• Patient must be ≥ 2.5 years of age.
• Patient and/or authorized representative must be willing and able to give informed consent/assent and any authorizations required by local law for participation in the study.
• Patient and their caregiver must be willing and able (in the Investigator’s opinion) to comply with all protocol requirements.
• Patient must have completed dosing with STK-001 and the End of Study Visit in Study STK-001-DS-101, with an acceptable safety profile per Investigator judgment.
• Patient must have satisfactory compliance with study visits and procedures in Study STK-001-DS-101 per Investigator and Sponsor judgment.
• Patient must meet age-appropriate institutional standard practices for intrathecal (IT) drug administration procedures.
• Patient and/or family (or caretaker) must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
• Patient must have completed Study STK-001-DS-101 within 4 weeks of the start of their participation in Study STK-001-DS-501, unless approved by the Sponsor.

• Patient has met any withdrawal criteria from Study STK-001-DS-101.
• Patient is currently being treated as maintenance therapy with an antiepileptic drug acting primarily as a sodium channel blocker including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide.
• Patient has clinically significant unstable medical conditions other than epilepsy.
• Patient has had clinically relevant symptoms or a clinically significant illness (in the judgment of the Investigator) at Screening or prior to dosing on Day 1, other than epilepsy.
• Patient has a spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt.
• Patient has clinically significant (in the judgment of the Investigator) abnormal laboratory values at baseline or prior to dosing on Day 1.
• Patient has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3-fold upper limit of normal (ULN), serum creatinine > ULN or platelet count < lower limit of normal at baseline and upon repeat testing.
• Patient has clinically significant abnormalities (in the judgment of the Investigator) in the 12-lead ECG measured at Screening/Baseline (This includes 12-lead ECG from STK-001-DS-101 [Visit 6 or Visit 9], if STK-001-DS-101 Visit 6 or Visit 9 and STK-001-DS-501 Visit 1 are the Same Day).
• Patient has a psychiatric or behavioral disorder which, in the opinion of the Investigator, may interfere with the patient’s participation in the study.
• Patient is currently taking, or within 4 weeks prior to Screening/Baseline has taken any anticoagulant (including but not limited to heparins, warfarin and other vitamin K antagonists, dabigatran, rivaroxaban and apixaban), or within 7 days prior to Screening/Baseline, has taken any antiplatelet (including but not limited to aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, ticlopidine. and dipyridamole).
• Patient is a female of childbearing potential, or patient is a fertile male with female partner(s) of childbearing potential, unless willing to ensure that they or their partners use effective contraception throughout the duration of the study and for at least 6 months after their last dose of STK-001.
• . Patient is a female who is lactating or planning pregnancy during the duration of the study and for at least 6 months after their last dose of STK-001.
• Patient has any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, may influence the results of the study, or may affect the patient’s ability to participate in the study.
• Patient has been treated (or is being treated) with an investigational product (other than STK-001) since participating in Study STK-001-DS-101.
• Patient is participating in an observational study, unless approved by the Sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/25/23. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age.
• Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
• Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
• Admission to the database within one year of injury.
• If patient is discharged as Minimal Deficit or Recovered, they must be hospitalized in the system for at least one week before discharge.
• Discharge from the system as:
  • Having completed inpatient acute rehabilitation;
  • Achieving a neurologic status of normal or minimal deficit;
  • Deceased.
• Reside in the geographic catchment area of the system (greater Minnesota, Iowa, North Dakota, South Dakota, and western Wisconsin) at the time of the injury. Patients may be injured outside of the catchment area.
• A US citizen or non-US citizen who is expected to stay in the catchment area.

• Completion of an organized rehabilitation program prior to the admission to the system.
• Patients who are discharged as deceased.

• Male or female, age ≥ 18 years old.
• Having hepatic encephalopathy (HE).
• Are in the hospital (Methodist or St. Marys). Consented in an exam room or hospital room
• Must be able to carry on a conversation.
• Ability of subject or caregiver to provide written, informed consent. (LAR needed if subject is HE)
• Cirrhosis of any etiology.

• Individual < 18 years old.
• Known history of voice disorder or surgery that may alter voice characteristics.
• Smoking or vaping use currently or within the last 3 months
• Severe chronic obstructive pulmonary disease
• Inability to speak.
• Upper respiratory tract infection within the last week.
• Acute alcohol intoxication.
• VHI-10 score greater than 11.
• West Haven Criteria Grade 4.

• Age ≥ 40 years.
• Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA < 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e., AUA low and favorable intermediate risk prostate cancer).
• International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction).
• Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization.
• Planned bilateral nerves-paring prostatectomy.

• Moderate or severe ED based in IIEF criteria (score < 21).
• History of prior pelvic or penile surgery.
• Current or prior androgen deprivation therapy.
• Planned non-nerve sparing prostatectomy.

Eligibility last updated 4/14/23. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.

• Adult patients (age ≥ 18 years old).
• Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester.
• Scheduled for pre-HCT pulmonary function test by the primary team.

• Limited mobility requiring use of gait aid or wheelchair.
• Fall risk.

Aim 1

• Healthy, normal subjects around the approximate age of menopause (~ 51).
• In the 40-60 year age range without known cardiac conditions.
• Without symptoms referable to the heart, namely chest pain or shortness of breath. 

Aim 2

• Subjects from the ongoing “Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women after Bilateral Oophorectomy: A Randomized Controlled Trial” study.  
• Subjects in this cohort will be between 21 and 45 years of age, at the onset of the study.
• Willingness to return for follow up exam +/- 3 weeks of 12 month post-operative follow-up appointment.
• These subjects will undergo two cardiac MRI/MRE exams one with-in +/- three weeks of their bilateral oophorectomy surgery and with-in +/- three weeks of their 12 month follow-up appointment.

• Known cardiac conditions, symptoms referable to the heart; namely, chest pain or shortness of breath. 
• For Magnetic Resonance Imaging (MRI) participants:
  • Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, deep brain stimulator, or severe claustrophobia;
  • Body weight over 500 pounds (or 226 kilograms), and chest/waist/hip circumference over 160 cm, due to MRI system limit (70-cm bore, < 400 lbs.).

• Male or female, ≥ 10 years of age.
• Diagnosis of Hidradenitis Suppurativa (HS) by a dermatologist or practitioner experienced in making a diagnosis of HS.
• Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.
• Immediate family members (for saliva and genetics data).

• Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.

Clinician Participants

• Clinicians employed at Mayo Clinic who provide care to patients visiting the Mayo Clinic Department of Nephrology and Hypertension Dialysis Services.

Patient Participants

• Adult patients (18 years of age and older).
• Receive long-term dialysis treatment and services at Mayo Clinic.

• Minors (under the age of 18 years).
• Non-English speaking.
• Lack the ability to provide informed consent.

• Female patient with a diagnosis of Ulcerative Colitis (UC) or Crohn’s Disease (CD) seen in the IBD clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.
• Who are between 18-64 years of age.
• Ability to provide informed consent.
• Ability to complete all aspects of this trial.

• Female patients with a diagnosis of UC or CD with medical co-morbidity or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
• Participation in another organized wellness program.

• Patients with benign biliary obstruction.
• Patients with malignant biliary obstruction.
• Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous transhepatic biliary drainage (PTBD).

• Patients with gallstone disease.
• Patients who will undergo ERCP who currently have a percuteanous biliary drain placed.
• Patients who will undergo PTBD who currently have a biliary stent placed.
• Female patients who are pregnant.
• Prisoners and other vulnerable populations.

Eligibility last updated 10/12/21. Questions regarding updates should be directed to the study team contact.

• Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
• Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
• Refractory gastroparesis, defined using our previously published data, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3  antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
•  Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours hours or gastric emptying T half greater than 174 minutes. For inclusion, the qualifying gastric emptying scintigraphy will be the baseline gastric emptying test.
• No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.

• Another active disorder which could explain symptoms in the opinion of the investigator.
• Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
• Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider..
• Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
• Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
• New medications for gastroparesis-related symptoms started within 1 month prior to registration.
• Pregnancy or nursing.
• Failure to give informed consent.
• Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
• Botox injection into the pylorus within 3 months prior to registration.
•  Allergy to eggs and Ensure.

Eligibility last updated 8/3/23. Questions regarding updates should be directed to the study team contact.

• Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
• Patients must have histologically confirmed uterine serous carcinoma with at least one lesion suitable for biopsy without significant risk to the patient.  Patient disease must be evaluable or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Biopsiable lesion can be same as evaluable lesion.
• Patients must have had at least one prior line of cytotoxic chemotherapy. Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy
• Patients must have HER2-positive or HER2-expressing tumors determined by a CLIA-certified laboratory. Specific requirement of HER2 status is outlined below:
  • HER2 1-3 + expression by IHC; OR
  • HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH); OR
  • If local testing is not feasible, patients will submit archival tissue for central HER2 testing to determine eligibility. Patients with unknown or negative HER2 testing will not be eligible.
• Patients must have archival FFPE tissue available for central confirmation of HER2 testing.
• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of DS-8201a in combination with olaparib in patients < 18 years of age, children are excluded from this study.
• ECOG performance status ≤ 1 (Karnofsky ≥ 70%).
• Patients must have adequate organ and marrow function within 14 days of randomization/enrollment as defined below:
  • Hemoglobin ≥ 10.0 g/dL;
  • Absolute neutrophil count ≥ 1,000/mcL**;
  • Platelets ≥ 100,000/mcL*;
  • Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), (< 3 × ULN in the presence of documented Gilbert’s syndrome or liver metastases at baseline);
  • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN;
  • International Normalized ratio ≤ 1.5 × ULN (INR)/Prothrombin time (PT) and activated partial thromboplastin time (aPTT);
  • Creatinine ≤ 1.5 × institutional ULN OR;
  • Glomerular filtration rate (GFR) ≥ 51 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2). 
  • *No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment.
  • **No administration of G-CSF is allowed within 1 week prior to screening assessment.
• Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization/enrollment.
• Patients who are Human Immunodeficiency Virus (HIV) positive may participate IF they meet the following eligibility requirements:
  • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective.
  • They must have an undetectable viral load and a CD4 count ≥ 250 cells/µL within 7 days of enrolment.They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.
  • HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Patients with brain metastases should be stable and off steroids and at least 4 weeks from radiation at the time of registration.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be better than class 2B.
• The effects of DS-8201a and olaparib on the developing human fetus are unknown. For this reason and because HER2 antibody conjugated to a topoisomerase 1 inhibitor agents as well as PARP inhibitors are known to be teratogenic; thus, women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 7 months (WOCBP only) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of DS-8201a and olaparib administration. For methods considered as highly effective methods of contraception.
• Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone [FSH] > 40 mIU/mL and estradiol < 40 pg/mL [<147 pmol/L] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
• Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study.
• Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
• Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible.

• Patients who have had chemotherapy (including antibody drug therapy) within 4 weeks with the following exceptions: 1 week for weekly paclitaxel; 2 weeks or five half-lives, whichever is longer, for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents, hormonal agents; or 6 weeks for nitrosoureas or mitomycin C.
• Patients who have had radiation therapy within 4 weeks.
• Patients who have had a major surgery within 4 weeks.
• Patients who are receiving any other investigational agents.
• For the dose expansion cohort: Patients who have received prior PARP inhibitors.
• Patients with a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e., Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to DS-8201a, the inactive ingredients in the drug product, olaparib, or severe hypersensitivity to other monoclonal antibodies.
• Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
• Patients with a medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class IIb to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization.
• Patients with a corrected QT interval (QTc) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead ECG.
• Patients with clinically significant corneal disease in the opinion of the Investigator.
• Patients with multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated.
• Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
• Patients receiving chloroquine or hydroxychloroquine will require a washout period of ≥ 14 days to be eligible for the study.
• Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤ 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy).
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because DS-8201a is a HER2 antibody conjugated to a topoisomerase 1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with DS-8201a, breastfeeding should be discontinued if the mother is treated with DS-8201a. These potential risks may also apply to other agents used in this study.

Eligibility last updated 8/26/21. Questions regarding updates should be directed to the study team contact.

• Adult patients, ≥ 18 years of age.
• Using the Mayo patient iPhone app. (determined automatically via Mayo software).

• Inability to provide informed consent.
• Age under 18 years.

• Age ≥ 18 years.
• Histological or cytological confirmation of brain tumor and/or suspected brain tumor based on clinical and radiologic findings.
• Prior chemotherapy and/or radiation treatment directed to the known/suspected tumor.
• Radiographic evidence of residual or previously unresected tumor.
• Willingness to undergo surgery and sign informed consent.
• Patients not currently eligible for an alternate competing interventional clinical trial.
• Enrollment in the Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors (IRB#12-003458)

• Age < 18 years.
• Prior gross total resection of brain tumor leading to absence of visible latent disease (exemption available for post-operative enrollment).
• Any contraindication to surgery, including anyone who in the opinion of the surgeon is at unreasonably elevated risk of wound complications.
• Avastin within the past 6 months for any reason.
• Patients who have not yet undergone surgery or radiation, but who would be appropriate candidates for an alternate interventional clinical trial (e.g., post-operative fractionated vs. single fraction radiation to the surgical cavity for surgical brain mets).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/20/22. Questions regarding updates should be directed to the study team contact.

• Patients coming to Mayo Clinic’s Genetic Heart Rhythm Clinic for evaluation or follow-up for their GHD.  
• Patients 18 years and older.

• Patient inability or unwillingness to participate in the study.
• Patients 17 years and under.

• Informed consent, or consent via legally authorized representative, if institutionally required for subjects with decompensated liver cirrhosis with current HE Grade 1 or 2, prior to any study-related procedures.
• Male or female patients age ≥ 18 years old.
• Cirrhosis of the liver.
• Patient has diuretic-resistant ascites, intractable ascites, or in the opinion of the Investigator, is unsuitable for treatment with an effective dose of diuretics for other reasons.
• Patients must have required in the 60-day period from the last LVP before consent, between 3 and 9 LVPs, including the last LVP on or before the day of consent.
• Dates for all LVPs occurring within 90 days prior to consent have been recorded. The volume of ascites removed at each of the LVPs must also have been recorded for the 90 days period prior to the last LVPs before consent.
• Serum creatinine (SCr) ≤ 2.00 mg/dL determined prior to randomization with value at randomization being less than 1.5 fold higher than value obtained at the screening visit.
• Women of child-bearing potential (e.g., not post-menopausal for at least one year or surgically sterile) must be neither pregnant nor lactating and must agree to use adequate birth control or be abstinent for the duration of the study.
• If patient is treated with beta blockers, dose has been stable for at least 30 days prior to randomization and may be maintained on that dose for the trial duration.
• If patient is treated with diuretics, patient has been on a stable daily dose for at least 10 days prior to consent.
• Willing and able to comply with trial instructions.

• Ascites with causes other than cirrhosis; such as cardiac or nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis.
• Urinary sodium excretion > 100 mmol/day between day of consent and randomization.
• Total bilirubin > 5 mg/dL.
• Blood clotting International normalized ratio (INR) > 2.5.
• Platelet count ≤ 100,000/µL for the first eight patients enrolled. Eligibility of patients with a platelet count > 65,000 but < 100,000/µL should be confirmed with the Medical Monitor.
• Current or recent (within 3 months of consent) renal dialysis.
• Current or recent (within 1 month of consent) hepatic encephalopathy Grade 3 or 4 (WestHaven criteria).
• Superimposed acute liver failure/injury due to factors including acute alcoholic hepatitis, acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning).
• History or presence of hepatic hydrothorax that has required a thoracentesis in the 7 days prior to randomization, or anticipated to require one within 7 days post-randomization, known pulmonary hypertension or a history of hepatopulmonary syndrome.
• Current or recent treatment (within 7 days of randomization) with octreotide, midodrine, vasopressin, dopamine or other vasopressors.
• Treatment with ACE inhibitors or ARBs 30 days prior to randomization.
• Current or recent (in the previous 60 days from consent) episode of respiratory failure requiring positive airway pressure (PAP) devices or intubation.
• Sepsis episode in the previous 28 days from consent.
• Episode of SBP within 14 days prior to consent. If a patient develops SBP in the pretreatment period randomization cannot occur for a minimum of 10 days and documented resolution of SBP.
• SBP at baseline visit (LVP -1).
• Episode of gastrointestinal hemorrhage (non-variceal) within 28 days prior to consent.
• Episode of bleeding esophageal varices within one week prior to consent.
• Ongoing documented or suspected infection.
• Severe cardiovascular disease that is a contraindication to terlipressin therapy such as a history of myocardial infarction, angina pectoris, advanced arteriosclerosis, uncontrolled cardiac arrhythmia, severe coronary insufficiency or uncontrolled hypertension.
• Findings suggestive of severe organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive renal pathology).
• Use of nephrotoxic drugs (e.g., aminoglycosides) in the 2 weeks before randomization
• Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced progressive neoplasia such as hepatocellular carcinoma, unless eligible for transplant).
• Patients, who in the judgement of the Investigator, have been excessive alcohol drinkers in the past 12 weeks.
• Patient is in the opinion of the investigator, despite previous education on sodium restriction, anticipated to remain grossly non-compliant of sodium restricted diet.
• Recipient of renal or liver transplant.
• Implanted alfapump or previous recipient of alfapump that had pump removed within past 3 months
• Planned elective surgery related to cirrhosis complications, for example for hernia repair.
• Known allergy or hypersensitivity to terlipressin.
• Participation in other clinical research studies involving the treatment with other investigational drugs or evaluation with implantable devices within 30 days of consent.

Eligibility last updated 4/14/22.  Questions regarding updates should be directed to the study team contact.

• Men and women above 18 years of age.
• Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM) or with monoclonal gammopathy of undetermined significance (MGUS) or amyloid light-chain (AL) amyloidosis or healthy controls from their households.

• Age under 18 years
• Pregnancy
• Substance abuse
• Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
• Chronic gastrointestinal disorder
• Gastrointestinal surgeries in the past 2 years  
• Chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)

Eligibility last updated6/9/22. Questions regarding updates should be directed to the study team contact.

• English-speaking patient (aged 18 or older).
• Has received dexamethasone either intravenously or as a prescription in the past 2 weeks. 
• Patients do not have to be experiencing hiccups at the time of contact, but it is anticipated that these patients will likely have recurrent symptoms based on further or episodic dexamethasone treatment. 
• Patients must currently be in an outpatient setting, as it is unlikely that an educational session would be relevant or of value to an inpatient.

• Individuals under 18 years of age.

• Ages 18 years of age or older.
• Patients with bleeding secondary to HHT, GAVE, SBA and OGIB.
• Age and sex matched patients without bleeding (controls).
• Patients willing to provide written informed consent.

• Unwillingness/unable to provide informed consent.

• Age ≥ 1 year(s) old (no maximum age).
• Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of ≥ 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign).
• If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy.
• If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study.
• If biopsy has already been completed at an outside institution, pathology must be reviewed at Mayo Clinic for trial enrollment.
• Able to undergo MRI Brain.
• Negative urine pregnancy test completed ≤ 7 days prior to registration, for women of childbearing potential only.
• Primary language of English or Spanish for patients and their caregiver.
• Patient or caregiver willing and able to provide written informed consent.
• Caregiver able to complete questionnaires by themselves or with assistance.
• Willing to return to enrolling institution for follow-up during the active monitoring phase of the study.

• Any patient who has received previous radiation to the brain.
• Any patient who has received previous chemotherapy.
• Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2).
• Any of the following:
  • Pregnant women;
  • Nursing women;
  • Women of childbearing potential who are unwilling to employ adequate contraception.
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• 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.
• Other active malignancy ≤ 5 years prior to registration.
  • EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix.
  • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
• Patients > 16 years with an Eastern Cooperative Oncology Group (ECOG) score ≥ 4 and patients ≤ 16 years with a Lansky play scale ≤ 20.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

• Adults ≥ 18 years old.
• DLMP employees who work on-site at SDSC.
• Plan to complete the two dose SARS-CoV-2 vaccination schedule.

• Children < 18 years old.
• Subjects who have previously been diagnosed with SARS-CoV-2 infection.
• Subjects who test SARS-CoV-2 antibody positive on the pre-vaccination sample indicating prior infection.

• Adult participants (≥ 25 years of age).
• PLS diagnosis is based on the new PLS diagnostic criteria.
• Symptom onset was no more than 15 years prior to baseline.
• Ability to independently walk with or without an assistive device (e.g., walker) at the baseline evaluation.
• In cases where a molecular test has been done prior to enrollment in this study, HSP or HSP- related mutations are negative.
• Expected to have at least some bulbar symptoms (dysarthria, dysphagia, drooling or pseudobulbar affect); however, the absence of these symptoms will not exclude participants when molecular testing is negative for known HSP.
• UMN symptoms and signs in a region other than the legs.
• Normal brain and spinal cord neuroimaging except for changes expected for PLS.
• No active major neurological diseases other than PLS and no history of major neurological diseases.
• No major unstable medical diseases that require treatment (e.g., active cancer, dialysis) in the past 6 months.
• Participant is residing within a commutable distance to the study site and is willing to visit the study site as required.
• No history of ALS or PLS in immediate family and no family history of hereditary spastic paraplegia (HSP).
• gia (HSP) If disease duration is less than 5 years, no significant lower motor neuron (LMN) degeneration upon the EMG examination within 12 months before enrollment (evident entrapment neuropathy or radiculopathy are acceptable). If EMG tests were not done in this period, an EMG test should be obtained through regular patient care (through insurance) in order to make a diagnosis of PLS (this cost will not be covered by this research study). If disease duration is more than 5 years and at least one EMG was performed post-diagnosis, an EMG examination 12 months prior to enrollment is not required.
• Participant understands the study’s purpose, has capacity to consent, and is willing to sign the informed consent form.

• Unwilling or unable to give informed consent.
• UMN symptoms and signs only in the legs.
• Unwilling or unable to visit the study site as required.
• Clinically obvious cognitive impairment that precludes obtaining informed consent, as determined by the site PI.
• Participating in clinical treatment trials.

Eligibility last updated 5/3/22. Questions regarding updates should be directed to the study team contact.

• Patient presenting to a General Internal Medicine Service.
• Patient in one of the 3 Mayo Clinic Campuses (Rochester, Arizona, Florida).
• Patient with an undiagnosed mass: New or enlarging lymph nodes clinically or on imaging:
  • New mass on imaging of soft tissues, bone, spleen, adrenal gland, retroperitoneum, or intraabdominal location without clear organ association .
• Patient has understood and signed the informed consent to participate in the registry.
• Patient has the ability to complete all aspects of registry enrollment.
• Aged 18 and older.

• Mass involving the breast, brain, kidney, lung, ovary/adnexa, liver, pancreas, sinus, throat, or thyroid gland will be addressed by the respective specialty areas.  
• Patients with a known history of any condition or factor judged by the investigator to preclude participation in the registry or which might hinder adherence.
• Lacking the capacity to consent.
• Prisoners or institutionalized individuals.
• Pregnant women.

Eligibility last updated 9/17/21. Questions regarding updates should be directed to the study team contact.

Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Study Arm 1 Preschool Children < 6 years old Asthma Group (N=200) :

• Diagnosis of asthma.
• In the absence of an asthma diagnosis:
  • Persistent wheezing of at least one year;
  • Even distribution of socio-demographics including age, gender, race and ethnicity.

• Actively sick with covid or flu.

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200) :

• Diagnosis of allergy.
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Diagnosis of asthma.
• Recurrent wheezing.
• Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls (N=200) : 

• Not having or suspected of having any known upper/lower respiratory disease.
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Diagnosis of asthma or any known upper/lower respiratory disease.
• Diagnosis of allergy.
• Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 2 Children 6-17 years of age Asthma Group (N=200) :

• Diagnosis of asthma.
• In the absence of an asthma diagnosis:
  • Persistent wheezing of at least one year.
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls  (N=200) :

• Diagnosis of allergy. 
• Even distribution of sociodemographics including age, gender, race and ethnicity.

• Diagnosis of asthma.
• Recurrent wheezing.
• Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200) :

•  Not having or suspected of having any known upper/lower respiratory disease.
• Even distribution of sociodemographics including age, gender, race and ethnicity. 

• Diagnosis of asthma or recurrent wheezing.
• Diagnosis of allergy.
• Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 3  Adults > 18 years old
Asthma Group (N=200) :

• Diagnosis of asthma.
• Even distribution of sociodemographics including age, gender, race and ethnicity. 

• Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200) :

• Diagnosis of allergy.
• Even distribution of sociodemographics including age, gender, race and ethnicity. 

• Diagnosis of asthma.
• Recurrent wheezing.
• Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200) :

•  Not having or suspected of having any known upper/lower respiratory disease.
• Even distribution of socio-demographics including age, gender, race and ethnicity.

Exclusion Criteriao: 

• Diagnosis of asthma.
• Diagnosis of allergy.
• Actively sick with covid or flu.

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

• Patient has provided informed consent
• Patient is willing and able to comply with clinic visits and procedures outlined in the study protocol
• Male or female, at least 18 years of age
• Patients must have an ECOG performance status of 0 or 1.
• Laboratory measurements, blood counts:
  • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. Red blood cell
    (RBC) transfusions are allowed to meet hemoglobin eligibility within limits set per
    Exclusion Criterion #4 
  • Absolute neutrophil count (ANC) at least 1.5 x 10^9/L without growth factor support
    within 2 weeks of study treatment initiation
  • Platelets at least 100 x 10^9/L
• Laboratory measurements, renal function:
  • Patients must have adequate renal function as demonstrated by a creatinine clearance of at least 30 mL/min; calculated by the Cockcroft Gault formula
• Adequate liver function, as demonstrated by:
  • AST less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
  • ALT less than or equal to 2.5 x ULN or less than or equal to 5 x ULN in patients with liver metastases
  • Bilirubin less than or equal to 1.5 x ULN, or less than or equal to 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert’s syndrome or genetic equivalent
• Pretreatment blood cross-match completed (Section 7.8.1.1)
• Male and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
• Measurable disease according to response evaluation criteria in solid tumors (RECIST),Version 1.1. Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
• Patients must have a life expectancy of 3 months or greater, in the opinion of the investigator.

Safety Run-in Cohort 1 and Phase 2 Cohort 1
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
Run-in Cohort 1 and Phase 2 Cohort 1 must fulfill the following cohort-specific inclusion
criteria:

• Patients previously untreated for unresectable locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for estrogen receptor (ER), progesterone receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) according to the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline (Appendix 9).
• Patients whose tumors are considered PD-L1 negative, as determined by an approved test according to local standards.
• Prior systemic treatment for neoadjuvant and/or adjuvant therapy and/or curative intent radiation therapy is permitted if completed at least 6 months prior to enrollment.

Note: Maintenance therapies are not counted as separate lines of therapy.

Safety Run-in Cohort 2 and Phase 2 Cohort 2
In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Safety
Run-in Cohort 2 and Phase 2 Cohort 2 must fulfill the following cohort-specific inclusion
criterion:

• Patients with unresectable, locally advanced or mTNBC that is histologically or cytologically confirmed based on the most recent analyzed biopsy or other pathology specimen, defined as negative for ER, PR, and HER2 according to the most recent ASCO/CAP guideline (Appendix 9), who have received 1 prior line of therapy in the unresectable, locally advanced/metastatic setting. Patients must have been previously treated with a taxane in the neoadjuvant, adjuvant, or locally advanced/metastatic setting
• Patients with tumors considered positive for PD-L1 expression (as determined by an approved test according to local standards) must have received an immune checkpoint inhibitor for 1L treatment of locally advanced/metastatic disease

• Positive serum pregnancy test.
• Breastfeeding female.
• Active central nervous system (CNS) disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
• Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
• History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
• Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
• Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents.
• Current participation in another interventional clinical trial.
• Known inherited or acquired bleeding disorders.
• Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
• Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which patients are not on active anticancer therapies and who are in complete remission for over 2 years.
• Known active or chronic hepatitis B or C infection or human immunodeficiency virus infection in medical history).
• Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
• Uncontrolled pleural effusion.
• Uncontrolled hypercalcemia (ionized calcium >1.5 mmol/L) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
• Uncontrolled tumor-related pain.
• Severe/serious systemic infection within 4 weeks of randomization.
• Rapid deterioration during screening prior to enrollment (eg, significant change in performance status, 20% or greater decrease in serum albumin levels or uncontrolled tumorrelated pain)
• Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and followup
  examinations
• Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted
• Patients who have received a live vaccine within 30 days of randomization
   

Safety Run-in Cohort 1 and Phase 2 Cohort 1
Patients who meet the following exclusion criterion are not eligible to be enrolled into Safety
Run-in Cohort 1 or Phase 2 Cohort 1:

• Disease progression within 6 months following neoadjuvant/adjuvant therapy or rapid visceral progression and/or symptomatic disease, where single-agent chemotherapy would not be appropriate.

NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing
hormone agonists for breast cancer, and treatment with bisphosphonates and receptor
activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no
required minimum washout period for these therapies. Patients should be recovered from the
effects of radiation.

Safety Run-in Cohort 2 and Phase 2 Cohort 2
Patients who meet any of the following exclusion criteria are not eligible to be enrolled into
Safety Run-in Cohort 2 or Phase 2 Cohort 2:

• Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment
• Patients who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor
• High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1
• Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent
  • Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study
  • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

NOTE: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormonereleasing hormone agonists for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B ligand inhibitors are not criteria for exclusion. There is no required minimum washout period for these therapies. Patients should be recovered from the effects of radiation.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Progressive or recurrent WHO Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma).
• Have an enhancing mass on MRI amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery.
• Willing to undergo resection or biopsy of their glioblastoma at Mayo Clinic in Rochester, MN.
• ECOG Performance Status (PS) of 0 or 1 and KPS ≥ 70.
  • Note: PS must be assessed again within 7 days prior to first dose of study drug.
• The following laboratory values obtained ≤ 15 days prior to registration:
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
  • Platelet count ≥ 100,000/mm^3;
  • Hemoglobin ≥ 9.0 g/dL without transfusion or EPO dependency (≤ 7 days prior to assessment);
  • Creatinine ≤ 2.0 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min;
  • Total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels > 1.5 x ULN;
  • Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN;
  • INR/PT/aPTT ≤ 1.5 × ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy.
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only (POCBP).
  • Note: If testing done for eligibility is > 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.
• POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 120 days after last dose. 
• Provide written informed consent.
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
• Willing to provide tissue and blood samples for correlative research purposes.

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:

• Pregnant persons.
• Nursing persons.
• Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception.
• Signs or symptoms of life-threatening raised intracranial pressure: as defined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7 day delay in scheduling neurosurgery.
• Prior treatment.
• Received bevacizumab (AVASTIN) ≤ 28 days prior to registration.
  Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study.
• Received a live vaccine ≤ 30 days prior to registration.
• Major surgery ≤ 28 days prior to registration.
• Requirement for dexamethasone dose of > 2mg/day ≤ 2 days prior to registration.
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
• 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.
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
• Other active malignancy requiring systemic treatment ≤ 1 year prior to registration.
• History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
• Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration.
  • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
• Known history of active TB (Bacillus Tuberculosis).
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Hypersensitivity to pembrolizumab or any of its excipients.
• Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/16/23. Questions regarding updates should be directed to the study team contact.