N)ncnc1-c1cc(F)cc(NC(=O)c2ccc(C3CC3)cc2F)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Remibrutinib 100 mg twice daily (bid)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of SjS according to the 2016 ACR/EULAR criteria
Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains
Screening ESSPRI ≥ 5
Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to screening
Unstimulated salivary flow > 0 mL/min.

Exclusion Criteria:

Sjögren's Syndrome overlap syndromes with another autoimmune disease as primary illness
DMARDs or kinase inhibitors within 3 months prior to baseline above certain doses OR maintained during study
Rituximab or other B cell depleting drug within 12 months of Screening .
Current use of prednisone or equivalent > 15mg/d or dose change within 2 weeks prior to Screening
Use of medication known to cause, as a major side effect, dry mouth / eyes
HIV, Hepatitis C, Hepatitis B, known or suspected history of an ongoing, chronic or recurrent infectious disease such as tuberculosis
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Ketamine - IV after cord clamping; IV infusion for 12 hours OR in the weaning population IV Ketamine infusion for 12 hours in the Montefiore CTRC

Ketamine: Subjects in the intervention arm will receive bolus and infusion dosing as noted in arm/group descriptions at the time of cord clamping. Duration of infusion will be 12 hours. Breastmilk, maternal serum and urine, side effects, adverse events, and efficacy endpoints will be measured over the 12 hour infusion and over 15 hours after infusion discontinuation. For the weaning population, they will receive a 12 hour infusion in the CTRC and stay an additional 12 hours in the CTRC (or until discharged). Breastmilk, maternal serum and urine, side effects, adverse events, and efficacy endpoints will be measured over the 12 hour infusion and for 12 hours after infusion discontinuation.
Eligibility criteria:
Inclusion Criteria:

Adult female patients (i.e., ≥18 years of age) and able to provide informed consent
Cesarean Delivery, Scheduled or Non-Emergent (delivery within 15 minutes not necessary), or female weaning off of breastfeeding
Cesarean cohort: ASA PS 2 or 3, with or without E designation (delivery within 15 minutes not necessary), Scheduled or Non-Emergent
Spinal anesthesia with intrathecal morphine if Cesarean Delivery, Scheduled or Non-Emergent
Multimodal postop analgesia with IV ketorolac, PO NSAID, and PO APAP if Cesarean Delivery, Scheduled or Non-Emergent
Women who do not plan to breastfeed or who want to temporarily withhold breastfeeding or who are weaning off of breastfeeding (Part 1)

Exclusion Criteria:

Cesarean Delivery under General Anesthesia
Allergies to study medications
ASA PS 4 or 4E
ASA PS with E designation because delivery within 15 minutes required
ASA PS greater than 4 (moribund patients)
Contraindications to spinal anesthesia
Contraindications to NSAIDs (gastric bypass, etc.)
Contraindication to any other multimodal analgesia medicine
Significant psychiatric history (depression and anxiety NOT exclusion criteria), uncontrolled hyperthyroidism, cardiac disease, fever, hypertension
Adverse occurrence during caesarean section such as hemorrhage, need for transfusion, hemodynamic instability
Placenta accreta spectrum or previa with large anticipated blood loss
History of hallucinations, alcohol or illicit substance use/abuse, chronic opioid therapy, or chronic pain (chronic pain - defined by any condition requiring consistent follow up with pain specialist or daily administration of pain medications that could augment sedative effects)
Pre-eclampsia with severe features
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 5ml of Lidocaine 2% Jelly

lidocaine topical: 5cc 2% lidocaine jelly applied intraurethral
Eligibility criteria:
Inclusion Criteria:

Female patients
>18 years of age
Already scheduled (or being scheduled) for UDS to assess urinary incontinence
Able to speak and read in English

Exclusion Criteria:

Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome
Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke)
Active UTI
Pelvic organ prolapse that is unable to be easily reduced
Pregnancy or breastfeeding
Allergy or hypersensitivity to lidocaine or local anesthetics
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
Have HbA1c between ≥7.0% and ≤10.5%.
Have a stable weight (± 5%) for at least 3 months before screening.
Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

Have type 1 diabetes mellitus.
Have had chronic or acute pancreatitis any time prior to study entry.
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: 10 mg tirzepatide administered SC once a week.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
Have HbA1c between ≥7.0% and ≤10.5%.
Have a stable weight (± 5%) for at least 3 months before screening.
Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

Have type 1 diabetes mellitus.
Have had chronic or acute pancreatitis any time prior to study entry.
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: 15 mg tirzepatide administered SC once a week.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
Have HbA1c between ≥7.0% and ≤10.5%.
Have a stable weight (± 5%) for at least 3 months before screening.
Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

Have type 1 diabetes mellitus.
Have had chronic or acute pancreatitis any time prior to study entry.
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Intervention: Tacrolimus
Trial phase: Phase 4
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects who had allogeneic blood or marrow transplantation (BMT) at Mayo Clinic in Rochester Minnesota

Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.

Tacrolimus: Recommended starting dose was in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses
Eligibility criteria:
Inclusion Criteria:

Individuals will be identified from within the adult allogeneic BMT program at Mayo Clinic in Rochester, Minnesota
Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease (GVHD)

Exclusion Criteria:

Vulnerable populations
Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced thrombotic microangiopathy
Lacking the capacity to consent in English and declining to participate in research
Intervention: Albendazole
Trial phase: Phase 2
ATC code: P02CA03
SMILES: CCCSc1ccc2nc(NC(=O)OC)[nH]c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Albendazole 400mg in single dose
Eligibility criteria:
Inclusion Criteria:

Infection with T. trichiura by Kato Katz.
Body weight >15kg.
Accepts participation

Exclusion Criteria:

Albendazole and/or mebendazol treatment in the previous 3 months.
Allergy to the study drugs
Acute medical conditions
Clinical trial participation in the previous 3 months.
Pregnancy.
Intervention: X062KF5ZV3
Trial phase: Phase 2
SMILES: CC(C)C(=O)N1CCCC12CN(C(C(N)=O)C(C)O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Eligibility criteria:
Inclusion Criteria:

A primary diagnosis of PTSD [Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic event occurring ≥12 months prior to screening.
PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

Exclusion Criteria:

Complex PTSD.
Trauma focused psychotherapies.
Primary traumatic event occurred prior to 2001.
Primary traumatic event was followed by further major traumatic life episodes.
Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
Current use of medications with primarily central nervous system activities
Other clinically significant medical histories that may interfere with completing the study.
Intervention: X062KF5ZV3
Trial phase: Phase 2
SMILES: CC(C)C(=O)N1CCCC12CN(C(C(N)=O)C(C)O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Eligibility criteria:
Inclusion Criteria:

A primary diagnosis of PTSD [Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic event occurring ≥12 months prior to screening.
PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

Exclusion Criteria:

Complex PTSD.
Trauma focused psychotherapies.
Primary traumatic event occurred prior to 2001.
Primary traumatic event was followed by further major traumatic life episodes.
Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
Current use of medications with primarily central nervous system activities
Other clinically significant medical histories that may interfere with completing the study.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
Eligibility criteria:
Inclusion Criteria:

ASA I-III
Age 18 years or older
Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion Criteria:

History of allergy to local anesthetic, or one of the study medications
Pre-existing neurological deficits
Psychiatric or cognitive disorders that prohibit patients from following study protocol
History of drug or alcohol abuse
Chronic opioid use (longer than 3 months)
Chronic pain syndromes
Infection at the site of injection
Patients with severe pulmonary disease
Herniated cervical disc, cervical myelopathy
Contraindication for general anesthesia and/or interscalene nerve block
Pregnancy
Open shoulder arthrotomies.
Non English speakers
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
Eligibility criteria:
Inclusion Criteria:

ASA I-III
Age 18 years or older
Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion Criteria:

History of allergy to local anesthetic, or one of the study medications
Pre-existing neurological deficits
Psychiatric or cognitive disorders that prohibit patients from following study protocol
History of drug or alcohol abuse
Chronic opioid use (longer than 3 months)
Chronic pain syndromes
Infection at the site of injection
Patients with severe pulmonary disease
Herniated cervical disc, cervical myelopathy
Contraindication for general anesthesia and/or interscalene nerve block
Pregnancy
Open shoulder arthrotomies.
Non English speakers
Intervention: Arimoclomol
Trial phase: Phase 3
ATC code: N07XX17
SMILES: [O-][n+]1cccc(C(Cl)=NOCC(O)CN2CCCCC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Arimoclomol base 248 mg 3 times daily
Eligibility criteria:
Inclusion Criteria:

Patient is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures.
Patient has completed the IBM4809 trial on treatment with Investigational Medicinal Product (IMP).

Exclusion Criteria:

Known or suspected allergy or intolerance to arimoclomol or its constituents.
Exposure to any other investigational treatment within 30 days or <5 half-lives of the baseline visit or taking part or planning to take part in another interventional trial.
Significant protocol deviation in the blinded IBM4809 trial based on the investigator's judgement in discussion with the medical monitor.

Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants up to 3 months after last dose. Premenopausal women must have a negative pregnancy test prior to dosing with trial medication. Acceptable methods of birth control are:

Hormonal methods associated with inhibition of ovulation such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before arimoclomol administration.
Total abstinence from sexual intercourse since the last menses before arimoclomol administration. (The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence [calendar, symptothermal, post-ovulation] methods are not acceptable methods of contraception).
Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
Any concurrent condition that in the investigator's opinion will significantly interfere with assessment of safety or efficacy.
Inability to comply with the protocol-specified procedures/evaluations and scheduled visits as per the investigator.