ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00286468
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2006-04-01; Completion date: 2007-06-01
Enrollment: 500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.

Detailed description:
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and glyburide intervention 2: Alogliptin and glyburide intervention 3: Glyburide
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.

Protocol documents:
Clinical trial NCT00303485
Conditions: Post Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2007-06-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months. arm 2: Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
Interventions: intervention 1: Placebo intervention 2: Vitamin D and calcium supplementation intervention 3: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: po monthly for 6 months intervention 2: As prescribed intervention 3: 150mg po monthly for 6 months

Protocol documents:
Clinical trial NCT00312338
Conditions: Bacterial Conjunctivitis
Sponsor: Alcon Research
Start date: 2006-06-01; Completion date: 2007-06-01
Enrollment: 137 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Detailed description:

Arms: arm 1: Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. arm 2: Healthy Subjects receiving no treatment
Interventions: intervention 1: VIGAMOX
Intervention descriptions: intervention 1: 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days

Protocol documents:
Clinical trial NCT00357968
Conditions: Coronary Artery Disease
Sponsor: Eli Lilly and Company
Start date: 2006-08-01; Completion date: 2007-06-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: One time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days. Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days. arm 2: One time oral LD of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for 14 days. Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days.
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel intervention 3: Placebo for Prasugrel intervention 4: Placebo for Clopidogrel
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol documents:
Clinical trial NCT00398216
Conditions: Thrombosis Hip Replacement
Keywords: Anti-coagulant hip replacement hip replacement surgery unilateral hip replacement surgery DeepVein Thrombosis Venous Thromboembolism pulmonary embolism Prevention of Blood Clots
Sponsor: Daiichi Sankyo
Start date: 2006-05-01; Completion date: 2007-06-01
Enrollment: 903 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

Detailed description:

Interventions: intervention 1: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00405522
Conditions: Spinal Puncture
Keywords: Lumbar Puncture Pediatrics Propofol Remifentanil sedation Oncology
Sponsor: The Hospital for Sick Children
Start date: 2006-11-01; Completion date: 2007-06-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Detailed description:
Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg intervention 2: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Intervention descriptions: intervention 1: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus. intervention 2: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

Protocol documents:
Clinical trial NCT00453063
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2007-03-01; Completion date: 2007-06-01
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: mometasone furoate intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning intervention 2: Two sprays in each nostril once daily in the morning

Protocol documents:
Clinical trial NCT00713323
Conditions: Pain Peripheral Neuropathy
Keywords: Pain Peripheral Neuropathy
Sponsor: Jazz Pharmaceuticals
Start date: 2005-10-01; Completion date: 2007-06-01
Enrollment: 380 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.

Detailed description:
This was a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. The study provided continued availability of Sativex® to subjects who completed the preceding double-blind neuropathic pain studies. Consenting, eligible subjects who had participated in previous GW Pharma Ltd (GW) randomised, placebo-controlled clinical studies entered the study (Visit 1, Day 0) and commenced dosing. Study visits took place at Week 2 (Visit 2, Day 14), Week 14 (Visit 3, Day 98), and Week 26 (Visit 4, Day 182). Subjects returned to the centre for an end of treatment visit at week 38 (Visit 5, Day 266). All subjects received Sativex®. This was followed by a five week randomised-withdrawal phase (Part B) for a subset of subjects. An end of study visit took place 28 days after Visit 5 (or 5b or 5c) or withdrawal from the study.

Arms: arm 1: Active treatment
Interventions: intervention 1: Sativex®
Intervention descriptions: intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Protocol documents:
Clinical trial NCT01061034
Conditions: Aspirin Blood Level Proton Pump Inhiditor Treatment
Keywords: pharmacokinetics aspirin proton pump inhiditor
Sponsor: Assaf-Harofeh Medical Center
Start date: 2007-03-01; Completion date: 2007-06-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.

We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.

healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.

All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.

Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.

Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.

Detailed description:

Interventions: intervention 1: aspirin and omeprazole
Intervention descriptions: intervention 1: aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.

Protocol documents:
Clinical trial NCT01100086
Conditions: Healthy Volunteers
Keywords: Healthy subjects Opioid
Sponsor: Purdue Pharma LP
Start date: 2007-01-01; Completion date: 2007-06-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fasted state.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms: arm 1: Reformulated OXY 10 mg x 1 dose arm 2: Original OxyContin® (OXY)10 mg x 1 dose
Interventions: intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 10-mg tablet x 1 dose taken without food intervention 2: Original OxyContin® (OXY) 10-mg tablet x 1 dose taken without food

Protocol documents:
Clinical trial NCT01378416
Conditions: Leukemia
Keywords: Acute myelogenous leukemia myelodysplastic Syndrome cancer
Sponsor: Eisai Inc.
Start date: 2005-04-01; Completion date: 2007-06-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Decitabine (Dacogen)
Intervention descriptions: intervention 1: Intravenous injection; total dose-per-cycle was 135 mg/m\^2 of decitabine.

Protocol documents:
Clinical trial NCT02283788
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2007-03-01; Completion date: 2007-06-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy adult men and women

Detailed description:
The purpose of this randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched change from baseline using individually corrected QT (QTcI) interval durations in adult healthy volunteers.

Arms: arm 1: A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days arm 2: A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days arm 3: A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days arm 4: A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
Interventions: intervention 1: BIA 2-093 intervention 2: Moxifloxacin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02283840
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2007-05-01; Completion date: 2007-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Detailed description:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design to evaluate and compare the relative bioavailability and therefore the bioequivalence of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations (CTF versus TBM) after a single oral dose administration under fasting conditions

Arms: arm 1: One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)

One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) arm 2: One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) arm 3: One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)

One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) arm 4: One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) arm 5: One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)

One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) arm 6: One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)
Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00350103
Conditions: Painful Diabetic Neuropathy
Keywords: Painful Diabetic Neuropathy Lacosamide
Sponsor: UCB Pharma
Start date: 2006-06-30; Completion date: 2007-06-29
Enrollment: 551 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.

The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.

Detailed description:

Arms: arm 1: Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. arm 2: Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. arm 3: Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase
Interventions: intervention 1: SPM 929 intervention 2: Placebo
Intervention descriptions: intervention 1: * Pharmaceutical form: Immediate release film-coated tablets
* Concentration: 50mg/ 100mg
* Route of administration: Oral use intervention 2: * Pharmaceutical form: Immediate release film-coated tablets
* Route of administration: Oral use

Protocol documents:
Clinical trial NCT04144088
Conditions: Hyperuricemia
Sponsor: Chung Shan Medical University
Start date: 2006-06-01; Completion date: 2007-06-30
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.

Detailed description:
The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine with both safety and efficacy in treating hyperuricemia.

We conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled. Patients were then randomized into three arms: Traditional Chinese Medicine formulae: "Wu-Ling San", "Yin-Chen Wu-Ling San" or placebo for 4 weeks. Efficacy and safety were evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid\<6 mg/dL at Week 4. Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8, serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at Week 4.

Arms: arm 1: Drug : Wu Ling San Extract Granules "Sun-Ten" arm 2: Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN" arm 3: Drug : 1/10 Wu Ling San
Interventions: intervention 1: Wu Ling San intervention 2: Yin-Chen Wu Ling San intervention 3: Placebo
Intervention descriptions: intervention 1: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks. intervention 2: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks. intervention 3: 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.

Protocol documents:
Clinical trial NCT00097591
Conditions: Coronary Arteriosclerosis Acute Coronary Syndromes
Sponsor: Eli Lilly and Company
Start date: 2004-11-01; Completion date: 2007-07-01
Enrollment: 13619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Detailed description:

Arms: arm 1: Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily arm 2: Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents: